Barriers to the conduct of randomised clinical trials within all disease areas.

PubMed

Djurisic, Snezana; Rath, Ana; Gaber, Sabrina; Garattini, Silvio; Bertele, Vittorio; Ngwabyt, Sandra-Nadia; Hivert, Virginie; Neugebauer, Edmund A M; Laville, Martine; Hiesmayr, Michael; Demotes-Mainard, Jacques; Kubiak, Christine; Jakobsen, Janus C; Gluud, Christian

2017-08-01

Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers. We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential. The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area.

Team building: electronic management-clinical translational research (eM-CTR) systems.

PubMed

Cecchetti, Alfred A; Parmanto, Bambang; Vecchio, Marcella L; Ahmad, Sjarif; Buch, Shama; Zgheib, Nathalie K; Groark, Stephen J; Vemuganti, Anupama; Romkes, Marjorie; Sciurba, Frank; Donahoe, Michael P; Branch, Robert A

2009-12-01

Classical drug exposure: response studies in clinical pharmacology represent the quintessential prototype for Bench to Bedside-Clinical Translational Research. A fundamental premise of this approach is for a multidisciplinary team of researchers to design and execute complex, in-depth mechanistic studies conducted in relatively small groups of subjects. The infrastructure support for this genre of clinical research is not well-handled by scaling down of infrastructure used for large Phase III clinical trials. We describe a novel, integrated strategy, whose focus is to support and manage a study using an Information Hub, Communication Hub, and Data Hub design. This design is illustrated by an application to a series of varied projects sponsored by Special Clinical Centers of Research in chronic obstructive pulmonary disease at the University of Pittsburgh. In contrast to classical informatics support, it is readily scalable to large studies. Our experience suggests the culture consequences of research group self-empowerment is not only economically efficient but transformative to the research process.

The Information Technology Infrastructure for the Translational Genomics Core and the Partners Biobank at Partners Personalized Medicine

PubMed Central

Boutin, Natalie; Holzbach, Ana; Mahanta, Lisa; Aldama, Jackie; Cerretani, Xander; Embree, Kevin; Leon, Irene; Rathi, Neeta; Vickers, Matilde

2016-01-01

The Biobank and Translational Genomics core at Partners Personalized Medicine requires robust software and hardware. This Information Technology (IT) infrastructure enables the storage and transfer of large amounts of data, drives efficiencies in the laboratory, maintains data integrity from the time of consent to the time that genomic data is distributed for research, and enables the management of complex genetic data. Here, we describe the functional components of the research IT infrastructure at Partners Personalized Medicine and how they integrate with existing clinical and research systems, review some of the ways in which this IT infrastructure maintains data integrity and security, and discuss some of the challenges inherent to building and maintaining such infrastructure. PMID:26805892

Multidisciplinary acute care research organization (MACRO): if you build it, they will come.

PubMed

Early, Barbara J; Huang, David T; Callaway, Clifton W; Zenati, Mazen; Angus, Derek C; Gunn, Scott R; Yealy, Donald M; Unikel, Daniel; Billiar, Timothy R; Peitzman, Andrew B; Sperry, Jason L

2013-07-01

Clinical research will increasingly play a core role in the evolution and growth of acute care surgery program development across the country. What constitutes an efficient and effective clinical research infrastructure in the current fiscal and academic environment remains obscure. We sought to characterize the effects of implementation of a multidisciplinary acute care research organization (MACRO) at a busy tertiary referral university setting. In 2008, to minimize redundancy and cost as well as to maximize existing resources promoting acute care research, MACRO was created, unifying clinical research infrastructure among the Departments of Critical Care Medicine, Emergency Medicine, and Surgery. During the periods 2008 to 2012, we performed a retrospective analysis and determined volume of clinical studies, patient enrollment for both observational and interventional trials, and staff growth since MACRO's origination and characterized changes over time. From 2008 to 2011, the volume of patients enrolled in clinical studies, which MACRO facilitates has significantly increased more than 300%. The percentage of interventional/observational trials has remained stable during the same period (50-60%). Staff has increased from 6 coordinators to 10, with an additional 15 research associates allowing 24/7 service. With this significant growth, MACRO has become financially self-sufficient, and additional outside departments now seek MACRO's services. Appropriate organization of acute care clinical research infrastructure minimizes redundancy and can promote sustainable, efficient growth in the current academic environment. Further studies are required to determine if similar models can be successful at other acute care surgery programs.

Clinical research in a hospital--from the lone rider to teamwork.

PubMed

Hannisdal, E

1996-01-01

Clinical research of high international standard is very demanding and requires clinical data of high quality, software, hardware and competence in research design and statistical treatment of data. Most busy clinicians have little time allocated for clinical research and this increases the need for a potent infrastructure. This paper describes how the Norwegian Radium Hospital, a specialized cancer hospital, has reorganized the clinical research process. This includes a new department, the Clinical Research Office, which serves the formal framework, a central Diagnosis Registry, clinical databases and multicentre studies. The department assists about 120 users, mainly clinicians. Installation of a network software package with over 10 programs has strongly provided an internal standardization, reduced the costs and saved clinicians a great deal of time. The hospital is building up about 40 diagnosis-specific clinical databases with up to 200 variables registered. These databases are shared by the treatment group and seem to be important tools for quality assurance. We conclude that the clinical research process benefits from a firm infrastructure facilitating teamwork through extensive use of modern information technology. We are now ready for the next phase, which is to work for a better external technical framework for cooperation with other institutions throughout the world.

Utilizing an integrated infrastructure for outcomes research: a systematic review.

PubMed

Dixon, Brian E; Whipple, Elizabeth C; Lajiness, John M; Murray, Michael D

2016-03-01

To explore the ability of an integrated health information infrastructure to support outcomes research. A systematic review of articles published from 1983 to 2012 by Regenstrief Institute investigators using data from an integrated electronic health record infrastructure involving multiple provider organisations was performed. Articles were independently assessed and classified by study design, disease and other metadata including bibliometrics. A total of 190 articles were identified. Diseases included cognitive, (16) cardiovascular, (16) infectious, (15) chronic illness (14) and cancer (12). Publications grew steadily (26 in the first decade vs. 100 in the last) as did the number of investigators (from 15 in 1983 to 62 in 2012). The proportion of articles involving non-Regenstrief authors also expanded from 54% in the first decade to 72% in the last decade. During this period, the infrastructure grew from a single health system into a health information exchange network covering more than 6 million patients. Analysis of journal and article metrics reveals high impact for clinical trials and comparative effectiveness research studies that utilised data available in the integrated infrastructure. Integrated information infrastructures support growth in high quality observational studies and diverse collaboration consistent with the goals for the learning health system. More recent publications demonstrate growing external collaborations facilitated by greater access to the infrastructure and improved opportunities to study broader disease and health outcomes. Integrated information infrastructures can stimulate learning from electronic data captured during routine clinical care but require time and collaboration to reach full potential. © 2015 Health Libraries Group.

Recruitment practices and the politics of inclusion in cancer clinical trials.

PubMed

Joseph, Galen; Dohan, Daniel

2012-09-01

Since the U.S. National Institutes of Health (NIH) Revitalization Act of 1993, researchers with federal funding have been required to include "minorities and women" in their clinical trials, and inclusion in research has come to be seen as an important strategy for reducing health disparities. On the basis of ethnographic research in oncology clinics in an academic medical center and a public hospital over a period of two years, this article examines how the NIH inclusion mandate is playing out in the context of oncology clinical trials. We argue that although individual patients are recruited to particular trials by individual providers, recruitment processes are shaped by the structural inequities in the U.S. health care system that create differential access to medical facilities with different and unequal research infrastructures. Given the heterogeneity of clinical trials, research infrastructures, and the U.S. health care system, the meanings of inclusion in research are multiple, and inclusion by itself does not ensure equity.

Open-source mobile digital platform for clinical trial data collection in low-resource settings.

PubMed

van Dam, Joris; Omondi Onyango, Kevin; Midamba, Brian; Groosman, Nele; Hooper, Norman; Spector, Jonathan; Pillai, Goonaseelan Colin; Ogutu, Bernhards

2017-02-01

Governments, universities and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In this context we piloted the use of a novel mobile digital health platform, designed specifically for low-resource environments, to support high-quality data collection in a clinical research study. Our primary aim was to assess the feasibility of a using a mobile digital platform for clinical trial data collection in a low-resource setting. Secondarily, we sought to explore the potential benefits of such an approach. The investigative site was a research institute in Nairobi, Kenya. We integrated an open-source platform for mobile data collection commonly used in the developing world with an open-source, standard platform for electronic data capture in clinical trials. The integration was developed using common data standards (Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model), maximising the potential to extend the approach to other platforms. The system was deployed in a pharmacokinetic study involving healthy human volunteers. The electronic data collection platform successfully supported conduct of the study. Multidisciplinary users reported high levels of satisfaction with the mobile application and highlighted substantial advantages when compared with traditional paper record systems. The new system also demonstrated a potential for expediting data quality review. This pilot study demonstrated the feasibility of using a mobile digital platform for clinical research data collection in low-resource settings. Sustainable scientific capabilities and infrastructure are essential to attract and support clinical research studies. Since many research structures in Africa are being developed anew, stakeholders should consider implementing innovative technologies and approaches.

Lessons learned: Infrastructure development and financial management for large, publically funded, international trials

PubMed Central

Larson, Gregg S; Carey, Cate; Grarup, Jesper; Hudson, Fleur; Sachi, Karen; Vjecha, Michael J; Gordin, Fred

2015-01-01

Background/Aims Randomized clinical trials are widely recognized as essential to address world-wide clinical and public health research questions. However, for many conditions, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly-funded, international trials that reduce cost without compromising data integrity, and recommend an approach to cost reporting that permits comparison of clinical trials. Methods We describe the organizational and financial characteristics of INSIGHT, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. Results It is possible to reduce costs of participant follow-up and not compromise clinical trial quality or integrity. The INSIGHT network has successfully completed four large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publically funded trials in other disease areas, particularly trials dependent on international collaborations. Conclusion New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity; minimal up-front costs; payments for performance; and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They include institutional resistance to financial change, growing trial complexity, and the difficulty of sustaining network infrastructure absent stable research work. There is also a need for more central monitoring, improved and harmonized regulations, and a widely-applied metric for measuring and comparing cost efficiency in clinical trials. ClinicalTrials.gov is recommended as a location where standardized trial cost information could be made publicly accessible. PMID:26908541

Building sustainable multi-functional prospective electronic clinical data systems.

PubMed

Randhawa, Gurvaneet S; Slutsky, Jean R

2012-07-01

A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a national clinical research enterprise.

PubMed

Crowley, William F; Sherwood, Louis; Salber, Patricia; Scheinberg, David; Slavkin, Hal; Tilson, Hugh; Reece, E Albert; Catanese, Veronica; Johnson, Stephen B; Dobs, Adrian; Genel, Myron; Korn, Allan; Reame, Nancy; Bonow, Robert; Grebb, Jack; Rimoin, David

2004-03-03

The clinical research infrastructure of the United States is currently at a critical crossroads. To leverage the enormous biomedical research gains made in the past century efficiently, a drastic need exists to reengineer this system into a coordinated, safe, and more efficient and effective enterprise. To accomplish this task, clinical research must be transformed from its current state as a cottage industry to an enterprise-wide health care pipeline whose function is to bring the novel research from both government and private entities to the US public. We propose the establishment of a unique public-private partnership termed the National Clinical Research Enterprise (NCRE). Its agenda should consist of informed public participation, supportive information technologies, a skilled workforce, and adequate funding in clinical research. Devoting only 0.25% of the budgets from all health care stakeholders to support the NCRE would permit adequate funding to build the infrastructure required to address these problems in an enterprise fashion. All participants in the US health care delivery system must come together to focus on system-wide improvements that will benefit the public.

Epilepsy informatics and an ontology-driven infrastructure for large database research and patient care in epilepsy.

PubMed

Sahoo, Satya S; Zhang, Guo-Qiang; Lhatoo, Samden D

2013-08-01

The epilepsy community increasingly recognizes the need for a modern classification system that can also be easily integrated with effective informatics tools. The 2010 reports by the United States President's Council of Advisors on Science and Technology (PCAST) identified informatics as a critical resource to improve quality of patient care, drive clinical research, and reduce the cost of health services. An effective informatics infrastructure for epilepsy, which is underpinned by a formal knowledge model or ontology, can leverage an ever increasing amount of multimodal data to improve (1) clinical decision support, (2) access to information for patients and their families, (3) easier data sharing, and (4) accelerate secondary use of clinical data. Modeling the recommendations of the International League Against Epilepsy (ILAE) classification system in the form of an epilepsy domain ontology is essential for consistent use of terminology in a variety of applications, including electronic health records systems and clinical applications. In this review, we discuss the data management issues in epilepsy and explore the benefits of an ontology-driven informatics infrastructure and its role in adoption of a "data-driven" paradigm in epilepsy research. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

Epilepsy informatics and an ontology-driven infrastructure for large database research and patient care in epilepsy

PubMed Central

Sahoo, Satya S.; Zhang, Guo-Qiang; Lhatoo, Samden D.

2013-01-01

Summary The epilepsy community increasingly recognizes the need for a modern classification system that can also be easily integrated with effective informatics tools. The 2010 reports by the United States President's Council of Advisors on Science and Technology (PCAST) identified informatics as a critical resource to improve quality of patient care, drive clinical research, and reduce the cost of health services. An effective informatics infrastructure for epilepsy, which is underpinned by a formal knowledge model or ontology, can leverage an ever increasing amount of multimodal data to improve (1) clinical decision support, (2) access to information for patients and their families, (3) easier data sharing, and (4) accelerate secondary use of clinical data. Modeling the recommendations of the International League Against Epilepsy (ILAE) classification system in the form of an epilepsy domain ontology is essential for consistent use of terminology in a variety of applications, including electronic health records systems and clinical applications. In this review, we discuss the data management issues in epilepsy and explore the benefits of an ontology-driven informatics infrastructure and its role in adoption of a “data-driven” paradigm in epilepsy research. PMID:23647220

Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project.

PubMed

Anderson, H Vernon; Weintraub, William S; Radford, Martha J; Kremers, Mark S; Roe, Matthew T; Shaw, Richard E; Pinchotti, Dana M; Tcheng, James E

2013-05-07

Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials.

PubMed

Larson, Gregg S; Carey, Cate; Grarup, Jesper; Hudson, Fleur; Sachi, Karen; Vjecha, Michael J; Gordin, Fred

2016-04-01

Randomized clinical trials are widely recognized as essential to address worldwide clinical and public health research questions. However, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly funded, international trials that reduce cost without compromising data integrity and recommend an approach to cost reporting that permits comparison of clinical trials. We describe the organizational and financial characteristics of The International Network for Strategic Initiatives in Global HIV Trials, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. It is possible to reduce costs of participants' follow-up and not compromise clinical trial quality or integrity. The International Network for Strategic Initiatives in Global HIV Trials network has successfully completed three large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publicly funded trials in other disease areas, particularly trials dependent on international collaborations. New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity, minimal up-front costs, payments for performance, and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They include institutional resistance to financial change, growing trial complexity, and the difficulty of sustaining network infrastructure absent stable research work. There is also a need for more central monitoring, improved and harmonized regulations, and a widely applied metric for measuring and comparing cost efficiency in clinical trials. ClinicalTrials.gov is recommended as a location where standardized trial cost information could be made publicly accessible. © The Author(s) 2016.

Quality Assurance in Biobanking for Pre-Clinical Research

PubMed Central

Simeon-Dubach, Daniel; Zeisberger, Steffen M.; Hoerstrup, Simon P.

2016-01-01

It is estimated that not less than USD 28 billion are spent each year in the USA alone on irreproducible pre-clinical research, which is not only a fundamental loss of investment and resources but also a strong inhibitor of efficiency for upstream processes regarding the translation towards clinical applications and therapies. The issues and cost of irreproducibility has mainly been published on pre-clinical research. In contrast to pre-clinical research, test material is often being transferred into humans in clinical research. To protect treated human subjects and guarantee a defined quality standard in the field of clinical research, the manufacturing and processing infrastructures have to strictly follow and adhere to certain (inter-)national quality standards. It is assumed and suggested by the authors that by an implementation of certain quality standards within the area of pre-clinical research, billions of USD might be saved and the translation phase of promising pre-clinical results towards clinical applications may substantially be improved. In this review, we discuss how an implementation of a quality assurance (QA) management system might positively improve sample quality and sustainability within pre-clinically focused biobank infrastructures. Biobanks are frequently positioned at the very beginning of the biomedical research value chain, and, since almost every research material has been stored in a biobank during the investigated life cycle, biobanking seems to be of substantial importance from this perspective. The role model of a QA-regulated biobank structure can be found in biobanks within the context of clinical research organizations such as in regenerative medicine clusters. PMID:27781023

Clinical investigations for SUS, the Brazilian public health system.

PubMed

Paula, Ana Patrícia de; Giozza, Silvana Pereira; Pereira, Michelle Zanon; Boaventura, Patrícia Souza; Santos, Leonor Maria Pacheco; Sachetti, Camile Giaretta; Tamayo, César Omar Carranza; Kowalski, Clarissa Campos Guaragna; Elias, Flavia Tavares Silva; Serruya, Suzanne Jacob; Guimarães, Reinaldo

2012-01-01

Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

76 FR 55074 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-06

... Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333; 93.702, ARRA Related Construction...

Clinical Bioinformatics: challenges and opportunities

PubMed Central

2012-01-01

Background Network Tools and Applications in Biology (NETTAB) Workshops are a series of meetings focused on the most promising and innovative ICT tools and to their usefulness in Bioinformatics. The NETTAB 2011 workshop, held in Pavia, Italy, in October 2011 was aimed at presenting some of the most relevant methods, tools and infrastructures that are nowadays available for Clinical Bioinformatics (CBI), the research field that deals with clinical applications of bioinformatics. Methods In this editorial, the viewpoints and opinions of three world CBI leaders, who have been invited to participate in a panel discussion of the NETTAB workshop on the next challenges and future opportunities of this field, are reported. These include the development of data warehouses and ICT infrastructures for data sharing, the definition of standards for sharing phenotypic data and the implementation of novel tools to implement efficient search computing solutions. Results Some of the most important design features of a CBI-ICT infrastructure are presented, including data warehousing, modularity and flexibility, open-source development, semantic interoperability, integrated search and retrieval of -omics information. Conclusions Clinical Bioinformatics goals are ambitious. Many factors, including the availability of high-throughput "-omics" technologies and equipment, the widespread availability of clinical data warehouses and the noteworthy increase in data storage and computational power of the most recent ICT systems, justify research and efforts in this domain, which promises to be a crucial leveraging factor for biomedical research. PMID:23095472

76 FR 24890 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

....nih.gov . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333; 93.702...

75 FR 70934 - National Center For Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-19

... . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333; 93.702, ARRA...

76 FR 24500 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

[email protected] . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333...

75 FR 16816 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure; 93.306, 93.333; 93.702, ARRA Related Construction...

Developing a data infrastructure for a learning health system: the PORTAL network

PubMed Central

McGlynn, Elizabeth A; Lieu, Tracy A; Durham, Mary L; Bauck, Alan; Laws, Reesa; Go, Alan S; Chen, Jersey; Feigelson, Heather Spencer; Corley, Douglas A; Young, Deborah Rohm; Nelson, Andrew F; Davidson, Arthur J; Morales, Leo S; Kahn, Michael G

2014-01-01

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings. PMID:24821738

Laboratory challenges in the scaling up of HIV, TB, and malaria programs: The interaction of health and laboratory systems, clinical research, and service delivery.

PubMed

Birx, Deborah; de Souza, Mark; Nkengasong, John N

2009-06-01

Strengthening national health laboratory systems in resource-poor countries is critical to meeting the United Nations Millennium Development Goals. Despite strong commitment from the international community to fight major infectious diseases, weak laboratory infrastructure remains a huge rate-limiting step. Some major challenges facing laboratory systems in resource-poor settings include dilapidated infrastructure; lack of human capacity, laboratory policies, and strategic plans; and limited synergies between clinical and research laboratories. Together, these factors compromise the quality of test results and impact patient management. With increased funding, the target of laboratory strengthening efforts in resource-poor countries should be the integrating of laboratory services across major diseases to leverage resources with respect to physical infrastructure; types of assays; supply chain management of reagents and equipment; and maintenance of equipment.

Crossing the Chasm: Information Technology to Biomedical Informatics

PubMed Central

Fahy, Brenda G.; Balke, C. William; Umberger, Gloria H.; Talbert, Jeffery; Canales, Denise Niles; Steltenkamp, Carol L.; Conigliaro, Joseph

2011-01-01

Accelerating the translation of new scientific discoveries to improve human health and disease management is the overall goal of a series of initiatives integrated in the National Institutes of Health (NIH) “Roadmap for Medical Research.” The Clinical and Translational Research Award (CTSA) program is, arguably, the most visible component of the NIH Roadmap providing resources to institutions to transform their clinical and translational research enterprises along the goals of the Roadmap. The CTSA program emphasizes biomedical informatics as a critical component for the accomplishment of the NIH’s translational objectives. To be optimally effective, emerging biomedical informatics programs must link with the information technology (IT) platforms of the enterprise clinical operations within academic health centers. This report details one academic health center’s transdisciplinary initiative to create an integrated academic discipline of biomedical informatics through the development of its infrastructure for clinical and translational science infrastructure and response to the CTSA mechanism. This approach required a detailed informatics strategy to accomplish these goals. This transdisciplinary initiative was the impetus for creation of a specialized biomedical informatics core, the Center for Biomedical Informatics (CBI). Development of the CBI codified the need to incorporate medical informatics including quality and safety informatics and enterprise clinical information systems within the CBI. This paper describes the steps taken to develop the biomedical informatics infrastructure, its integration with clinical systems at one academic health center, successes achieved, and barriers encountered during these efforts. PMID:21383632

Leveraging Epidemiology and Clinical Studies of Cancer Outcomes: Recommendations and Opportunities for Translational Research

PubMed Central

2013-01-01

As the number of cancer survivors continues to grow, research investigating the factors that affect cancer outcomes, such as disease recurrence, risk of second malignant neoplasms, and the late effects of cancer treatments, becomes ever more important. Numerous epidemiologic studies have investigated factors that affect cancer risk, but far fewer have addressed the extent to which demographic, lifestyle, genomic, clinical, and psychosocial factors influence cancer outcomes. To identify research priorities as well as resources and infrastructure needed to advance the field of cancer outcomes and survivorship research, the National Cancer Institute sponsored a workshop titled “Utilizing Data from Cancer Survivor Cohorts: Understanding the Current State of Knowledge and Developing Future Research Priorities” on November 3, 2011, in Washington, DC. This commentary highlights recent findings presented at the workshop, opportunities to leverage existing data, and recommendations for future research, data, and infrastructure needed to address high priority clinical and research questions. Multidisciplinary teams that include epidemiologists, clinicians, biostatisticians, and bioinformaticists will be essential to facilitate future cancer outcome studies focused on improving clinical care of cancer patients, identifying those at high risk of poor outcomes, and implementing effective interventions to ultimately improve the quality and duration of survival. PMID:23197494

The CTSA Consortium's Catalog of Assets for Translational and Clinical Health Research (CATCHR)

PubMed Central

Mapes, Brandy; Basford, Melissa; Zufelt, Anneliese; Wehbe, Firas; Harris, Paul; Alcorn, Michael; Allen, David; Arnim, Margaret; Autry, Susan; Briggs, Michael S.; Carnegie, Andrea; Chavis‐Keeling, Deborah; De La Pena, Carlos; Dworschak, Doris; Earnest, Julie; Grieb, Terri; Guess, Marilyn; Hafer, Nathaniel; Johnson, Tesheia; Kasper, Amanda; Kopp, Janice; Lockie, Timothy; Lombardo, Vincetta; McHale, Leslie; Minogue, Andrea; Nunnally, Beth; O'Quinn, Deanna; Peck, Kelly; Pemberton, Kieran; Perry, Cheryl; Petrie, Ginny; Pontello, Andria; Posner, Rachel; Rehman, Bushra; Roth, Deborah; Sacksteder, Paulette; Scahill, Samantha; Schieri, Lorri; Simpson, Rosemary; Skinner, Anne; Toussant, Kim; Turner, Alicia; Van der Put, Elaine; Wasser, June; Webb, Chris D.; Williams, Maija; Wiseman, Lori; Yasko, Laurel; Pulley, Jill

2014-01-01

Abstract The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. Catalog of Assets for Translational and Clinical Health Research (CATCHR) is the Consortium's effort to collect and make available information on programs and resources to maximize efficiency and facilitate collaborations. By capturing information on a broad range of assets supporting the entire clinical and translational research spectrum, CATCHR aims to provide the necessary infrastructure and processes to establish and maintain an open‐access, searchable database of consortium resources to support multisite clinical and translational research studies. Data are collected using rigorous, defined methods, with the resulting information made visible through an integrated, searchable Web‐based tool. Additional easy‐to‐use Web tools assist resource owners in validating and updating resource information over time. In this paper, we discuss the design and scope of the project, data collection methods, current results, and future plans for development and sustainability. With increasing pressure on research programs to avoid redundancy, CATCHR aims to make available information on programs and core facilities to maximize efficient use of resources. PMID:24456567

[The Competence Network for HIV/AIDS. Data, Samples, Facts].

PubMed

Michalik, Claudia; Skaletz-Rorowski, Adriane; Brockmeyer, Norbert H

2016-04-01

With funding for the Competence Networks in Medicine from the Federal Ministry of Education and Research, the Competence Network for HIV/AIDS (KompNet HIV/AIDS) was established as an interdisciplinary research association. Essential working groups were incorporated all over Germany, which are active in clinical and basic HIV/AIDS research. After successful establishment, providing research infrastructure for national and international cooperation in the field of HIV/AIDS was the focus of the network. By bringing together research activities, preconditions are created for improving HIV infection treatment and increasing life expectancy of HIV-infected patients. The members of KompNet HIV/AIDS are HIV experts from university clinics, HIV physicians, patient representatives, as well as national reference centers. As a scientific research basis, the network established an HIV patient cohort. Clinical and sociodemographic data of HIV patients were documented biannually and complemented by serum and DNA-samples collected twice per year. Furthermore, a child cohort was set up. Within the KompNet HIV/AIDS, a research infrastructure for HIV was established for internal, external as well international scientists. Within the HIV cohort a total of 16,500 patients are documented. The associated biobank comprises ~ 56,000 serum samples and ~ 16,000 DNA samples. The child cohort consists of 647 HIV-exposed and 230 infected children. The KompNet HIV/AIDS cohorts became an important partner in several international collaborations. Nevertheless, the maintenance of such infrastructures without public funding is a challenge.

IT Infrastructure for Biomedical Research in North-West Germany.

PubMed

Seeger, Insa; Zeleke, Atinkut; Freitag, Michael; Röhrig, Rainer

2017-01-01

The efficient use of routine data for biomedical research presupposes an IT infrastructure designed for health care facilities. The objective of this study was to analyse which IT infrastructure is used in hospitals and by general practitioners' (GP) practices in the region Oldenburg-Bremen and to examine how well this supports research projects. To this end, IT managers and GPs were interviewed. The usage of hospital information systems (HIS) and data warehouse systems (DWS) in hospitals is of major importance for the study. Over 90 % use DWS for administration, 42 % for clinical research. None of the hospitals implemented consent for the use of routine data for research. Only a third of the GPs have participated in studies. The GPs' offices based EHR systems in use offer virtually no support for research projects. The study results demonstrate that technical and organisational measures are required for the further usage of routine data in the region.

American Recovery and Reinvestment Act-comparative effectiveness research infrastructure investments: emerging data resources, tools and publications.

PubMed

Segal, Courtney; Holve, Erin

2014-11-01

The Recovery Act provided a substantial, one-time investment in data infrastructure for comparative effectiveness research (CER). A review of the publications, data, and tools developed as a result of this support has informed understanding of the level of effort undertaken by these projects. Structured search queries, as well as outreach efforts, were conducted to identify and review resources from American Recovery and Reinvestment Act of 2009 CER projects building electronic clinical data infrastructure. The findings from this study provide a spectrum of productivity across a range of topics and settings. A total of 451 manuscripts published in 192 journals, and 141 data resources and tools were identified and address gaps in evidence on priority populations, conditions, and the infrastructure needed to support CER.

Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS): Architecture

PubMed Central

Mandl, Kenneth D; Kohane, Isaac S; McFadden, Douglas; Weber, Griffin M; Natter, Marc; Mandel, Joshua; Schneeweiss, Sebastian; Weiler, Sarah; Klann, Jeffrey G; Bickel, Jonathan; Adams, William G; Ge, Yaorong; Zhou, Xiaobo; Perkins, James; Marsolo, Keith; Bernstam, Elmer; Showalter, John; Quarshie, Alexander; Ofili, Elizabeth; Hripcsak, George; Murphy, Shawn N

2014-01-01

We describe the architecture of the Patient Centered Outcomes Research Institute (PCORI) funded Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS, http://www.SCILHS.org) clinical data research network, which leverages the $48 billion dollar federal investment in health information technology (IT) to enable a queryable semantic data model across 10 health systems covering more than 8 million patients, plugging universally into the point of care, generating evidence and discovery, and thereby enabling clinician and patient participation in research during the patient encounter. Central to the success of SCILHS is development of innovative ‘apps’ to improve PCOR research methods and capacitate point of care functions such as consent, enrollment, randomization, and outreach for patient-reported outcomes. SCILHS adapts and extends an existing national research network formed on an advanced IT infrastructure built with open source, free, modular components. PMID:24821734

Reorganizing the General Clinical Research Center to improve the clinical and translational research enterprise.

PubMed

Allen, David; Ripley, Elizabeth; Coe, Antoinette; Clore, John

2013-12-01

In 2010, Virginia Commonwealth University (VCU) was granted a Clinical and Translational Science Award which prompted reorganization and expansion of their clinical research infrastructure. A case study approach is used to describe the implementation of a business and cost recovery model for clinical and translational research and the transformation of VCU's General Clinical Research Center and Clinical Trials Office to a combined Clinical Research Services entity. We outline the use of a Plan, Do, Study, Act cycle that facilitated a thoughtful transition process, which included the identification of required changes and cost recovery processes for implementation. Through this process, the VCU Center for Clinical and Translational Research improved efficiency, increased revenue recovered, reduced costs, and brought a high level of fiscal responsibility through financial reporting.

StaR Child Health: developing evidence-based guidance for the design, conduct and reporting of paediatric trials.

PubMed

Van't Hoff, William; Offringa, Martin

2015-02-01

There has been a huge upsurge in clinical research in children in the last decade, stimulated in England by dedicated research infrastructure and support through the National Institute for Health Research. This infrastructure offering research design, expert review, trial management, research nurse, data support and dedicated facilities enables paediatricians to conduct more and better research. The challenge is how to design and conduct trials that will make a real difference to children's health. Standards for Research (StaR) in Child Health was founded in 2009 to address the paucity and shortcomings of paediatric clinical trials. This global initiative involves methodologists, clinicians, patient advocacy groups and policy makers dedicated to developing practical, evidence-based standards for enhancing the reliability and relevance of paediatric clinical research. In this overview, we highlight the contribution of StaR to this agenda, describe the international context, and suggest how StaR's future plans could be integrated with new and existing support for research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Crossing the chasm: information technology to biomedical informatics.

PubMed

Fahy, Brenda G; Balke, C William; Umberger, Gloria H; Talbert, Jeffery; Canales, Denise Niles; Steltenkamp, Carol L; Conigliaro, Joseph

2011-06-01

Accelerating the translation of new scientific discoveries to improve human health and disease management is the overall goal of a series of initiatives integrated in the National Institutes of Health (NIH) "Roadmap for Medical Research." The Clinical and Translational Science Award (CTSA) program is, arguably, the most visible component of the NIH Roadmap providing resources to institutions to transform their clinical and translational research enterprises along the goals of the Roadmap. The CTSA program emphasizes biomedical informatics as a critical component for the accomplishment of the NIH's translational objectives. To be optimally effective, emerging biomedical informatics programs must link with the information technology platforms of the enterprise clinical operations within academic health centers.This report details one academic health center's transdisciplinary initiative to create an integrated academic discipline of biomedical informatics through the development of its infrastructure for clinical and translational science infrastructure and response to the CTSA mechanism. This approach required a detailed informatics strategy to accomplish these goals. This transdisciplinary initiative was the impetus for creation of a specialized biomedical informatics core, the Center for Biomedical Informatics (CBI). Development of the CBI codified the need to incorporate medical informatics including quality and safety informatics and enterprise clinical information systems within the CBI. This article describes the steps taken to develop the biomedical informatics infrastructure, its integration with clinical systems at one academic health center, successes achieved, and barriers encountered during these efforts.

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

PubMed

Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

2017-03-15

Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P < 0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional; all matched P < 0.05). Conclusions: Use of a clinical research-focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

The PBRN Initiative

PubMed Central

Curro, F.A.; Vena, D.; Naftolin, F.; Terracio, L.; Thompson, V.P.

2012-01-01

The NIDCR-supported Practice-based Research Network initiative presents dentistry with an unprecedented opportunity by providing a pathway for modifying and advancing the profession. It encourages practitioner participation in the transfer of science into practice for the improvement of patient care. PBRNs vary in infrastructure and design, and sustaining themselves in the long term may involve clinical trial validation by regulatory agencies. This paper discusses the PBRN concept in general and uses the New York University College of Dentistry’s Practitioners Engaged in Applied Research and Learning (PEARL) Network as a model to improve patient outcomes. The PEARL Network is structured to ensure generalizability of results, data integrity, and to provide an infrastructure in which scientists can address clinical practitioner research interests. PEARL evaluates new technologies, conducts comparative effectiveness research, participates in multidisciplinary clinical studies, helps evaluate alternative models of healthcare, educates and trains future clinical faculty for academic positions, expands continuing education to include “benchmarking” as a form of continuous feedback to practitioners, adds value to dental schools’ educational programs, and collaborates with the oral health care and pharmaceutical industries and medical PBRNs to advance the dental profession and further the integration of dental research and practice into contemporary healthcare (NCT00867997, NCT01268605). PMID:22699662

A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome?

PubMed

Rath, Ana; Salamon, Valérie; Peixoto, Sandra; Hivert, Virginie; Laville, Martine; Segrestin, Berenice; Neugebauer, Edmund A M; Eikermann, Michaela; Bertele, Vittorio; Garattini, Silvio; Wetterslev, Jørn; Banzi, Rita; Jakobsen, Janus C; Djurisic, Snezana; Kubiak, Christine; Demotes-Mainard, Jacques; Gluud, Christian

2017-11-22

Evidence-based clinical practice is challenging in all fields, but poses special barriers in the field of rare diseases. The present paper summarises the main barriers faced by clinical research in rare diseases, and highlights opportunities for improvement. Systematic literature searches without meta-analyses and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. Barriers specific to rare diseases comprise the difficulty to recruit participants because of rarity, scattering of patients, limited knowledge on natural history of diseases, difficulties to achieve accurate diagnosis and identify patients in health information systems, and difficulties choosing clinically relevant outcomes. Evidence-based clinical practice for rare diseases should start by collecting clinical data in databases and registries; defining measurable patient-centred outcomes; and selecting appropriate study designs adapted to small study populations. Rare diseases constitute one of the most paradigmatic fields in which multi-stakeholder engagement, especially from patients, is needed for success. Clinical research infrastructures and expertise networks offer opportunities for establishing evidence-based clinical practice within rare diseases.

Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research.

PubMed

Morris, Michael J; Basch, Ethan M; Wilding, George; Hussain, Maha; Carducci, Michael A; Higano, Celestia; Kantoff, Philip; Oh, William K; Small, Eric J; George, Daniel; Mathew, Paul; Beer, Tomasz M; Slovin, Susan F; Ryan, Charles; Logothetis, Christopher; Scher, Howard I

2009-01-01

In 2005, the US Department of Defense, through the US Army Medical Research and Materiel Command, Office of the Congressionally Directed Medical Research Programs, created a funding mechanism to form a clinical trials consortium to conduct phase I and II studies in prostate cancer. This is the first report of the Prostate Cancer Clinical Trials Consortium (PCCTC). The Department of Defense award supports a consortium of 10 prostate cancer research centers. Memorial Sloan-Kettering Cancer Center was awarded the Coordinating Center grant for the consortium and charged with creating an infrastructure to conduct early-phase multicenter clinical trials. Each participating center was required to introduce >or=1 clinical trial per year and maintain accrual of a minimum of 35 patients per year. The PCCTC was launched in 2006 and now encompasses 10 leading prostate cancer research centers. Fifty-one trials have been opened, and 1386 patients have been accrued at member sites. Members share an online clinical trial management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, an administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review are established. The PCCTC fulfills a congressional directive to create a clinical trials instrument dedicated to early-phase prostate cancer studies. The member institutions have built an administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. Clinical trials are open and accruing in excess of federally mandated goals.

The COMET Sleep Research Platform.

PubMed

Nichols, Deborah A; DeSalvo, Steven; Miller, Richard A; Jónsson, Darrell; Griffin, Kara S; Hyde, Pamela R; Walsh, James K; Kushida, Clete A

2014-01-01

The Comparative Outcomes Management with Electronic Data Technology (COMET) platform is extensible and designed for facilitating multicenter electronic clinical research. Our research goals were the following: (1) to conduct a comparative effectiveness trial (CET) for two obstructive sleep apnea treatments-positive airway pressure versus oral appliance therapy; and (2) to establish a new electronic network infrastructure that would support this study and other clinical research studies. The COMET platform was created to satisfy the needs of CET with a focus on creating a platform that provides comprehensive toolsets, multisite collaboration, and end-to-end data management. The platform also provides medical researchers the ability to visualize and interpret data using business intelligence (BI) tools. COMET is a research platform that is scalable and extensible, and which, in a future version, can accommodate big data sets and enable efficient and effective research across multiple studies and medical specialties. The COMET platform components were designed for an eventual move to a cloud computing infrastructure that enhances sustainability, overall cost effectiveness, and return on investment.

The COMET Sleep Research Platform

PubMed Central

Nichols, Deborah A.; DeSalvo, Steven; Miller, Richard A.; Jónsson, Darrell; Griffin, Kara S.; Hyde, Pamela R.; Walsh, James K.; Kushida, Clete A.

2014-01-01

Introduction: The Comparative Outcomes Management with Electronic Data Technology (COMET) platform is extensible and designed for facilitating multicenter electronic clinical research. Background: Our research goals were the following: (1) to conduct a comparative effectiveness trial (CET) for two obstructive sleep apnea treatments—positive airway pressure versus oral appliance therapy; and (2) to establish a new electronic network infrastructure that would support this study and other clinical research studies. Discussion: The COMET platform was created to satisfy the needs of CET with a focus on creating a platform that provides comprehensive toolsets, multisite collaboration, and end-to-end data management. The platform also provides medical researchers the ability to visualize and interpret data using business intelligence (BI) tools. Conclusion: COMET is a research platform that is scalable and extensible, and which, in a future version, can accommodate big data sets and enable efficient and effective research across multiple studies and medical specialties. The COMET platform components were designed for an eventual move to a cloud computing infrastructure that enhances sustainability, overall cost effectiveness, and return on investment. PMID:25848590

Developing a data infrastructure for a learning health system: the PORTAL network.

PubMed

McGlynn, Elizabeth A; Lieu, Tracy A; Durham, Mary L; Bauck, Alan; Laws, Reesa; Go, Alan S; Chen, Jersey; Feigelson, Heather Spencer; Corley, Douglas A; Young, Deborah Rohm; Nelson, Andrew F; Davidson, Arthur J; Morales, Leo S; Kahn, Michael G

2014-01-01

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A data protection scheme for medical research networks. Review after five years of operation.

PubMed

Helbing, K; Demiroglu, S Y; Rakebrandt, F; Pommerening, K; Rienhoff, O; Sax, U

2010-01-01

The data protection requirements matured in parallel to new clinical tests generating more personal data since the 1960s. About ten years ago it was recognized that a generic data protection scheme for medical research networks is required, which reinforces patient rights but also allows economically feasible medical research compared to "hand-carved" individual solutions. To give recommendations for more efficient IT infrastructures for medical research networks in compliance with data protection requirements. The IT infrastructures of three medical research networks were reviewed with respect to the relevant data management modules. Recommendations are derived to increase cost efficiency in research networks assessing the consequences of a service provider approach without lowering the data protection level. The existing data protection schemes are very complex. Smaller research networks cannot afford the implementation of such schemes. Larger networks struggle to keep them sustainable. Due to a modular redesign in the medical research network community, a new approach offers opportunities for an efficient sustainable IT infrastructure involving a service provider concept. For standard components 70-80% of the costs could be cut down, for open source components about 37% over a three-year period. Future research networks should switch to a service-oriented approach to achieve a sustainable, cost-efficient IT infrastructure.

Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience.

PubMed

Michalsky, Marc P; Inge, Thomas H; Teich, Steven; Eneli, Ihuoma; Miller, Rosemary; Brandt, Mary L; Helmrath, Michael; Harmon, Carroll M; Zeller, Meg H; Jenkins, Todd M; Courcoulas, Anita; Buncher, Ralph C

2014-02-01

The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Data were obtained from the Teen-LABS database, and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. All centers had extensive multidisciplinary involvement in the assessment, pre-operative education, and post-operative management of adolescents undergoing WLS. Eligibility criteria and pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well-developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. The composition of clinical team and institutional resources is consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. © 2013 Published by Elsevier Inc.

Adolescent Bariatric Surgery Program Characteristics: The Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study Experience

PubMed Central

Michalsky, M.P.; Inge, T.H.; Teich, S.; Eneli, I.; Miller, R.; Brandt, M.L.; Helmrath, M.; Harmon, C.M.; Zeller, M.H.; Jenkins, T.M.; Courcoulas, A.; Buncher, C.R.

2013-01-01

Background The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Methods Data were obtained from the Teen-LABS database and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. Results All centers had extensive multidisciplinary involvement in the assessment, preoperative education and post-operative management of adolescents undergoing WLS. Eligibility criteria, pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. Conclusions The composition of clinical team and institutional resources are consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. PMID:24491361

National Institutes of Health eliminates funding for national architecture linking primary care research.

PubMed

Peterson, Kevin A

2007-01-01

With the ending of the National Electronic Clinical Trial and Research Network (NECTAR) pilot programs and the abridgement of Clinical Research Associate initiative, the National Institutes of Health Roadmap presents a strategic shift for practice-based research networks from direct funding of a harmonized national infrastructure of cooperating research networks to a model of local engagement of primary care clinics performing practice-based research under the aegis of regional academic health centers through Clinical and Translational Science Awards. Although this may present important opportunities for partnering between community practices and large health centers, for primary care researchers, the promise of a transformational change that brings a unified national primary care community into the clinical research enterprise seems likely to remain unfulfilled.

76 FR 57748 - National Cancer Institute Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... Cancer Institute Special Emphasis Panel; Core Infrastructure and Methodological Research for Cancer... Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer... Panel; Community Clinical Oncology Program Research Bases (U10). Date: November 9, 2011. Time: 8:30 a.m...

NCI Awards 18 Grants to Continue the Early Detection Research Network (EDRN) Biomarkers Effort | Division of Cancer Prevention

Cancer.gov

The NCI has awarded 18 grants to continue the Early Detection Research Network (EDRN), a national infrastructure that supports the integrated development, validation, and clinical application of biomarkers for the early detection of cancer. The awards fund 7 Biomarker Developmental Laboratories, 8 Clinical Validation Centers, 2 Biomarker Reference Laboratories, and a Data

Applying a Conceptual Framework to Maximize the Participation of Diverse Populations in Cancer Clinical Trials

PubMed Central

Napoles, Anna; Cook, Elise; Ginossar, Tamar; Knight, Kendrea D.; Ford, Marvella E.

2017-01-01

The underrepresentation of ethnically diverse populations in cancer clinical trials results in the inequitable distribution of the risks and benefits of this research. Using a case study approach, we apply a conceptual framework of factors associated with the participation of diverse population groups in cancer clinical trials developed by Dr. Jean Ford and colleagues to increase understanding of the specific strategies, and barriers and promoters addressed by these strategies, that resulted in marked success in accrual of racially and ethnically diverse populations in cancer clinical research. Results indicate that the studies presented were able to successfully engage minority participants due to the creation and implementation of multi-level, multifaceted strategies that included: culturally and linguistically appropriate outreach, education, and research studies that were accessible in local communities; infrastructure to support engagement of key stakeholders, clinicians, and organizations serving minority communities; testimonials by ethnically diverse cancer survivors; availability of medical interpretation services; and providing infrastructure that facilitated the engagement in clinical research of clinicians who care for minority patient populations. These strategic efforts were effective in addressing limited awareness of trials, lack of opportunities to participate, and acceptance of engagement in cancer clinical trials. Careful attention to the context and population characteristics in which cancer clinical trials are conducted will be necessary to address disparities in research participation and cancer outcomes. These studies illustrate that progress on minority accrual into clinical research requires intentional efforts to overcome barriers at all three stages of the accrual process: awareness, opportunity and acceptance of participation. PMID:28052822

Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS): architecture.

PubMed

Mandl, Kenneth D; Kohane, Isaac S; McFadden, Douglas; Weber, Griffin M; Natter, Marc; Mandel, Joshua; Schneeweiss, Sebastian; Weiler, Sarah; Klann, Jeffrey G; Bickel, Jonathan; Adams, William G; Ge, Yaorong; Zhou, Xiaobo; Perkins, James; Marsolo, Keith; Bernstam, Elmer; Showalter, John; Quarshie, Alexander; Ofili, Elizabeth; Hripcsak, George; Murphy, Shawn N

2014-01-01

We describe the architecture of the Patient Centered Outcomes Research Institute (PCORI) funded Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS, http://www.SCILHS.org) clinical data research network, which leverages the $48 billion dollar federal investment in health information technology (IT) to enable a queryable semantic data model across 10 health systems covering more than 8 million patients, plugging universally into the point of care, generating evidence and discovery, and thereby enabling clinician and patient participation in research during the patient encounter. Central to the success of SCILHS is development of innovative 'apps' to improve PCOR research methods and capacitate point of care functions such as consent, enrollment, randomization, and outreach for patient-reported outcomes. SCILHS adapts and extends an existing national research network formed on an advanced IT infrastructure built with open source, free, modular components. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A system architecture for sharing de-identified, research-ready brain scans and health information across clinical imaging centers.

PubMed

Chervenak, Ann L; van Erp, Theo G M; Kesselman, Carl; D'Arcy, Mike; Sobell, Janet; Keator, David; Dahm, Lisa; Murry, Jim; Law, Meng; Hasso, Anton; Ames, Joseph; Macciardi, Fabio; Potkin, Steven G

2012-01-01

Progress in our understanding of brain disorders increasingly relies on the costly collection of large standardized brain magnetic resonance imaging (MRI) data sets. Moreover, the clinical interpretation of brain scans benefits from compare and contrast analyses of scans from patients with similar, and sometimes rare, demographic, diagnostic, and treatment status. A solution to both needs is to acquire standardized, research-ready clinical brain scans and to build the information technology infrastructure to share such scans, along with other pertinent information, across hospitals. This paper describes the design, deployment, and operation of a federated imaging system that captures and shares standardized, de-identified clinical brain images in a federation across multiple institutions. In addition to describing innovative aspects of the system architecture and our initial testing of the deployed infrastructure, we also describe the Standardized Imaging Protocol (SIP) developed for the project and our interactions with the Institutional Review Board (IRB) regarding handling patient data in the federated environment.

A System Architecture for Sharing De-Identified, Research-Ready Brain Scans and Health Information Across Clinical Imaging Centers

PubMed Central

Chervenak, Ann L.; van Erp, Theo G.M.; Kesselman, Carl; D’Arcy, Mike; Sobell, Janet; Keator, David; Dahm, Lisa; Murry, Jim; Law, Meng; Hasso, Anton; Ames, Joseph; Macciardi, Fabio; Potkin, Steven G.

2015-01-01

Progress in our understanding of brain disorders increasingly relies on the costly collection of large standardized brain magnetic resonance imaging (MRI) data sets. Moreover, the clinical interpretation of brain scans benefits from compare and contrast analyses of scans from patients with similar, and sometimes rare, demographic, diagnostic, and treatment status. A solution to both needs is to acquire standardized, research-ready clinical brain scans and to build the information technology infrastructure to share such scans, along with other pertinent information, across hospitals. This paper describes the design, deployment, and operation of a federated imaging system that captures and shares standardized, de-identified clinical brain images in a federation across multiple institutions. In addition to describing innovative aspects of the system architecture and our initial testing of the deployed infrastructure, we also describe the Standardized Imaging Protocol (SIP) developed for the project and our interactions with the Institutional Review Board (IRB) regarding handling patient data in the federated environment. PMID:22941984

The Secure Medical Research Workspace: An IT Infrastructure to Enable Secure Research on Clinical Data

PubMed Central

Owen, Phillips; Mostafa, Javed; Lamm, Brent; Wang, Xiaoshu; Schmitt, Charles P.; Ahalt, Stanley C.

2013-01-01

Abstract Clinical data have tremendous value for translational research, but only if security and privacy concerns can be addressed satisfactorily. A collaboration of clinical and informatics teams, including RENCI, NC TraCS, UNC's School of Information and Library Science, Information Technology Service's Research Computing and other partners at the University of North Carolina at Chapel Hill have developed a system called the Secure Medical Research Workspace (SMRW) that enables researchers to use clinical data securely for research. SMRW significantly minimizes the risk presented when using identified clinical data, thereby protecting patients, researchers, and institutions associated with the data. The SMRW is built on a novel combination of virtualization and data leakage protection and can be combined with other protection methodologies and scaled to production levels. PMID:23751029

A data-rich recruitment core to support translational clinical research.

PubMed

Kost, Rhonda G; Corregano, Lauren M; Rainer, Tyler-Lauren; Melendez, Caroline; Coller, Barry S

2015-04-01

Underenrollment of clinical studies wastes resources and delays assessment of research discoveries. We describe the organization and impact of a centralized recruitment core delivering comprehensive recruitment support to investigators. The Rockefeller University Center for Clinical and Translational Science supports a centralized recruitment core, call center, Research Volunteer Repository, data infrastructure, and staff who provide expert recruitment services to investigators. During protocol development, consultations aim to optimize enrollment feasibility, develop recruitment strategy, budget, and advertising. Services during study conduct include advertising placement, repository queries, call management, prescreening, referral, and visit scheduling. Utilization and recruitment outcomes are tracked using dedicated software. For protocols receiving recruitment services during 2009-2013: median time from initiation of recruitment to the first enrolled participant was 10 days; of 4,047 first-time callers to the call center, 92% (n = 3,722) enrolled in the Research Volunteer Repository, with 99% retention; 23% of Repository enrollees subsequently enrolled in ≥1 research studies, with 89% retention. Of volunteers referred by repository queries, 49% (280/537) enrolled into the study, with 92% retained. Provision of robust recruitment infrastructure including expertise, a volunteer repository, data capture and real-time analysis accelerates protocol accrual. Application of recruitment science improves the quality of clinical investigation. © 2014 Wiley Periodicals, Inc.

A Data‐Rich Recruitment Core to Support Translational Clinical Research

PubMed Central

Corregano, Lauren M.; Rainer, Tyler‐Lauren; Melendez, Caroline; Coller, Barry S.

2014-01-01

Abstract Background Underenrollment of clinical studies wastes resources and delays assessment of research discoveries. We describe the organization and impact of a centralized recruitment core delivering comprehensive recruitment support to investigators. Methods The Rockefeller University Center for Clinical and Translational Science supports a centralized recruitment core, call center, Research Volunteer Repository, data infrastructure, and staff who provide expert recruitment services to investigators. During protocol development, consultations aim to optimize enrollment feasibility, develop recruitment strategy, budget, and advertising. Services during study conduct include advertising placement, repository queries, call management, prescreening, referral, and visit scheduling. Utilization and recruitment outcomes are tracked using dedicated software. Results For protocols receiving recruitment services during 2009–2013: median time from initiation of recruitment to the first enrolled participant was 10 days; of 4,047 first‐time callers to the call center, 92% (n = 3,722) enrolled in the Research Volunteer Repository, with 99% retention; 23% of Repository enrollees subsequently enrolled in ≥1 research studies, with 89% retention. Of volunteers referred by repository queries, 49% (280/537) enrolled into the study, with 92% retained. Conclusions Provision of robust recruitment infrastructure including expertise, a volunteer repository, data capture and real‐time analysis accelerates protocol accrual. Application of recruitment science improves the quality of clinical investigation. PMID:25381717

78 FR 61377 - Office of the Director, National Institutes of Health; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-03

...; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93... clearly unwarranted invasion of personal privacy. Name of Committee: Office of Research Infrastructure Programs Special Emphasis Panel; Biomedical Research Conference Review. Date: October 22, 2013. Time: 3:00...

Methodology of clinical research in rare diseases: development of a research program in juvenile neuronal ceroid lipofuscinosis (JNCL) via creation of a patient registry and collaboration with patient advocates

PubMed Central

de Blieck, Elisabeth A.; Augustine, Erika F.; Marshall, Frederick J.; Adams, Heather; Cialone, Jennifer; Dure, Leon; Kwon, Jennifer M.; Newhouse, Nicole; Rose, Katherine; Rothberg, Paul G.; Vierhile, Amy; Mink, Jonathan W.

2013-01-01

Introduction Juvenile neuronal ceroid lipofuscinosis (JNCL; Batten disease) is a rare, inherited, fatal lysosomal storage childhood disorder. True for many rare diseases, there are no treatments that impact the course of JNCL. The University of Rochester Batten Center’s (URBC) mission is to find treatments to slow, halt, or prevent JNCL. Objectives Our initial objective was to develop clinical research infrastructure preparatory to clinical trials, establish a JNCL research cohort, construct a disease-specific clinical outcome measure, and validate a non-invasive diagnostic sampling method. The long-term objective is to design and implement JNCL clinical trials. Methods The Unified Batten Disease Rating Scale (UBDRS) was developed. The Batten Disease Support and Research Association (BDSRA) referred participants; annual BDSRA meetings provided a mobile research setting for registry enrollment and UBDRS piloting. Neuropsychological examinations were performed, enabling external validation of the UBDRS. Buccal epithelial cell collection for genotyping was introduced. Telemedicine for remote UBDRS assessment was piloted. Results The registry enrolled 198 families representing 237 children with NCL. The UBDRS was piloted, validated and has been used to collect natural history data from 120 subjects. Funding and regulatory approval were obtained for a recently launched phase II clinical trial. Several additional lines of inquiry were reported. Conclusion The registry and BDSRA collaboration have enabled development of a clinical rating scale, natural history and neuropsychological studies, and genetic studies for disease confirmation. This work highlights an approach for preparatory natural history research and infrastructure development needed to facilitate efficient implementation of clinical trials in rare diseases. PMID:23628560

A Roadmap for Academic Health Centers to Establish Good Laboratory Practice-Compliant Infrastructure

PubMed Central

Adamo, Joan E.; Bauer, Gerhard; Berro, Marlene; Burnett, Bruce K.; Hartman, Karen A.; Masiello, Lisa M.; Moorman-White, Diane; Rubinstein, Eric P.; Schuff, Kathryn G.

2012-01-01

Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration (FDA) regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take prior to the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials. PMID:22373618

Primary care research--a blueprint for action for Singapore.

PubMed

Chuan, T N; Gan, G L

2001-01-01

Primary care research, hitherto overshadowed by research in the tertiary institutions, lacks impetus due to image, limitations of resources and poor infrastructure. This article looks into the current state of research development and the barriers. These hurdles can be overcome by a paradigm shift through the initiation of regular research meetings, training, infrastructure support and a collaborative research network to optimize time and resources. This will open the door to a wide field of primary care research, from basic, clinical research to health service and health system analysis and evaluation. Family physicians can tap on this opportunity to sharpen their critical appraisal skills through research, which can form an integral part of their continuous professional development. A network of pro-research family physicians will foster a vibrant research culture and pave the way to a renaissance of primary care research.

Standardized Cardiovascular Data for Clinical Research, Registries, and Patient Care

PubMed Central

Anderson, H. Vernon; Weintraub, William S.; Radford, Martha J.; Kremers, Mark S.; Roe, Matthew T.; Shaw, Richard E.; Pinchotti, Dana M.; Tcheng, James E.

2013-01-01

Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nevertheless these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the two major technical standards organizations in healthcare, the Clinical Data Interchange Standards Consortium and Health Level 7 International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care. PMID:23500238

2005 Tri-Service Infrastructure Systems Conference and Exhibition. Volume 13, Tracks 20, 21 and Workshop

DTIC Science & Technology

2005-08-04

Dennis Mekkers and Daniel M. Katz Current Research in Fate Current Research in Fate & Transport of Chemical and Biological Contaminants in Water... Grafenwoehr Health/Dental Clinic 33U.S. Army Health Facility Planning Agency • $58M in Construction, $86M in Design • 23 Projects in Pipeline • HFPA...Troop Medical Clinic Grafenwoehr Health/Dental Clinic 38U.S. Army Health Facility Planning Agency Army “Medical BRAC” Projects Afghanistan -- CPT

Sharing and reuse of individual participant data from clinical trials: principles and recommendations

PubMed Central

Ohmann, Christian; Banzi, Rita; Canham, Steve; Battaglia, Serena; Matei, Mihaela; Ariyo, Christopher; Becnel, Lauren; Bierer, Barbara; Bowers, Sarion; Clivio, Luca; Dias, Monica; Druml, Christiane; Faure, Hélène; Fenner, Martin; Galvez, Jose; Ghersi, Davina; Gluud, Christian; Houston, Paul; Karam, Ghassan; Kalra, Dipak; Krleža-Jerić, Karmela; Kubiak, Christine; Kuchinke, Wolfgang; Kush, Rebecca; Lukkarinen, Ari; Marques, Pedro Silverio; Newbigging, Andrew; O’Callaghan, Jennifer; Ravaud, Philippe; Schlünder, Irene; Shanahan, Daniel; Sitter, Helmut; Spalding, Dylan; Tudur-Smith, Catrin; van Reusel, Peter; van Veen, Evert-Ben; Visser, Gerben Rienk; Wilson, Julia; Demotes-Mainard, Jacques

2017-01-01

Objectives We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. Design and methods This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. Outcome We developed principles and practical recommendations on how to share data from clinical trials. Results The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata. Conclusions The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains. PMID:29247106

Building Infrastructure to Accelerate Transfer of Basic Research in Spinal Cord Injury (SCI) to Clinical Practice: North American Clinical Trials Network

DTIC Science & Technology

2013-08-01

RISCIS trial. 2. Participation by NACTN sites in the Novartis clinical trial of the monoclonal antibody to Nogo. Martin Schwab, PhD...Martha Horn and Simone Hirsch at Traumacenter, Murnau; Kristin Lorenz and Petra Schatz at Hohe Warte, Bayreuth. 8 Neurorehabilitation and Neural Repair

Modifying the clinical research infrastructure at a dedicated clinical trials unit: assessment of trial development, activation, and participant accrual

PubMed Central

Tang, Chad; Hess, Kenneth R.; Sanders, Dwana; Davis, Suzanne; Buzdar, Aman; Kurzrock, Razelle; Lee, J. Jack; Meric-Bernstam, Funda; Hong, David

2017-01-01

Purpose Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center and analyzed their effects on the trial activation timeline and enrollment. Experimental Design Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results We identified 3 facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship (industry [133 ICT and 133 non-ICT trials] or institutional [68 ICT and 68 non-ICT trials]). ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrollment (median difference of 0.3 months for industry vs. 1.2 months for institutional) (all matched P<0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional) (all matched P<0.05). Conclusions Use of a clinical research–focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. PMID:27852698

Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.

PubMed

Freedman, Andrew N; Sansbury, Leah B; Figg, William D; Potosky, Arnold L; Weiss Smith, Sheila R; Khoury, Muin J; Nelson, Stefanie A; Weinshilboum, Richard M; Ratain, Mark J; McLeod, Howard L; Epstein, Robert S; Ginsburg, Geoffrey S; Schilsky, Richard L; Liu, Geoffrey; Flockhart, David A; Ulrich, Cornelia M; Davis, Robert L; Lesko, Lawrence J; Zineh, Issam; Randhawa, Gurvaneet; Ambrosone, Christine B; Relling, Mary V; Rothman, Nat; Xie, Heng; Spitz, Margaret R; Ballard-Barbash, Rachel; Doroshow, James H; Minasian, Lori M

2010-11-17

Recent advances in genomic research have demonstrated a substantial role for genomic factors in predicting response to cancer therapies. Researchers in the fields of cancer pharmacogenomics and pharmacoepidemiology seek to understand why individuals respond differently to drug therapy, in terms of both adverse effects and treatment efficacy. To identify research priorities as well as the resources and infrastructure needed to advance these fields, the National Cancer Institute (NCI) sponsored a workshop titled "Cancer Pharmacogenomics: Setting a Research Agenda to Accelerate Translation" on July 21, 2009, in Bethesda, MD. In this commentary, we summarize and discuss five science-based recommendations and four infrastructure-based recommendations that were identified as a result of discussions held during this workshop. Key recommendations include 1) supporting the routine collection of germline and tumor biospecimens in NCI-sponsored clinical trials and in some observational and population-based studies; 2) incorporating pharmacogenomic markers into clinical trials; 3) addressing the ethical, legal, social, and biospecimen- and data-sharing implications of pharmacogenomic and pharmacoepidemiologic research; and 4) establishing partnerships across NCI, with other federal agencies, and with industry. Together, these recommendations will facilitate the discovery and validation of clinical, sociodemographic, lifestyle, and genomic markers related to cancer treatment response and adverse events, and they will improve both the speed and efficiency by which new pharmacogenomic and pharmacoepidemiologic information is translated into clinical practice.

Secondary Use of Clinical Data: the Vanderbilt Approach

PubMed Central

Danciu, Ioana; Cowan, James D.; Basford, Melissa; Wang, Xiaoming; Saip, Alexander; Osgood, Susan; Shirey-Rice, Jana; Kirby, Jacqueline; Harris, Paul A.

2014-01-01

The last decade has seen an exponential growth in the quantity of clinical data collected nationwide, triggering an increase in opportunities to reuse the data for biomedical research. The Vanderbilt research data warehouse framework consists of identified and de-identified clinical data repositories, fee-for-service custom services, and tools built atop the data layer to assist researchers across the enterprise. Providing resources dedicated to research initiatives benefits not only the research community, but also clinicians, patients and institutional leadership. This work provides a summary of our approach in the secondary use of clinical data for research domain, including a description of key components and a list of lessons learned, designed to assist others assembling similar services and infrastructure. PMID:24534443

S3DB core: a framework for RDF generation and management in bioinformatics infrastructures

PubMed Central

2010-01-01

Background Biomedical research is set to greatly benefit from the use of semantic web technologies in the design of computational infrastructure. However, beyond well defined research initiatives, substantial issues of data heterogeneity, source distribution, and privacy currently stand in the way towards the personalization of Medicine. Results A computational framework for bioinformatic infrastructure was designed to deal with the heterogeneous data sources and the sensitive mixture of public and private data that characterizes the biomedical domain. This framework consists of a logical model build with semantic web tools, coupled with a Markov process that propagates user operator states. An accompanying open source prototype was developed to meet a series of applications that range from collaborative multi-institution data acquisition efforts to data analysis applications that need to quickly traverse complex data structures. This report describes the two abstractions underlying the S3DB-based infrastructure, logical and numerical, and discusses its generality beyond the immediate confines of existing implementations. Conclusions The emergence of the "web as a computer" requires a formal model for the different functionalities involved in reading and writing to it. The S3DB core model proposed was found to address the design criteria of biomedical computational infrastructure, such as those supporting large scale multi-investigator research, clinical trials, and molecular epidemiology. PMID:20646315

The Electronic Data Methods (EDM) forum for comparative effectiveness research (CER).

PubMed

Holve, Erin; Segal, Courtney; Lopez, Marianne Hamilton; Rein, Alison; Johnson, Beth H

2012-07-01

AcademyHealth convened the Electronic Data Methods (EDM) Forum to collect, synthesize, and share lessons from eleven projects that are building infrastructure and using electronic clinical data for comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). This paper provides a brief review of participating projects and provides a framework of common challenges. EDM Forum staff conducted a text review of relevant grant programs' funding opportunity announcements; projects' research plans; and available information on projects' websites. Additional information was obtained from presentations provided by each project; phone calls with project principal investigators, affiliated partners, and staff from the Agency for Healthcare Research and Quality (AHRQ); and six site visits. Projects participating in the EDM Forum are building infrastructure and developing innovative strategies to address a set of methodological, and data and informatics challenges, here identified in a common framework. The eleven networks represent more than 20 states and include a range of partnership models. Projects vary substantially in size, from 11,000 to more than 7.5 million individuals. Nearly all of the AHRQ priority populations and conditions are addressed. In partnership with the projects, the EDM Forum is focused on identifying and sharing lessons learned to advance the national dialogue on the use of electronic clinical data to conduct CER and PCOR. These efforts have the shared goal of addressing challenges in traditional research studies and data sources, and aim to build infrastructure and generate evidence to support a learning health care system that can improve patient outcomes.

Integrated information systems for translational medicine.

PubMed

Winter, A; Funkat, G; Haeber, A; Mauz-Koerholz, C; Pommerening, K; Smers, S; Stausberg, J

2007-01-01

Translational medicine research needs a two-way information highway between 'bedside' and 'bench'. Unfortunately there are still weak links between successfully integrated information roads for bench, i.e. research networks, and bedside, i.e. regional or national health information systems. The question arises, what measures have to be taken to overcome the deficiencies. It is examined how patient care-related costs of clinical research can be separated and shared by health insurances, whether quality of patient care data is sufficient for research, how patient identity can be maintained without conflict to privacy, how care and research records can be archived, and how information systems for care and research can be integrated. Since clinical trials improve quality of care, insurers share parts of the costs. Quality of care data has to be improved by introducing minimum basic data sets. Pseudonymization solves the conflict between needs for patient identity and privacy. Archiving patient care records and research records is similar and XML and CDISC can be used. Principles of networking infrastructures for care and research still differ. They have to be bridged first and harmonized later. To link information systems for care (bed) and for research (bench) needs technical infrastructures as well as economic and organizational regulations.

Experimental and clinical psychopharmacology: National Institute on Drug Abuse's clinical research agenda.

PubMed

Leshner, Alan I

2002-08-01

Studies of drugs and behavior are a core component of virtually every portfolio within the broad purview of the National Institute on Drug Abuse (NIDA). Moreover, psychopharmacological research is an important vehicle for advancing understanding of how drugs of abuse produce their effects, particularly including addiction. However, as with all major public health issues, simply understanding the issue is not enough. NIDA's psychopharmacology projects, therefore, span basic, clinical, and applied (e.g., medication development) research activities. These include the establishment of a nationwide clinical trials network designed to provide an infrastructure to test both behavioral and psychopharmacological treatments in a real-life practice setting with diverse patients.

The biobank for the molecular classification of kidney disease: research translation and precision medicine in nephrology.

PubMed

Muruve, Daniel A; Mann, Michelle C; Chapman, Kevin; Wong, Josee F; Ravani, Pietro; Page, Stacey A; Benediktsson, Hallgrimur

2017-07-26

Advances in technology and the ability to interrogate disease pathogenesis using systems biology approaches are exploding. As exemplified by the substantial progress in the personalized diagnosis and treatment of cancer, the application of systems biology to enable precision medicine in other disciplines such as Nephrology is well underway. Infrastructure that permits the integration of clinical data, patient biospecimens and advanced technologies is required for institutions to contribute to, and benefit from research in molecular disease classification and to devise specific and patient-oriented treatments. We describe the establishment of the Biobank for the Molecular Classification of Kidney Disease (BMCKD) at the University of Calgary, Alberta, Canada. The BMCKD consists of a fully equipped wet laboratory, an information technology infrastructure, and a formal operational, ethical and legal framework for banking human biospecimens and storing clinical data. The BMCKD first consolidated a large retrospective cohort of kidney biopsy specimens to create a population-based renal pathology database and tissue inventory of glomerular and other kidney diseases. The BMCKD will continue to prospectively bank all kidney biopsies performed in Southern Alberta. The BMCKD is equipped to perform molecular, clinical and epidemiologic studies in renal pathology. The BMCKD also developed formal biobanking procedures for human specimens such as blood, urine and nucleic acids collected for basic and clinical research studies or for advanced diagnostic technologies in clinical care. The BMCKD is guided by standard operating procedures, an ethics framework and legal agreements with stakeholders that include researchers, data custodians and patients. The design and structure of the BMCKD permits its inclusion in a wide variety of research and clinical activities. The BMCKD is a core multidisciplinary facility that will bridge basic and clinical research and integrate precision medicine into renal pathology and nephrology.

The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned

PubMed Central

Shapiro, Mark; Silva, Susan G; Compton, Scott; Chrisman, Allan; DeVeaugh-Geiss, Joseph; Breland-Noble, Alfiee; Kondo, Douglas; Kirchner, Jerry; March, John S

2009-01-01

Background In 2003, the National Institute of Mental Health funded the Child and Adolescent Psychiatry Trials Network (CAPTN) under the Advanced Center for Services and Intervention Research (ACSIR) mechanism. At the time, CAPTN was believed to be both a highly innovative undertaking and a highly speculative one. One reviewer even suggested that CAPTN was "unlikely to succeed, but would be a valuable learning experience for the field." Objective To describe valuable lessons learned in building a clinical research network in pediatric psychiatry, including innovations intended to decrease barriers to research participation. Methods The CAPTN Team has completed construction of the CAPTN network infrastructure, conducted a large, multi-center psychometric study of a novel adverse event reporting tool, and initiated a large antidepressant safety registry and linked pharmacogenomic study focused on severe adverse events. Specific challenges overcome included establishing structures for network organization and governance; recruiting over 150 active CAPTN participants and 15 child psychiatry training programs; developing and implementing procedures for site contracts, regulatory compliance, indemnification and malpractice coverage, human subjects protection training and IRB approval; and constructing an innovative electronic casa report form (eCRF) running on a web-based electronic data capture system; and, finally, establishing procedures for audit trail oversight requirements put forward by, among others, the Food and Drug Administration (FDA). Conclusion Given stable funding for network construction and maintenance, our experience demonstrates that judicious use of web-based technologies for profiling investigators, investigator training, and capturing clinical trials data, when coupled to innovative approaches to network governance, data management and site management, can reduce the costs and burden and improve the feasibility of incorporating clinical research into routine clinical practice. Having successfully achieved its initial aim of constructing a network infrastructure, CAPTN is now a capable platform for large safety registries, pharmacogenetic studies, and randomized practical clinical trials in pediatric psychiatry. PMID:19320979

Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women).

PubMed

Hess, Connie N; Rao, Sunil V; Kong, David F; Aberle, Laura H; Anstrom, Kevin J; Gibson, C Michael; Gilchrist, Ian C; Jacobs, Alice K; Jolly, Sanjit S; Mehran, Roxana; Messenger, John C; Newby, L Kristin; Waksman, Ron; Krucoff, Mitchell W

2013-09-01

Women are at higher risk than men for bleeding and vascular complications after percutaneous coronary intervention (PCI). Compared with femoral access, radial access reduces these complications but may be more challenging in women because of higher rates of radial artery spasm, tortuosity, and occlusion as well as lower rates of procedure success. Whether the safety advantages of radial versus femoral access in women undergoing PCI are outweighed by reduced effectiveness has not been studied. The Study of Access site For Enhancement of PCI for Women is a prospective, randomized clinical trial comparing radial with femoral arterial access in women undergoing PCI. In conjunction with the US Food and Drug Administration's Critical Path Cardiac Safety Research Consortium, this study embeds the randomized clinical trial into the existing infrastructure of the National Cardiovascular Data Registry CathPCI Registry through the National Institute of Health's National Cardiovascular Research Infrastructure. The primary efficacy end point is a composite of bleeding (Bleeding Academic Research Consortium types 2, 3, or 5) or vascular complication requiring intervention occurring at 72 hours after PCI or by hospital discharge. The primary feasibility end point is procedure success. Secondary end points include procedure duration, contrast volume, radiation dose, quality of life, and a composite of 30-day death, vascular complication, or unplanned revascularization. © 2013.

Implementation of a health data-sharing infrastructure across diverse primary care organizations.

PubMed

Cole, Allison M; Stephens, Kari A; Keppel, Gina A; Lin, Ching-Ping; Baldwin, Laura-Mae

2014-01-01

Practice-based research networks bring together academic researchers and primary care clinicians to conduct research that improves health outcomes in real-world settings. The Washington, Wyoming, Alaska, Montana, and Idaho region Practice and Research Network implemented a health data-sharing infrastructure across 9 clinics in 3 primary care organizations. Following implementation, we identified challenges and solutions. Challenges included working with diverse primary care organizations, adoption of health information data-sharing technology in a rapidly changing local and national landscape, and limited resources for implementation. Overarching solutions included working with a multidisciplinary academic implementation team, maintaining flexibility, and starting with an established network for primary care organizations. Approaches outlined may generalize to similar initiatives and facilitate adoption of health data sharing in other practice-based research networks.

Implementation of a Health Data-Sharing Infrastructure Across Diverse Primary Care Organizations

PubMed Central

Cole, Allison M.; Stephens, Kari A.; Keppel, Gina A.; Lin, Ching-Ping; Baldwin, Laura-Mae

2014-01-01

Practice-based research networks bring together academic researchers and primary care clinicians to conduct research that improves health outcomes in real-world settings. The Washington, Wyoming, Alaska, Montana, and Idaho region Practice and Research Network implemented a health data-sharing infrastructure across 9 clinics in 3 primary care organizations. Following implementation, we identified challenges and solutions. Challenges included working with diverse primary care organizations, adoption of health information data-sharing technology in a rapidly changing local and national landscape, and limited resources for implementation. Overarching solutions included working with a multidisciplinary academic implementation team, maintaining flexibility, and starting with an established network for primary care organizations. Approaches outlined may generalize to similar initiatives and facilitate adoption of health data sharing in other practice-based research networks. PMID:24594564

Clinical Trials Network / Building Infrastructure to Accelerate Transfer of Basic Research in Spinal Cord Injury (SCI) to Clinical Practice

DTIC Science & Technology

2015-05-01

Glasgow Coma Scale (GCS) and of associated injuries with the Abbreviated Injury Scale . The American Spinal Injury Association impairment scale (AIS) is...registry protocol includes: the AIS Impairment Scale , and where appropriate, the Functional Independence Measure FIM™, the Spinal Cord Independence...have been achieved with the registry. Enrollment of 762 participants has demonstrated that is feasible to acquire prospective standardized research

Improving Defense Health Program Medical Research Processes

DTIC Science & Technology

2017-08-08

needed for DHP medical research , such as the Army’s Clinical and Translational Research Program Office, 38 the Navy’s Research Methods Training Program... research stated, “key infrastructure for a learning health system will encompass three core elements: data networks, methods , and workforce.” 221 A 2012... Research Methods Training Program, 132 which will be further discussed in Appendix D.2. AIR FORCE Air Force Instruction 40-402, Protection of

Novel infrastructure for sepsis biomarker research in critically ill neonates and children.

PubMed

Juskewitch, Justin E; Enders, Felicity T; Abraham, Roshini S; Huskins, W Charles

2013-02-01

Sepsis biomarker research requires an infrastructure to identify septic patients efficiently and to collect and store specimens properly. We developed a novel infrastructure to study biomarkers of sepsis in children. Patients in pediatric and neonatal intensive care units were enrolled prospectively; enrollment information was stored in a secure, remotely accessible database. Researchers were notified of electronic medical record (EMR) orders for blood cultures (a surrogate for a diagnostic evaluation of suspected sepsis) by a page triggered by the order. Staff confirmed patient enrollment and remotely submitted an EMR order for collection of study specimens simultaneous with the blood culture. Specimens were processed and stored by a mobile clinical research unit. Over 2 years, 2029 patients were admitted; 138 were enrolled. Staff received pages for 95% of blood cultures collected from enrolled patients. The median time between the blood culture order and collection was 34 minutes (range 9-241). Study specimens were collected simultaneously with 41 blood cultures. The median times between specimen collection and storage for flow cytometry and cytokine analysis were 33 minutes (range 0-82) and 52 minutes (range 28-98), respectively. This novel infrastructure facilitated prompt, proper collection and storage of specimens for sepsis biomarker analysis. © 2013 Wiley Periodicals, Inc.

Monitoring Artificial Pancreas Trials Through Agent-based Technologies

PubMed Central

Scarpellini, Stefania; Di Palma, Federico; Toffanin, Chiara; Del Favero, Simone; Magni, Lalo; Bellazzi, Riccardo

2014-01-01

The increase in the availability and reliability of network connections lets envision systems supporting a continuous remote monitoring of clinical parameters useful either for overseeing chronic diseases or for following clinical trials involving outpatients. We report here the results achieved by a telemedicine infrastructure that has been linked to an artificial pancreas platform and used during a trial of the AP@home project, funded by the European Union. The telemedicine infrastructure is based on a multiagent paradigm and is able to deliver to the clinic any information concerning the patient status and the operation of the artificial pancreas. A web application has also been developed, so that the clinic staff and the researchers involved in the design of the blood glucose control algorithms are able to follow the ongoing experiments. Albeit the duration of the experiments in the trial discussed in the article was limited to only 2 days, the system proved to be successful for monitoring patients, in particular overnight when the patients are sleeping. Based on that outcome we can conclude that the infrastructure is suitable for the purpose of accomplishing an intelligent monitoring of an artificial pancreas either during longer trials or whenever that system will be used as a routine treatment. PMID:24876570

Partnership between CTSI and Business Schools Can Promote Best Practices for Core Facilities and Resources

PubMed Central

Reeves, Lilith; Dunn‐Jensen, Linda M.; Baldwin, Timothy T.; Tatikonda, Mohan V.

2013-01-01

Abstract Biomedical research enterprises require a large number of core facilities and resources to supply the infrastructure necessary for translational research. Maintaining the financial viability and promoting efficiency in an academic environment can be particularly challenging for medical schools and universities. The Indiana Clinical and Translational Sciences Institute sought to improve core and service programs through a partnership with the Indiana University Kelley School of Business. The program paired teams of Masters of Business Administration students with cores and programs that self‐identified the need for assistance in project management, financial management, marketing, or resource efficiency. The projects were developed by CTSI project managers and business school faculty using service‐learning principles to ensure learning for students who also received course credit for their participation. With three years of experience, the program demonstrates a successful partnership that improves clinical research infrastructure by promoting business best practices and providing a valued learning experience for business students. PMID:23919365

Partnership between CTSI and business schools can promote best practices for core facilities and resources.

PubMed

Reeves, Lilith; Dunn-Jensen, Linda M; Baldwin, Timothy T; Tatikonda, Mohan V; Cornetta, Kenneth

2013-08-01

Biomedical research enterprises require a large number of core facilities and resources to supply the infrastructure necessary for translational research. Maintaining the financial viability and promoting efficiency in an academic environment can be particularly challenging for medical schools and universities. The Indiana Clinical and Translational Sciences Institute sought to improve core and service programs through a partnership with the Indiana University Kelley School of Business. The program paired teams of Masters of Business Administration students with cores and programs that self-identified the need for assistance in project management, financial management, marketing, or resource efficiency. The projects were developed by CTSI project managers and business school faculty using service-learning principles to ensure learning for students who also received course credit for their participation. With three years of experience, the program demonstrates a successful partnership that improves clinical research infrastructure by promoting business best practices and providing a valued learning experience for business students. © 2013 Wiley Periodicals, Inc.

Clinical Research: A Globalized Network

PubMed Central

Richter, Trevor A.

2014-01-01

Clinical research has become increasingly globalized, but the extent of globalization has not been assessed. To describe the globalization of clinical research, we used all (n = 13,208) multinational trials registered at ClinicalTrials.gov to analyzed geographic connections among individual countries. Our findings indicate that 95% (n = 185) of all countries worldwide have participated in multinational clinical research. Growth in the globalization of clinical research peaked in 2009, suggesting that the global infrastructure that supports clinical research might have reached its maximum capacity. Growth in the globalization of clinical research is attributable to increased involvement of non-traditional markets, particularly in South America and Asia. Nevertheless, Europe is the most highly interconnected geographic region (60.64% of global connections), and collectively, Europe, North America, and Asia comprise more than 85% of all global connections. Therefore, while the expansion of clinical trials into non-traditional markets has increased over the last 20 years and connects countries across the globe, traditional markets still dominate multinational clinical research, which appears to have reached a maximum global capacity. PMID:25517976

NIPTE: a multi-university partnership supporting academic drug development.

PubMed

Gurvich, Vadim J; Byrn, Stephen R

2013-10-01

The strategic goal of academic translational research is to accelerate translational science through the improvement and development of resources for moving discoveries across translational barriers through 'first in humans' studies. To achieve this goal, access to drug discovery resources and preclinical IND-enabling infrastructure is crucial. One potential approach of research institutions for coordinating preclinical development, based on a model from the National Institute for Pharmaceutical Technology and Education (NIPTE), can provide academic translational and medical centers with access to a wide variety of enabling infrastructure for developing small molecule clinical candidates in an efficient, cost-effective manner. Copyright © 2013 Elsevier Ltd. All rights reserved.

Infrastructure and distributed learning methodology for privacy-preserving multi-centric rapid learning health care: euroCAT.

PubMed

Deist, Timo M; Jochems, A; van Soest, Johan; Nalbantov, Georgi; Oberije, Cary; Walsh, Seán; Eble, Michael; Bulens, Paul; Coucke, Philippe; Dries, Wim; Dekker, Andre; Lambin, Philippe

2017-06-01

Machine learning applications for personalized medicine are highly dependent on access to sufficient data. For personalized radiation oncology, datasets representing the variation in the entire cancer patient population need to be acquired and used to learn prediction models. Ethical and legal boundaries to ensure data privacy hamper collaboration between research institutes. We hypothesize that data sharing is possible without identifiable patient data leaving the radiation clinics and that building machine learning applications on distributed datasets is feasible. We developed and implemented an IT infrastructure in five radiation clinics across three countries (Belgium, Germany, and The Netherlands). We present here a proof-of-principle for future 'big data' infrastructures and distributed learning studies. Lung cancer patient data was collected in all five locations and stored in local databases. Exemplary support vector machine (SVM) models were learned using the Alternating Direction Method of Multipliers (ADMM) from the distributed databases to predict post-radiotherapy dyspnea grade [Formula: see text]. The discriminative performance was assessed by the area under the curve (AUC) in a five-fold cross-validation (learning on four sites and validating on the fifth). The performance of the distributed learning algorithm was compared to centralized learning where datasets of all institutes are jointly analyzed. The euroCAT infrastructure has been successfully implemented in five radiation clinics across three countries. SVM models can be learned on data distributed over all five clinics. Furthermore, the infrastructure provides a general framework to execute learning algorithms on distributed data. The ongoing expansion of the euroCAT network will facilitate machine learning in radiation oncology. The resulting access to larger datasets with sufficient variation will pave the way for generalizable prediction models and personalized medicine.

Sharing and reuse of individual participant data from clinical trials: principles and recommendations.

PubMed

Ohmann, Christian; Banzi, Rita; Canham, Steve; Battaglia, Serena; Matei, Mihaela; Ariyo, Christopher; Becnel, Lauren; Bierer, Barbara; Bowers, Sarion; Clivio, Luca; Dias, Monica; Druml, Christiane; Faure, Hélène; Fenner, Martin; Galvez, Jose; Ghersi, Davina; Gluud, Christian; Groves, Trish; Houston, Paul; Karam, Ghassan; Kalra, Dipak; Knowles, Rachel L; Krleža-Jerić, Karmela; Kubiak, Christine; Kuchinke, Wolfgang; Kush, Rebecca; Lukkarinen, Ari; Marques, Pedro Silverio; Newbigging, Andrew; O'Callaghan, Jennifer; Ravaud, Philippe; Schlünder, Irene; Shanahan, Daniel; Sitter, Helmut; Spalding, Dylan; Tudur-Smith, Catrin; van Reusel, Peter; van Veen, Evert-Ben; Visser, Gerben Rienk; Wilson, Julia; Demotes-Mainard, Jacques

2017-12-14

We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. We developed principles and practical recommendations on how to share data from clinical trials. The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata. The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium: Reaching in Partnership for Optimal Orthopaedic Rehabilitation Outcomes

PubMed Central

Stanhope, Steven J.; Wilken, Jason M.; Pruziner, Alison L.; Dearth, Christopher L.; Wyatt, Marilynn; Ziemke, CAPT Gregg W.; Strickland, Rachel; Milbourne, Suzanne A.; Kaufman, Kenton R.

2017-01-01

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium began in September 2011 as a cooperative agreement with the Department of Defense (DoD) Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program. A partnership was formed with DoD Military Treatment Facilities (MTFs), U.S. Department of Veterans Affairs (VA) Centers, the National Institutes of Health (NIH), academia, and industry to rapidly conduct innovative, high-impact, and sustainable clinically relevant research. The BADER Consortium has a unique research capacity-building focus that creates infrastructures and strategically connects and supports research teams to conduct multiteam research initiatives primarily led by MTF and VA investigators. BADER relies on strong partnerships with these agencies to strengthen and support orthopaedic rehabilitation research. Its focus is on the rapid forming and execution of projects focused on obtaining optimal functional outcomes for patients with limb loss and limb injuries. The Consortium is based on an NIH research capacity-building model that comprises essential research support components that are anchored by a set of BADER-funded and initiative-launching studies. Through a partnership with the DoD/VA Extremity Trauma and Amputation Center of Excellence, the BADER Consortium’s research initiative-launching program has directly supported the identification and establishment of eight BADER-funded clinical studies. BADER’s Clinical Research Core (CRC) staff, who are embedded within each of the MTFs, have supported an additional 37 non-BADER Consortium-funded projects. Additional key research support infrastructures that expedite the process for conducting multisite clinical trials include an omnibus Cooperative Research and Development Agreement and the NIH Clinical Trials Database. A 2015 Defense Health Board report highlighted the Consortium’s vital role, stating the research capabilities of the DoD Advanced Rehabilitation Centers are significantly enhanced and facilitated by the BADER Consortium. PMID:27849456

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium: Reaching in Partnership for Optimal Orthopaedic Rehabilitation Outcomes.

PubMed

Stanhope, Steven J; Wilken, Jason M; Pruziner, Alison L; Dearth, Christopher L; Wyatt, Marilynn; Ziemke, Gregg W; Strickland, Rachel; Milbourne, Suzanne A; Kaufman, Kenton R

2016-11-01

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium began in September 2011 as a cooperative agreement with the Department of Defense (DoD) Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program. A partnership was formed with DoD Military Treatment Facilities (MTFs), U.S. Department of Veterans Affairs (VA) Centers, the National Institutes of Health (NIH), academia, and industry to rapidly conduct innovative, high-impact, and sustainable clinically relevant research. The BADER Consortium has a unique research capacity-building focus that creates infrastructures and strategically connects and supports research teams to conduct multiteam research initiatives primarily led by MTF and VA investigators.BADER relies on strong partnerships with these agencies to strengthen and support orthopaedic rehabilitation research. Its focus is on the rapid forming and execution of projects focused on obtaining optimal functional outcomes for patients with limb loss and limb injuries. The Consortium is based on an NIH research capacity-building model that comprises essential research support components that are anchored by a set of BADER-funded and initiative-launching studies. Through a partnership with the DoD/VA Extremity Trauma and Amputation Center of Excellence, the BADER Consortium's research initiative-launching program has directly supported the identification and establishment of eight BADER-funded clinical studies. BADER's Clinical Research Core (CRC) staff, who are embedded within each of the MTFs, have supported an additional 37 non-BADER Consortium-funded projects. Additional key research support infrastructures that expedite the process for conducting multisite clinical trials include an omnibus Cooperative Research and Development Agreement and the NIH Clinical Trials Database. A 2015 Defense Health Board report highlighted the Consortium's vital role, stating the research capabilities of the DoD Advanced Rehabilitation Centers are significantly enhanced and facilitated by the BADER Consortium. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

About BTTC | Center for Cancer Research

Cancer.gov

About Combined Forces Drive BTTC The Brain Tumor Trials Collaborative (BTTC) was created in 2003 - a combined effort of many professionals, entities and organizations to help those suffering from brain tumors. The National Cancer Institute's (NCI) Center for Cancer Research serves as the lead institution and provides the administrative infrastructure, clinical database and

Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure.

PubMed

Joseph, Christine Lm; Ownby, Dennis R; Zoratti, Edward; Johnson, Dayna; Considine, Shannon; Bourgeois, Renee; Melkonian, Christina; Miree, Cheryl; Johnson, Christine Cole; Lu, Mei

2016-01-01

Modernized approaches to multisite randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in "real life" settings. We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma. Using encounter and prescription databases, a list of potentially-eligible patients was linked to the Epic appointment scheduling system. Patients were enrolled during a scheduled visit and then electronically randomized to a tailored versus generic online intervention. 1146 appointments for 580 eligible patients visiting 5 clinics were identified, of which 45.9% (266/580) were randomized to reach targeted enrollment (n=250). RDC facilitated multisite enrollment. Intervention content was further personalized through real- time entry of asthma medications prescribed at the clinic visit. EMR monitoring helped with recruitment trouble-shooting. Systemic challenges included a system-wide EMR transition and a system-wide reorganization of clinic staffing. Modernized RCTs can accelerate translation of research findings. Electronic initiatives facilitated implementation of this RCT; however, adaptations to recruitment strategies resulted in a more "explanatory" framework. .

Developing a clinical trial unit to advance research in an academic institution.

PubMed

Croghan, Ivana T; Viker, Steven D; Limper, Andrew H; Evans, Tamara K; Cornell, Alissa R; Ebbert, Jon O; Gertz, Morie A

2015-11-01

Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit. Copyright © 2015 Mayo Clinic. Published by Elsevier Inc. All rights reserved.

The impact of clinical research activities on communities in rural Africa: the development of the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso.

PubMed

Tinto, Halidou; Valea, Innocent; Sorgho, Hermann; Tahita, Marc Christian; Traore, Maminata; Bihoun, Biébo; Guiraud, Issa; Kpoda, Hervé; Rouamba, Jérémi; Ouédraogo, Sayouba; Lompo, Palpouguini; Yara, Sandrine; Kabore, William; Ouédraogo, Jean-Bosco; Guiguemdé, Robert Tinga; Binka, Fred N; Ogutu, Bernhards

2014-03-22

The opportunities for developing new drugs and vaccines for malaria control look brighter now than ten years ago. However, there are few places in sub-Saharan Africa with the necessary infrastructure and expertise to support such research in compliance to international standards of clinical research (ICH-GCP). The Clinical Research Unit of Nanoro (CRUN) was founded in 2008 to provide a much-needed GCP-compliant clinical trial platform for an imminent large-scale Phase 3 malaria vaccine trial. A dynamic approach was used that entailed developing the required infrastructure and human resources, while engaging local communities in the process as key stakeholders. This provided a better understanding and ownership of the research activities by the local population. Within five years (2008-2013), the CRUN set up a fully and well-equipped GCP-compliant clinical trial research facility, which enabled to attract 25 grants. The research team grew from ten health workers prior to 2008 to 254 in 2013. A Health and Demographic Surveillance System (HDSS), which covers a total population of about 60,000 people in 24 villages was set up in the district. The local community contributed to the development of the facility through the leadership of the king and the mayor of Nanoro. As a result of their active advocacy, the government extended the national electrical grid to the new research center, and later to the entire village. This produced a positive impact on the community's quality of life. The quality of health care improved substantially, due to the creation of more elaborate clinical laboratory services and the acquisition of state-of-the-art equipment. Involving the community in the key steps of establishing the centre provided the foundation for what was to become the CRUN success story. This experience demonstrates that when clinical trials research sites are carefully developed and implemented, they can have a positive and powerful impact on local communities in resource-poor settings, well beyond the task of generating expected study data.

@neurIST: infrastructure for advanced disease management through integration of heterogeneous data, computing, and complex processing services.

PubMed

Benkner, Siegfried; Arbona, Antonio; Berti, Guntram; Chiarini, Alessandro; Dunlop, Robert; Engelbrecht, Gerhard; Frangi, Alejandro F; Friedrich, Christoph M; Hanser, Susanne; Hasselmeyer, Peer; Hose, Rod D; Iavindrasana, Jimison; Köhler, Martin; Iacono, Luigi Lo; Lonsdale, Guy; Meyer, Rodolphe; Moore, Bob; Rajasekaran, Hariharan; Summers, Paul E; Wöhrer, Alexander; Wood, Steven

2010-11-01

The increasing volume of data describing human disease processes and the growing complexity of understanding, managing, and sharing such data presents a huge challenge for clinicians and medical researchers. This paper presents the @neurIST system, which provides an infrastructure for biomedical research while aiding clinical care, by bringing together heterogeneous data and complex processing and computing services. Although @neurIST targets the investigation and treatment of cerebral aneurysms, the system's architecture is generic enough that it could be adapted to the treatment of other diseases. Innovations in @neurIST include confining the patient data pertaining to aneurysms inside a single environment that offers clinicians the tools to analyze and interpret patient data and make use of knowledge-based guidance in planning their treatment. Medical researchers gain access to a critical mass of aneurysm related data due to the system's ability to federate distributed information sources. A semantically mediated grid infrastructure ensures that both clinicians and researchers are able to seamlessly access and work on data that is distributed across multiple sites in a secure way in addition to providing computing resources on demand for performing computationally intensive simulations for treatment planning and research.

Knowledge Translation in Rehabilitation: A Shared Vision.

PubMed

Moore, Jennifer L; Shikako-Thomas, Keiko; Backus, Deborah

2017-07-01

Advances in rehabilitation provide the infrastructure for research and clinical data to improve care and patient outcomes. However, gaps between research and practice are prevalent. Knowledge translation (KT) aims to decrease the gap between research and its clinical use. This special communication summarizes KT-related proceedings from the 2016 IV STEP conference, describes current KT in rehabilitation science, and provides suggestions for its application in clinical care. We propose a vision for rehabilitation clinical practice and research that includes the development, adaptation, and implementation of evidence-based practice recommendations, which will contribute to a learning health care system. A clinical research culture that supports this vision and methods to engage key stakeholders to innovate rehabilitation science and practice are described. Through implementation of this vision, we can lead an evolution in rehabilitation practice to ultimately prevent disabilities, predict better outcomes, exploit plasticity, and promote participation.

Foundational biomedical informatics research in the clinical and translational science era: a call to action.

PubMed

Payne, Philip R O; Embi, Peter J; Niland, Joyce

2010-01-01

Advances in clinical and translational science, along with related national-scale policy and funding mechanisms, have provided significant opportunities for the advancement of applied clinical research informatics (CRI) and translational bioinformatics (TBI). Such efforts are primarily oriented to application and infrastructure development and are critical to the conduct of clinical and translational research. However, they often come at the expense of the foundational CRI and TBI research needed to grow these important biomedical informatics subdisciplines and ensure future innovations. In light of this challenge, it is critical that a number of steps be taken, including the conduct of targeted advocacy campaigns, the development of community-accepted research agendas, and the continued creation of forums for collaboration and knowledge exchange. Such efforts are needed to ensure that the biomedical informatics community is able to advance CRI and TBI science in the context of the modern clinical and translational science era.

Standard requirements for GCP-compliant data management in multinational clinical trials.

PubMed

Ohmann, Christian; Kuchinke, Wolfgang; Canham, Steve; Lauritsen, Jens; Salas, Nader; Schade-Brittinger, Carmen; Wittenberg, Michael; McPherson, Gladys; McCourt, John; Gueyffier, Francois; Lorimer, Andrea; Torres, Ferràn

2011-03-22

A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit. Section IN01 is dedicated to international aspects and ST01 to the competence of a trials unit's staff. The standard is intended to provide an open and widely used set of requirements for GCP-compliant data management, particularly in academic trial units. It is the intention that ECRIN will use these requirements as the basis for the certification of ECRIN data centres.

Clinical trial network for the promotion of clinical research for rare diseases in Japan: muscular dystrophy clinical trial network.

PubMed

Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi

2016-07-11

Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to an improvement of neuromuscular disease treatment in Japan.

Developing a European grid infrastructure for cancer research: vision, architecture and services

PubMed Central

Tsiknakis, M; Rueping, S; Martin, L; Sfakianakis, S; Bucur, A; Sengstag, T; Brochhausen, M; Pucaski, J; Graf, N

2007-01-01

Life sciences are currently at the centre of an information revolution. The nature and amount of information now available opens up areas of research that were once in the realm of science fiction. During this information revolution, the data-gathering capabilities have greatly surpassed the data-analysis techniques. Data integration across heterogeneous data sources and data aggregation across different aspects of the biomedical spectrum, therefore, is at the centre of current biomedical and pharmaceutical R&D. This paper reports on original results from the ACGT integrated project, focusing on the design and development of a European Biomedical Grid infrastructure in support of multi-centric, post-genomic clinical trials (CTs) on cancer. Post-genomic CTs use multi-level clinical and genomic data and advanced computational analysis and visualization tools to test hypotheses in trying to identify the molecular reasons for a disease and the stratification of patients in terms of treatment. The paper provides a presentation of the needs of users involved in post-genomic CTs and presents indicative scenarios, which drive the requirements of the engineering phase of the project. Subsequently, the initial architecture specified by the project is presented, and its services are classified and discussed. A range of such key services, including the Master Ontology on sCancer, which lie at the heart of the integration architecture of the project, is presented. Special efforts have been taken to describe the methodological and technological framework of the project, enabling the creation of a legally compliant and trustworthy infrastructure. Finally, a short discussion of the forthcoming work is included, and the potential involvement of the cancer research community in further development or utilization of the infrastructure is described. PMID:22275955

About BTTC | Center for Cancer Research

Cancer.gov

About Combined Forces Drive BTTC The Brain Tumor Trials Collaborative (BTTC) was created in 2003 - a combined effort of many professionals, entities and organizations to help those suffering from brain tumors. The National Cancer Institute's (NCI) Center for Cancer Research serves as the lead institution and provides the administrative infrastructure, clinical database and oversight for the collaborative.

Towards public health decision support: a systematic review of bidirectional communication approaches.

PubMed

Dixon, Brian E; Gamache, Roland E; Grannis, Shaun J

2013-05-01

To summarize the literature describing computer-based interventions aimed at improving bidirectional communication between clinical and public health. A systematic review of English articles using MEDLINE and Google Scholar. Search terms included public health, epidemiology, electronic health records, decision support, expert systems, and decision-making. Only articles that described the communication of information regarding emerging health threats from public health agencies to clinicians or provider organizations were included. Each article was independently reviewed by two authors. Ten peer-reviewed articles highlight a nascent but promising area of research and practice related to alerting clinicians about emerging threats. Current literature suggests that additional research and development in bidirectional communication infrastructure should focus on defining a coherent architecture, improving interoperability, establishing clear governance, and creating usable systems that will effectively deliver targeted, specific information to clinicians in support of patient and population decision-making. Increasingly available clinical information systems make it possible to deliver timely, relevant knowledge to frontline clinicians in support of population health. Future work should focus on developing a flexible, interoperable infrastructure for bidirectional communications capable of integrating public health knowledge into clinical systems and workflows.

Using the LOINC Semantic Structure to Integrate Community-based Survey Items into a Concept-based Enterprise Data Dictionary to Support Comparative Effectiveness Research.

PubMed

Co, Manuel C; Boden-Albala, Bernadette; Quarles, Leigh; Wilcox, Adam; Bakken, Suzanne

2012-01-01

In designing informatics infrastructure to support comparative effectiveness research (CER), it is necessary to implement approaches for integrating heterogeneous data sources such as clinical data typically stored in clinical data warehouses and those that are normally stored in separate research databases. One strategy to support this integration is the use of a concept-oriented data dictionary with a set of semantic terminology models. The aim of this paper is to illustrate the use of the semantic structure of Clinical LOINC (Logical Observation Identifiers, Names, and Codes) in integrating community-based survey items into the Medical Entities Dictionary (MED) to support the integration of survey data with clinical data for CER studies.

caGrid 1.0 : an enterprise Grid infrastructure for biomedical research.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oster, S.; Langella, S.; Hastings, S.

To develop software infrastructure that will provide support for discovery, characterization, integrated access, and management of diverse and disparate collections of information sources, analysis methods, and applications in biomedical research. Design: An enterprise Grid software infrastructure, called caGrid version 1.0 (caGrid 1.0), has been developed as the core Grid architecture of the NCI-sponsored cancer Biomedical Informatics Grid (caBIG{trademark}) program. It is designed to support a wide range of use cases in basic, translational, and clinical research, including (1) discovery, (2) integrated and large-scale data analysis, and (3) coordinated study. Measurements: The caGrid is built as a Grid software infrastructure andmore » leverages Grid computing technologies and the Web Services Resource Framework standards. It provides a set of core services, toolkits for the development and deployment of new community provided services, and application programming interfaces for building client applications. Results: The caGrid 1.0 was released to the caBIG community in December 2006. It is built on open source components and caGrid source code is publicly and freely available under a liberal open source license. The core software, associated tools, and documentation can be downloaded from the following URL: .« less

International Neurocognitive Normative Study: Neurocognitive Comparison Data in Diverse Resource Limited Settings: AIDS Clinical Trials Group A5271

PubMed Central

Robertson, K; Jiang, H; Evans, SR; Marra, CM; Berzins, B; Hakim, J; Sacktor, N; Silva, M Tulius; Campbell, TB; Nair, A; Schouten, J; Kumwenda, J; Supparatpinyo, K; Tripathy, S.; Kumarasamy, N; La Rosa, A; Montano, S; Mwafongo, A; Firnhaber, C; Sanne, I; Naini, L.; Amod, F; Walawander, A

2016-01-01

Summary ACTG A5271 collected neurocognitive normative comparison test data in 2400 at-risk HIV seronegative participants from Brazil, India, Malawi, Peru, South Africa, Thailand and Zimbabwe. The participants were enrolled in strata by site (10 levels), age (2 levels), education (2 levels), and gender (2 levels). These data provide necessary normative data infrastructure for future clinical research and care in these diverse resource limited settings. Infrastructure for conducting neurological research in resource limited settings (RLS) is limited. The lack of neurological and neuropsychological (NP) assessment, and normative data needed for clinical interpretation impede research and clinical care. Here we report on ACTG 5271, which provided neurological training of clinical site personnel, and collected neurocognitive normative comparison data in diverse settings. At 10 sites in seven RLS countries, we provided training for NP assessments. We collected normative comparison data on HIV- participants from Brazil (n=240), India (n=480), Malawi (n=481), Peru (n=239), South Africa (480), Thailand (n=240) and Zimbabwe (n=240). Participants had a negative HIV test within 30 days before standardized NP exams were administered at baseline, and 770 at six-months. Participants were enrolled in 8 strata, gender (female and male), education (<10 years and ≥ 10 years), and age (<35 years and ≥35 years). Of 2400 enrolled, 770 completed the six-month follow up. As expected, significant between-country differences were evident in all the neurocognitive test scores (p<.0001). There was variation between the age, gender and education strata on the neurocognitive tests. Age and education were important variables for all tests; older participants had poorer performance and those with higher education had better performance. Women had better performance on verbal learning/memory and speed of processing tests, while men performed better on motor tests. This study provides the necessary neurocognitive normative data needed to build infrastructure for future neurological and neurocognitive studies in diverse RLS. These normative data are a much-needed resource for both clinicians and researchers. PMID:26733457

A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings.

PubMed

Bright, Patricia L; Nelson, Robert M

2012-11-01

A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The model lends itself to a decision tree that can be adapted to the local context and resources so as to provide procedural guidance. This approach can help in planning and establishing organisational policies that govern the provision of ancillary care.

Building Cyberinfrastructures for Earth and Space Sciences so that they will come: lessons learnt from Australia

NASA Astrophysics Data System (ADS)

Wyborn, L. A.; Woodcock, R.

2013-12-01

One of the greatest drivers for change in the way scientific research is undertaken in Australia was the development of the Australian eResearch Infrastructure which was coordinated by the then Australian Government Department of Innovation, Industry, Science and Research. There were two main tranches of funding: the 2007-2013 National Collaborative Research Infrastructure Strategy (NCRIS) and the 2009 Education and Investment Framework (EIF) Super Science Initiative. Investments were in two areas: the Australian e-Research Infrastructure and domain specific capabilities: combined investment in both is 1,452M with at least 456M being invested in eResearch infrastructure. NCRIS was specifically designed as a community-guided process to provide researchers, both academic and government, with major research facilities, supporting infrastructures and networks necessary for world-class research. Extensive community engagement was sought to inform decisions on where Australia could best make strategic infrastructure investments to further develop its research capacity and improve research outcomes over the next 5 to 10years. The current (2007-2014) Australian e-Research Infrastructure has 2 components: 1. The National eResearch physical infrastructure which includes two petascale HPC facilities (one in Canberra and one in Perth), a 10 Gbps national network (National Research Network), a national data storage infrastructure comprising 8 multi petabyte data stores and shared access methods (Australian Access Federation). 2. A second component is focused on research integration infrastructures and includes the Australian National Data Service, which is concerned with better management, description and access to distributed research data in Australia and the National eResearch Collaboration Tools and Resources (NeCTAR) project. NeCTAR is centred on developing problem oriented digital laboratories which provide better and coordinated access to research tools, data environments and workflows. The eResearch Infrastructure Stack is designed to support 12 individual domain-specific capabilities. Four are relevant to the Earth and Space Sciences: (1) AuScope (a national Earth Science Infrastructure Program), (2) the Integrated Marine Observing System (IMOS), (3) the Terrestrial Ecosystems Research Network (TERN) and (4) the Australian Urban Research Infrastructure Network (AURIN). The two main research integration infrastructures, ANDS and NeCTAR, are seen as pivotal to the success of the Australian eResearch Infrastructure. Without them, there was a risk that that the investments in new computers and data storage would provide physical infrastructure, but few would come to use it as the skills barriers to entry were too high. ANDS focused on transforming Australia's research data environment. Its flagship is Research Data Australia, an Internet-based discovery service designed to provide rich connections between data, projects, researchers and institutions, and promote visibility of Australian research data collections in search engines. NeCTAR focused on building eResearch infrastructure in four areas: virtual laboratories, tools, a federated research cloud and a hosting service. Combined, ANDS and NeCTAR are ensuring that people ARE coming and ARE using the physical infrastructures that were built.

Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective.

PubMed

Ogutu, Bernhards R; Baiden, Rita; Diallo, Diadier; Smith, Peter G; Binka, Fred N

2010-04-20

The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that capacity development in clinical trials is best carried out in the context of preparation for specific trials. In this regard MCTA centres involved in the phase III malaria vaccine trial were, on average, more successful at consolidating the training and infrastructure support than those centres focussing only on drug trials.

Sustainable development of a GCP-compliant clinical trials platform in Africa: the Malaria Clinical Trials Alliance perspective

PubMed Central

2010-01-01

Background The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Case description Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. Conclusion In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that capacity development in clinical trials is best carried out in the context of preparation for specific trials. In this regard MCTA centres involved in the phase III malaria vaccine trial were, on average, more successful at consolidating the training and infrastructure support than those centres focussing only on drug trials. PMID:20406478

Research Networking Systems: The State of Adoption at Institutions Aiming to Augment Translational Research Infrastructure

PubMed Central

Obeid, Jihad S; Johnson, Layne M; Stallings, Sarah; Eichmann, David

2015-01-01

Fostering collaborations across multiple disciplines within and across institutional boundaries is becoming increasingly important with the growing emphasis on translational research. As a result, Research Networking Systems that facilitate discovery of potential collaborators have received significant attention by institutions aiming to augment their research infrastructure. We have conducted a survey to assess the state of adoption of these new tools at the Clinical and Translational Science Award (CTSA) funded institutions. Survey results demonstrate that most CTSA funded institutions have either already adopted or were planning to adopt one of several available research networking systems. Moreover a good number of these institutions have exposed or plan to expose the data on research expertise using linked open data, an established approach to semantic web services. Preliminary exploration of these publically-available data shows promising utility in assessing cross-institutional collaborations. Further adoption of these technologies and analysis of the data are needed, however, before their impact on cross-institutional collaboration in research can be appreciated and measured. PMID:26491707

Research Networking Systems: The State of Adoption at Institutions Aiming to Augment Translational Research Infrastructure.

PubMed

Obeid, Jihad S; Johnson, Layne M; Stallings, Sarah; Eichmann, David

Fostering collaborations across multiple disciplines within and across institutional boundaries is becoming increasingly important with the growing emphasis on translational research. As a result, Research Networking Systems that facilitate discovery of potential collaborators have received significant attention by institutions aiming to augment their research infrastructure. We have conducted a survey to assess the state of adoption of these new tools at the Clinical and Translational Science Award (CTSA) funded institutions. Survey results demonstrate that most CTSA funded institutions have either already adopted or were planning to adopt one of several available research networking systems. Moreover a good number of these institutions have exposed or plan to expose the data on research expertise using linked open data, an established approach to semantic web services. Preliminary exploration of these publically-available data shows promising utility in assessing cross-institutional collaborations. Further adoption of these technologies and analysis of the data are needed, however, before their impact on cross-institutional collaboration in research can be appreciated and measured.

Biomedical informatics research network: building a national collaboratory to hasten the derivation of new understanding and treatment of disease.

PubMed

Grethe, Jeffrey S; Baru, Chaitan; Gupta, Amarnath; James, Mark; Ludaescher, Bertram; Martone, Maryann E; Papadopoulos, Philip M; Peltier, Steven T; Rajasekar, Arcot; Santini, Simone; Zaslavsky, Ilya N; Ellisman, Mark H

2005-01-01

Through support from the National Institutes of Health's National Center for Research Resources, the Biomedical Informatics Research Network (BIRN) is pioneering the use of advanced cyberinfrastructure for medical research. By synchronizing developments in advanced wide area networking, distributed computing, distributed database federation, and other emerging capabilities of e-science, the BIRN has created a collaborative environment that is paving the way for biomedical research and clinical information management. The BIRN Coordinating Center (BIRN-CC) is orchestrating the development and deployment of key infrastructure components for immediate and long-range support of biomedical and clinical research being pursued by domain scientists in three neuroimaging test beds.

Health information exchanges--Unfulfilled promise as a data source for clinical research.

PubMed

Parker, Carol; Weiner, Michael; Reeves, Mathew

2016-03-01

To determine the use of health information exchange organizations (HIEs) to support and conduct clinical research. This scoping review included US-based studies published between January 2003 and March 2014 that used data from an HIE to address at least one of three categories of research: clinical or epidemiological research, financial evaluation, or utilization of health services. Eligibility was not restricted to research on HIEs. Studies with research questions outside of the evaluation of HIEs themselves were sought. Eighteen articles met final study inclusion criteria from an initial list of 847 hits. Fifteen studies addressed a clinical or epidemiological research question, 6 addressed a financial consideration, and 8 addressed a utilization issue. Considerable overlap was found among the research categories: 13 articles addressed more than one category. Of the eighteen included studies, only two used HIE data to answer a research objective that was NOT specific to HIE use. Research designs were varied and ranged from observational studies, such as cohort and cross-sectional studies, to randomized trials. The 18 articles represent the involvement of a small number of HIEs; 7 of the studies were from a single HIE. This review demonstrates that HIE-provided information is available and used to answer clinical or epidemiological, financial, or utilization-based research questions; however, the majority of the studies using HIE data are done with the primary goal of evaluating the use and impact of HIEs on health care delivery and outcomes. As HIEs mature and become integrated parts of the health care industry, the authors anticipate that fewer studies will be published that describe or validate the role of HIEs, and more will use HIEs as multi-institutional data sources for conducting clinical research and improving health services and clinical outcomes. Articles identified in this review indicate the limited extent that HIE data are being used for clinical research outside of the evaluation of HIEs themselves, as well as the limited number of specific HIEs that are involved in generating published research. Significant barriers exist that prevent HIEs from developing into an invaluable resource for clinical research including technological infrastructure limitations, business processes limiting secondary use of data, and lack of participating provider support. Research to better understand challenges to developing the necessary infrastructure and policies to foster HIE engagement in research would be valuable as HIEs represent an opportunity to engage non-traditional health care provider research partners. Copyright © 2015. Published by Elsevier Ireland Ltd.

Clinical Knowledge Governance Framework for Nationwide Data Infrastructure Projects.

PubMed

Wulff, Antje; Haarbrandt, Birger; Marschollek, Michael

2018-01-01

The availability of semantically-enriched and interoperable clinical information models is crucial for reusing once collected data across institutions like aspired in the German HiGHmed project. Funded by the Federal Ministry of Education and Research, this nationwide data infrastructure project adopts the openEHR approach for semantic modelling. Here, strong governance is required to define high-quality and reusable models. Design of a clinical knowledge governance framework for openEHR modelling in cross-institutional settings like HiGHmed. Analysis of successful practices from international projects, published ideas on archetype governance and own modelling experiences as well as modelling of BPMN processes. We designed a framework by presenting archetype variations, roles and responsibilities, IT support and modelling workflows. Our framework has great potential to make the openEHR modelling efforts manageable. Because practical experiences are rare, prospectively our work will be predestinated to evaluate the benefits of such structured governance approaches.

Five strategies for accelerating the war on cancer in an era of budget deficits.

PubMed

Doroshow, James H; Croyle, Robert T; Niederhuber, John E

2009-02-01

In recent years, the National Institutes of Health's largest institute, the National Cancer Institute (NCI), has adapted to difficult economic conditions by leveraging its robust infrastructure -- which includes risk factor surveillance and population monitoring, research centers (focused on basic, translation, clinical, and behavioral sciences), clinical trials and health care research networks, and rigorously validated statistical models -- to maximize the impact of scientific progress on the public health. To continue advancement and realize the opportunity of significant, population-level changes in cancer mortality, the NCI recommends that five national-level actions be taken: (1) significantly increase enrollment of Medicare patients into cancer clinical trials through adequate physician reimbursement, (2) increase NCI/Centers for Medicare and Medicaid Services collaboration on clinical trials research to evaluate the therapeutic efficacy of anticancer drugs, (3) establish a national outcomes research demonstration project to test strategies for measuring and improving health care quality and provide an evidence base for public policy, (4) leverage existing tobacco-control collaborations and possible new authorities at the U.S. Food and Drug Administration to realize the outstanding health gains possible from a reduction in tobacco use, and (5) increase colorectal cancer screening rates though intensified collaboration between federal agencies working to address barriers to access and use of screening. These cost-effective strategies provide the opportunity for extraordinary results in an era of budget deficits. Of the chronic diseases, cancer has the strongest national research infrastructure that can be leveraged to produce rapid results to inform budget prioritization and public policy, as well as mobilize new projects to answer critical public health questions.

More ethical and more efficient clinical research: multiplex trial design.

PubMed

Keus, Frederik; van der Horst, Iwan C C; Nijsten, Maarten W

2014-08-14

Today's clinical research faces challenges such as a lack of clinical equipoise between treatment arms, reluctance in randomizing for multiple treatments simultaneously, inability to address interactions and increasingly restricted resources. Furthermore, many trials are biased by extensive exclusion criteria, relatively small sample size and less appropriate outcome measures. We propose a 'Multiplex' trial design that preserves clinical equipoise with a continuous and factorial trial design that will also result in more efficient use of resources. This multiplex design accommodates subtrials with appropriate choice of treatment arms within each subtrial. Clinical equipoise should increase consent rates while the factorial design is the best way to identify interactions. The multiplex design may evolve naturally from today's research limitations and challenges, while principal objections seem absent. However this new design poses important infrastructural, organisational and psychological challenges that need in depth consideration.

Using the LOINC Semantic Structure to Integrate Community-based Survey Items into a Concept-based Enterprise Data Dictionary to Support Comparative Effectiveness Research

PubMed Central

Co, Manuel C.; Boden-Albala, Bernadette; Quarles, Leigh; Wilcox, Adam; Bakken, Suzanne

2012-01-01

In designing informatics infrastructure to support comparative effectiveness research (CER), it is necessary to implement approaches for integrating heterogeneous data sources such as clinical data typically stored in clinical data warehouses and those that are normally stored in separate research databases. One strategy to support this integration is the use of a concept-oriented data dictionary with a set of semantic terminology models. The aim of this paper is to illustrate the use of the semantic structure of Clinical LOINC (Logical Observation Identifiers, Names, and Codes) in integrating community-based survey items into the Medical Entities Dictionary (MED) to support the integration of survey data with clinical data for CER studies. PMID:24199059

The Organization of European Cancer Institute Pathobiology Working Group and its support of European biobanking infrastructures for translational cancer research.

PubMed

Riegman, Peter H J; de Jong, Bas W D; Llombart-Bosch, Antonio

2010-04-01

Today's translational cancer research increasingly depends on international multi-center studies. Biobanking infrastructure or comprehensive sample exchange platforms to enable networking of clinical cancer biobanks are instrumental to facilitate communication, uniform sample quality, and rules for exchange. The Organization of European Cancer Institutes (OECI) Pathobiology Working Group supports European biobanking infrastructure by maintaining the OECI-TuBaFrost exchange platform and organizing regular meetings. This platform originated from a European Commission project and is updated with knowledge from ongoing and new biobanking projects. This overview describes how European biobanking projects that have a large impact on clinical biobanking, including EuroBoNeT, SPIDIA, and BBMRI, contribute to the update of the OECI-TuBaFrost exchange platform. Combining the results of these European projects enabled the creation of an open (upon valid registration only) catalogue view of cancer biobanks and their available samples to initiate research projects. In addition, closed environments supporting active projects could be developed together with the latest views on quality, access rules, ethics, and law. With these contributions, the OECI Pathobiology Working Group contributes to and stimulates a professional attitude within biobanks at the European comprehensive cancer centers. Improving the fundamentals of cancer sample exchange in Europe stimulates the performance of large multi-center studies, resulting in experiments with the desired statistical significance outcome. With this approach, future innovation in cancer patient care can be realized faster and more reliably.

Ten years of the Immune Tolerance Network: an integrated clinical research organization.

PubMed

Bluestone, Jeffrey A; Krensky, Alan M; Turka, Laurence A; Rotrosen, Daniel; Matthews, Jeffrey B

2010-02-17

The U.S. National Institutes of Health Roadmap and the U.S. Food and Drug Administration's Critical Path Initiative have endorsed the establishment of large academic clinical research networks as part of the solution to the growing divide between increased R&D spending and the lagging number of new drugs making it to market. Clearly, the role of these networks as translational science incubators that complement industry-sponsored programs is laudable and much-needed. However, the path to success for such organizations is less clear. Here, drawing on the experiences of the Immune Tolerance Network, a multidisciplinary clinical research network founded in 1999, we discuss some of the barriers inherent in developing such consortia and offer firsthand insight into the planning, resources, and organizational infrastructure required for a successful research program.

Evaluating Various Areas of Process Improvement in an Effort to Improve Clinical Research: Discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management Workshop

PubMed Central

Cola, Philip A.; Rosenblum, Daniel

2013-01-01

Abstract Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to “improve human health.” Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH's National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled “Learning by doing; applying evidence‐based tools to re‐engineer clinical research management” took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants. PMID:23919369

Evaluating various areas of process improvement in an effort to improve clinical research: discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management workshop.

PubMed

Strasser, Jane E; Cola, Philip A; Rosenblum, Daniel

2013-08-01

Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to "improve human health." Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH's National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled "Learning by doing; applying evidence-based tools to re-engineer clinical research management" took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants. © 2013 Wiley Periodicals, Inc.

Establishment of a Research Pharmacy to Support Ebola Clinical Research in Liberia

PubMed Central

Pierson, Jerome F.; Kirchoff, Matthew Carl; Tyee, Rev Tegli; Rhie, Julie K.; Montello, Michael J

2017-01-01

Objective This paper describes the establishment of a research pharmacy to support the PREVAIL vaccine study for Ebola Virus Disease. Setting This paper describes the establishment of the pharmacy element to support the overall research program during an Ebola outbreak in Monrovia, Liberia in 2014 and 2015. Practice Innovation The need to rapidly establish infrastructure to support the Liberian-US joint clinical research partnership in response to the emerging Ebola Virus Disease provided the opportunity for collaboration among Liberian and US pharmacists. Evaluation and Results Experiences of the Liberian and US pharmacists involved in the program are described. Conclusion The partnership was successful in the conduct of the study, but more importantly, capacity for Liberian pharmacists to support clinical research was established. Additionally, the US team learned several important lessons that will help prepare them for responding to research needs in future infectious disease outbreaks. PMID:28610940

A Framework for Conducting Deceased Donor Research in the United States.

PubMed

Glazier, Alexandra K; Heffernan, Kate Gallin; Rodrigue, James R

2015-11-01

There are a number of regulatory barriers both perceived and real that have hampered widespread clinical research in the field of donation and transplantation. This article sets forth a framework clarifying the existing legal requirements and their application to the conduct of research on deceased donors and donor organs within the United States. Recommendations are focused on resolving some of the ambiguity surrounding deceased donor authorization for research, Health Insurance Portability and Accountability Act requirements and the role of institutional review board oversight. The successful conduct of clinical research in the field of donation and transplantation requires an understanding of these regulatory nuances as well as identification of important ethical principles to consider. Facilitation of these concepts will ultimately provide support for innovative research designed to increase the availability of organs for transplantation. Further work identifying the optimal infrastructure for overview of clinical research in the field should be given priority.

Current State of Information Technologies for the Clinical Research Enterprise across Academic Medical Centers

PubMed Central

Murphy, Shawn N.; Dubey, Anil; Embi, Peter J.; Harris, Paul A.; Richter, Brent G.; Turisco, Fran; Weber, Griffin M.; Tcheng, James E.; Keogh, Diane

2012-01-01

Abstract Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how clinical research is being performed. The Clinical Research Forum’s IT Roundtable performed a survey of 17 representative academic medical centers (AMCs) to understand the adoption rate and implementation strategies within this field. The results were compared with similar surveys from 4 and 6 years ago. We found the adoption rate for four prominent areas of IT‐supported clinical research had increased remarkably, specifically regulatory compliance, electronic data capture for clinical trials, data repositories for secondary use of clinical data, and infrastructure for supporting collaboration. Adoption of other areas of clinical research IT was more irregular with wider differences between AMCs. These differences appeared to be partially due to a set of openly available applications that have emerged to occupy an important place in the landscape of clinical research enterprise‐level support at AMC’s. Clin Trans Sci 2012; Volume #: 1–4 PMID:22686207

Clinical Research Informatics for Big Data and Precision Medicine.

PubMed

Weng, C; Kahn, M G

2016-11-10

To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors.

Clinical Research Informatics for Big Data and Precision Medicine

PubMed Central

Kahn, M. G.

2016-01-01

Summary Objectives To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. Methods We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. Results The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. Conclusion The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors. PMID:27830253

Collaborative translational research leading to multicenter clinical trials in Duchenne muscular dystrophy: the Cooperative International Neuromuscular Research Group (CINRG).

PubMed

Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P

2002-10-01

Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.

Ten steps to developing a national agenda to address financial conflicts of interest in industry sponsored clinical research.

PubMed

Tereskerz, Patricia M; Moreno, Jonathan

2005-01-01

Financial liaisons between clinical researchers, research institutions, and industrial sponsors have gained momentum in recent years. In the process, it has been argued by many that trust in the research infrastructure is being eroded by the financial conflicts of interest that emerge from these arrangements. Yet, the financial resources of industry are needed to continue technology transfer from the bench to the bedside. Policy makers and government regulators are currently struggling to determine how to best manage financial conflicts of interest that emerge from these liaisons. Various organizations and government entities have proposed different strategies. This paper explores the limitations of existing measures and recommends that a unified national agenda is needed. We propose 10 steps to develop an agenda to address financial conflicts of interest in industry-sponsored clinical research.

A Logic Model for Community Engagement within the CTSA Consortium: Can We Measure What We Model?

PubMed Central

Eder, Milton Mickey; Carter-Edwards, Lori; Hurd, Thelma C.; Rumala, Bernice B.; Wallerstein, Nina

2013-01-01

The Clinical Translation Science Award (CTSA) initiative calls upon academic health centers to engage communities around a clinical research relationship measured ultimately in terms of public health. Among a few initiatives involving university accountability for advancing public interests, a small CTSA workgroup devised a community engagement (CE) logic model that organizes common activities within a university-community infrastructure to facilitate community engagement in research. While the model focuses on the range of institutional CE inputs, it purposefully does not include an approach for assessing how community engagement influences research implementation and outcomes. Rather, with communities and individuals beginning to transition into new research roles, this article emphasizes studying community engagement through specific relationship types and assessing how expanded research teams contribute to the full spectrum of translational science. The authors propose a typology consisting of three relationship types—engagement, collaboration and shared leadership—to provide a foundation for investigating community–academic contributions to the new CTSA research paradigm. The typology shifts attention from specific community–academic activities and, instead, encourages analyses focused on measuring the strength of relationships through variables like synergy and trust. The collaborative study of CE relationships will inform an understanding of CTSA infrastructure development in support of translational research and its goal, which is expressed in the logic model: better science, better answers, better population health. PMID:23752038

Digital pathology in nephrology clinical trials, research, and pathology practice.

PubMed

Barisoni, Laura; Hodgin, Jeffrey B

2017-11-01

In this review, we will discuss (i) how the recent advancements in digital technology and computational engineering are currently applied to nephropathology in the setting of clinical research, trials, and practice; (ii) the benefits of the new digital environment; (iii) how recognizing its challenges provides opportunities for transformation; and (iv) nephropathology in the upcoming era of kidney precision and predictive medicine. Recent studies highlighted how new standardized protocols facilitate the harmonization of digital pathology database infrastructure and morphologic, morphometric, and computer-aided quantitative analyses. Digital pathology enables robust protocols for clinical trials and research, with the potential to identify previously underused or unrecognized clinically useful parameters. The integration of digital pathology with molecular signatures is leading the way to establishing clinically relevant morpho-omic taxonomies of renal diseases. The introduction of digital pathology in clinical research and trials, and the progressive implementation of the modern software ecosystem, opens opportunities for the development of new predictive diagnostic paradigms and computer-aided algorithms, transforming the practice of renal disease into a modern computational science.

Standard requirements for GCP-compliant data management in multinational clinical trials

PubMed Central

2011-01-01

Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit. Section IN01 is dedicated to international aspects and ST01 to the competence of a trials unit's staff. Conclusions The standard is intended to provide an open and widely used set of requirements for GCP-compliant data management, particularly in academic trial units. It is the intention that ECRIN will use these requirements as the basis for the certification of ECRIN data centres. PMID:21426576

Telemammography Using Satellite Communications

NASA Technical Reports Server (NTRS)

1996-01-01

Telemammography, the electronic transmission of digitized mammograms, can connect patients with timely, critical medical expertise; howev er, an adequate terrestrial communications infrastructure does not exist in these areas. NASA Lewis Research Center's Advanced Space Commu nications Laboratory is now working with leading breast cancer resear ch hospitals, including the Cleveland Clinic and the University of Virginia, to perform the critical research necessary to allow new satell ite networks to support telemammography.

Retooling Institutional Support Infrastructure for Clinical Research

PubMed Central

Snyder, Denise C.; Brouwer, Rebecca N.; Ennis, Cory L.; Spangler, Lindsey L.; Ainsworth, Terry L.; Budinger, Susan; Mullen, Catherine; Hawley, Jeffrey; Uhlenbrauck, Gina; Stacy, Mark

2016-01-01

Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can detract investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a transition to unified research support. PMID:27125563

Towards public health decision support: a systematic review of bidirectional communication approaches

PubMed Central

Dixon, Brian E; Gamache, Roland E; Grannis, Shaun J

2013-01-01

Objective To summarize the literature describing computer-based interventions aimed at improving bidirectional communication between clinical and public health. Materials and Methods A systematic review of English articles using MEDLINE and Google Scholar. Search terms included public health, epidemiology, electronic health records, decision support, expert systems, and decision-making. Only articles that described the communication of information regarding emerging health threats from public health agencies to clinicians or provider organizations were included. Each article was independently reviewed by two authors. Results Ten peer-reviewed articles highlight a nascent but promising area of research and practice related to alerting clinicians about emerging threats. Current literature suggests that additional research and development in bidirectional communication infrastructure should focus on defining a coherent architecture, improving interoperability, establishing clear governance, and creating usable systems that will effectively deliver targeted, specific information to clinicians in support of patient and population decision-making. Conclusions Increasingly available clinical information systems make it possible to deliver timely, relevant knowledge to frontline clinicians in support of population health. Future work should focus on developing a flexible, interoperable infrastructure for bidirectional communications capable of integrating public health knowledge into clinical systems and workflows. PMID:23467470

ResearchMatch: A National Registry to Recruit Volunteers for Clinical Research

PubMed Central

Harris, Paul A.; Scott, Kirstin W; Lebo, Laurie; Hassan, NikNik; Lighter, Chad; Pulley, Jill

2013-01-01

The authors designed ResearchMatch, a disease-neutral, web-based recruitment registry to help match individuals who wish to participate in clinical research studies with researchers actively searching for volunteers throughout the United States. In this article, they describe ResearchMatch’s stakeholders, workflow model, technical infrastructure, and, for the registry’s first 19 months of operation, utilization metrics. Having launched volunteer registration tools in November 2009 and researcher registration tools in March 2010, ResearchMatch had, as of June 2011, registered 15,871 volunteer participants from all 50 states. The registry was created as a collaborative project for institutions in the Clinical and Translational Science Awards (CTSA) consortium. Also as of June 2011, a total of 751 researchers from 61 participating CTSA institutions had registered to use the tool to recruit participants into 540 active studies and trials. ResearchMatch has proven successful in connecting volunteers with researchers, and the authors are currently evaluating regulatory and workflow options to open access to researchers at non-CTSA institutions. PMID:22104055

Opportunities and challenges for comparative effectiveness research (CER) with Electronic Clinical Data: a perspective from the EDM forum.

PubMed

Holve, Erin; Segal, Courtney; Hamilton Lopez, Marianne

2012-07-01

The Electronic Data Methods (EDM) Forum brings together perspectives from the Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies (PROSPECT) studies, the Scalable Distributed Research Networks, and the Enhanced Registries projects. This paper discusses challenges faced by the research teams as part of their efforts to develop electronic clinical data (ECD) infrastructure to support comparative effectiveness research (CER). The findings reflect a set of opportunities for transdisciplinary learning, and will ideally enhance the transparency and generalizability of CER using ECD. Findings are based on 6 exploratory site visits conducted under naturalistic inquiry in the spring of 2011. Themes, challenges, and innovations were identified in the visit summaries through coding, keyword searches, and review for complex concepts. : The identified overarching challenges and emerging opportunities include: the substantial level of effort to establish and sustain data sharing partnerships; the importance of understanding the strengths and limitations of clinical informatics tools, platforms, and models that have emerged to enable research with ECD; the need for rigorous methods to assess data validity, quality, and context for multisite studies; and, emerging opportunities to achieve meaningful patient and consumer engagement and work collaboratively with multidisciplinary teams. The new infrastructure must evolve to serve a diverse set of potential users and must scale to address a range of CER or patient-centered outcomes research (PCOR) questions. To achieve this aim-to improve the quality, transparency, and reproducibility of CER and PCOR-a high level of collaboration and support is necessary to foster partnership and best practices as part of the EDM Forum.

Combining clinical practice and academic work in nursing: A qualitative study about perceived importance, facilitators and barriers regarding clinical academic careers for nurses in university hospitals.

PubMed

van Oostveen, Catharina J; Goedhart, Nicole S; Francke, Anneke L; Vermeulen, Hester

2017-12-01

To obtain in-depth insight into the perceptions of nurse academics and other stakeholders regarding the importance, facilitators and barriers for nurses combining clinical and academic work in university hospitals. Combining clinical practice and academic work facilitates the use of research findings for high-quality patient care. However, nurse academics move away from the bedside because clinical academic careers for nurses have not yet been established in the Netherlands. This qualitative study was conducted in two Dutch university hospitals and their affiliated medical faculties and universities of applied sciences. Data were collected between May 2015 and August 2016. We used purposive sampling for 24 interviews. We asked 14 participants in two focus groups for their perceptions of importance, facilitators and barriers in nurses' combined clinical and academic work in education and research. We audiotaped, transcribed and thematically analysed the interviews and focus groups. Three themes related to perceived importance, facilitators and barriers: culture, leadership and infrastructure. These themes represent deficiencies in facilitating clinical academic careers for nurses. The current nursing culture emphasises direct patient care, which is perceived as an academic misfit. Leadership is lacking at all levels, resulting in the underuse of nurse academics and the absence of supporting structures for nurses who combine clinical and academic work. The present nursing culture appears to be the root cause of the dearth of academic positions and established clinical academic posts. A culture change would require a show of leadership that would promote and enable combined research, teaching and clinical practice and that would introduce clinical academic career pathways for nurses. Meanwhile, nurse academics should collaborate with established medical academics for whom combined roles are mainstream, and they should take advantage of their established infrastructure for success. © 2017 John Wiley & Sons Ltd.

Publicly funded practice-oriented clinical trials: of importance for healthcare payers.

PubMed

Neyt, Mattias; Christiaens, Thierry; Demotes, Jacques; Walley, Tom; Hulstaert, Frank

2016-11-01

Many questions of relevance to patients/society are not answered by industry-sponsored clinical trials. We consider whether there are benefits to governments in funding practice-oriented clinical trials. A literature search including publications on institutions' websites was performed and supplemented with information gathered from (inter)national stakeholders. Areas were identified where public funding of clinical trials is of importance for society, such as head-to-head comparisons or medical areas where companies have no motivation to invest. The available literature suggests publicly funded research programs could provide a positive return on investment. The main hurdles (e.g., sufficient funding and absence of equipoise) and success factors (e.g., selection of research questions and research infrastructure) for the successful conduct of publicly funded trials were identified. Governments should see public funding of pragmatic practice-oriented clinical trials as a good opportunity to improve the selection and quality of treatments and stimulate efficient use of limited resources.

Developing research and recruitment while fostering stakeholder engagement in a National Institutes of Mental Health-funded Interventions and Practice Research Infrastructure Programs grant for depression.

PubMed

Stirman, Shannon Wiltsey; Goldstein, Lizabeth A; Wrenn, Glenda; Barrett, Marna; Gibbons, Mary Beth Connolly; Casiano, Delane; Thompson, Donald; Green, Patricia P; Heintz, Laura; Barber, Jacques P; Crits-Christoph, Paul

2010-01-01

In the context of a National Institutes of Mental Health-funded Interventions and Practice Research Infrastructure Programs (IP-RISP) grant for the treatment of depression, a partnership was developed between a community mental health organization and a team of researchers. This paper describes the collaborative process, key challenges, and strategies employed to meet the goals of the first phase of the grant, which included development of a working and sustainable partnership and building capacity for recruitment and research. This paper was developed through the use of qualitative interviews and discussion with a variety of IP-RISP partners. Communication with multiple stakeholders through varied channels, feedback from stakeholders on research procedures, and employing a research liaison at the clinic have been key strategies in the first phase of the grant. The strategies we employed allowed multiple stakeholders to contribute to the larger mission of the IP-RISP and helped to establish an ongoing research program within the mental health organization.

Radiotherapy physics research in the UK: challenges and proposed solutions

PubMed Central

Mackay, R I; Burnet, N G; Green, S; Illidge, T M; Staffurth, J N

2012-01-01

In 2011, the Clinical and Translational Radiotherapy Research Working Group (CTRad) of the National Cancer Research Institute brought together UK radiotherapy physics leaders for a think tank meeting. Following a format that CTRad had previously and successfully used with clinical oncologists, 23 departments were asked to complete a pre-meeting evaluation of their radiotherapy physics research infrastructure and the strengths, weaknesses, opportunities and threats within their own centre. These departments were brought together with the CTRad Executive Group and research funders to discuss the current state of radiotherapy physics research, perceived barriers and possible solutions. In this Commentary, we summarise the submitted materials, presentations and discussions from the meeting and propose an action plan. It is clear that there are challenges in both funding and staffing of radiotherapy physics research. Programme and project funding streams sometimes struggle to cater for physics-led work, and increased representation on research funding bodies would be valuable. Career paths for academic radiotherapy physicists need to be examined and an academic training route identified within Modernising Scientific Careers; the introduction of formal job plans may allow greater protection of research time, and should be considered. Improved access to research facilities, including research linear accelerators, would enhance research activity and pass on developments to patients more quickly; research infrastructure could be benchmarked against centres in the UK and abroad. UK National Health Service departments wishing to undertake radiotherapy research, with its attendant added value for patients, need to develop a strategy with their partner higher education institution, and collaboration between departments may provide enhanced opportunities for funded research. PMID:22972972

Radiotherapy physics research in the UK: challenges and proposed solutions.

PubMed

Mackay, R I; Burnet, N G; Green, S; Illidge, T M; Staffurth, J N

2012-10-01

In 2011, the Clinical and Translational Radiotherapy Research Working Group (CTRad) of the National Cancer Research Institute brought together UK radiotherapy physics leaders for a think tank meeting. Following a format that CTRad had previously and successfully used with clinical oncologists, 23 departments were asked to complete a pre-meeting evaluation of their radiotherapy physics research infrastructure and the strengths, weaknesses, opportunities and threats within their own centre. These departments were brought together with the CTRad Executive Group and research funders to discuss the current state of radiotherapy physics research, perceived barriers and possible solutions. In this Commentary, we summarise the submitted materials, presentations and discussions from the meeting and propose an action plan. It is clear that there are challenges in both funding and staffing of radiotherapy physics research. Programme and project funding streams sometimes struggle to cater for physics-led work, and increased representation on research funding bodies would be valuable. Career paths for academic radiotherapy physicists need to be examined and an academic training route identified within Modernising Scientific Careers; the introduction of formal job plans may allow greater protection of research time, and should be considered. Improved access to research facilities, including research linear accelerators, would enhance research activity and pass on developments to patients more quickly; research infrastructure could be benchmarked against centres in the UK and abroad. UK National Health Service departments wishing to undertake radiotherapy research, with its attendant added value for patients, need to develop a strategy with their partner higher education institution, and collaboration between departments may provide enhanced opportunities for funded research.

Maryland's Special Populations Network. A model for cancer disparities research, education, and training.

PubMed

Baquet, Claudia R; Mack, Kelly M; Mishra, Shiraz I; Bramble, Joy; Deshields, Mary; Datcher, Delores; Savoy, Mervin; Brooks, Sandra E; Boykin-Brown, Stephanie; Hummel, Kery

2006-10-15

The unequal burden of cancer in minority and underserved communities nationally and in Maryland is a compelling crisis. The Maryland Special Populations Cancer Research Network (MSPN) developed an infrastructure covering Maryland's 23 jurisdictions and Baltimore City through formal partnerships between the University of Maryland School of Medicine, University of Maryland Statewide Health Network, University of Maryland Eastern Shore, and community partners in Baltimore City, rural Eastern Shore, rural Western Maryland, rural Southern Maryland, and Piscataway Conoy Tribe and statewide American Indians. Guided by the community-based participatory framework, the MSPN undertook a comprehensive assessment (of needs, strengths, and resources available) that laid the foundation for programmatic efforts in community-initiated cancer awareness and education, research, and training. The MSPN infrastructure was used to implement successful and innovative community-based cancer education interventions and technological solutions; conduct education and promotion of clinical trials, cancer health disparities research, and minority faculty cancer research career development; and leverage additional resources for sustainability. MSPN engaged in informed advocacy among decision- and policymakers at state and national levels, and its community-based clinical trials program was recognized by the U.S. Department of Health and Human Services as a Best Practice Award. The solutions to reduce and eliminate cancer health disparities are complex and require comprehensive and focused multidisciplinary cancer health disparities research, training, and education strategies implemented through robust community-academic partnerships. Cancer 2006. (c) American Cancer Society.

p-BioSPRE—an information and communication technology framework for transnational biomaterial sharing and access

PubMed Central

Weiler, Gabriele; Schröder, Christina; Schera, Fatima; Dobkowicz, Matthias; Kiefer, Stephan; Heidtke, Karsten R; Hänold, Stefanie; Nwankwo, Iheanyi; Forgó, Nikolaus; Stanulla, Martin; Eckert, Cornelia; Graf, Norbert

2014-01-01

Biobanks represent key resources for clinico-genomic research and are needed to pave the way to personalised medicine. To achieve this goal, it is crucial that scientists can securely access and share high-quality biomaterial and related data. Therefore, there is a growing interest in integrating biobanks into larger biomedical information and communication technology (ICT) infrastructures. The European project p-medicine is currently building an innovative ICT infrastructure to meet this need. This platform provides tools and services for conducting research and clinical trials in personalised medicine. In this paper, we describe one of its main components, the biobank access framework p-BioSPRE (p-medicine Biospecimen Search and Project Request Engine). This generic framework enables and simplifies access to existing biobanks, but also to offer own biomaterial collections to research communities, and to manage biobank specimens and related clinical data over the ObTiMA Trial Biomaterial Manager. p-BioSPRE takes into consideration all relevant ethical and legal standards, e.g., safeguarding donors’ personal rights and enabling biobanks to keep control over the donated material and related data. The framework thus enables secure sharing of biomaterial within open and closed research communities, while flexibly integrating related clinical and omics data. Although the development of the framework is mainly driven by user scenarios from the cancer domain, in this case, acute lymphoblastic leukaemia and Wilms tumour, it can be extended to further disease entities. PMID:24567758

Programs | Office of Cancer Genomics

Cancer.gov

OCG facilitates cancer genomics research through a series of highly-focused programs. These programs generate and disseminate genomic data for use by the cancer research community. OCG programs also promote advances in technology-based infrastructure and create valuable experimental reagents and tools. OCG programs encourage collaboration by interconnecting with other genomics and cancer projects in order to accelerate translation of findings into the clinic. Below are OCG’s current, completed, and initiated programs:

EDM forum supplement overview.

PubMed

Calonge, Ned

2012-07-01

The Agency for Health Research and Quality funded the Electronic Data Methods Forum (EDM Forum) to share the experiences and learnings from 11 research teams funded through three different grant programs, each of which involve the use of electronic clinical data in Comparative Effectiveness Research and Patient-Centered Outcomes Research. This overview is meant to describe the context in which the EDM forum was created and to introduce the set of papers in this supplement to Medical Care that describe the challenges and approaches to the use of electronic clinical data in the three key areas of analytic methods, clinical informatics and data governance. The participants in the EDM Forum are providing innovative approaches to generate information that can support the building of a "learning health care system." The compilation of papers presented in this supplement should serve as a resource to others working to develop the infrastructure for collecting, validating and using electronic data for research.

CREST biorepository for translational studies on malignant mesothelioma, lung cancer and other respiratory tract diseases: Informatics infrastructure and standardized annotation.

PubMed

Ugolini, Donatella; Neri, Monica; Bennati, Luca; Canessa, Pier Aldo; Casanova, Georgia; Lando, Cecilia; Leoncini, Giacomo; Marroni, Paola; Parodi, Barbara; Simonassi, Claudio; Bonassi, Stefano

2012-03-01

Advances in molecular epidemiology and translational research have led to the need for biospecimen collection. The Cancer of the Respiratory Tract (CREST) biorepository is concerned with pleural malignant mesothelioma (MM) and lung cancer (LC). The biorepository staff has collected demographic and epidemiological data directly from consenting subjects using a structured questionnaire, in agreement with The Public Population Project in Genomics (P(3)G). Clinical and follow-up data were collected. Sample data were also recorded. The architecture is based on a database designed with Microsoft Access. Data standardization was carried out to conform with established conventions or procedures. As from January 31, 2011, the overall number of recruited subjects was 1,857 (454 LC, 245 MM, 130 other cancers and 1,028 controls). Due to its infrastructure, CREST was able to join international projects, sharing samples and/or data with other research groups in the field. The data management system allows CREST to be involved, through a minimum data set, in the national project for the construction of the Italian network of Oncologic BioBanks (RIBBO), and in the infrastructure of a pan-European biobank network (BBMRI). The CREST biorepository is a valuable tool for translational studies on respiratory tract diseases, because of its simple and efficient infrastructure.

caGrid 1.0: An Enterprise Grid Infrastructure for Biomedical Research

PubMed Central

Oster, Scott; Langella, Stephen; Hastings, Shannon; Ervin, David; Madduri, Ravi; Phillips, Joshua; Kurc, Tahsin; Siebenlist, Frank; Covitz, Peter; Shanbhag, Krishnakant; Foster, Ian; Saltz, Joel

2008-01-01

Objective To develop software infrastructure that will provide support for discovery, characterization, integrated access, and management of diverse and disparate collections of information sources, analysis methods, and applications in biomedical research. Design An enterprise Grid software infrastructure, called caGrid version 1.0 (caGrid 1.0), has been developed as the core Grid architecture of the NCI-sponsored cancer Biomedical Informatics Grid (caBIG™) program. It is designed to support a wide range of use cases in basic, translational, and clinical research, including 1) discovery, 2) integrated and large-scale data analysis, and 3) coordinated study. Measurements The caGrid is built as a Grid software infrastructure and leverages Grid computing technologies and the Web Services Resource Framework standards. It provides a set of core services, toolkits for the development and deployment of new community provided services, and application programming interfaces for building client applications. Results The caGrid 1.0 was released to the caBIG community in December 2006. It is built on open source components and caGrid source code is publicly and freely available under a liberal open source license. The core software, associated tools, and documentation can be downloaded from the following URL: https://cabig.nci.nih.gov/workspaces/Architecture/caGrid. Conclusions While caGrid 1.0 is designed to address use cases in cancer research, the requirements associated with discovery, analysis and integration of large scale data, and coordinated studies are common in other biomedical fields. In this respect, caGrid 1.0 is the realization of a framework that can benefit the entire biomedical community. PMID:18096909

caGrid 1.0: an enterprise Grid infrastructure for biomedical research.

PubMed

Oster, Scott; Langella, Stephen; Hastings, Shannon; Ervin, David; Madduri, Ravi; Phillips, Joshua; Kurc, Tahsin; Siebenlist, Frank; Covitz, Peter; Shanbhag, Krishnakant; Foster, Ian; Saltz, Joel

2008-01-01

To develop software infrastructure that will provide support for discovery, characterization, integrated access, and management of diverse and disparate collections of information sources, analysis methods, and applications in biomedical research. An enterprise Grid software infrastructure, called caGrid version 1.0 (caGrid 1.0), has been developed as the core Grid architecture of the NCI-sponsored cancer Biomedical Informatics Grid (caBIG) program. It is designed to support a wide range of use cases in basic, translational, and clinical research, including 1) discovery, 2) integrated and large-scale data analysis, and 3) coordinated study. The caGrid is built as a Grid software infrastructure and leverages Grid computing technologies and the Web Services Resource Framework standards. It provides a set of core services, toolkits for the development and deployment of new community provided services, and application programming interfaces for building client applications. The caGrid 1.0 was released to the caBIG community in December 2006. It is built on open source components and caGrid source code is publicly and freely available under a liberal open source license. The core software, associated tools, and documentation can be downloaded from the following URL: https://cabig.nci.nih.gov/workspaces/Architecture/caGrid. While caGrid 1.0 is designed to address use cases in cancer research, the requirements associated with discovery, analysis and integration of large scale data, and coordinated studies are common in other biomedical fields. In this respect, caGrid 1.0 is the realization of a framework that can benefit the entire biomedical community.

Utilisation of a thoracic oncology database to capture radiological and pathological images for evaluation of response to chemotherapy in patients with malignant pleural mesothelioma

PubMed Central

Carey, George B; Kazantsev, Stephanie; Surati, Mosmi; Rolle, Cleo E; Kanteti, Archana; Sadiq, Ahad; Bahroos, Neil; Raumann, Brigitte; Madduri, Ravi; Dave, Paul; Starkey, Adam; Hensing, Thomas; Husain, Aliya N; Vokes, Everett E; Vigneswaran, Wickii; Armato, Samuel G; Kindler, Hedy L; Salgia, Ravi

2012-01-01

Objective An area of need in cancer informatics is the ability to store images in a comprehensive database as part of translational cancer research. To meet this need, we have implemented a novel tandem database infrastructure that facilitates image storage and utilisation. Background We had previously implemented the Thoracic Oncology Program Database Project (TOPDP) database for our translational cancer research needs. While useful for many research endeavours, it is unable to store images, hence our need to implement an imaging database which could communicate easily with the TOPDP database. Methods The Thoracic Oncology Research Program (TORP) imaging database was designed using the Research Electronic Data Capture (REDCap) platform, which was developed by Vanderbilt University. To demonstrate proof of principle and evaluate utility, we performed a retrospective investigation into tumour response for malignant pleural mesothelioma (MPM) patients treated at the University of Chicago Medical Center with either of two analogous chemotherapy regimens and consented to at least one of two UCMC IRB protocols, 9571 and 13473A. Results A cohort of 22 MPM patients was identified using clinical data in the TOPDP database. After measurements were acquired, two representative CT images and 0–35 histological images per patient were successfully stored in the TORP database, along with clinical and demographic data. Discussion We implemented the TORP imaging database to be used in conjunction with our comprehensive TOPDP database. While it requires an additional effort to use two databases, our database infrastructure facilitates more comprehensive translational research. Conclusions The investigation described herein demonstrates the successful implementation of this novel tandem imaging database infrastructure, as well as the potential utility of investigations enabled by it. The data model presented here can be utilised as the basis for further development of other larger, more streamlined databases in the future. PMID:23103606

Assessing clinical researchers' information needs to create responsive portals and tools: my Research Assistant (MyRA) at the University of Utah: a case study.

PubMed

Reich, Margaret; Shipman, Jean P; Narus, Scott P; Weir, Charlene; Madsen, Randy; Schultz, N Dustin; Cameron, Justin M; Adamczyk, Abby L; Mitchell, Joyce A

2013-01-01

How can health sciences librarians and biomedical informaticians offer relevant support to Clinical and Translational Science Award (CTSA) personnel? The Spencer S. Eccles Health Sciences Library and the associate vice president for information technology for the health sciences office at the University of Utah conducted a needs assessment. Faculty and staff from these two units, with the services of a consultant and other CTSA partners, employed a survey, focus groups, interviews, and committee discussions. An information portal was created to meet identified needs. A directive white paper was created. The process employed to plan a virtual and physical collaborative, collegial space for clinical researchers at the university and its three inter-institutional CTSA partners is described. The university's model can assist other librarians and informaticians with how to become part of a CTSA-focused infrastructure for clinical and translational research and serve researchers in general.

The Infrastructure of Academic Research.

ERIC Educational Resources Information Center

Davey, Ken

1996-01-01

Canadian university infrastructures have eroded as seen in aging equipment, deteriorating facilities, and fewer skilled personnel to maintain and operate research equipment. Research infrastructure includes administrative overhead, facilities and equipment, and research personnel including faculty, technicians, and students. The biggest erosion of…

Uniform data collection in routine clinical practice in cardiovascular patients for optimal care, quality control and research: The Utrecht Cardiovascular Cohort.

PubMed

Asselbergs, Folkert W; Visseren, Frank Lj; Bots, Michiel L; de Borst, Gert J; Buijsrogge, Marc P; Dieleman, Jan M; van Dinther, Baukje Gf; Doevendans, Pieter A; Hoefer, Imo E; Hollander, Monika; de Jong, Pim A; Koenen, Steven V; Pasterkamp, Gerard; Ruigrok, Ynte M; van der Schouw, Yvonne T; Verhaar, Marianne C; Grobbee, Diederick E

2017-05-01

Background Cardiovascular disease remains the major contributor to morbidity and mortality. In routine care for patients with an elevated cardiovascular risk or with symptomatic cardiovascular disease information is mostly collected in an unstructured manner, making the data of limited use for structural feedback, quality control, learning and scientific research. Objective The Utrecht Cardiovascular Cohort (UCC) initiative aims to create an infrastructure for uniform registration of cardiovascular information in routine clinical practice for patients referred for cardiovascular care at the University Medical Center Utrecht, the Netherlands. This infrastructure will promote optimal care according to guidelines, continuous quality control in a learning healthcare system and creation of a research database. Methods The UCC comprises three parts. UCC-1 comprises enrolment of all eligible cardiovascular patients in whom the same information will be collected, based on the Dutch cardiovascular management guideline. A sample of UCC-1 will be invited for UCC-2. UCC-2 involves an enrichment through extensive clinical measurements with emphasis on heart failure, cerebral ischaemia, arterial aneurysms, diabetes mellitus and elevated blood pressure. UCC-3 comprises on-top studies, with in-depth measurements in smaller groups of participants typically based on dedicated project grants. All participants are followed up for morbidity and mortality through linkage with national registries. Conclusion In a multidisciplinary effort with physicians, patients and researchers the UCC sets a benchmark for a learning cardiovascular healthcare system. UCC offers an invaluable resource for future high quality care as well as for first-class research for investigators.

Clinical research informatics and electronic health record data.

PubMed

Richesson, R L; Horvath, M M; Rusincovitch, S A

2014-08-15

The goal of this survey is to discuss the impact of the growing availability of electronic health record (EHR) data on the evolving field of Clinical Research Informatics (CRI), which is the union of biomedical research and informatics. Major challenges for the use of EHR-derived data for research include the lack of standard methods for ensuring that data quality, completeness, and provenance are sufficient to assess the appropriateness of its use for research. Areas that need continued emphasis include methods for integrating data from heterogeneous sources, guidelines (including explicit phenotype definitions) for using these data in both pragmatic clinical trials and observational investigations, strong data governance to better understand and control quality of enterprise data, and promotion of national standards for representing and using clinical data. The use of EHR data has become a priority in CRI. Awareness of underlying clinical data collection processes will be essential in order to leverage these data for clinical research and patient care, and will require multi-disciplinary teams representing clinical research, informatics, and healthcare operations. Considerations for the use of EHR data provide a starting point for practical applications and a CRI research agenda, which will be facilitated by CRI's key role in the infrastructure of a learning healthcare system.

Clinical Research Informatics and Electronic Health Record Data

PubMed Central

Horvath, M. M.; Rusincovitch, S. A.

2014-01-01

Summary Objectives The goal of this survey is to discuss the impact of the growing availability of electronic health record (EHR) data on the evolving field of Clinical Research Informatics (CRI), which is the union of biomedical research and informatics. Results Major challenges for the use of EHR-derived data for research include the lack of standard methods for ensuring that data quality, completeness, and provenance are sufficient to assess the appropriateness of its use for research. Areas that need continued emphasis include methods for integrating data from heterogeneous sources, guidelines (including explicit phenotype definitions) for using these data in both pragmatic clinical trials and observational investigations, strong data governance to better understand and control quality of enterprise data, and promotion of national standards for representing and using clinical data. Conclusions The use of EHR data has become a priority in CRI. Awareness of underlying clinical data collection processes will be essential in order to leverage these data for clinical research and patient care, and will require multi-disciplinary teams representing clinical research, informatics, and healthcare operations. Considerations for the use of EHR data provide a starting point for practical applications and a CRI research agenda, which will be facilitated by CRI’s key role in the infrastructure of a learning healthcare system. PMID:25123746

Needs assessment for collaborative network in pediatric clinical research and education.

PubMed

Ishiguro, Akira; Sasaki, Hatoko; Yahagi, Naohisa; Kato, Hitoshi; Kure, Shigeo; Mori, Rintaro

2017-01-01

A collaborative network for pediatric research has not been fully established in Japan. To identify the network infrastructure, we conducted a survey on the support and education for clinical research currently available in children's hospitals. In November 2014, a 27-question survey was distributed to 31 hospitals belonging to the Japanese Association of Children's Hospitals and Related Institutions (JACHRI) to assess clinical research support, research education, research achievements, and their expectations. All the hospitals responded to the survey. Overall, 74.2% of hospitals had clinical research support divisions. Although all hospitals had ethics committees, <30% of the hospitals had a data manager, intellectual property management unit, biostatistician, and English-language editor. Seven hospitals had education programs for clinical research. The number of seminars and workshops for clinical research had significant correlations with the number of physicians (r = 0.927), pediatricians (r = 0.922), and clinical trial management physicians (r = 0.962). There was a significant difference in the number of clinical trials initiated by physicians between hospitals with research education programs and those without (P < 0.01). The number of education programs was significantly correlated with the number of original articles and case reports in English (r = 0.788), and the number of publications in Japanese (r = 0.648). All hospitals recognized the need for a leader to establish a collaborative network for clinical research. Important factors for creating a collaborative system for pediatric research in Japan were identified. Human resources to support clinical research are a key factor to improve clinical research education and research achievements. © 2016 Japan Pediatric Society.

A novel smart lighting clinical testbed.

PubMed

Gleason, Joseph D; Oishi, Meeko; Simkulet, Michelle; Tuzikas, Arunas; Brown, Lee K; Brueck, S R J; Karlicek, Robert F

2017-07-01

A real-time, feedback-capable, variable spectrum lighting system was recently installed at the University of New Mexico Hospital to facilitate biomedical research on the health impacts of lighting. The system consists of variable spectrum troffers, color sensors, occupancy sensors, and computing and communication infrastructure, and is the only such clinical facility in the US. The clinical environment posed special challenges for installation as well as for ongoing maintenance and operations. Pilot studies are currently underway to evaluate the effectiveness of the system to regulate circadian phase in subjects with delayed sleep-wake phase disorder.

The dependence of educational infrastructure on clinical infrastructure.

PubMed Central

Cimino, C.

1998-01-01

The Albert Einstein College of Medicine needed to assess the growth of its infrastructure for educational computing as a first step to determining if student needs were being met. Included in computing infrastructure are space, equipment, software, and computing services. The infrastructure was assessed by reviewing purchasing and support logs for a six year period from 1992 to 1998. This included equipment, software, and e-mail accounts provided to students and to faculty for educational purposes. Student space has grown at a constant rate (averaging 14% increase each year respectively). Student equipment on campus has grown by a constant amount each year (average 8.3 computers each year). Student infrastructure off campus and educational support of faculty has not kept pace. It has either declined or remained level over the six year period. The availability of electronic mail clearly demonstrates this with accounts being used by 99% of students, 78% of Basic Science Course Leaders, 38% of Clerkship Directors, 18% of Clerkship Site Directors, and 8% of Clinical Elective Directors. The collection of the initial descriptive infrastructure data has revealed problems that may generalize to other medical schools. The discrepancy between infrastructure available to students and faculty on campus and students and faculty off campus creates a setting where students perceive a paradoxical declining support for computer use as they progress through medical school. While clinical infrastructure may be growing, it is at the expense of educational infrastructure at affiliate hospitals. PMID:9929262

Overview of the Oral HIV/AIDS Research Alliance Program

PubMed Central

Shiboski, C.H.; Webster-Cyriaque, J.Y.; Ghannoum, M.; Greenspan, J.S.; Dittmer, D.

2011-01-01

The Oral HIV/AIDS Research Alliance is part of the AIDS Clinical Trials Group, the largest HIV clinical trial organization in the world, and it is funded by the National Institute of Dental and Craniofacial Research, in collaboration with the National Institute of Allergy and Infectious Diseases. The alliance’s main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving—in particular, the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens. Furthermore, oral fluids are being explored for their potential monitoring and diagnostic role with respect to HIV disease and coinfections. This article presents an overview of the alliance, its scientific agenda, and an outline of the novel interventional and noninterventional clinical studies ongoing and developing within the AIDS Clinical Trials Group infrastructure in the United States and internationally. PMID:21441477

Overview of the oral HIV/AIDS Research Alliance Program.

PubMed

Shiboski, C H; Webster-Cyriaque, J Y; Ghannoum, M; Greenspan, J S; Dittmer, D

2011-04-01

The Oral HIV/AIDS Research Alliance is part of the AIDS Clinical Trials Group, the largest HIV clinical trial organization in the world, and it is funded by the National Institute of Dental and Craniofacial Research, in collaboration with the National Institute of Allergy and Infectious Diseases. The alliance's main objective is to investigate the oral complications associated with HIV/AIDS as the epidemic is evolving-in particular, the effects of potent antiretrovirals on the development of oral mucosal lesions and associated fungal and viral pathogens. Furthermore, oral fluids are being explored for their potential monitoring and diagnostic role with respect to HIV disease and coinfections. This article presents an overview of the alliance, its scientific agenda, and an outline of the novel interventional and noninterventional clinical studies ongoing and developing within the AIDS Clinical Trials Group infrastructure in the United States and internationally.

Leveraging electronic health records for clinical research.

PubMed

Raman, Sudha R; Curtis, Lesley H; Temple, Robert; Andersson, Tomas; Ezekowitz, Justin; Ford, Ian; James, Stefan; Marsolo, Keith; Mirhaji, Parsa; Rocca, Mitra; Rothman, Russell L; Sethuraman, Barathi; Stockbridge, Norman; Terry, Sharon; Wasserman, Scott M; Peterson, Eric D; Hernandez, Adrian F

2018-04-30

Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper. Copyright © 2018 Elsevier, Inc. All rights reserved.

Electronic health records to facilitate clinical research.

PubMed

Cowie, Martin R; Blomster, Juuso I; Curtis, Lesley H; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faiez; Zalewski, Andrew

2017-01-01

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.

PubMed

Burbach, J P M; Kurk, S A; Coebergh van den Braak, R R J; Dik, V K; May, A M; Meijer, G A; Punt, C J A; Vink, G R; Los, M; Hoogerbrugge, N; Huijgens, P C; Ijzermans, J N M; Kuipers, E J; de Noo, M E; Pennings, J P; van der Velden, A M T; Verhoef, C; Siersema, P D; van Oijen, M G H; Verkooijen, H M; Koopman, M

2016-11-01

Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients. This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

Mandibular third molar surgery in 396 patients at a Norwegian university clinic: Morbidity recorded after 1 week utilizing an e-infrastructure for clinical research.

PubMed

Øyri, Hauk; Bjørnland, Tore; Barkvoll, Pål; Jensen, Janicke Liaaen

2016-01-01

To evaluate morbidity 1 week after mandibular third molar (3M) surgery in the authors' department. A prospective 1-year clinical study of patients followed up for 1 week after 3M surgery was performed. Consecutive patients of 18 years or older having 3M surgery under local anaesthesia were included. Patients not able to attend a follow-up appointment after 1 week were excluded. Demographic data, indication for surgery and clinical findings were recorded. Outcome variables were days requiring analgesic, days absent from work/school and complications. All data recording was performed utilizing an e-infrastructure for clinical research (InReach, University Health Network, www.uhnsl.com). Three hundred and ninety-six patients were examined 1 week after surgery. Mean number of days requiring analgesics was 3.8 and mean number of days absent from work/school after surgery was 0.6. Minor complications were reported by 7% of patients. Female patients reported more days requiring analgesics compared to male patients. Smokers had a higher odds ratio for being absent ≥ 3 days. Prophylactic removal of 3Ms was associated with fewer days requiring analgesics and days absent from work/school as compared to teeth with local disease. Overall morbidity after 3M surgery was low. Compared to patients subjected to therapeutic removal of 3Ms, patients undergoing prophylactic removal seem to have less pain and a faster return to normal activities.

Facilities | Hydrogen and Fuel Cells | NREL

Science.gov Websites

integration research. Photo of the Hydrogen Infrastructure Testing and Research Facility building, with hydrogen fueling station and fuel cell vehicles. Hydrogen Infrastructure Testing and Research Facility The Hydrogen Infrastructure Testing and Research Facility (HITRF) at the ESIF combines electrolyzers, a

'Cloud computing' and clinical trials: report from an ECRIN workshop.

PubMed

Ohmann, Christian; Canham, Steve; Danielyan, Edgar; Robertshaw, Steve; Legré, Yannick; Clivio, Luca; Demotes, Jacques

2015-07-29

Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.

Improving academic leadership and oversight in large industry-sponsored clinical trials: the ARO-CRO model

PubMed Central

Goldenberg, Neil A.; Spyropoulos, Alex C.; Halperin, Jonathan L.; Kessler, Craig M.; Schulman, Sam; Turpie, Alexander G. G.; Skene, Allan M.; Cutler, Neal R.

2011-01-01

Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, the contract research organization (CRO) that typically assists in executing the trial, regulatory agencies, and academicians, provides inadequate leadership and oversight of the development process. Conventional academic steering committees are not provided with the independent infrastructure by which to verify statistical analyses and conclusions regarding safety and efficacy. We propose an alternative approach centered on partnerships between CROs and university-based academic research organizations (AROs). In this model, the ARO takes responsibility for processes that address journal requirements and regulatory expectations for independent academic oversight (including oversight of Steering Committee and Data and Safety Monitoring Board activities), whereas the CRO provides infrastructure for efficient trial execution, site monitoring, and data management. The ARO engages academic experts throughout the trial process and minimizes conflicts of interest in individual industry relationships via diversification of sponsors, agents, and therapeutic areas. Although numerous models can be entertained, the ARO-CRO model is uniquely structured to meet the demand for greater assurance of integrity in clinical trials and the needs of each stakeholder in the process. PMID:21068436

AGING WATER INFRASTRUCTURE RESEARCH PROGRAM: ADDRESSING THE CHALLENGE THROUGH INNOVATION

EPA Science Inventory

A driving force behind the Sustainable Water Infrastructure (SI) initiative and the Aging Water Infrastructure (AWI) research program is the Clean Water and Drinking Water Infrastructure Gap Analysis. In this report, EPA estimated that if operation, maintenance, and capital inves...

Patient Engagement in Kidney Research: Opportunities and Challenges Ahead

PubMed Central

Molnar, Amber O.; Barua, Moumita; Konvalinka, Ana; Schick-Makaroff, Kara

2017-01-01

Purpose of Review: Patient engagement in research is increasingly recognized as an important component of the research process and may facilitate translation of research findings. To heighten awareness on this important topic, this review presents opportunities and challenges of patient engagement in research, drawing on specific examples from 4 areas of Canadian kidney research conducted by New Investigators in the Kidney Research Scientist Core Education and National Training (KRESCENT) Program. Sources of Information: Research expertise, published reports, peer-reviewed articles, and research funding body websites. Methods: In this review, the definition, purpose, and potential benefits of patient engagement in research are discussed. Approaches toward patient engagement that may help with translation and uptake of research findings into clinical practice are highlighted. Opportunities and challenges of patient engagement are presented in both basic science and clinical research with the following examples of kidney research: (1) precision care in focal and segmental glomerulosclerosis, (2) systems biology approaches to improve management of chronic kidney disease and enhance kidney graft survival, (3) reducing the incidence of suboptimal dialysis initiation, and (4) use of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in kidney practice. Key Findings: Clinical research affords more obvious opportunities for patient engagement. The most obvious step at which to engage patients is in the setting of research priorities. Engagement at all stages of the research cycle may prove to be more challenging, and requires a detailed plan, along with funds and infrastructure to ensure that it is not merely tokenistic. Basic science research is several steps removed from the clinical application and involves complex scientific concepts, which makes patient engagement inherently more difficult. Limitations: This is a narrative review of the literature that has been partly influenced by the perspectives and experiences of the authors and focuses on research conducted by the authors. The evidence base to support the suggested benefits of patient engagement in research is currently limited. Implications: The formal incorporation of patients’ priorities, perspectives, and experiences is now recognized as a key component of the research process. If patients and researchers are able to effectively work together, this could enhance research quality and efficiency. To effectively engage patients, proper infrastructure and dedicated funding are needed. Going forward, a rigorous evaluation of patient engagement strategies and their effectiveness will be needed. PMID:29225906

Patient Engagement in Kidney Research: Opportunities and Challenges Ahead.

PubMed

Molnar, Amber O; Barua, Moumita; Konvalinka, Ana; Schick-Makaroff, Kara

2017-01-01

Patient engagement in research is increasingly recognized as an important component of the research process and may facilitate translation of research findings. To heighten awareness on this important topic, this review presents opportunities and challenges of patient engagement in research, drawing on specific examples from 4 areas of Canadian kidney research conducted by New Investigators in the Kidney Research Scientist Core Education and National Training (KRESCENT) Program. Research expertise, published reports, peer-reviewed articles, and research funding body websites. In this review, the definition, purpose, and potential benefits of patient engagement in research are discussed. Approaches toward patient engagement that may help with translation and uptake of research findings into clinical practice are highlighted. Opportunities and challenges of patient engagement are presented in both basic science and clinical research with the following examples of kidney research: (1) precision care in focal and segmental glomerulosclerosis, (2) systems biology approaches to improve management of chronic kidney disease and enhance kidney graft survival, (3) reducing the incidence of suboptimal dialysis initiation, and (4) use of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in kidney practice. Clinical research affords more obvious opportunities for patient engagement. The most obvious step at which to engage patients is in the setting of research priorities. Engagement at all stages of the research cycle may prove to be more challenging, and requires a detailed plan, along with funds and infrastructure to ensure that it is not merely tokenistic. Basic science research is several steps removed from the clinical application and involves complex scientific concepts, which makes patient engagement inherently more difficult. This is a narrative review of the literature that has been partly influenced by the perspectives and experiences of the authors and focuses on research conducted by the authors. The evidence base to support the suggested benefits of patient engagement in research is currently limited. The formal incorporation of patients' priorities, perspectives, and experiences is now recognized as a key component of the research process. If patients and researchers are able to effectively work together, this could enhance research quality and efficiency. To effectively engage patients, proper infrastructure and dedicated funding are needed. Going forward, a rigorous evaluation of patient engagement strategies and their effectiveness will be needed.

Research Challenges and Opportunities for Clinically Oriented Academic Radiology Departments.

PubMed

Decker, Summer J; Grajo, Joseph R; Hazelton, Todd R; Hoang, Kimberly N; McDonald, Jennifer S; Otero, Hansel J; Patel, Midhir J; Prober, Allen S; Retrouvey, Michele; Rosenkrantz, Andrew B; Roth, Christopher G; Ward, Robert J

2016-01-01

Between 2004 and 2012, US funding for the biomedical sciences decreased to historic lows. Health-related research was crippled by receiving only 1/20th of overall federal scientific funding. Despite the current funding climate, there is increased pressure on academic radiology programs to establish productive research programs. Whereas larger programs have resources that can be utilized at their institutions, small to medium-sized programs often struggle with lack of infrastructure and support. To address these concerns, the Association of University Radiologists' Radiology Research Alliance developed a task force to explore any untapped research productivity potential in these smaller radiology departments. We conducted an online survey of faculty at smaller clinically funded programs and found that while they were interested in doing research and felt it was important to the success of the field, barriers such as lack of resources and time were proving difficult to overcome. One potential solution proposed by this task force is a collaborative structured research model in which multiple participants from multiple institutions come together in well-defined roles that allow for an equitable distribution of research tasks and pooling of resources and expertise. Under this model, smaller programs will have an opportunity to share their unique perspective on how to address research topics and make a measureable impact on the field of radiology as a whole. Through a health services focus, projects are more likely to succeed in the context of limited funding and infrastructure while simultaneously providing value to the field. Copyright © 2016 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

COOPEUS - connecting research infrastructures in environmental sciences

NASA Astrophysics Data System (ADS)

Koop-Jakobsen, Ketil; Waldmann, Christoph; Huber, Robert

2015-04-01

The COOPEUS project was initiated in 2012 bringing together 10 research infrastructures (RIs) in environmental sciences from the EU and US in order to improve the discovery, access, and use of environmental information and data across scientific disciplines and across geographical borders. The COOPEUS mission is to facilitate readily accessible research infrastructure data to advance our understanding of Earth systems through an international community-driven effort, by: Bringing together both user communities and top-down directives to address evolving societal and scientific needs; Removing technical, scientific, cultural and geopolitical barriers for data use; and Coordinating the flow, integrity and preservation of information. A survey of data availability was conducted among the COOPEUS research infrastructures for the purpose of discovering impediments for open international and cross-disciplinary sharing of environmental data. The survey showed that the majority of data offered by the COOPEUS research infrastructures is available via the internet (>90%), but the accessibility to these data differ significantly among research infrastructures; only 45% offer open access on their data, whereas the remaining infrastructures offer restricted access e.g. do not release raw data or sensible data, demand user registration or require permission prior to release of data. These rules and regulations are often installed as a form of standard practice, whereas formal data policies are lacking in 40% of the infrastructures, primarily in the EU. In order to improve this situation COOPEUS has installed a common data-sharing policy, which is agreed upon by all the COOPEUS research infrastructures. To investigate the existing opportunities for improving interoperability among environmental research infrastructures, COOPEUS explored the opportunities with the GEOSS common infrastructure (GCI) by holding a hands-on workshop. Through exercises directly registering resources, the first steps were taken to implement the GCI as a platform for documenting the capabilities of the COOPEUS research infrastructures. COOPEUS recognizes the potential for the GCI to become an important platform promoting cross-disciplinary approaches in the studies of multifaceted environmental challenges. Recommendations from the workshop participants also revealed that in order to attract research infrastructures to use the GCI, the registration process must be simplified and accelerated. However, also the data policies of the individual research infrastructure, or lack thereof, can prevent the use of the GCI or other portals, due to unclarities regarding data management authority and data ownership. COOPEUS shall continue to promote cross-disciplinary data exchange in the environmental field and will in the future expand to also include other geographical areas.

Merging clinical chemistry biomarker data with a COPD database - building a clinical infrastructure for proteomic studies.

PubMed

Eriksson, Jonatan; Andersson, Simone; Appelqvist, Roger; Wieslander, Elisabet; Truedsson, Mikael; Bugge, May; Malm, Johan; Dahlbäck, Magnus; Andersson, Bo; Fehniger, Thomas E; Marko-Varga, György

2016-01-01

Data from biological samples and medical evaluations plays an essential part in clinical decision making. This data is equally important in clinical studies and it is critical to have an infrastructure that ensures that its quality is preserved throughout its entire lifetime. We are running a 5-year longitudinal clinical study, KOL-Örestad, with the objective to identify new COPD (Chronic Obstructive Pulmonary Disease) biomarkers in blood. In the study, clinical data and blood samples are collected from both private and public health-care institutions and stored at our research center in databases and biobanks, respectively. The blood is analyzed by Mass Spectrometry and the results from this analysis then linked to the clinical data. We built an infrastructure that allows us to efficiently collect and analyze the data. We chose to use REDCap as the EDC (Electronic Data Capture) tool for the study due to its short setup-time, ease of use, and flexibility. REDCap allows users to easily design data collection modules based on existing templates. In addition, it provides two functions that allow users to import batches of data; through a web API (Application Programming Interface) as well as by uploading CSV-files (Comma Separated Values). We created a software, DART (Data Rapid Translation), that translates our biomarker data into a format that fits REDCap's CSV-templates. In addition, DART is configurable to work with many other data formats as well. We use DART to import our clinical chemistry data to the REDCap database. We have shown that a powerful and internationally adopted EDC tool such as REDCap can be extended so that it can be used efficiently in proteomic studies. In our study, we accomplish this by using DART to translate our clinical chemistry data to a format that fits the templates of REDCap.

From computer-assisted intervention research to clinical impact: The need for a holistic approach.

PubMed

Ourselin, Sébastien; Emberton, Mark; Vercauteren, Tom

2016-10-01

The early days of the field of medical image computing (MIC) and computer-assisted intervention (CAI), when publishing a strong self-contained methodological algorithm was enough to produce impact, are over. As a community, we now have substantial responsibility to translate our scientific progresses into improved patient care. In the field of computer-assisted interventions, the emphasis is also shifting from the mere use of well-known established imaging modalities and position trackers to the design and combination of innovative sensing, elaborate computational models and fine-grained clinical workflow analysis to create devices with unprecedented capabilities. The barriers to translating such devices in the complex and understandably heavily regulated surgical and interventional environment can seem daunting. Whether we leave the translation task mostly to our industrial partners or welcome, as researchers, an important share of it is up to us. We argue that embracing the complexity of surgical and interventional sciences is mandatory to the evolution of the field. Being able to do so requires large-scale infrastructure and a critical mass of expertise that very few research centres have. In this paper, we emphasise the need for a holistic approach to computer-assisted interventions where clinical, scientific, engineering and regulatory expertise are combined as a means of moving towards clinical impact. To ensure that the breadth of infrastructure and expertise required for translational computer-assisted intervention research does not lead to a situation where the field advances only thanks to a handful of exceptionally large research centres, we also advocate that solutions need to be designed to lower the barriers to entry. Inspired by fields such as particle physics and astronomy, we claim that centralised very large innovation centres with state of the art technology and health technology assessment capabilities backed by core support staff and open interoperability standards need to be accessible to the wider computer-assisted intervention research community. Copyright © 2016. Published by Elsevier B.V.

[Challenges in the organization of investigator initiated trials: in transplantation medicine].

PubMed

Schnitzbauer, A A; Lamby, P E; Mutzbauer, I; von Hassel, J; Geissler, E K; Schlitt, H J

2011-03-01

Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product. We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach. Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry. Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.

Aging Water Infrastructure Research Program Update: Innovation & Research for the 21st Century

EPA Science Inventory

This slide presentation summarizes key elements of the EOA, Office of Research and Development’s (ORD) Aging Water Infrastructure (AWI)) Research program. An overview of the national problems posed by aging water infrastructure is followed by a brief description of EPA’s overall...

Development of a public health nursing data infrastructure.

PubMed

Monsen, Karen A; Bekemeier, Betty; P Newhouse, Robin; Scutchfield, F Douglas

2012-01-01

An invited group of national public health nursing (PHN) scholars, practitioners, policymakers, and other stakeholders met in October 2010 identifying a critical need for a national PHN data infrastructure to support PHN research. This article summarizes the strengths, limitations, and gaps specific to PHN data and proposes a research agenda for development of a PHN data infrastructure. Future implications are suggested, such as issues related to the development of the proposed PHN data infrastructure and future research possibilities enabled by the infrastructure. Such a data infrastructure has potential to improve accountability and measurement, to demonstrate the value of PHN services, and to improve population health. © 2012 Wiley Periodicals, Inc.

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality

PubMed Central

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G.; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H.; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

Objective To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. Study design and setting We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Results Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Conclusion Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders’ individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research. PMID:28715491

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

PubMed

von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H; Pauli-Magnus, Christiane; Briel, Matthias

2017-01-01

To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders' individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research.

A Disability and Health Institutional Research Capacity Building and Infrastructure Model Evaluation: A Tribal College-Based Case Study

ERIC Educational Resources Information Center

Moore, Corey L.; Manyibe, Edward O.; Sanders, Perry; Aref, Fariborz; Washington, Andre L.; Robertson, Cherjuan Y.

2017-01-01

Purpose: The purpose of this multimethod study was to evaluate the institutional research capacity building and infrastructure model (IRCBIM), an emerging innovative and integrated approach designed to build, strengthen, and sustain adequate disability and health research capacity (i.e., research infrastructure and investigators' research skills)…

A method for analyzing the business case for provider participation in the National Cancer Institute's Community Clinical Oncology Program and similar federally funded, provider-based research networks.

PubMed

Reiter, Kristin L; Song, Paula H; Minasian, Lori; Good, Marjorie; Weiner, Bryan J; McAlearney, Ann Scheck

2012-09-01

The Community Clinical Oncology Program (CCOP) plays an essential role in the efforts of the National Cancer Institute (NCI) to increase enrollment in clinical trials. Currently, there is little practical guidance in the literature to assist provider organizations in analyzing the return on investment (ROI), or business case, for establishing and operating a provider-based research network (PBRN) such as the CCOP. In this article, the authors present a conceptual model of the business case for PBRN participation, a spreadsheet-based tool and advice for evaluating the business case for provider participation in a CCOP organization. A comparative, case-study approach was used to identify key components of the business case for hospitals attempting to support a CCOP research infrastructure. Semistructured interviews were conducted with providers and administrators. Key themes were identified and used to develop the financial analysis tool. Key components of the business case included CCOP start-up costs, direct revenue from the NCI CCOP grant, direct expenses required to maintain the CCOP research infrastructure, and incidental benefits, most notably downstream revenues from CCOP patients. The authors recognized the value of incidental benefits as an important contributor to the business case for CCOP participation; however, currently, this component is not calculated. The current results indicated that providing a method for documenting the business case for CCOP or other PBRN involvement will contribute to the long-term sustainability and expansion of these programs by improving providers' understanding of the financial implications of participation. Copyright © 2011 American Cancer Society.

The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial.

PubMed

Mbuagbaw, Lawrence; Thabane, Lehana; Ongolo-Zogo, Pierre; Lang, Trudie

2011-06-09

Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.

Establishment of a research pharmacy to support Ebola clinical research in Liberia.

PubMed

Pierson, Jerome F; Kirchoff, Matthew Carl; Tyee, Rev Tijli; Montello, Michael J; Rhie, Julie K

This article describes the establishment of a research pharmacy to support the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) vaccine study for Ebola virus disease. This article describes the establishment of the pharmacy element to support the overall research program during an Ebola outbreak in Monrovia, Liberia, in 2014 and 2015. The need for the rapid establishment of infrastructure to support the Liberia-United States joint clinical research partnership in response to the emerging Ebola virus disease provided the opportunity for collaboration among Liberian and U.S. pharmacists. Resource austere and research naïve. Research pharmacy prepared and randomized 1500 vaccinations in support of PREVAIL. Experiences of the Liberian and U.S. pharmacists involved in the program are described. The partnership was successful in the conduct of the study. More importantly, the capacity for Liberian pharmacists to support clinical research was established. In addition, the U.S. team learned several important lessons that will help prepare them for responding to research needs in future infectious disease outbreaks. Published by Elsevier Inc.

An evaluation of the 'Designated Research Team' approach to building research capacity in primary care.

PubMed

Cooke, Jo; Nancarrow, Susan; Dyas, Jane; Williams, Martin

2008-06-27

This paper describes an evaluation of an initiative to increase the research capability of clinical groups in primary and community care settings in a region of the United Kingdom. The 'designated research team' (DRT) approach was evaluated using indicators derived from a framework of six principles for research capacity building (RCB) which include: building skills and confidence, relevance to practice, dissemination, linkages and collaborations, sustainability and infrastructure development. Information was collated on the context, activities, experiences, outputs and impacts of six clinical research teams supported by Trent Research Development Support Unit (RDSU) as DRTs. Process and outcome data from each of the teams was used to evaluate the extent to which the DRT approach was effective in building research capacity in each of the six principles (as evidenced by twenty possible indicators of research capacity development). The DRT approach was found to be well aligned to the principles of RCB and generally effective in developing research capabilities. It proved particularly effective in developing linkages, collaborations and skills. Where research capacity was slow to develop, this was reflected in poor alignment between the principles of RCB and the characteristics of the team, their activities or environment. One team was unable to develop a research project and the funding was withdrawn at an early stage. For at least one individual in each of the remaining five teams, research activity was sustained beyond the funding period through research partnerships and funding successes. An enabling infrastructure, including being freed from clinical duties to undertake research, and support from senior management were found to be important determinants of successful DRT development. Research questions of DRTs were derived from practice issues and several projects generated outputs with potential to change daily practice, including the use of research evidence in practice and in planning service changes. The DRT approach was effective at RCB in teams situated in a supportive organisation and in particular, where team members could be freed from clinical duties and management backing was strong. The developmental stage of the team and the research experience of constituent members also appeared to influence success. The six principles of RCB were shown to be useful as a framework for both developing and evaluating RCB initiatives.

Cardiovascular drug discovery in the academic setting: building infrastructure, harnessing strengths, and seeking synergies.

PubMed

Gardell, Stephen J; Roth, Gregory P; Kelly, Daniel P

2010-10-01

The flow of innovative, effective, and safe new drugs from pharmaceutical laboratories for the treatment and prevention of cardiovascular disease has slowed to a trickle. While the need for breakthrough cardiovascular disease drugs is still paramount, the incentive to develop these agents has been blunted by burgeoning clinical development costs coupled with a heightened risk of failure due to the unprecedented nature of the emerging drug targets and increasingly challenging regulatory environment. A fuller understanding of the drug targets and employing novel biomarker strategies in clinical trials should serve to mitigate the risk. In any event, these current challenges have evoked changing trends in the pharmaceutical industry, which have created an opportunity for non-profit biomedical research institutions to play a pivotal partnering role in early stage drug discovery. The obvious strengths of academic research institutions is the breadth of their scientific programs and the ability and motivation to "go deep" to identify and characterize new target pathways that unlock the specific mysteries of cardiovascular diseases--leading to a bounty of novel therapeutic targets and prescient biomarkers. However, success in the drug discovery arena within the academic environment is contingent upon assembling the requisite infrastructure, annexing the talent to interrogate and validate the drug targets, and building translational bridges with pharmaceutical organizations and patient-oriented researchers.

Highways of the future : a strategic plan for highway infrastructure research and development

DOT National Transportation Integrated Search

2008-07-01

This Highways of the FutureA Strategic Plan for Highway Infrastructure Research and Development was developed in response to a need expressed by the staff of the Federal Highway Administration (FHWA) Office of Infrastructure Research and Developme...

TRANSVAC research infrastructure - Results and lessons learned from the European network of vaccine research and development.

PubMed

Geels, Mark J; Thøgersen, Regitze L; Guzman, Carlos A; Ho, Mei Mei; Verreck, Frank; Collin, Nicolas; Robertson, James S; McConkey, Samuel J; Kaufmann, Stefan H E; Leroy, Odile

2015-10-05

TRANSVAC was a collaborative infrastructure project aimed at enhancing European translational vaccine research and training. The objective of this four year project (2009-2013), funded under the European Commission's (EC) seventh framework programme (FP7), was to support European collaboration in the vaccine field, principally through the provision of transnational access (TNA) to critical vaccine research and development (R&D) infrastructures, as well as by improving and harmonising the services provided by these infrastructures through joint research activities (JRA). The project successfully provided all available services to advance 29 projects and, through engaging all vaccine stakeholders, successfully laid down the blueprint for the implementation of a permanent research infrastructure for early vaccine R&D in Europe. Copyright © 2015. Published by Elsevier Ltd.

Identifying Audiences of E-Infrastructures - Tools for Measuring Impact

PubMed Central

van den Besselaar, Peter

2012-01-01

Research evaluation should take into account the intended scholarly and non-scholarly audiences of the research output. This holds too for research infrastructures, which often aim at serving a large variety of audiences. With research and research infrastructures moving to the web, new possibilities are emerging for evaluation metrics. This paper proposes a feasible indicator for measuring the scope of audiences who use web-based e-infrastructures, as well as the frequency of use. In order to apply this indicator, a method is needed for classifying visitors to e-infrastructures into relevant user categories. The paper proposes such a method, based on an inductive logic program and a Bayesian classifier. The method is tested, showing that the visitors are efficiently classified with 90% accuracy into the selected categories. Consequently, the method can be used to evaluate the use of the e-infrastructure within and outside academia. PMID:23239995

IT Infrastructure Projects: A Framework for Analysis. ECAR Research Bulletin

ERIC Educational Resources Information Center

Grochow, Jerrold M.

2014-01-01

Just as maintaining a healthy infrastructure of water delivery and roads is essential to the functioning of cities and towns, maintaining a healthy infrastructure of information technology is essential to the functioning of universities. Deterioration in IT infrastructure can lead to deterioration in research, teaching, and administration. Given…

Commonwealth Infrastructure Funding for Australian Universities: 2004 to 2011

ERIC Educational Resources Information Center

Koshy, Paul; Phillimore, John

2013-01-01

This paper provides an overview of recent trends in the provision of general infrastructure funding by the Commonwealth for Australian universities (Table A providers) over the period 2004 to 2011. It specifically examines general infrastructure development and excludes funding for research infrastructure through the Australian Research Council or…

A Cloud-based Infrastructure and Architecture for Environmental System Research

NASA Astrophysics Data System (ADS)

Wang, D.; Wei, Y.; Shankar, M.; Quigley, J.; Wilson, B. E.

2016-12-01

The present availability of high-capacity networks, low-cost computers and storage devices, and the widespread adoption of hardware virtualization and service-oriented architecture provide a great opportunity to enable data and computing infrastructure sharing between closely related research activities. By taking advantage of these approaches, along with the world-class high computing and data infrastructure located at Oak Ridge National Laboratory, a cloud-based infrastructure and architecture has been developed to efficiently deliver essential data and informatics service and utilities to the environmental system research community, and will provide unique capabilities that allows terrestrial ecosystem research projects to share their software utilities (tools), data and even data submission workflow in a straightforward fashion. The infrastructure will minimize large disruptions from current project-based data submission workflows for better acceptances from existing projects, since many ecosystem research projects already have their own requirements or preferences for data submission and collection. The infrastructure will eliminate scalability problems with current project silos by provide unified data services and infrastructure. The Infrastructure consists of two key components (1) a collection of configurable virtual computing environments and user management systems that expedite data submission and collection from environmental system research community, and (2) scalable data management services and system, originated and development by ORNL data centers.

Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?

PubMed

Laville, Martine; Segrestin, Berenice; Alligier, Maud; Ruano-Rodríguez, Cristina; Serra-Majem, Lluis; Hiesmayr, Michael; Schols, Annemie; La Vecchia, Carlo; Boirie, Yves; Rath, Ana; Neugebauer, Edmund A M; Garattini, Silvio; Bertele, Vittorio; Kubiak, Christine; Demotes-Mainard, Jacques; Jakobsen, Janus C; Djurisic, Snezana; Gluud, Christian

2017-09-11

Evidence-based clinical research poses special barriers in the field of nutrition. The present review summarises the main barriers to research in the field of nutrition that are not common to all randomised clinical trials or trials on rare diseases and highlights opportunities for improvements. Systematic academic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. Many nutrients occur in multiple forms that differ in biological activity, and several factors can alter their bioavailability which raises barriers to their assessment. These include specific difficulties with blinding procedures, with assessments of dietary intake, and with selecting appropriate outcomes as patient-centred outcomes may occur decennia into the future. The methodologies and regulations for drug trials are, however, applicable to nutrition trials. Research on clinical nutrition should start by collecting clinical data systematically in databases and registries. Measurable patient-centred outcomes and appropriate study designs are needed. International cooperation and multistakeholder engagement are key for success.

Integration in primary community care networks (PCCNs): examination of governance, clinical, marketing, financial, and information infrastructures in a national demonstration project in Taiwan

PubMed Central

Lin, Blossom Yen-Ju

2007-01-01

Background Taiwan's primary community care network (PCCN) demonstration project, funded by the Bureau of National Health Insurance on March 2003, was established to discourage hospital shopping behavior of people and drive the traditional fragmented health care providers into cooperate care models. Between 2003 and 2005, 268 PCCNs were established. This study profiled the individual members in the PCCNs to study the nature and extent to which their network infrastructures have been integrated among the members (clinics and hospitals) within individual PCCNs. Methods The thorough questionnaire items, covering the network working infrastructures – governance, clinical, marketing, financial, and information integration in PCCNs, were developed with validity and reliability confirmed. One thousand five hundred and fifty-seven clinics that had belonged to PCCNs for more than one year, based on the 2003–2005 Taiwan Primary Community Care Network List, were surveyed by mail. Nine hundred and twenty-eight clinic members responded to the surveys giving a 59.6 % response rate. Results Overall, the PCCNs' members had higher involvement in the governance infrastructure, which was usually viewed as the most important for establishment of core values in PCCNs' organization design and management at the early integration stage. In addition, it found that there existed a higher extent of integration of clinical, marketing, and information infrastructures among the hospital-clinic member relationship than those among clinic members within individual PCCNs. The financial infrastructure was shown the least integrated relative to other functional infrastructures at the early stage of PCCN formation. Conclusion There was still room for better integrated partnerships, as evidenced by the great variety of relationships and differences in extent of integration in this study. In addition to provide how the network members have done for their initial work at the early stage of network forming in this study, the detailed surveyed items, the concepts proposed by the managerial and theoretical professionals, could be a guide for those health care providers who have willingness to turn their business into multi-organizations. PMID:17577422

Integration in primary community care networks (PCCNs): examination of governance, clinical, marketing, financial, and information infrastructures in a national demonstration project in Taiwan.

PubMed

Lin, Blossom Yen-Ju

2007-06-19

Taiwan's primary community care network (PCCN) demonstration project, funded by the Bureau of National Health Insurance on March 2003, was established to discourage hospital shopping behavior of people and drive the traditional fragmented health care providers into cooperate care models. Between 2003 and 2005, 268 PCCNs were established. This study profiled the individual members in the PCCNs to study the nature and extent to which their network infrastructures have been integrated among the members (clinics and hospitals) within individual PCCNs. The thorough questionnaire items, covering the network working infrastructures--governance, clinical, marketing, financial, and information integration in PCCNs, were developed with validity and reliability confirmed. One thousand five hundred and fifty-seven clinics that had belonged to PCCNs for more than one year, based on the 2003-2005 Taiwan Primary Community Care Network List, were surveyed by mail. Nine hundred and twenty-eight clinic members responded to the surveys giving a 59.6 % response rate. Overall, the PCCNs' members had higher involvement in the governance infrastructure, which was usually viewed as the most important for establishment of core values in PCCNs' organization design and management at the early integration stage. In addition, it found that there existed a higher extent of integration of clinical, marketing, and information infrastructures among the hospital-clinic member relationship than those among clinic members within individual PCCNs. The financial infrastructure was shown the least integrated relative to other functional infrastructures at the early stage of PCCN formation. There was still room for better integrated partnerships, as evidenced by the great variety of relationships and differences in extent of integration in this study. In addition to provide how the network members have done for their initial work at the early stage of network forming in this study, the detailed surveyed items, the concepts proposed by the managerial and theoretical professionals, could be a guide for those health care providers who have willingness to turn their business into multi-organizations.

Innovation networks for improving access and quality across the healthcare ecosystem.

PubMed

Carroll, Mark; James, Judith A; Lardiere, Michael R; Proser, Michelle; Rhee, Kyu; Sayre, Michael H; Shore, Jay H; Ternullo, Joseph

2010-01-01

Partnerships between patient communities, healthcare providers, and academic researchers are key to stepping up the pace and public health impact of clinical and translational research supported by the National Institutes of Health. With emphasis shifting toward community engagement and faster translation of research advances into clinical practice, academic researchers have a vital stake in widening the use of health information technology systems and telehealth networks to support collaboration and innovation. However, limited interaction between academic institutions and healthcare providers hinders the ability to form and sustain the integrated networks that are needed to conduct meaningful community-engaged research that improves public health outcomes. Healthcare providers, especially those affiliated with smaller practices, will need sustainable infrastructure and real incentives to utilize such networks, as well as training and additional resources for ongoing technical assistance.

CARDIO-i2b2: integrating arrhythmogenic disease data in i2b2.

PubMed

Segagni, Daniele; Tibollo, Valentina; Dagliati, Arianna; Napolitano, Carlo; G Priori, Silvia; Bellazzi, Riccardo

2012-01-01

The CARDIO-i2b2 project is an initiative to customize the i2b2 bioinformatics tool with the aim to integrate clinical and research data in order to support translational research in cardiology. In this work we describe the implementation and the customization of i2b2 to manage the data of arrhytmogenic disease patients collected at the Fondazione Salvatore Maugeri of Pavia in a joint project with the NYU Langone Medical Center (New York, USA). The i2b2 clinical research chart data warehouse is populated with the data obtained by the research database called TRIAD. The research infrastructure is extended by the development of new plug-ins for the i2b2 web client application able to properly select and export phenotypic data and to perform data analysis.

The role of the independent clinical laboratory in new assay development and commercialization.

PubMed

Ellis, David G

2003-01-01

Most would agree that these are exciting times in the field of laboratory medicine. As the body of scientific knowledge expands and research activities, such as those catalyzed by the sequencing of the human genome, bring us closer to the promise of personalized medicine, the clinical laboratory industry will have increasing opportunities to partner with owners of intellectual property to develop and commercialize new diagnostic tests. The large, independent clinical laboratories are particularly well positioned to commercialize important new tests, with their broad market penetration, infrastructure, and the scale to run esoteric tests cost-effectively.

Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment.

PubMed

Turisco, Fran; Keogh, Diane; Stubbs, Connie; Glaser, John; Crowley, William F

2005-12-01

Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.

The UK clinical research network--has it been a success for dermatology clinical trials?

PubMed

Thomas, Kim S; Koller, Karin; Foster, Katharine; Perdue, Jo; Charlesworth, Lisa; Chalmers, Joanne R

2011-06-16

Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

Image BOSS: a biomedical object storage system

NASA Astrophysics Data System (ADS)

Stacy, Mahlon C.; Augustine, Kurt E.; Robb, Richard A.

1997-05-01

Researchers using biomedical images have data management needs which are oriented perpendicular to clinical PACS. The image BOSS system is designed to permit researchers to organize and select images based on research topic, image metadata, and a thumbnail of the image. Image information is captured from existing images in a Unix based filesystem, stored in an object oriented database, and presented to the user in a familiar laboratory notebook metaphor. In addition, the ImageBOSS is designed to provide an extensible infrastructure for future content-based queries directly on the images.

Personalized Medicine for ARDS: The 2035 Research Agenda

PubMed Central

Beitler, Jeremy R.; Goligher, Ewan C.; Schmidt, Matthieu; Spieth, Peter M.; Zanella, Alberto; Martin-Loeches, Ignacio; Calfee, Carolyn S.; Cavalcanti, Alexandre B.

2016-01-01

Survival from ARDS has increased substantially in the last twenty years as a result of key advances in lung-protective ventilation and resuscitation. Similarly, clinical practice improvements have contributed to an impressive decline in nosocomial ARDS incidence. Personalizing mechanical ventilation for further lung protection is a top research priority for the years ahead. However, the ARDS research agenda must be broader in scope. The clinical syndrome of ARDS includes a heterogeneous assemblage of pathophysiological processes leading to lung injury. Further understanding of these varied, complex biological underpinnings of ARDS pathogenesis is needed to inform therapeutic discovery and tailor management strategy to the individual patient. While some therapies may be applicable broadly to all ARDS patients, others may benefit only certain biologically distinct subsets. The twenty-year ARDSne(x)t research agenda calls for bringing personalized medicine to ARDS, asking simultaneously both whether a treatment affords clinically meaningful benefit and for whom. This expanded scope necessitates acquisition of highly granular biological, physiological, and clinical data as the new standard across studies. Tremendous investment in research infrastructure and global collaboration will be vital to fulfilling this agenda. PMID:27040103

Pavement Technology and Airport Infrastructure Expansion Impact

NASA Astrophysics Data System (ADS)

Sabib; Setiawan, M. I.; Kurniasih, N.; Ahmar, A. S.; Hasyim, C.

2018-01-01

This research aims for analyzing construction and infrastructure development activities potential contribution towards Airport Performance. This research is correlation study with variable research that includes Airport Performance as X variable and construction and infrastructure development activities as Y variable. The population in this research is 148 airports in Indonesia. The sampling technique uses total sampling, which means 148 airports that becomes the population unit then all of it become samples. The results of coefficient correlation (R) test showed that construction and infrastructure development activities variable have a relatively strong relationship with Airport Performance variable, but the value of Adjusted R Square shows that an increase in the construction and infrastructure development activities is influenced by factor other than Airport Performance.

Romanian contribution to research infrastructure database for EPOS

NASA Astrophysics Data System (ADS)

Ionescu, Constantin; Craiu, Andreea; Tataru, Dragos; Balan, Stefan; Muntean, Alexandra; Nastase, Eduard; Oaie, Gheorghe; Asimopolos, Laurentiu; Panaiotu, Cristian

2014-05-01

European Plate Observation System - EPOS is a long-term plan to facilitate integrated use of data, models and facilities from mainly distributed existing, but also new, research infrastructures for solid Earth Science. In EPOS Preparatory Phase were integrated the national Research Infrastructures at pan European level in order to create the EPOS distributed research infrastructures, structure in which, at the present time, Romania participates by means of the earth science research infrastructures of the national interest declared on the National Roadmap. The mission of EPOS is to build an efficient and comprehensive multidisciplinary research platform for solid Earth Sciences in Europe and to allow the scientific community to study the same phenomena from different points of view, in different time periods and spatial scales (laboratory and field experiments). At national scale, research and monitoring infrastructures have gathered a vast amount of geological and geophysical data, which have been used by research networks to underpin our understanding of the Earth. EPOS promotes the creation of comprehensive national and regional consortia, as well as the organization of collective actions. To serve the EPOS goals, in Romania a group of National Research Institutes, together with their infrastructures, gathered in an EPOS National Consortium, as follows: 1. National Institute for Earth Physics - Seismic, strong motion, GPS and Geomagnetic network and Experimental Laboratory; 2. National Institute of Marine Geology and Geoecology - Marine Research infrastructure and Euxinus integrated regional Black Sea observation and early-warning system; 3. Geological Institute of Romania - Surlari National Geomagnetic Observatory and National lithoteque (the latter as part of the National Museum of Geology) 4. University of Bucharest - Paleomagnetic Laboratory After national dissemination of EPOS initiative other Research Institutes and companies from the potential stakeholders group also show their interest to participate in the EPOS National Consortium.

Envri Cluster - a Community-Driven Platform of European Environmental Researcher Infrastructures for Providing Common E-Solutions for Earth Science

NASA Astrophysics Data System (ADS)

Asmi, A.; Sorvari, S.; Kutsch, W. L.; Laj, P.

2017-12-01

European long-term environmental research infrastructures (often referred as ESFRI RIs) are the core facilities for providing services for scientists in their quest for understanding and predicting the complex Earth system and its functioning that requires long-term efforts to identify environmental changes (trends, thresholds and resilience, interactions and feedbacks). Many of the research infrastructures originally have been developed to respond to the needs of their specific research communities, however, it is clear that strong collaboration among research infrastructures is needed to serve the trans-boundary research requires exploring scientific questions at the intersection of different scientific fields, conducting joint research projects and developing concepts, devices, and methods that can be used to integrate knowledge. European Environmental research infrastructures have already been successfully worked together for many years and have established a cluster - ENVRI cluster - for their collaborative work. ENVRI cluster act as a collaborative platform where the RIs can jointly agree on the common solutions for their operations, draft strategies and policies and share best practices and knowledge. Supporting project for the ENVRI cluster, ENVRIplus project, brings together 21 European research infrastructures and infrastructure networks to work on joint technical solutions, data interoperability, access management, training, strategies and dissemination efforts. ENVRI cluster act as one stop shop for multidisciplinary RI users, other collaborative initiatives, projects and programmes and coordinates and implement jointly agreed RI strategies.

e-Infrastructures supporting research into depression, self-harm and suicide.

PubMed

McCafferty, S; Doherty, T; Sinnott, R O; Watt, J

2010-08-28

The Economic and Social Research Council (ESRC)-funded Data Management through e-Social Sciences (DAMES) project is investigating, as one of its four research themes, how research into depression, self-harm and suicide may be enhanced through the adoption of e-Science infrastructures and techniques. In this paper, we explore the challenges in supporting such research infrastructures and describe the distributed and heterogeneous datasets that need to be provisioned to support such research. We describe and demonstrate the application of an advanced user and security-driven infrastructure that has been developed specifically to meet these challenges in an on-going study into depression, self-harm and suicide.

Infrastructure for Personalized Medicine at Partners HealthCare

PubMed Central

Weiss, Scott T.; Shin, Meini Sumbada

2016-01-01

Partners HealthCare Personalized Medicine (PPM) is a center within the Partners HealthCare system (founded by Massachusetts General Hospital and Brigham and Women’s Hospital) whose mission is to utilize genetics and genomics to improve the care of patients in a cost effective manner. PPM consists of five interconnected components: (1) Laboratory for Molecular Medicine (LMM), a CLIA laboratory performing genetic testing for patients world-wide; (2) Translational Genomics Core (TGC), a core laboratory providing genomic platforms for Partners investigators; (3) Partners Biobank, a biobank of samples (DNA, plasma and serum) for 50,000 Consented Partners patients; (4) Biobank Portal, an IT infrastructure and viewer to bring together genotypes, samples, phenotypes (validated diagnoses, radiology, and clinical chemistry) from the electronic medical record to Partners investigators. These components are united by (5) a common IT system that brings researchers, clinicians, and patients together for optimal research and patient care. PMID:26927187

Nurse awareness of clinical research: a survey in a Japanese University Hospital

PubMed Central

2014-01-01

Background Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research. Methods As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed. Results Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse. Conclusions These findings suggest that clinical nurses have only limited knowledge on clinical research and the importance to have chances to make nurses aware of clinical research-related issues is suggested to establish an extended research team. Because of the study limitations, further study is warranted to determine the role of clinical nurses in establishing a suitable infrastructure for ethical pursuit of clinical research. PMID:24989623

Policy Model of Sustainable Infrastructure Development (Case Study : Bandarlampung City, Indonesia)

NASA Astrophysics Data System (ADS)

Persada, C.; Sitorus, S. R. P.; Marimin; Djakapermana, R. D.

2018-03-01

Infrastructure development does not only affect the economic aspect, but also social and environmental, those are the main dimensions of sustainable development. Many aspects and actors involved in urban infrastructure development requires a comprehensive and integrated policy towards sustainability. Therefore, it is necessary to formulate an infrastructure development policy that considers various dimensions of sustainable development. The main objective of this research is to formulate policy of sustainable infrastructure development. In this research, urban infrastructure covers transportation, water systems (drinking water, storm water, wastewater), green open spaces and solid waste. This research was conducted in Bandarlampung City. This study use a comprehensive modeling, namely the Multi Dimensional Scaling (MDS) with Rapid Appraisal of Infrastructure (Rapinfra), it uses of Analytic Network Process (ANP) and it uses system dynamics model. The findings of the MDS analysis showed that the status of Bandarlampung City infrastructure sustainability is less sustainable. The ANP analysis produces 8 main indicators of the most influential in the development of sustainable infrastructure. The system dynamics model offered 4 scenarios of sustainable urban infrastructure policy model. The best scenario was implemented into 3 policies consist of: the integrated infrastructure management, the population control, and the local economy development.

Understanding facilitators and barriers to reengineering the clinical research enterprise in community-based practice settings.

PubMed

Kukafka, Rita; Allegrante, John P; Khan, Sharib; Bigger, J Thomas; Johnson, Stephen B

2013-09-01

Solutions are employed to support clinical research trial tasks in community-based practice settings. Using the IT Implementation Framework (ITIF), an integrative framework intended to guide the synthesis of theoretical perspectives for planning multi-level interventions to enhance IT use, we sought to understand the barriers and facilitators to clinical research in community-based practice settings preliminary to implementing new informatics solutions for improving clinical research infrastructure. The studies were conducted in practices within the Columbia University Clinical Trials Network. A mixed-method approach, including surveys, interviews, time-motion studies, and observations was used. The data collected, which incorporates predisposing, enabling, and reinforcing factors in IT use, were analyzed according to each phase of ITIF. Themes identified in the first phase of ITIF were 1) processes and tools to support clinical trial research and 2) clinical research peripheral to patient care processes. Not all of the problems under these themes were found to be amenable to IT solutions. Using the multi-level orientation of the ITIF, we set forth strategies beyond IT solutions that can have an impact on reengineering clinical research tasks in practice-based settings. Developing strategies to target enabling and reinforcing factors, which focus on organizational factors, and the motivation of the practice at large to use IT solutions to integrate clinical research tasks with patient care processes, is most challenging. The ITIF should be used to consider both IT and non-IT solutions concurrently for reengineering of clinical research in community-based practice settings. © 2013.

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC): experiences from a successful ERS Clinical Research Collaboration.

PubMed

Chalmers, James D; Crichton, Megan; Goeminne, Pieter C; Loebinger, Michael R; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

2017-09-01

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areasTo understand some of the key features of successful disease registriesTo review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 yearsTo understand the key research priorities identified by EMBARC for the next 5 years.

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC): experiences from a successful ERS Clinical Research Collaboration

PubMed Central

Crichton, Megan; Goeminne, Pieter C.; Loebinger, Michael R.; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja ; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

2017-01-01

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. Educational aims To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areas To understand some of the key features of successful disease registries To review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 years To understand the key research priorities identified by EMBARC for the next 5 years PMID:28894479

Genomic cloud computing: legal and ethical points to consider

PubMed Central

Dove, Edward S; Joly, Yann; Tassé, Anne-Marie; Burton, Paul; Chisholm, Rex; Fortier, Isabel; Goodwin, Pat; Harris, Jennifer; Hveem, Kristian; Kaye, Jane; Kent, Alistair; Knoppers, Bartha Maria; Lindpaintner, Klaus; Little, Julian; Riegman, Peter; Ripatti, Samuli; Stolk, Ronald; Bobrow, Martin; Cambon-Thomsen, Anne; Dressler, Lynn; Joly, Yann; Kato, Kazuto; Knoppers, Bartha Maria; Rodriguez, Laura Lyman; McPherson, Treasa; Nicolás, Pilar; Ouellette, Francis; Romeo-Casabona, Carlos; Sarin, Rajiv; Wallace, Susan; Wiesner, Georgia; Wilson, Julia; Zeps, Nikolajs; Simkevitz, Howard; De Rienzo, Assunta; Knoppers, Bartha M

2015-01-01

The biggest challenge in twenty-first century data-intensive genomic science, is developing vast computer infrastructure and advanced software tools to perform comprehensive analyses of genomic data sets for biomedical research and clinical practice. Researchers are increasingly turning to cloud computing both as a solution to integrate data from genomics, systems biology and biomedical data mining and as an approach to analyze data to solve biomedical problems. Although cloud computing provides several benefits such as lower costs and greater efficiency, it also raises legal and ethical issues. In this article, we discuss three key ‘points to consider' (data control; data security, confidentiality and transfer; and accountability) based on a preliminary review of several publicly available cloud service providers' Terms of Service. These ‘points to consider' should be borne in mind by genomic research organizations when negotiating legal arrangements to store genomic data on a large commercial cloud service provider's servers. Diligent genomic cloud computing means leveraging security standards and evaluation processes as a means to protect data and entails many of the same good practices that researchers should always consider in securing their local infrastructure. PMID:25248396

Genomic cloud computing: legal and ethical points to consider.

PubMed

Dove, Edward S; Joly, Yann; Tassé, Anne-Marie; Knoppers, Bartha M

2015-10-01

The biggest challenge in twenty-first century data-intensive genomic science, is developing vast computer infrastructure and advanced software tools to perform comprehensive analyses of genomic data sets for biomedical research and clinical practice. Researchers are increasingly turning to cloud computing both as a solution to integrate data from genomics, systems biology and biomedical data mining and as an approach to analyze data to solve biomedical problems. Although cloud computing provides several benefits such as lower costs and greater efficiency, it also raises legal and ethical issues. In this article, we discuss three key 'points to consider' (data control; data security, confidentiality and transfer; and accountability) based on a preliminary review of several publicly available cloud service providers' Terms of Service. These 'points to consider' should be borne in mind by genomic research organizations when negotiating legal arrangements to store genomic data on a large commercial cloud service provider's servers. Diligent genomic cloud computing means leveraging security standards and evaluation processes as a means to protect data and entails many of the same good practices that researchers should always consider in securing their local infrastructure.

Contemporary (post-Wills) survey of the views of Australian medical researchers: importance of funding, infrastructure and motivators for a research career.

PubMed

Shewan, Louise G; Glatz, Jane A; Bennett, Christine C; Coats, Andrew J S

To investigate the perceptions of Australian health and medical researchers 4 years after the Wills Report recommended and led to a substantial increase in health and medical research funding in Australia. A telephone poll of 501 active health and medical researchers, conducted between 28 April and 5 May, 2003. Researchers' views on the adequacy of funding, infrastructure and support, salary, community recognition, the excitement of discovery and research outcomes such as publication and patenting in research. Research funding was the most important concern: 91% of researchers (455/498) viewed funding as "very" or "extremely" important to their role, but only 10% (52/500) were "very" or "extremely" satisfied with the level of funding. Research infrastructure and support were seen as "very" or "extremely" important by 90% of researchers (449/501), while only 21% (104/501) were "very" or "extremely" satisfied. Researchers in medical research institutes were significantly more likely to be satisfied (27% [56/205] "very" or "extremely" satisfied) with the level of infrastructure and support than those working in universities (15% [41/268] "very" or "extremely" satisfied; P = 0.001). Among the factors that motivate researchers, the excitement of discovery stood out in terms of both high importance and satisfaction. Publications were viewed as more important research outcomes than patenting or commercial ventures. Funding and infrastructure support remain overwhelmingly researchers' greatest concerns. University-based researchers were less satisfied with infrastructure and support than those in independent medical research institutes.

A new paradigm for improved co-ordination and efficacy of European biomedical research: taking diabetes as a model.

PubMed

Halban, P A; Boulton, A J M; Smith, U

2013-03-01

Today, European biomedical and health-related research is insufficiently well funded and is fragmented, with no common vision, less-than-optimal sharing of resources, and inadequate support and training in clinical research. Improvements to the competitiveness of European biomedical research will depend on the creation of new infrastructures that must be dynamic and free of bureaucracy, involve all stakeholders and facilitate faster delivery of new discoveries from bench to bedside. Taking diabetes research as the model, a new paradigm for European biomedical research is presented, which offers improved co-ordination and common resources that will benefit both academic and industrial clinical research. This includes the creation of a European Council for Health Research, first proposed by the Alliance for Biomedical Research in Europe, which will bring together and consult with all health stakeholders to develop strategic and multidisciplinary research programmes addressing the full innovation cycle. A European Platform for Clinical Research in Diabetes is proposed by the Alliance for European Diabetes Research (EURADIA) in response to the special challenges and opportunities presented by research across the European region, with the need for common standards and shared expertise and data.

International neurocognitive normative study: neurocognitive comparison data in diverse resource-limited settings: AIDS Clinical Trials Group A5271.

PubMed

Robertson, K; Jiang, H; Evans, S R; Marra, C M; Berzins, B; Hakim, J; Sacktor, N; Silva, M Tulius; Campbell, T B; Nair, A; Schouten, J; Kumwenda, J; Supparatpinyo, K; Tripathy, S; Kumarasamy, N; la Rosa, A; Montano, S; Mwafongo, A; Firnhaber, C; Sanne, I; Naini, L; Amod, F; Walawander, A

2016-08-01

Infrastructure for conducting neurological research in resource-limited settings (RLS) is limited. The lack of neurological and neuropsychological (NP) assessment and normative data needed for clinical interpretation impedes research and clinical care. Here, we report on ACTG 5271, which provided neurological training of clinical site personnel and collected neurocognitive normative comparison data in diverse settings. At ten sites in seven RLS countries, we provided training for NP assessments. We collected normative comparison data on HIV- participants from Brazil (n = 240), India (n = 480), Malawi (n = 481), Peru (n = 239), South Africa (480), Thailand (n = 240), and Zimbabwe (n = 240). Participants had a negative HIV test within 30 days before standardized NP exams were administered at baseline and 770 at 6 months. Participants were enrolled in eight strata, gender (female and male), education (<10 and ≥10 years), and age (<35 and ≥35 years). Of 2400 enrolled, 770 completed the 6-month follow-up. As expected, significant between-country differences were evident in all the neurocognitive test scores (p < 0.0001). There was variation between the age, gender, and education strata on the neurocognitive tests. Age and education were important variables for all tests; older participants had poorer performance, and those with higher education had better performance. Women had better performance on verbal learning/memory and speed of processing tests, while men performed better on motor tests. This study provides the necessary neurocognitive normative data needed to build infrastructure for future neurological and neurocognitive studies in diverse RLS. These normative data are a much-needed resource for both clinicians and researchers.

The GEOSS solution for enabling data interoperability and integrative research.

PubMed

Nativi, Stefano; Mazzetti, Paolo; Craglia, Max; Pirrone, Nicola

2014-03-01

Global sustainability research requires an integrative research effort underpinned by digital infrastructures (systems) able to harness data and heterogeneous information across disciplines. Digital data and information sharing across systems and applications is achieved by implementing interoperability: a property of a product or system to work with other products or systems, present or future. There are at least three main interoperability challenges a digital infrastructure must address: technological, semantic, and organizational. In recent years, important international programs and initiatives are focusing on such an ambitious objective. This manuscript presents and combines the studies and the experiences carried out by three relevant projects, focusing on the heavy metal domain: Global Mercury Observation System, Global Earth Observation System of Systems (GEOSS), and INSPIRE. This research work recognized a valuable interoperability service bus (i.e., a set of standards models, interfaces, and good practices) proposed to characterize the integrative research cyber-infrastructure of the heavy metal research community. In the paper, the GEOSS common infrastructure is discussed implementing a multidisciplinary and participatory research infrastructure, introducing a possible roadmap for the heavy metal pollution research community to join GEOSS as a new Group on Earth Observation community of practice and develop a research infrastructure for carrying out integrative research in its specific domain.

Evaluation of a Clinical Cancer Trial Research Training Workshop: Helping Nurses Build Capacity in Southwest Virginia.

PubMed

Burnett, Camille; Bullock, Linda; Collins, Cathleen A; Hauser, Lindsay

2016-11-01

Residents of Southwest Virginia (SWVA) face significant barriers in accessing the most advanced forms of cancer care, cancer risk reduction, and clinical trials involvement. A collaboration between the University of Virginia (UVA) Cancer Center and UVA School of Nursing was forged with oncology caregivers in this region to build community capacity to support Cancer Clinical trials (CCT) by strengthening the workforce, and thus improving health outcomes for this underserved region of Appalachia. The UVA School of Nursing designed an educational workshop focusing on the basics of CCT to facilitate the development of a skilled nursing workforce in the SWVA region that could provide care to patients on protocol and/or to encourage residents to participate in trials. The goal of the workshop was to offer a CCT training session for oncology nurses that fostered the knowledge and skills necessary to facilitate and support CCT infrastructure across this high-risk region. This evaluation reports the learning outcomes of the CCT training on 32 nurse participants from SWVA. Evaluations of the training program showed high rates of satisfaction, increased comfort level with CCTs, and increased knowledge and attitude toward CCTs. These findings provide information about a curriculum that could be useful in educating other oncology nurses and student nurses how to care for patients who may be enrolled in a clinical trial. Nurses can also be advocates for participation in clinical trials once they have the knowledge and are comfortable in their own understanding of a trial's usefulness. Educating the nursing workforce is an essential component of building capacity and infrastructure to support clinical trials research. © 2016 Wiley Periodicals, Inc.

Exercise and Fall Prevention: Narrowing the Research-to-Practice Gap and Enhancing Integration of Clinical and Community Practice.

PubMed

Li, Fuzhong; Eckstrom, Elizabeth; Harmer, Peter; Fitzgerald, Kathleen; Voit, Jan; Cameron, Kathleen A

2016-02-01

Falls in older adults are a global public health crisis, but mounting evidence from randomized controlled trials shows that falls can be reduced through exercise. Public health authorities and healthcare professionals endorse the use of evidence-based, exercise-focused fall interventions, but there are major obstacles to translating and disseminating research findings into healthcare practice, including lack of evidence of the transferability of efficacy trial results to clinical and community settings, insufficient local expertise to roll out community exercise programs, and inadequate infrastructure to integrate evidence-based programs into clinical and community practice. The practical solutions highlighted in this article can be used to address these evidence-to-practice challenges. Falls and their associated healthcare costs can be reduced by better integrating research on exercise intervention into clinical practice and community programs. © 2016 The Authors. The Journal of the American Geriatrics Society published by Wiley Periodicals, Inc. on behalf of The American Geriatrics Society.

[caCORE: core architecture of bioinformation on cancer research in America].

PubMed

Gao, Qin; Zhang, Yan-lei; Xie, Zhi-yun; Zhang, Qi-peng; Hu, Zhang-zhi

2006-04-18

A critical factor in the advancement of biomedical research is the ease with which data can be integrated, redistributed and analyzed both within and across domains. This paper summarizes the Biomedical Information Core Infrastructure built by National Cancer Institute Center for Bioinformatics in America (NCICB). The main product from the Core Infrastructure is caCORE--cancer Common Ontologic Reference Environment, which is the infrastructure backbone supporting data management and application development at NCICB. The paper explains the structure and function of caCORE: (1) Enterprise Vocabulary Services (EVS). They provide controlled vocabulary, dictionary and thesaurus services, and EVS produces the NCI Thesaurus and the NCI Metathesaurus; (2) The Cancer Data Standards Repository (caDSR). It provides a metadata registry for common data elements. (3) Cancer Bioinformatics Infrastructure Objects (caBIO). They provide Java, Simple Object Access Protocol and HTTP-XML application programming interfaces. The vision for caCORE is to provide a common data management framework that will support the consistency, clarity, and comparability of biomedical research data and information. In addition to providing facilities for data management and redistribution, caCORE helps solve problems of data integration. All NCICB-developed caCORE components are distributed under open-source licenses that support unrestricted usage by both non-profit and commercial entities, and caCORE has laid the foundation for a number of scientific and clinical applications. Based on it, the paper expounds caCORE-base applications simply in several NCI projects, of which one is CMAP (Cancer Molecular Analysis Project), and the other is caBIG (Cancer Biomedical Informatics Grid). In the end, the paper also gives good prospects of caCORE, and while caCORE was born out of the needs of the cancer research community, it is intended to serve as a general resource. Cancer research has historically contributed to many areas beyond tumor biology. At the same time, the paper makes some suggestions about the study at the present time on biomedical informatics in China.

NREL Serves as the Energy Department's Showcase for Cutting-Edge Fuel Cell

Science.gov Websites

vehicle on loan from Hyundai through a one-year Cooperative Research and Development Agreement and a B produced at the Hydrogen Infrastructure Testing and Research Facility (HITRF) located at NREL's Energy and infrastructure as part of the Energy Department's Hydrogen Fueling Infrastructure Research and

Overview of U.S. EPA Aging Water Infrastructure Research Program - Interfacing with the Water Industry on Technology Assessment

EPA Science Inventory

This slide presentation summarizes key elements of the EPA Office of Research and Development’s (ORD) Aging Water Infrastructure (AWI) Research program. An overview of the national problems posed by aging water infrastructure is followed by a brief description of EPA’s overall r...

FOSS Tools for Research Infrastructures - A Success Story?

NASA Astrophysics Data System (ADS)

Stender, V.; Schroeder, M.; Wächter, J.

2015-12-01

Established initiatives and mandated organizations, e.g. the Initiative for Scientific Cyberinfrastructures (NSF, 2007) or the European Strategy Forum on Research Infrastructures (ESFRI, 2008), promote and foster the development of sustainable research infrastructures. The basic idea behind these infrastructures is the provision of services supporting scientists to search, visualize and access data, to collaborate and exchange information, as well as to publish data and other results. Especially the management of research data is gaining more and more importance. In geosciences these developments have to be merged with the enhanced data management approaches of Spatial Data Infrastructures (SDI). The Centre for GeoInformationTechnology (CeGIT) at the GFZ German Research Centre for Geosciences has the objective to establish concepts and standards of SDIs as an integral part of research infrastructure architectures. In different projects, solutions to manage research data for land- and water management or environmental monitoring have been developed based on a framework consisting of Free and Open Source Software (FOSS) components. The framework provides basic components supporting the import and storage of data, discovery and visualization as well as data documentation (metadata). In our contribution, we present our data management solutions developed in three projects, Central Asian Water (CAWa), Sustainable Management of River Oases (SuMaRiO) and Terrestrial Environmental Observatories (TERENO) where FOSS components build the backbone of the data management platform. The multiple use and validation of tools helped to establish a standardized architectural blueprint serving as a contribution to Research Infrastructures. We examine the question of whether FOSS tools are really a sustainable choice and whether the increased efforts of maintenance are justified. Finally it should help to answering the question if the use of FOSS for Research Infrastructures is a success story.

The wealth of nations and the dissemination of cardiovascular research.

PubMed

Winnik, Stephan; Speer, Timo; Raptis, Dimitri A; Walker, Janina H; Hasun, Matthias; Clavien, Pierre-Alain; Komajda, Michel; Bax, Jeroen J; Tendera, Michal; Fox, Kim; Van de Werf, Frans; Mundow, Ciara; Lüscher, Thomas F; Ruschitzka, Frank; Nallamothu, Brahmajee K; Matter, Christian M

2013-11-05

This study aimed at understanding whether investigators from less wealthy countries were at a disadvantage in disseminating their research, after accounting for potential differences in research quality and infrastructure. In this bibliometric analysis a representative random selection of 10% (n=1002 studies) of all abstracts submitted to the European Society of Cardiology (ESC) congress 2006 was followed for publication and citation from September 2006 to December 2011. The main variable of interest was the per-capita gross domestic product (GDP) of the country of the principal investigator. Using multivariable models that adjusted for socioeconomic indicators and previously identified markers of research quality, we examined the relationship between per-capita GDP and three study endpoints: Acceptance at the ESC congress, full-text publication, and number of two-year citations. Among 1002 abstracts from 63 countries, per-capita GDP was positively correlated with all three study endpoints. After adjusting for markers of research quality and infrastructure, per-capita GDP remained a strong predictor for acceptance at the ESC congress (adjusted OR for every 10,000 USD increase in per-capita GDP, 1.44; 95% CI, 1.15 to 1.80), full-text publication within 5years (adjusted OR, 1.49; 95% CI, 1.17 to 1.90), and high citation frequency (adjusted OR, 2.30; 95% CI, 1.31 to 4.04). These findings were largely consistent in a subgroup of abstracts of high-quality, prospective clinical trials. Investigators in less wealthy countries face challenges to disseminate their research, even after accounting for potential differences in the quality of their work and research infrastructure. © 2013. Published by Elsevier Ireland Ltd. All rights reserved.

Toward Information Infrastructure Studies: Ways of Knowing in a Networked Environment

NASA Astrophysics Data System (ADS)

Bowker, Geoffrey C.; Baker, Karen; Millerand, Florence; Ribes, David

This article presents Information Infrastructure Studies, a research area that takes up some core issues in digital information and organization research. Infrastructure Studies simultaneously addresses the technical, social, and organizational aspects of the development, usage, and maintenance of infrastructures in local communities as well as global arenas. While infrastructure is understood as a broad category referring to a variety of pervasive, enabling network resources such as railroad lines, plumbing and pipes, electrical power plants and wires, this article focuses on information infrastructure, such as computational services and help desks, or federating activities such as scientific data repositories and archives spanning the multiple disciplines needed to address such issues as climate warming and the biodiversity crisis. These are elements associated with the internet and, frequently today, associated with cyberinfrastructure or e-science endeavors. We argue that a theoretical understanding of infrastructure provides the context for needed dialogue between design, use, and sustainability of internet-based infrastructure services. This article outlines a research area and outlines overarching themes of Infrastructure Studies. Part one of the paper presents definitions for infrastructure and cyberinfrastructure, reviewing salient previous work. Part two portrays key ideas from infrastructure studies (knowledge work, social and political values, new forms of sociality, etc.). In closing, the character of the field today is considered.

Transformative Use of an Improved All-Payer Hospital Discharge Data Infrastructure for Community-Based Participatory Research: A Sustainability Pathway

PubMed Central

Salemi, Jason L; Salinas-Miranda, Abraham A; Wilson, Roneé E; Salihu, Hamisu M

2015-01-01

Objective To describe the use of a clinically enhanced maternal and child health (MCH) database to strengthen community-engaged research activities, and to support the sustainability of data infrastructure initiatives. Data Sources/Study Setting Population-based, longitudinal database covering over 2.3 million mother–infant dyads during a 12-year period (1998–2009) in Florida. Setting: A community-based participatory research (CBPR) project in a socioeconomically disadvantaged community in central Tampa, Florida. Study Design Case study of the use of an enhanced state database for supporting CBPR activities. Principal Findings A federal data infrastructure award resulted in the creation of an MCH database in which over 92 percent of all birth certificate records for infants born between 1998 and 2009 were linked to maternal and infant hospital encounter-level data. The population-based, longitudinal database was used to supplement data collected from focus groups and community surveys with epidemiological and health care cost data on important MCH disparity issues in the target community. Data were used to facilitate a community-driven, decision-making process in which the most important priorities for intervention were identified. Conclusions Integrating statewide all-payer, hospital-based databases into CBPR can empower underserved communities with a reliable source of health data, and it can promote the sustainability of newly developed data systems. PMID:25879276

Harmonizing clinical terminologies: driving interoperability in healthcare.

PubMed

Hamm, Russell A; Knoop, Sarah E; Schwarz, Peter; Block, Aaron D; Davis, Warren L

2007-01-01

Internationally, there are countless initiatives to build National Healthcare Information Networks (NHIN) that electronically interconnect healthcare organizations by enhancing and integrating current information technology (IT) capabilities. The realization of such NHINs will enable the simple and immediate exchange of appropriate and vital clinical data among participating organizations. In order for institutions to accurately and automatically exchange information, the electronic clinical documents must make use of established clinical codes, such as those of SNOMED-CT, LOINC and ICD-9 CM. However, there does not exist one universally accepted coding scheme that encapsulates all pertinent clinical information for the purposes of patient care, clinical research and population heatlh reporting. In this paper, we propose a combination of methods and standards that target the harmonization of clinical terminologies and encourage sustainable, interoperable infrastructure for healthcare.

The NIDA Methamphetamine Clinical Trials Group: a strategy to increase clinical trials research capacity.

PubMed

Elkashef, Ahmed; Rawson, Richard A; Smith, Edwina; Pearce, Valerie; Flammino, Frank; Campbell, Jan; Donovick, Roger; Gorodetzky, Charles; Haning, William; Mawhinney, Joseph; McCann, Michael; Weis, Dennis; Williams, Lorie; Ling, Walter; Vocci, Frank

2007-04-01

In order to increase the number of investigative teams and sites conducting research on pharmacological treatments for methamphetamine use disorders, the National Institute on Drug Abuse (NIDA) established an infrastructure of clinical sites in areas where methamphetamine addiction is prevalent. This multi-site infrastructure would serve to run multiple Phases II and III protocols effectively and expeditiously. NIDA collaborated with investigators from the University of California at Los Angeles (UCLA) to set up the Methamphetamine Clinical Trials Group (MCTG). This paper describes the development process, as well as data from a test trial to assess the capability of research-naive sites to recruit research participants and conduct study procedures according to research protocol. Subsequent trials are also described. A total of 151 candidates signed consent; 65 individuals were enrolled and 35 (53.8%) completed the 12 weeks' behavioral trial. Self-reported substance use report (SUR) showed comparable use of methamphetamine across sites with the individual site means ranging from 59% (site 5) to 80% (site 3). Drug use as measured by urinalysis was greatly reduced at week 13 compared to the baseline measure; the average rate of methamphetamine-free urine samples across all participants in sites at week 13 was 53%. The highest percentage of methamphetamine-free samples was 85% at site 5; the lowest was at site 1 (40%). Addiction severity index (ASI) composite scores at baseline and protocol completion for all participants demonstrated improvement in all categories over time, except for the medical composite score. The largest composite score reduction in baseline-protocol completion was in the drug domain (0.23 versus 0.15). The changes in the ASI scores from baseline to week 13 were consistent across all five sites. Outcomes of the behavioral trial indicated that the MCTG recruited well; collected study data accurately and reliably; and created a vehicle that can assess promising pharmacotherapies for methamphetamine addiction treatment medications. The MCTG strategy appears to be a feasible approach to increase NIDA's capacity to conduct clinical trials to evaluate potential pharmacotherapies for methamphetamine addiction.

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.

PubMed

Berendt, Louise; Håkansson, Cecilia; Bach, Karin Friis; Dalhoff, Kim; Andreasen, Per Buch; Petersen, Lene Grejs; Andersen, Elin; Poulsen, Henrik Enghusen

2008-01-05

To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark. Retrospective review of applications for drug trials to the Danish Medicines Agency, 1993-2006. Applications for drug trials for alternate years were classified as academic or commercial trials. A random subset of academic trials was reviewed for number of participants in and intended monitoring of the trials. Academic and commercial drug trials showed an identical steady decline from 1993 to 2006 and no noticeable change after 2004 when good clinical practice became mandatory for academic trials. The Clinical Trials Directive introduced in May 2004 to ensure good clinical practice for academic drug trials was not associated with a decline in research activity in Denmark; presumably because good clinical practice units had already been in place in Danish universities since 1999. With such an infrastructure academic researchers can do drug trials under the same regulations as drug companies.

Data protection in biomaterial banks for Parkinson's disease research: the model of GEPARD (Gene Bank Parkinson's Disease Germany).

PubMed

Eggert, Karla; Wüllner, Ullrich; Antony, Gisela; Gasser, Thomas; Janetzky, Bernd; Klein, Christine; Schöls, Ludger; Oertel, Wolfgang

2007-04-15

Parkinson's disease (PD) is the second most common neurodegenerative disease. Although 10 gene loci have been identified to cause a Parkinsonian syndrome, these loci account only for a minority of PD patients. Large, systematic research programs are required to collect, store, and analyze DNA samples and clinical information to support further discovery of additional genetic components of PD or other movement disorders. Such programs facilitate research into the relationship between genotype and phenotype. The German Competence Network on Parkinson's disease (CNP) initiated the Gene Bank Parkinson's Disease Germany (GEPARD), providing an administrative and scientific infrastructure for the storage of DNA and clinical data that are electronically accessible and protective of patient rights. In this article, we offer guidance on how to establish a framework for a clinical genetic data and DNA bank, and describe GEPARD as a model that may be useful to other local, national, and international research groups developing similar programs.

Establishing a clinical trials network in nephrology: experience of the Australasian Kidney Trials Network

PubMed Central

Morrish, Alicia T; Hawley, Carmel M; Johnson, David W; Badve, Sunil V; Perkovic, Vlado; Reidlinger, Donna M; Cass, Alan

2014-01-01

Chronic kidney disease is a major public health problem globally. Despite this, there are fewer high-quality, high-impact clinical trials in nephrology than other internal medicine specialties, which has led to large gaps in evidence. To address this deficiency, the Australasian Kidney Trials Network, a Collaborative Research Group, was formed in 2005. Since then, the Network has provided infrastructure and expertise to conduct patient-focused high-quality, investigator-initiated clinical trials in nephrology. The Network has not only been successful in engaging the nephrology community in Australia and New Zealand but also in forming collaborations with leading researchers from other countries. This article describes the establishment, development, and functions of the Network. The article also discusses the current and future funding strategies to ensure uninterrupted conduct of much needed clinical trials in nephrology to improve the outcomes of patients affected by kidney diseases with cost-effective interventions. PMID:24088955

Embedding clinical interventions into observational studies

PubMed Central

Newman, Anne B.; Avilés-Santa, M. Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm. James; Krucoff, Mitchell; Kuller, Lewis H.; Lewis, Cora E.; Robinson, Jennifer G.; Taylor, Herman; Treviño, Roberto P.; Weintraub, William

2017-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

Green Infrastructure Research at EPA's Edison Environmental Center

EPA Science Inventory

The presentation outline includes: (1) Green infrastructure research objectives (2) Introduction to ongoing research projects - Aspects of design, construction, and maintenence that affect function - Real-world applications of GI research

Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) Technology Infrastructure for a Distributed Data Network

PubMed Central

Schilling, Lisa M.; Kwan, Bethany M.; Drolshagen, Charles T.; Hosokawa, Patrick W.; Brandt, Elias; Pace, Wilson D.; Uhrich, Christopher; Kamerick, Michael; Bunting, Aidan; Payne, Philip R.O.; Stephens, William E.; George, Joseph M.; Vance, Mark; Giacomini, Kelli; Braddy, Jason; Green, Mika K.; Kahn, Michael G.

2013-01-01

Introduction: Distributed Data Networks (DDNs) offer infrastructure solutions for sharing electronic health data from across disparate data sources to support comparative effectiveness research. Data sharing mechanisms must address technical and governance concerns stemming from network security and data disclosure laws and best practices, such as HIPAA. Methods: The Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) deploys TRIAD grid technology, a common data model, detailed technical documentation, and custom software for data harmonization to facilitate data sharing in collaboration with stakeholders in the care of safety net populations. Data sharing partners host TRIAD grid nodes containing harmonized clinical data within their internal or hosted network environments. Authorized users can use a central web-based query system to request analytic data sets. Discussion: SAFTINet DDN infrastructure achieved a number of data sharing objectives, including scalable and sustainable systems for ensuring harmonized data structures and terminologies and secure distributed queries. Initial implementation challenges were resolved through iterative discussions, development and implementation of technical documentation, governance, and technology solutions. PMID:25848567

Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) Technology Infrastructure for a Distributed Data Network.

PubMed

Schilling, Lisa M; Kwan, Bethany M; Drolshagen, Charles T; Hosokawa, Patrick W; Brandt, Elias; Pace, Wilson D; Uhrich, Christopher; Kamerick, Michael; Bunting, Aidan; Payne, Philip R O; Stephens, William E; George, Joseph M; Vance, Mark; Giacomini, Kelli; Braddy, Jason; Green, Mika K; Kahn, Michael G

2013-01-01

Distributed Data Networks (DDNs) offer infrastructure solutions for sharing electronic health data from across disparate data sources to support comparative effectiveness research. Data sharing mechanisms must address technical and governance concerns stemming from network security and data disclosure laws and best practices, such as HIPAA. The Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) deploys TRIAD grid technology, a common data model, detailed technical documentation, and custom software for data harmonization to facilitate data sharing in collaboration with stakeholders in the care of safety net populations. Data sharing partners host TRIAD grid nodes containing harmonized clinical data within their internal or hosted network environments. Authorized users can use a central web-based query system to request analytic data sets. SAFTINet DDN infrastructure achieved a number of data sharing objectives, including scalable and sustainable systems for ensuring harmonized data structures and terminologies and secure distributed queries. Initial implementation challenges were resolved through iterative discussions, development and implementation of technical documentation, governance, and technology solutions.

The federal role in the health information infrastructure: a debate of the pros and cons of government intervention.

PubMed Central

Shortliffe, E H; Bleich, H L; Caine, C G; Masys, D R; Simborg, D W

1996-01-01

Some observers feel that the federal government should play a more active leadership role in educating the medical community and in coordinating and encouraging a more rapid and effective implementation of clinically relevant applications of wide-area networking. Other people argue that the private sector is recognizing the importance of these issues and will, when the market demands it, adopt and enhance the telecommunications systems that are needed to produce effective uses of the National Information Infrastructure (NII) by the healthcare community. This debate identifies five areas for possible government involvement: convening groups for the development of standards; providing funding for research and development; ensuring the equitable distribution of resources, particularly to places and people considered by private enterprise to provide low opportunities for profit; protecting rights of privacy, intellectual property, and security; and overcoming the jurisdictional barriers to cooperation, particularly when states offer conflicting regulations. Arguments against government involvement include the likely emergence of an adequate infrastructure under free market forces, the often stifling effect of regulation, and the need to avoid a common-and-control mentality in an infrastructure that is best promoted collaboratively. PMID:8816347

A national clinical decision support infrastructure to enable the widespread and consistent practice of genomic and personalized medicine.

PubMed

Kawamoto, Kensaku; Lobach, David F; Willard, Huntington F; Ginsburg, Geoffrey S

2009-03-23

In recent years, the completion of the Human Genome Project and other rapid advances in genomics have led to increasing anticipation of an era of genomic and personalized medicine, in which an individual's health is optimized through the use of all available patient data, including data on the individual's genome and its downstream products. Genomic and personalized medicine could transform healthcare systems and catalyze significant reductions in morbidity, mortality, and overall healthcare costs. Critical to the achievement of more efficient and effective healthcare enabled by genomics is the establishment of a robust, nationwide clinical decision support infrastructure that assists clinicians in their use of genomic assays to guide disease prevention, diagnosis, and therapy. Requisite components of this infrastructure include the standardized representation of genomic and non-genomic patient data across health information systems; centrally managed repositories of computer-processable medical knowledge; and standardized approaches for applying these knowledge resources against patient data to generate and deliver patient-specific care recommendations. Here, we provide recommendations for establishing a national decision support infrastructure for genomic and personalized medicine that fulfills these needs, leverages existing resources, and is aligned with the Roadmap for National Action on Clinical Decision Support commissioned by the U.S. Office of the National Coordinator for Health Information Technology. Critical to the establishment of this infrastructure will be strong leadership and substantial funding from the federal government. A national clinical decision support infrastructure will be required for reaping the full benefits of genomic and personalized medicine. Essential components of this infrastructure include standards for data representation; centrally managed knowledge repositories; and standardized approaches for leveraging these knowledge repositories to generate patient-specific care recommendations at the point of care.

Prevention of Posttraumatic Contractures with Ketotifen (PERK)

DTIC Science & Technology

2017-10-01

opportunity to design a Phase III RCT on the use of ketotifen in post -traumatic joint contractures. The goal is to design and develop the infrastructure to...Research (CIHR) for the Phase III RCT. 2. KEYWORDS Post -traumatic contractures, elbow fractures, randomized clinical trial, multicenter, ketotifen...application to use ketotifen in post -traumatic joint contracture prevention was submitted to the Division of Pulmonary, Allergy, and Rheumatology

IT Infrastructure Components for Biobanking

PubMed Central

Prokosch, H.U.; Beck, A.; Ganslandt, T.; Hummel, M.; Kiehntopf, M.; Sax, U.; Ückert, F.; Semler, S.

2010-01-01

Objective Within translational research projects in the recent years large biobanks have been established, mostly supported by homegrown, proprietary software solutions. No general requirements for biobanking IT infrastructures have been published yet. This paper presents an exemplary biobanking IT architecture, a requirements specification for a biorepository management tool and exemplary illustrations of three major types of requirements. Methods We have pursued a comprehensive literature review for biobanking IT solutions and established an interdisciplinary expert panel for creating the requirements specification. The exemplary illustrations were derived from a requirements analysis within two university hospitals. Results The requirements specification comprises a catalog with more than 130 detailed requirements grouped into 3 major categories and 20 subcategories. Special attention is given to multitenancy capabilities in order to support the project-specific definition of varying research and bio-banking contexts, the definition of workflows to track sample processing, sample transportation and sample storage and the automated integration of preanalytic handling and storage robots. Conclusion IT support for biobanking projects can be based on a federated architectural framework comprising primary data sources for clinical annotations, a pseudonymization service, a clinical data warehouse with a flexible and user-friendly query interface and a biorepository management system. Flexibility and scalability of all such components are vital since large medical facilities such as university hospitals will have to support biobanking for varying monocentric and multicentric research scenarios and multiple medical clients. PMID:23616851

IT Infrastructure Components for Biobanking.

PubMed

Prokosch, H U; Beck, A; Ganslandt, T; Hummel, M; Kiehntopf, M; Sax, U; Uckert, F; Semler, S

2010-01-01

Within translational research projects in the recent years large biobanks have been established, mostly supported by homegrown, proprietary software solutions. No general requirements for biobanking IT infrastructures have been published yet. This paper presents an exemplary biobanking IT architecture, a requirements specification for a biorepository management tool and exemplary illustrations of three major types of requirements. We have pursued a comprehensive literature review for biobanking IT solutions and established an interdisciplinary expert panel for creating the requirements specification. The exemplary illustrations were derived from a requirements analysis within two university hospitals. The requirements specification comprises a catalog with more than 130 detailed requirements grouped into 3 major categories and 20 subcategories. Special attention is given to multitenancy capabilities in order to support the project-specific definition of varying research and bio-banking contexts, the definition of workflows to track sample processing, sample transportation and sample storage and the automated integration of preanalytic handling and storage robots. IT support for biobanking projects can be based on a federated architectural framework comprising primary data sources for clinical annotations, a pseudonymization service, a clinical data warehouse with a flexible and user-friendly query interface and a biorepository management system. Flexibility and scalability of all such components are vital since large medical facilities such as university hospitals will have to support biobanking for varying monocentric and multicentric research scenarios and multiple medical clients.

What elements of the work environment are most responsible for health worker dissatisfaction in rural primary care clinics in Tanzania?

PubMed

Mbaruku, Godfrey M; Larson, Elysia; Kimweri, Angela; Kruk, Margaret E

2014-08-03

In countries with high maternal and newborn morbidity and mortality, reliable access to quality healthcare in rural areas is essential to save lives. Health workers who are satisfied with their jobs are more likely to remain in rural posts. Understanding what factors influence health workers' satisfaction can help determine where resources should be focused. Although there is a growing body of research assessing health worker satisfaction in hospitals, less is known about health worker satisfaction in rural, primary health clinics. This study explores the workplace satisfaction of health workers in primary health clinics in rural Tanzania. Overall, 70 health workers in rural Tanzania participated in a self-administered job satisfaction survey. We calculated mean ratings for 17 aspects of the work environment. We used principal components analysis (PCA) to identify groupings of these variables. We then examined the bivariate associations between health workers demographics and clinic characteristics and each of the satisfaction scales. Results showed that 73.9% of health workers strongly agreed that they were satisfied with their job; however, only 11.6% strongly agreed that they were satisfied with their level of pay and 2.9% with the availability of equipment and supplies. Two categories of factors emerged from the PCA: the tools and infrastructure to provide care, and supportive interpersonal environment. Nurses and medical attendants (compared to clinical officers) and older health workers had higher satisfaction scale ratings. Two dimensions of health workers' work environment, namely infrastructure and supportive interpersonal work environment, explained much of the variation in satisfaction among rural Tanzanian health workers in primary health clinics. Health workers were generally more satisfied with supportive interpersonal relationships than with the infrastructure. Human resource policies should consider how to improve these two aspects of work as a means for improving health worker morale and potentially rural attrition. (ISRCTN 17107760).

A survey of informatics platforms that enable distributed comparative effectiveness research using multi-institutional heterogeneous clinical data

PubMed Central

Sittig, Dean F.; Hazlehurst, Brian L.; Brown, Jeffrey; Murphy, Shawn; Rosenman, Marc; Tarczy-Hornoch, Peter; Wilcox, Adam B.

2012-01-01

Comparative Effectiveness Research (CER) has the potential to transform the current healthcare delivery system by identifying the most effective medical and surgical treatments, diagnostic tests, disease prevention methods and ways to deliver care for specific clinical conditions. To be successful, such research requires the identification, capture, aggregation, integration, and analysis of disparate data sources held by different institutions with diverse representations of the relevant clinical events. In an effort to address these diverse demands, there have been multiple new designs and implementations of informatics platforms that provide access to electronic clinical data and the governance infrastructure required for inter-institutional CER. The goal of this manuscript is to help investigators understand why these informatics platforms are required and to compare and contrast six, large-scale, recently funded, CER-focused informatics platform development efforts. We utilized an 8-dimension, socio-technical model of health information technology use to help guide our work. We identified six generic steps that are necessary in any distributed, multi-institutional CER project: data identification, extraction, modeling, aggregation, analysis, and dissemination. We expect that over the next several years these projects will provide answers to many important, and heretofore unanswerable, clinical research questions. PMID:22692259

Aging Water Infrastructure Research Program Innovation & Research for the 21st Century

EPA Science Inventory

The U.S. infrastructure is critical for providing essential services: protect public health and the environment and support and sustain our economy. Significant investment in water infrastructure: over 16,000 WWTPs serving 190 million people; about 54,000 community water syste...

Building a Common Pediatric Research Terminology for Accelerating Child Health Research

PubMed Central

Bailey, L. Charles; Forrest, Christopher B.; Padula, Michael A.; Hirschfeld, Steven

2014-01-01

Longitudinal observational clinical data on pediatric patients in electronic format is becoming widely available. A new era of multi-institutional data networks that study pediatric diseases and outcomes across disparate health delivery models and care settings are also enabling an innovative collaborative rapid improvement paradigm called the Learning Health System. However, the potential alignment of routine clinical care, observational clinical research, pragmatic clinical trials, and health systems improvement requires a data infrastructure capable of combining information from systems and workflows that historically have been isolated from each other. Removing barriers to integrating and reusing data collected in different settings will permit new opportunities to develop a more complete picture of a patient’s care and to leverage data from related research studies. One key barrier is the lack of a common terminology that provides uniform definitions and descriptions of clinical observations and data. A well-characterized terminology ensures a common meaning and supports data reuse and integration. A common terminology allows studies to build upon previous findings and to reuse data collection tools and data management processes. We present the current state of terminology harmonization and describe a governance structure and mechanism for coordinating the development of a common pediatric research terminology that links to clinical terminologies and can be used to align existing terminologies. By reducing the barriers between clinical care and clinical research, a Learning Health System can leverage and reuse not only its own data resources but also broader extant data resources. PMID:24534404

Design of e-Science platform for biomedical imaging research cross multiple academic institutions and hospitals

NASA Astrophysics Data System (ADS)

Zhang, Jianguo; Zhang, Kai; Yang, Yuanyuan; Ling, Tonghui; Wang, Tusheng; Wang, Mingqing; Hu, Haibo; Xu, Xuemin

2012-02-01

More and more image informatics researchers and engineers are considering to re-construct imaging and informatics infrastructure or to build new framework to enable multiple disciplines of medical researchers, clinical physicians and biomedical engineers working together in a secured, efficient, and transparent cooperative environment. In this presentation, we show an outline and our preliminary design work of building an e-Science platform for biomedical imaging and informatics research and application in Shanghai. We will present our consideration and strategy on designing this platform, and preliminary results. We also will discuss some challenges and solutions in building this platform.

The Breast Cancer Family Registry: an infrastructure for cooperative multinational, interdisciplinary and translational studies of the genetic epidemiology of breast cancer

PubMed Central

John, Esther M; Hopper, John L; Beck, Jeanne C; Knight, Julia A; Neuhausen, Susan L; Senie, Ruby T; Ziogas, Argyrios; Andrulis, Irene L; Anton-Culver, Hoda; Boyd, Norman; Buys, Saundra S; Daly, Mary B; O'Malley, Frances P; Santella, Regina M; Southey, Melissa C; Venne, Vickie L; Venter, Deon J; West, Dee W; Whittemore, Alice S; Seminara, Daniela

2004-01-01

Introduction The etiology of familial breast cancer is complex and involves genetic and environmental factors such as hormonal and lifestyle factors. Understanding familial aggregation is a key to understanding the causes of breast cancer and to facilitating the development of effective prevention and therapy. To address urgent research questions and to expedite the translation of research results to the clinical setting, the National Cancer Institute (USA) supported in 1995 the establishment of a novel research infrastructure, the Breast Cancer Family Registry, a collaboration of six academic and research institutions and their medical affiliates in the USA, Canada, and Australia. Methods The sites have developed core family history and epidemiology questionnaires, data dictionaries, and common protocols for biospecimen collection and processing and pathology review. An Informatics Center has been established to collate, manage, and distribute core data. Results As of September 2003, 9116 population-based and 2834 clinic-based families have been enrolled, including 2346 families from minority populations. Epidemiology questionnaire data are available for 6779 affected probands (with a personal history of breast cancer), 4116 unaffected probands, and 16,526 relatives with or without a personal history of breast or ovarian cancer. The biospecimen repository contains blood or mouthwash samples for 6316 affected probands, 2966 unaffected probands, and 10,763 relatives, and tumor tissue samples for 4293 individuals. Conclusion This resource is available to internal and external researchers for collaborative, interdisciplinary, and translational studies of the genetic epidemiology of breast cancer. Detailed information can be found at the URL . PMID:15217505

Effects and mechanisms of an allied health research position in a Queensland regional and rural health service: a descriptive case study.

PubMed

Wenke, Rachel J; Tynan, Anna; Scott, Annette; Mickan, Sharon

2017-10-30

The aim of the present case study is to illustrate the outcomes of a dedicated allied health (AH) research position within a large Queensland regional and rural health service. The secondary aim of the case study is to describe the enabling and hindering mechanisms to the success of the role. Semistructured interviews were conducted with the Executive Director of Allied Health and the current AH research fellow incumbent within the health service. A focus group was also undertaken with six stakeholders (e.g. clinicians, team leaders) who had engaged with the research position. Outcomes of the AH research fellow included clinical and service improvements, enhanced research culture and staff up-skilling, development of research infrastructure and the formation of strategic research collaborations. Despite being a sole position in a geographically expansive health service with constrained resources, key enabling mechanisms to the success of the role were identified, including strong advocacy and regular communication with the Executive. In conclusion, the case study highlights the potential value of an AH research position in building research capacity within a large non-metropolitan health service. Factors to facilitate ongoing success could include additional research and administrative funding, as well as increased use of technology and team-based research. What is known about the topic? Dedicated research positions embedded within health care settings are a well cited strategy to increase research capacity building of allied health professionals (AHPs). However the majority of these positions are within metropolitan health settings and unique challenges exist for these roles in regional and rural areas. Few studies have described the impact of dedicated AH research positions within regional health centres or the factors which facilitate or hinder their role. What does this paper add? Dedicated research positions within a non-metropolitan Australian health service may have a positive impact on AH clinical services, research culture, staff upskilling, research infrastructure and research collaborations. Key enabling mechanisms to support the role may include advocacy from higher level management, strong networks and communication channels. Additional research and administrative funding, the use of technology and team based research may enhance sustainability of such roles. What are the implications for practitioners? AH research positions have potential value in building research capacity within a large non-metropolitan health service. Health managers and researchers should be aware of the unique challenges to these roles and consider mechanisms that may best enhance and sustain outcomes of the positions including: the development of infrastructure (i.e. technology, website of resources), networks, and communication strategies (i.e. regular meetings with leadership and promotion internally).

[Clinical drug trials in Germany--an assessment of current status from the viewpoint of industry].

PubMed

Baumbauer, E

1996-01-01

Drug development today is a highly professional and costly affair, whereby quality and speed are decisive competitive factors in a global setting. Germany is in the process of losing its attractiveness for clinical drug research as evidenced by a significant decrease in funding of clinical drug research which at the moment amounts to about 1.5 billion DM/year. This decrease is due to an adverse environment created by a certain anxiety in public opinion regarding technological advances, an overburden of regulations, lack of an infrastructure in hospitals to work according to GCP and a regulatory agency which has to compete with momentarily more effective agencies in Europe (UK, France). A joint effort between industry and the medical profession is called for to change this situation for the better.

"Dancing on the edge of research" - What is needed to build and sustain research capacity within the massage therapy profession? A formative evaluation.

PubMed

Kania-Richmond, Ania; Menard, Martha B; Barberree, Beth; Mohring, Marvin

2017-04-01

Conducting research on massage therapy (MT) continues to be a significant challenge. To explore and identify the structures, processes, and resources required to enable viable, sustainable and high quality MT research activities in the Canadian context. Academically-based researchers and MT professionals involved in research. Formative evaluation and a descriptive qualitative approach were applied. Five main themes regarding the requirements of a productive and sustainable MT research infrastructure in Canada were identified: 1) core components, 2) variable components, 3) varying perspectives of stakeholder groups, 4) barriers to creating research infrastructure, and 5) negative metaphors. In addition, participants offered a number of recommendations on how to develop such an infrastructure. While barriers exist that require attention, participants' insights suggest there are various pathways through which a productive and sustainable MT research infrastructure can be achieved. Copyright © 2016 Elsevier Ltd. All rights reserved.

Research infrastructure support to address ecosystem dynamics

NASA Astrophysics Data System (ADS)

Los, Wouter

2014-05-01

Predicting the evolution of ecosystems to climate change or human pressures is a challenge. Even understanding past or current processes is complicated as a result of the many interactions and feedbacks that occur within and between components of the system. This talk will present an example of current research on changes in landscape evolution, hydrology, soil biogeochemical processes, zoological food webs, and plant community succession, and how these affect feedbacks to components of the systems, including the climate system. Multiple observations, experiments, and simulations provide a wealth of data, but not necessarily understanding. Model development on the coupled processes on different spatial and temporal scales is sensitive for variations in data and of parameter change. Fast high performance computing may help to visualize the effect of these changes and the potential stability (and reliability) of the models. This may than allow for iteration between data production and models towards stable models reducing uncertainty and improving the prediction of change. The role of research infrastructures becomes crucial is overcoming barriers for such research. Environmental infrastructures are covering physical site facilities, dedicated instrumentation and e-infrastructure. The LifeWatch infrastructure for biodiversity and ecosystem research will provide services for data integration, analysis and modeling. But it has to cooperate intensively with the other kinds of infrastructures in order to support the iteration between data production and model computation. The cooperation in the ENVRI project (Common operations of environmental research infrastructures) is one of the initiatives to foster such multidisciplinary research.

Predictors of Rural Health Clinics Managers' Willingness to Join Accountable Care Organizations

PubMed Central

T.H.Wan, Thomas; Masri, Maysoun Dimachkie; Ortiz, Judith

2014-01-01

Purpose The implementation of the Patient Protection and Affordable Care Act has facilitated the development of an innovative and integrated delivery care system, Accountable Care Organizations (ACOs). It is timely, to identify how health care managers in rural health clinics are responding to the ACO model. This research examines RHC managers' perceived benefits and barriers for implementing ACOs from an organizational ecology perspective. Methodology/Approach A survey was conducted in Spring of 2012 covering the present RHC network working infrastructures – 1) Organizational social network; 2) organizational care delivery structure; 3) ACO knowledge, perceived benefits, and perceived barriers; 4) quality and disease management programs; and 5) health information technology (HIT) infrastructure. One thousand one hundred sixty clinics were surveyed in the United States. They cover eight southeastern states (Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee) and California. A total of ninety-one responses were received. Findings RHC managers' personal perceptions on ACO's benefits and knowledge level explained the most variance in their willingness to join ACOs. Individual perceptions appear to be more influential than organizational and context factors in the predictive analysis. Research limitations/implications The study is primarily focused in the Southeastern region of the U.S. The generalizability is limited to this region. The predictors of rural health clinics' participation in ACOs are germane to guide the development of organizational strategies for enhancing the general knowledge about the innovativeness of delivering coordinated care and containing health care costs inspired by the Affordable Care Act. Originality/Value of Paper Rural health clinics are lagged behind the growth curve of ACO adoption. The diffusion of new knowledge about pros and cons of ACO is essential to reinforce the health care reform in the United States. PMID:25541569

Secure Secondary Use of Clinical Data with Cloud-based NLP Services. Towards a Highly Scalable Research Infrastructure.

PubMed

Christoph, J; Griebel, L; Leb, I; Engel, I; Köpcke, F; Toddenroth, D; Prokosch, H-U; Laufer, J; Marquardt, K; Sedlmayr, M

2015-01-01

The secondary use of clinical data provides large opportunities for clinical and translational research as well as quality assurance projects. For such purposes, it is necessary to provide a flexible and scalable infrastructure that is compliant with privacy requirements. The major goals of the cloud4health project are to define such an architecture, to implement a technical prototype that fulfills these requirements and to evaluate it with three use cases. The architecture provides components for multiple data provider sites such as hospitals to extract free text as well as structured data from local sources and de-identify such data for further anonymous or pseudonymous processing. Free text documentation is analyzed and transformed into structured information by text-mining services, which are provided within a cloud-computing environment. Thus, newly gained annotations can be integrated along with the already available structured data items and the resulting data sets can be uploaded to a central study portal for further analysis. Based on the architecture design, a prototype has been implemented and is under evaluation in three clinical use cases. Data from several hundred patients provided by a University Hospital and a private hospital chain have already been processed. Cloud4health has shown how existing components for secondary use of structured data can be complemented with text-mining in a privacy compliant manner. The cloud-computing paradigm allows a flexible and dynamically adaptable service provision that facilitates the adoption of services by data providers without own investments in respective hardware resources and software tools.

The Alpha Stem Cell Clinic: a model for evaluating and delivering stem cell-based therapies.

PubMed

Trounson, Alan; DeWitt, Natalie D; Feigal, Ellen G

2012-01-01

Cellular therapies require the careful preparation, expansion, characterization, and delivery of cells in a clinical environment. There are major challenges associated with the delivery of cell therapies and high costs that will limit the companies available to fully evaluate their merit in clinical trials, and will handicap their application at the present financial environment. Cells will be manufactured in good manufacturing practice or near-equivalent facilities with prerequisite safety practices in place, and cell delivery systems will be specialized and require well-trained medical and nursing staff, technicians or nurses trained to handle cells once delivered, patient counselors, as well as statisticians and database managers who will oversee the monitoring of patients in relatively long-term follow-up studies. The model proposed for Alpha Stem Cell Clinics will initially use the capacities and infrastructure that exist in the most advanced tertiary medical clinics for delivery of established bone marrow stem cell therapies. As the research evolves, they will incorporate improved procedures and cell preparations. This model enables commercialization of medical devices, reagents, and other products required for cell therapies. A carefully constructed cell therapy clinical infrastructure with the requisite scientific, technical, and medical expertise and operational efficiencies will have the capabilities to address three fundamental and critical functions: 1) fostering clinical trials; 2) evaluating and establishing safe and effective therapies, and 3) developing and maintaining the delivery of therapies approved by the Food and Drug Administration, or other regulatory agencies.

Strengthening the career development of clinical translational scientist trainees: a consensus statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees.

PubMed

Meyers, Frederick J; Begg, Melissa D; Fleming, Michael; Merchant, Carol

2012-04-01

The challenges for scholars committed to successful careers in clinical and translational science are increasingly well recognized. The Education and Career Development (EdCD) of the national Clinical and Translational Science Award consortium gathered thought leaders to propose sustainable solutions and an agenda for future studies that would strengthen the infrastructure across the spectrum of pre- and postdoctoral, MD and PhD, scholars. Six consensus statements were prepared that include: (1) the requirement for career development of a qualitatively different investigator; (2) the implications of interdisciplinary science for career advancement including institutional promotion and tenure actions that were developed for discipline-specific accomplishments; (3) the need for long-term commitment of institutions to scholars; (4) discipline-specific curricula are still required but curricula designed to promote team work and interdisciplinary training will promote innovation; (5) PhD trainees have many pathways to career satisfaction and success; and (6) a centralized infrastructure to enhance and reward mentoring is required. Several themes cut across all of the recommendations including team science, innovation, and sustained institutional commitment. Implied themes include an effective and diverse job force and the requirement for a well-crafted public policy that supports continued investments in science education. © 2012 Wiley Periodicals, Inc.

The ADVANCE network: accelerating data value across a national community health center network

PubMed Central

DeVoe, Jennifer E; Gold, Rachel; Cottrell, Erika; Bauer, Vance; Brickman, Andrew; Puro, Jon; Nelson, Christine; Mayer, Kenneth H; Sears, Abigail; Burdick, Tim; Merrell, Jonathan; Matthews, Paul; Fields, Scott

2014-01-01

The ADVANCE (Accelerating Data Value Across a National Community Health Center Network) clinical data research network (CDRN) is led by the OCHIN Community Health Information Network in partnership with Health Choice Network and Fenway Health. The ADVANCE CDRN will ‘horizontally’ integrate outpatient electronic health record data for over one million federally qualified health center patients, and ‘vertically’ integrate hospital, health plan, and community data for these patients, often under-represented in research studies. Patient investigators, community investigators, and academic investigators with diverse expertise will work together to meet project goals related to data integration, patient engagement and recruitment, and the development of streamlined regulatory policies. By enhancing the data and research infrastructure of participating organizations, the ADVANCE CDRN will serve as a ‘community laboratory’ for including disadvantaged and vulnerable patients in patient-centered outcomes research that is aligned with the priorities of patients, clinics, and communities in our network. PMID:24821740

Security Approaches in Using Tablet Computers for Primary Data Collection in Clinical Research

PubMed Central

Wilcox, Adam B.; Gallagher, Kathleen; Bakken, Suzanne

2013-01-01

Next-generation tablets (iPads and Android tablets) may potentially improve the collection and management of clinical research data. The widespread adoption of tablets, coupled with decreased software and hardware costs, has led to increased consideration of tablets for primary research data collection. When using tablets for the Washington Heights/Inwood Infrastructure for Comparative Effectiveness Research (WICER) project, we found that the devices give rise to inherent security issues associated with the potential use of cloud-based data storage approaches. This paper identifies and describes major security considerations for primary data collection with tablets; proposes a set of architectural strategies for implementing data collection forms with tablet computers; and discusses the security, cost, and workflow of each strategy. The paper briefly reviews the strategies with respect to their implementation for three primary data collection activities for the WICER project. PMID:25848559

Security approaches in using tablet computers for primary data collection in clinical research.

PubMed

Wilcox, Adam B; Gallagher, Kathleen; Bakken, Suzanne

2013-01-01

Next-generation tablets (iPads and Android tablets) may potentially improve the collection and management of clinical research data. The widespread adoption of tablets, coupled with decreased software and hardware costs, has led to increased consideration of tablets for primary research data collection. When using tablets for the Washington Heights/Inwood Infrastructure for Comparative Effectiveness Research (WICER) project, we found that the devices give rise to inherent security issues associated with the potential use of cloud-based data storage approaches. This paper identifies and describes major security considerations for primary data collection with tablets; proposes a set of architectural strategies for implementing data collection forms with tablet computers; and discusses the security, cost, and workflow of each strategy. The paper briefly reviews the strategies with respect to their implementation for three primary data collection activities for the WICER project.

Data discovery and data processing for environmental research infrastructures

NASA Astrophysics Data System (ADS)

Los, Wouter; Beranzoli, Laura; Corriero, Giuseppe; Cossu, Roberto; Fiore, Nicola; Hardisty, Alex; Legré, Yannick; Pagano, Pasquale; Puglisi, Giuseppe; Sorvari, Sanna; Turunen, Esa

2013-04-01

The European ENVRI project (Common operations of Environmental Research Infrastructures) is addressing common ICT solutions for the research infrastructures as selected in the ESFRI Roadmap. More specifically, the project is looking for solutions that will assist interdisciplinary users who want to benefit from the data and other services of more than a single research infrastructure. However, the infrastructure architectures, the data, data formats, scales and granularity are very different. Indeed, they deal with diverse scientific disciplines, from plate tectonics, the deep sea, sea and land surface up to atmosphere and troposphere, from the dead to the living environment, and with a variety of instruments producing increasingly larger amounts of data. One of the approaches in the ENVRI project is to design a common Reference Model that will serve to promote infrastructure interoperability at the data, technical and service levels. The analysis of the characteristics of the environmental research infrastructures assisted in developing the Reference Model, and which is also an example for comparable infrastructures worldwide. Still, it is for users already now important to have the facilities available for multi-disciplinary data discovery and data processing. The rise of systems research, addressing Earth as a single complex and coupled system is requiring such capabilities. So, another approach in the project is to adapt existing ICT solutions to short term applications. This is being tested for a few study cases. One of these is looking for possible coupled processes following a volcano eruption in the vertical column from deep sea to troposphere. Another one deals with volcano either human impacts on atmospheric and sea CO2 pressure and the implications for sea acidification and marine biodiversity and their ecosystems. And a third one deals with the variety of sensor and satellites data sensing the area around a volcano cone. Preliminary results on these studies will be reported. The common results will assist in shaping more generic solutions to be adopted by the appropriate research infrastructures.

Towards computer-assisted surgery in shoulder joint replacement

NASA Astrophysics Data System (ADS)

Valstar, Edward R.; Botha, Charl P.; van der Glas, Marjolein; Rozing, Piet M.; van der Helm, Frans C. T.; Post, Frits H.; Vossepoel, Albert M.

A research programme that aims to improve the state of the art in shoulder joint replacement surgery has been initiated at the Delft University of Technology. Development of improved endoprostheses for the upper extremities (DIPEX), as this effort is called, is a clinically driven multidisciplinary programme consisting of many contributory aspects. A part of this research programme focuses on the pre-operative planning and per-operative guidance issues. The ultimate goal of this part of the DIPEX project is to create a surgical support infrastructure that can be used to predict the optimal surgical protocol and can assist with the selection of the most suitable endoprosthesis for a particular patient. In the pre-operative planning phase, advanced biomechanical models of the endoprosthesis fixation and the musculo-skeletal system of the shoulder will be incorporated, which are adjusted to the individual's morphology. Subsequently, the support infrastructure must assist the surgeon during the operation in executing his surgical plan. In the per-operative phase, the chosen optimal position of the endoprosthesis can be realised using camera-assisted tools or mechanical guidance tools. In this article, the pathway towards the desired surgical support infrastructure is described. Furthermore, we discuss the pre-operative planning phase and the per-operative guidance phase, the initial work performed, and finally, possible approaches for improving prosthesis placement.

EPA Office of Research and Development Green Infrastructure Research

EPA Science Inventory

This presentation provides an overview introduction to the USEPA Office of Research and Development (ORD)'s ongoing green infrastructure (GI) research efforts for stormwater management. GI approaches that increase infiltration, evapotranspiration, and rainwater harvesting offer ...

Role of federal policy in building research infrastructure among emerging minorities: the Asian American experience.

PubMed

Trinh-Shevrin, Chau; Ro, Marguerite; Tseng, Winston; Islam, Nadia Shilpi; Rey, Mariano J; Kwon, Simona C

2012-01-01

Considerable progress in Asian American health research has occurred over the last two decades. However, greater and sustained federal support is needed for reducing health disparities in Asian American communities. PURPOSE OF THE ARTICLE: This paper reviews federal policies that support infrastructure to conduct minority health research and highlights one model for strengthening research capacity and infrastructure in Asian American communities. Research center infrastructures can play a significant role in addressing pipeline/workforce challenges, fostering campus-community research collaborations, engaging communities in health, disseminating evidence-based strategies and health information, and policy development. Research centers provide the capacity needed for academic institutions and communities to work together synergistically in achieving the goal to reduce health disparities in the Asian American community. Policies that support the development of concentrated and targeted research for Asian Americans must continue so that these centers will reach their full potential.

Patient participation in ERS guidelines and research projects: the EMBARC experience

PubMed Central

Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-01-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. Educational aims To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities. To understand the barriers and potential solutions to these barriers from a physician’s perspective, in order to ensure meaningful patient involvement in clinical projects. To understand the barriers and potential solutions from a patient’s perspective, in order to meaningfully involve patients in clinical projects. PMID:28894480

Patient participation in ERS guidelines and research projects: the EMBARC experience.

PubMed

Chalmers, James D; Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-09-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities.To understand the barriers and potential solutions to these barriers from a physician's perspective, in order to ensure meaningful patient involvement in clinical projects.To understand the barriers and potential solutions from a patient's perspective, in order to meaningfully involve patients in clinical projects.

Rehabilitation, Replacement and Redesign of the Nation's Water and Wastewater Infrastructure as a Valuable Adaptation Opportunity

EPA Science Inventory

In support of the Agency's Sustainable Water Infrastructure Initiative, EPA's Office of Research and Develpment initiated the Aging Water Infrastructure Research Program in 2007. The program, with its core focus on the support of strategic asset management, is designed to facili...

Building Evidence-Based Tobacco Treatment in the Eastern Mediterranean Region: Lessons Learned by the Syrian Center for Tobacco Studies

PubMed Central

Asfar, Taghrid; Ward, Kenneth D.; Al-Ali, Radwan; Maziak, Wasim

2016-01-01

The tobacco epidemic in Syria is characterized by high rates of cigarettes smoking in men and dramatic reemergence of waterpipe smoking, especially among youths and women. The Syrian Center for Tobacco Studies (SCTS), an NIH-funded pioneer research and capacity building institution, has developed a research infrastructure and conducted three randomized clinical trials to develop and rigorously test culturally-appropriate tobacco treatment programs integrated into primary healthcare (PHC) centers. This review aimed to discuss challenges and lessons learned from the Syrian experience. Addressing these challenges may inform future cessation research activities in Syria and other developing countries. To develop a research infrastructure, the SCTS has established Syria’s first IRB and trained physicians/medical students in both tobacco treatment and research methods. Main challenges to conduct the cessation trials were difficulties of coordination between the local and international collaborators; high Smoking Rates among PHC providers; lack of pharmacological agents used in tobacco treatment; and difficulties of conducting research in a politically volatile region. Strategies to overcome these challenges were ensuring an active and regular involvement of all investigator; and advocating for a national smoking-cessation plan that involves training health care providers in smoking cessation treatment and make pharmacological agents used in smoking cessation available. PMID:27563356

Translating research into practice: speeding the adoption of innovative health care programs.

PubMed

Bradley, Elizabeth H; Webster, Tashonna R; Baker, Dorothy; Schlesinger, Mark; Inouye, Sharon K; Barth, Michael C; Lapane, Kate L; Lipson, Debra; Stone, Robyn; Koren, Mary Jane

2004-07-01

For this study, the authors conducted case studies of four varied clinical programs to learn key factors influencing the diffusion and adoption of evidence-based innovations in health care. They found that the success and speed of the adoption/diffusion process depend on: the roles of senior management and clinical leadership; the generation of credible supportive data; an infrastructure dedicated to translating the innovation from research into practice; the extent to which changes in organizational culture are required; and the amount of coordination needed across departments or disciplines. The translation process also depends on the characteristics and resources of the adopting organization, and on the degree to which people believe that the innovation responds to immediate and significant pressures in their environment.

Better infrastructure for critical care trials: nomenclature, etymology, and informatics.

PubMed

Singh, Jeffrey M; Ferguson, Niall D

2009-01-01

The goals of this review article are to review the importance and value of standardized definitions in clinical research, as well as to propose the necessary tools and infrastructure needed to advance nosology and medial taxonomy to improve the quality of clinical trials in the field of critical care. We searched MEDLINE for relevant articles, reviewed those selected and their reference lists, and consulted personal files for relevant information. When the pathobiology of diseases is well understood, standard disease definitions can be extremely specific and precise; however, when the pathobiology of the disease is less well understood or more complex, biological markers may not be diagnostically useful or even available. In these cases, syndromic definitions effectively classify and group illnesses with similar symptoms and clinical signs. There is no clear gold standard for the diagnosis of many clinical entities in the intensive care unit, including notably both acute respiratory distress syndrome and sepsis. There are several types of consensus methods that can be used to explicate the judgmental approach that is often needed in these cases, including interactive or consensus groups, the nominal group technique, and the Delphi technique. Ideally, the definition development process will create clear and unambiguous language in which each definition accurately reflects the current understanding of the disease state. The development, implementation, evaluation, revision, and reevaluation of standardized definitions are keys for advancing the quality of clinical trials in the critical care arena.

A Novel Approach to High-Quality Postmortem Tissue Procurement: The GTEx Project.

PubMed

Carithers, Latarsha J; Ardlie, Kristin; Barcus, Mary; Branton, Philip A; Britton, Angela; Buia, Stephen A; Compton, Carolyn C; DeLuca, David S; Peter-Demchok, Joanne; Gelfand, Ellen T; Guan, Ping; Korzeniewski, Greg E; Lockhart, Nicole C; Rabiner, Chana A; Rao, Abhi K; Robinson, Karna L; Roche, Nancy V; Sawyer, Sherilyn J; Segrè, Ayellet V; Shive, Charles E; Smith, Anna M; Sobin, Leslie H; Undale, Anita H; Valentino, Kimberly M; Vaught, Jim; Young, Taylor R; Moore, Helen M

2015-10-01

The Genotype-Tissue Expression (GTEx) project, sponsored by the NIH Common Fund, was established to study the correlation between human genetic variation and tissue-specific gene expression in non-diseased individuals. A significant challenge was the collection of high-quality biospecimens for extensive genomic analyses. Here we describe how a successful infrastructure for biospecimen procurement was developed and implemented by multiple research partners to support the prospective collection, annotation, and distribution of blood, tissues, and cell lines for the GTEx project. Other research projects can follow this model and form beneficial partnerships with rapid autopsy and organ procurement organizations to collect high quality biospecimens and associated clinical data for genomic studies. Biospecimens, clinical and genomic data, and Standard Operating Procedures guiding biospecimen collection for the GTEx project are available to the research community.

Toward a Learning Health-care System – Knowledge Delivery at the Point of Care Empowered by Big Data and NLP

PubMed Central

Kaggal, Vinod C.; Elayavilli, Ravikumar Komandur; Mehrabi, Saeed; Pankratz, Joshua J.; Sohn, Sunghwan; Wang, Yanshan; Li, Dingcheng; Rastegar, Majid Mojarad; Murphy, Sean P.; Ross, Jason L.; Chaudhry, Rajeev; Buntrock, James D.; Liu, Hongfang

2016-01-01

The concept of optimizing health care by understanding and generating knowledge from previous evidence, ie, the Learning Health-care System (LHS), has gained momentum and now has national prominence. Meanwhile, the rapid adoption of electronic health records (EHRs) enables the data collection required to form the basis for facilitating LHS. A prerequisite for using EHR data within the LHS is an infrastructure that enables access to EHR data longitudinally for health-care analytics and real time for knowledge delivery. Additionally, significant clinical information is embedded in the free text, making natural language processing (NLP) an essential component in implementing an LHS. Herein, we share our institutional implementation of a big data-empowered clinical NLP infrastructure, which not only enables health-care analytics but also has real-time NLP processing capability. The infrastructure has been utilized for multiple institutional projects including the MayoExpertAdvisor, an individualized care recommendation solution for clinical care. We compared the advantages of big data over two other environments. Big data infrastructure significantly outperformed other infrastructure in terms of computing speed, demonstrating its value in making the LHS a possibility in the near future. PMID:27385912

Toward a Learning Health-care System - Knowledge Delivery at the Point of Care Empowered by Big Data and NLP.

PubMed

Kaggal, Vinod C; Elayavilli, Ravikumar Komandur; Mehrabi, Saeed; Pankratz, Joshua J; Sohn, Sunghwan; Wang, Yanshan; Li, Dingcheng; Rastegar, Majid Mojarad; Murphy, Sean P; Ross, Jason L; Chaudhry, Rajeev; Buntrock, James D; Liu, Hongfang

2016-01-01

The concept of optimizing health care by understanding and generating knowledge from previous evidence, ie, the Learning Health-care System (LHS), has gained momentum and now has national prominence. Meanwhile, the rapid adoption of electronic health records (EHRs) enables the data collection required to form the basis for facilitating LHS. A prerequisite for using EHR data within the LHS is an infrastructure that enables access to EHR data longitudinally for health-care analytics and real time for knowledge delivery. Additionally, significant clinical information is embedded in the free text, making natural language processing (NLP) an essential component in implementing an LHS. Herein, we share our institutional implementation of a big data-empowered clinical NLP infrastructure, which not only enables health-care analytics but also has real-time NLP processing capability. The infrastructure has been utilized for multiple institutional projects including the MayoExpertAdvisor, an individualized care recommendation solution for clinical care. We compared the advantages of big data over two other environments. Big data infrastructure significantly outperformed other infrastructure in terms of computing speed, demonstrating its value in making the LHS a possibility in the near future.

Role of EPA in Asset Management Research – The Aging Water Infrastructure Research Program

EPA Science Inventory

This slide presentation provides an overview of the EPA Office of Research and Development’s Aging Water infrastructure Research Program (AWIRP). The research program origins, goals, products, and plans are described. The research program focuses on four areas: condition asses...

Emergency medicine in Dubai, UAE.

PubMed

Partridge, Robert; Abbo, Michael; Virk, Alamjit

2009-08-18

Dubai has rapidly risen to prominence in the Persian Gulf region as a center of global commerce and tourism and as a cultural crossroad between East and West. The health-care infrastructure has undergone rapid development. Collaborations with academic medical centers now exist to advance clinical care, teaching and research. Emergency medicine has also advanced and is undergoing dynamic change. Dubai may soon emerge as a regional leader in emergency medicine training and practice.

CINRG: Infrastructure for Clinical Trials in Duchenne Dystrophy

DTIC Science & Technology

2013-09-01

research centers sharing a common goal of improving the quality of life of neuromuscular disease patients by cooperative planning , implementation, analysis...discrepancies were noted surrounding the regulatory binder, consent process and data records. The site personnel have a scheduled plan with the CINRG CC...missing long term follow-up visits). The project manager also reviewed the study records to date while onsite. A high priority plan was developed with the

Informatics in clinical research in oncology: current state, challenges, and a future perspective.

PubMed

Chahal, Amar P S

2011-01-01

The informatics landscape of clinical trials in oncology has changed significantly in the last 10 years. The current state of the infrastructure for clinical trial management, execution, and data management is reviewed. The systems, their functionality, the users, and the standards available to researchers are discussed from the perspective of the oncologist-researcher. Challenges in complexity and in the processing of information are outlined. These challenges include the lack of communication and information-interchange between systems, the lack of simplified standards, and the lack of implementation and adherence to the standards that are available. The clinical toxicology criteria from the National Cancer Institute (CTCAE) are cited as a successful standard in oncology, and HTTP on the Internet is referenced for its simplicity. Differences in the management of information standards between industries are discussed. Possible future advances in oncology clinical research informatics are addressed. These advances include strategic policy review of standards and the implementation of actions to make standards free, ubiquitous, simple, and easily interpretable; the need to change from a local data-capture- or transaction-driven model to a large-scale data-interpretation model that provides higher value to the oncologist and the patient; and the need for information technology investment in a readily available digital educational model for clinical research in oncology that is customizable for individual studies. These new approaches, with changes in information delivery to mobile platforms, will set the stage for the next decade in clinical research informatics.

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

Parallel digital forensics infrastructure.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liebrock, Lorie M.; Duggan, David Patrick

2009-10-01

This report documents the architecture and implementation of a Parallel Digital Forensics infrastructure. This infrastructure is necessary for supporting the design, implementation, and testing of new classes of parallel digital forensics tools. Digital Forensics has become extremely difficult with data sets of one terabyte and larger. The only way to overcome the processing time of these large sets is to identify and develop new parallel algorithms for performing the analysis. To support algorithm research, a flexible base infrastructure is required. A candidate architecture for this base infrastructure was designed, instantiated, and tested by this project, in collaboration with New Mexicomore » Tech. Previous infrastructures were not designed and built specifically for the development and testing of parallel algorithms. With the size of forensics data sets only expected to increase significantly, this type of infrastructure support is necessary for continued research in parallel digital forensics. This report documents the implementation of the parallel digital forensics (PDF) infrastructure architecture and implementation.« less

Embedding clinical interventions into observational studies.

PubMed

Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

2016-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. Copyright © 2015. Published by Elsevier Inc.

Rett Syndrome: Crossing the Threshold to Clinical Translation

PubMed Central

Katz, David M.; Bird, Adrian; Coenraads, Monica; Gray, Steven J.; Menon, Debashish U.; Philpot, Benjamin D.; Tarquinio, Daniel C.

2016-01-01

Lying at the intersection between neurobiology and epigenetics, Rett syndrome (RTT) has garnered intense interest in recent years, not only from a broad range of academic scientists, but also from the pharmaceutical and biotechnology industries. In addition to the critical need for treatments for this devastating disorder, optimism for developing RTT treatments derives from a unique convergence of factors, including a known monogenic cause, reversibility of symptoms in preclinical models, a strong clinical research infrastructure highlighted by an NIH-funded natural history study and well-established clinics with significant patient populations. Here, we review recent advances in understanding the biology of RTT, particularly promising preclinical findings, lessons from past clinical trials, and critical elements of trial design for rare disorders. PMID:26830113

Critical Infrastructure Protection: EMP Impacts on the U.S. Electric Grid

NASA Astrophysics Data System (ADS)

Boston, Edwin J., Jr.

The purpose of this research is to identify the United States electric grid infrastructure systems vulnerabilities to electromagnetic pulse attacks and the cyber-based impacts of those vulnerabilities to the electric grid. Additionally, the research identifies multiple defensive strategies designed to harden the electric grid against electromagnetic pulse attack that include prevention, mitigation and recovery postures. Research results confirm the importance of the electric grid to the United States critical infrastructures system and that an electromagnetic pulse attack against the electric grid could result in electric grid degradation, critical infrastructure(s) damage and the potential for societal collapse. The conclusions of this research indicate that while an electromagnetic pulse attack against the United States electric grid could have catastrophic impacts on American society, there are currently many defensive strategies under consideration designed to prevent, mitigate and or recover from an electromagnetic pulse attack. However, additional research is essential to further identify future target hardening opportunities, efficient implementation strategies and funding resources.

A Novel Program Trains Community‐Academic Teams to Build Research and Partnership Capacity

PubMed Central

Brown, Jen; LeBailly, Susan; McGee, Richard; Bayldon, Barbara; Huber, Gail; Kaleba, Erin; Lowry, Kelly Walker; Martens, Joseph; Mason, Maryann; Nuñez, Abel

2013-01-01

Abstract The Community‐Engaged Research Team Support (CERTS) program was developed and tested to build research and partnership capacity for community‐engaged research (CEnR) teams. Led by the Northwestern University Clinical and Translational Sciences Institute (NUCATS), the goals of CERTS were: (1) to help community‐academic teams build capacity for conducting rigorous CEnR and (2) to support teams as they prepare federal grant proposal drafts. The program was guided by an advisory committee of community and clinical partners, and representatives from Chicago's Clinical and Translational Science Institutes. Monthly workshops guided teams to write elements of NIH‐style research proposals. Draft reviewing fostered a collaborative learning environment and helped teams develop equal partnerships. The program culminated in a mock‐proposal review. All teams clarified their research and acquired new knowledge about the preparation of NIH‐style proposals. Trust, partnership collaboration, and a structured writing strategy were assets of the CERTS approach. CERTS also uncovered gaps in resources and preparedness for teams to be competitive for federally funded grants. Areas of need include experience as principal investigators, publications on study results, mentoring, institutional infrastructure, and dedicated time for research. PMID:23751028

A Federated Network for Translational Cancer Research Using Clinical Data and Biospecimens

PubMed Central

Becich, Michael J.; Bollag, Roni J.; Chavan, Girish; Corrigan, Julia; Dhir, Rajiv; Feldman, Michael D.; Gaudioso, Carmelo; Legowski, Elizabeth; Maihle, Nita J.; Mitchell, Kevin; Murphy, Monica; Sakthivel, Mayur; Tseytlin, Eugene; Weaver, JoEllen

2015-01-01

Advances in cancer research and personalized medicine will require significant new bridging infrastructures, including more robust biorepositories that link human tissue to clinical phenotypes and outcomes. In order to meet that challenge, four cancer centers formed the TIES Cancer Research Network, a federated network that facilitates data and biospecimen sharing among member institutions. Member sites can access pathology data that is de-identified and processed with the TIES natural language processing system, which creates a repository of rich phenotype data linked to clinical biospecimens. TIES incorporates multiple security and privacy best practices that, combined with legal agreements, network policies and procedures, enable regulatory compliance. The TIES Cancer Research Network now provides integrated access to investigators at all member institutions, where multiple investigator-driven pilot projects are underway. Examples of federated search across the network illustrate the potential impact on translational research, particularly for studies involving rare cancers, rare phenotypes, and specific biologic behaviors. The network satisfies several key desiderata including local control of data and credentialing, inclusion of rich phenotype information, and applicability to diverse research objectives. The TIES Cancer Research Network presents a model for a national data and biospecimen network. PMID:26670560

Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders

PubMed Central

Kim, Katherine K; Browe, Dennis K; Logan, Holly C; Holm, Roberta; Hack, Lori; Ohno-Machado, Lucila

2014-01-01

There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research. PMID:24302285

Centre for Research Infrastructure of Polish GNSS Data - response and possible contribution to EPOS

NASA Astrophysics Data System (ADS)

Araszkiewicz, Andrzej; Rohm, Witold; Bosy, Jaroslaw; Szolucha, Marcin; Kaplon, Jan; Kroszczynski, Krzysztof

2017-04-01

In the frame of the first call under Action 4.2: Development of modern research infrastructure of the science sector in the Smart Growth Operational Programme 2014-2020 in the late of 2016 the "EPOS-PL" project has launched. Following institutes are responsible for the implementation of this project: Institute of Geophysics, Polish Academy of Sciences - Project Leader, Academic Computer Centre Cyfronet AGH University of Science and Technology, Central Mining Institute, the Institute of Geodesy and Cartography, Wrocław University of Environmental and Life Sciences, Military University of Technology. In addition, resources constituting entrepreneur's own contribution will come from the Polish Mining Group. Research Infrastructure EPOS-PL will integrate both existing and newly built National Research Infrastructures (Theme Centre for Research Infrastructures), which, under the premise of the program EPOS, are financed exclusively by the national founds. In addition, the e-science platform will be developed. The Centre for Research Infrastructure of GNSS Data (CIBDG - Task 5) will be built based on the experience and facilities of two institutions: Military University of Technology and Wrocław University of Environmental and Life Sciences. The project includes the construction of the National GNNS Repository with data QC procedures and adaptation of two Regional GNNS Analysis Centres for rapid and long-term geodynamical monitoring.

Factors influencing recruitment to research: qualitative study of the experiences and perceptions of research teams

PubMed Central

2014-01-01

Background Recruiting the required number of participants is vital to the success of clinical research and yet many studies fail to achieve their expected recruitment rate. Increasing research participation is a key agenda within the NHS and elsewhere, but the optimal methods of improving recruitment to clinical research remain elusive. The aim of this study was to identify the factors that researchers perceive as influential in the recruitment of participants to clinically focused research. Methods Semi-structured interviews were conducted with 11 individuals from three clinical research teams based in London. Sampling was a combination of convenience and purposive. The interviews were audio recorded, transcribed verbatim and analysed using the framework method to identify key themes. Results Four themes were identified as influential to recruitment: infrastructure, nature of the research, recruiter characteristics and participant characteristics. The main reason individuals participate in clinical research was believed to be altruism, while logistical issues were considered important for those who declined. Suggestions to improve recruitment included reducing participant burden, providing support for individuals who do not speak English, and forming collaborations with primary care to improve the identification of, and access to, potentially eligible participants. Conclusions Recruiting the target number of research participants was perceived as difficult, especially for clinical trials. New and diverse strategies to ensure that all potentially eligible patients are invited to participate may be beneficial and require further exploration in different settings. Establishing integrated clinical and academic teams with shared responsibilities for recruitment may also facilitate this process. Language barriers and long journey times were considered negative influences to recruitment; although more prominent, these issues are not unique to London and are likely to be important influences in other locations. PMID:24456229

Network and computing infrastructure for scientific applications in Georgia

NASA Astrophysics Data System (ADS)

Kvatadze, R.; Modebadze, Z.

2016-09-01

Status of network and computing infrastructure and available services for research and education community of Georgia are presented. Research and Educational Networking Association - GRENA provides the following network services: Internet connectivity, network services, cyber security, technical support, etc. Computing resources used by the research teams are located at GRENA and at major state universities. GE-01-GRENA site is included in European Grid infrastructure. Paper also contains information about programs of Learning Center and research and development projects in which GRENA is participating.

Research Practices, Evaluation and Infrastructure in the Digital Environment

ERIC Educational Resources Information Center

Houghton, John W.

2004-01-01

This paper examines changing research practices in the digital environment and draws out implications for research evaluation and the development of research infrastructure. Reviews of the literature, quantitative indicators of research activities and our own field research in Australia suggest that a new mode of knowledge production is emerging,…

Changing Research Practices and Research Infrastructure Development

ERIC Educational Resources Information Center

Houghton, John W.

2005-01-01

This paper examines changing research practices in the digital environment and draws out implications for the development of research infrastructure. Reviews of the literature, quantitative indicators of research activities and our own field research in Australia suggest that there is a new mode of knowledge production emerging, changing research…

[Current situation and existing problems of acupuncture for primary hypertension].

PubMed

Zhang, Lili; Wei, Pengfei; Chen, Shaozong

2018-03-12

To analyze the present situation and existing problems of acupuncture for primary hypertension (PH) based on clinical research literature in recent 20 years. The clinical research literature regarding acupuncture for PH were searched from China National Knowledge Infrastructure (CNKI), VIP data network (VIP) and Wanfang database from 1997 through 2016; a total of 218 papers met the inclusive criteria. Microsoft Excel and Apriori algorithm of SPSS Clementine software were applied to analyze the data. The main acupoints of acupuncture for PH were Taichong (LR 3), Quchi (LI 11), Zusanli (ST 36) and Hegu (LI 4), but its support degree was only 12.21%. 127 papers were randomized controlled trials, accounting for 58.26%. 158 papers had clear diagnostic criteria, accounting for 72.48%. 138 papers had clear efficacy evaluation criteria, accounting for 63.30%. Only 5.05% of the papers were classified as high-quality literature by using Jadad scale. In recent 20 years, some rules existed in acupoint selection for PH, but the support degree was low so it could not accurately guide clinical treatment. Although the clinical literature quality of acupuncture for PH was gradually increasing, the proportion of high-quality literature was low, therefore modern medical research model and foreign similar research should be followed to design a more rigorous trial protocol. As a result, the quality of clinical research is increased to provide reference for future clinical treatment.

Clinical trials in "emerging markets": regulatory considerations and other factors.

PubMed

Singh, Romi; Wang, Ouhong

2013-11-01

Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

Stormwater management and ecosystem services: a review

NASA Astrophysics Data System (ADS)

Prudencio, Liana; Null, Sarah E.

2018-03-01

Researchers and water managers have turned to green stormwater infrastructure, such as bioswales, retention basins, wetlands, rain gardens, and urban green spaces to reduce flooding, augment surface water supplies, recharge groundwater, and improve water quality. It is increasingly clear that green stormwater infrastructure not only controls stormwater volume and timing, but also promotes ecosystem services, which are the benefits that ecosystems provide to humans. Yet there has been little synthesis focused on understanding how green stormwater management affects ecosystem services. The objectives of this paper are to review and synthesize published literature on ecosystem services and green stormwater infrastructure and identify gaps in research and understanding, establishing a foundation for research at the intersection of ecosystems services and green stormwater management. We reviewed 170 publications on stormwater management and ecosystem services, and summarized the state-of-the-science categorized by the four types of ecosystem services. Major findings show that: (1) most research was conducted at the parcel-scale and should expand to larger scales to more closely understand green stormwater infrastructure impacts, (2) nearly a third of papers developed frameworks for implementing green stormwater infrastructure and highlighted barriers, (3) papers discussed ecosystem services, but less than 40% quantified ecosystem services, (4) no geographic trends emerged, indicating interest in applying green stormwater infrastructure across different contexts, (5) studies increasingly integrate engineering, physical science, and social science approaches for holistic understanding, and (6) standardizing green stormwater infrastructure terminology would provide a more cohesive field of study than the diverse and often redundant terminology currently in use. We recommend that future research provide metrics and quantify ecosystem services, integrate disciplines to measure ecosystem services from green stormwater infrastructure, and better incorporate stormwater management into environmental policy. Our conclusions outline promising future research directions at the intersection of stormwater management and ecosystem services.

Examination of State-of-the-Art Rehabilitation Technologies for the Nation's Water Infrastructure - slides

EPA Science Inventory

The research overview of the US EPA Aging Water Infrastructure Research Program includes: Research areas: condition assessment; rehabilitation; advanced design/treatment concepts and Research project focused on innovative rehabilitation technologies to reduce costs and increase...

From Dyadic Ties to Information Infrastructures: Care-Coordination between Patients, Providers, Students and Researchers

PubMed Central

Purkayastha, S.; Biswas, R.; Jai Ganesh, A.U.; Otero, P.

2015-01-01

Summary Objective To share how an effectual merging of local and online networks in low resource regions can supplement and strengthen the local practice of patient centered care through the use of an online digital infrastructure powered by all stakeholders in healthcare. User Driven Health Care offers the dynamic integration of patient values and evidence based solutions for improved medical communication in medical care. Introduction This paper conceptualizes patient care-coordination through the lens of engaged stakeholders using digital infrastructures tools to integrate information technology. We distinguish this lens from the prevalent conceptualization of dyadic ties between clinician-patient, patient-nurse, clinician-nurse, and offer the holistic integration of all stakeholder inputs, in the clinic and augmented by online communication in a multi-national setting. Methods We analyze an instance of the user-driven health care (UDHC), a network of providers, patients, students and researchers working together to help manage patient care. The network currently focuses on patients from LMICs, but the provider network is global in reach. We describe UDHC and its opportunities and challenges in care-coordination to reduce costs, bring equity, and improve care quality and share evidence. Conclusion UDHC has resulted in coordinated global based local care, affecting multiple facets of medical practice. Shared information resources between providers with disparate knowledge, results in better understanding by patients, unique and challenging cases for students, innovative community based research and discovery learning for all. PMID:26123908

From Dyadic Ties to Information Infrastructures: Care-Coordination between Patients, Providers, Students and Researchers. Contribution of the Health Informatics Education Working Group.

PubMed

Purkayastha, S; Price, A; Biswas, R; Jai Ganesh, A U; Otero, P

2015-08-13

To share how an effectual merging of local and online networks in low resource regions can supplement and strengthen the local practice of patient centered care through the use of an online digital infrastructure powered by all stakeholders in healthcare. User Driven Health Care offers the dynamic integration of patient values and evidence based solutions for improved medical communication in medical care. This paper conceptualizes patient care-coordination through the lens of engaged stakeholders using digital infrastructures tools to integrate information technology. We distinguish this lens from the prevalent conceptualization of dyadic ties between clinician-patient, patient-nurse, clinician-nurse, and offer the holistic integration of all stakeholder inputs, in the clinic and augmented by online communication in a multi-national setting. We analyze an instance of the user-driven health care (UDHC), a network of providers, patients, students and researchers working together to help manage patient care. The network currently focuses on patients from LMICs, but the provider network is global in reach. We describe UDHC and its opportunities and challenges in care-coordination to reduce costs, bring equity, and improve care quality and share evidence. UDHC has resulted in coordinated global based local care, affecting multiple facets of medical practice. Shared information resources between providers with disparate knowledge, results in better understanding by patients, unique and challenging cases for students, innovative community based research and discovery learning for all.

Forging a critical alliance: Addressing the research needs of the United States critical illness and injury community.

PubMed

Cobb, J Perren; Ognibene, Frederick P; Ingbar, David H; Mann, Henry J; Hoyt, David B; Angus, Derek C; Thomas, Alvin V; Danner, Robert L; Suffredini, Anthony F

2009-12-01

Discuss the research needs of the critical illness and injury communities in the United States. Workshop session held during the 5 National Institutes of Health Symposium on the Functional Genomics of Critical Illness and Injury (November 15, 2007). The current clinical research infrastructure misses opportunities for synergy and does not address many important needs. In addition, it remains challenging to rapidly and properly implement system-wide changes based upon reproducible evidence from clinical research. Author presentations, panel discussion, attendee feedback. The critical illness and injury research communities seek better communication and interaction, both of which will improve the breadth and quality of acute care research. Success in meeting these needs should come from cooperative and strategic actions that favor collaboration, standardization of protocols, and strong leadership. An alliance framed on common goals will foster collaboration among experts to better promote clinical trials within the critically ill or injured patient population. The U.S. Critical Illness and Injury Trials Group was funded to create a clinical research framework that can reduce the barriers to investigation using an investigator-initiated, evidence-driven, inclusive approach that has proven successful elsewhere. This alliance will provide an annual venue for systematic review and strategic planning that will include framing the research agenda, raising awareness for the value of acute care research, gathering and promoting best practices, and bolstering the critical care workforce.

From information technology to informatics: the information revolution in dental education.

PubMed

Schleyer, Titus K; Thyvalikakath, Thankam P; Spallek, Heiko; Dziabiak, Michael P; Johnson, Lynn A

2012-01-01

The capabilities of information technology (IT) have advanced precipitously in the last fifty years. Many of these advances have enabled new and beneficial applications of IT in dental education. However, conceptually, IT use in dental schools is only in its infancy. Challenges and opportunities abound for improving how we support clinical care, education, and research with IT. In clinical care, we need to move electronic dental records beyond replicating paper, connect information on oral health to that on systemic health, facilitate collaborative care through teledentistry, and help clinicians apply evidence-based dentistry and preventive management strategies. With respect to education, we should adopt an evidence-based approach to IT use for teaching and learning, share effective educational content and methods, leverage technology-mediated changes in the balance of power between faculty and students, improve technology support for clinical teaching, and build an information infrastructure centered on learners and organizations. In research, opportunities include reusing clinical care data for research studies, helping advance computational methods for research, applying generalizable research tools in dentistry, and reusing research data and scientific workflows. In the process, we transition from a focus on IT-the mere technical aspects of applying computer technology-to one on informatics: the what, how, and why of managing information.

From Information Technology to Informatics: The Information Revolution in Dental Education

PubMed Central

Schleyer, Titus K.; Thyvalikakath, Thankam P.; Spallek, Heiko; Dziabiak, Michael P.; Johnson, Lynn A.

2014-01-01

The capabilities of information technology (IT) have advanced precipitously in the last fifty years. Many of these advances have enabled new and beneficial applications of IT in dental education. However, conceptually, IT use in dental schools is only in its infancy. Challenges and opportunities abound for improving how we support clinical care, education, and research with IT. In clinical care, we need to move electronic dental records beyond replicating paper, connect information on oral health to that on systemic health, facilitate collaborative care through teledentistry, and help clinicians apply evidence-based dentistry and preventive management strategies. With respect to education, we should adopt an evidence-based approach to IT use for teaching and learning, share effective educational content and methods, leverage technology-mediated changes in the balance of power between faculty and students, improve technology support for clinical teaching, and build an information infrastructure centered on learners and organizations. In research, opportunities include reusing clinical care data for research studies, helping advance computational methods for research, applying generalizable research tools in dentistry, and reusing research data and scientific workflows. In the process, we transition from a focus on IT—the mere technical aspects of applying computer technology—to one on informatics: the what, how, and why of managing information. PMID:22262557

The Impact of Airport Performance towards Construction and Infrastructure Expansion in Indonesia

NASA Astrophysics Data System (ADS)

Laksono, T. D.; Kurniasih, N.; Hasyim, C.; Setiawan, M. I.; Ahmar, A. S.

2018-01-01

Development that is generated from airport areas includes construction and infrastructure development. This research reviews about how the implementation of material management in certain construction project and the relationship between development especially construction and infrastructure development with Airport Performance. The method that is used in this research is mixed method. The population in this research is 297 airports that are existed in Indonesia. From those 297 airports then it is chosen airports that have the most completed data about construction project and it is obtained 148 airports. Based on the coefficient correlation (R) test it is known that construction and infrastructure development has relatively strong relation with airport performance variable, but there are still other factors that influence construction and infrastructure development become bigger effect.

Federated Web-accessible Clinical Data Management within an Extensible NeuroImaging Database

PubMed Central

Keator, David B.; Wei, Dingying; Fennema-Notestine, Christine; Pease, Karen R.; Bockholt, Jeremy; Grethe, Jeffrey S.

2010-01-01

Managing vast datasets collected throughout multiple clinical imaging communities has become critical with the ever increasing and diverse nature of datasets. Development of data management infrastructure is further complicated by technical and experimental advances that drive modifications to existing protocols and acquisition of new types of research data to be incorporated into existing data management systems. In this paper, an extensible data management system for clinical neuroimaging studies is introduced: The Human Clinical Imaging Database (HID) and Toolkit. The database schema is constructed to support the storage of new data types without changes to the underlying schema. The complex infrastructure allows management of experiment data, such as image protocol and behavioral task parameters, as well as subject-specific data, including demographics, clinical assessments, and behavioral task performance metrics. Of significant interest, embedded clinical data entry and management tools enhance both consistency of data reporting and automatic entry of data into the database. The Clinical Assessment Layout Manager (CALM) allows users to create on-line data entry forms for use within and across sites, through which data is pulled into the underlying database via the generic clinical assessment management engine (GAME). Importantly, the system is designed to operate in a distributed environment, serving both human users and client applications in a service-oriented manner. Querying capabilities use a built-in multi-database parallel query builder/result combiner, allowing web-accessible queries within and across multiple federated databases. The system along with its documentation is open-source and available from the Neuroimaging Informatics Tools and Resource Clearinghouse (NITRC) site. PMID:20567938

Clinical Computing in General Dentistry

PubMed Central

Schleyer, Titus K.L.; Thyvalikakath, Thankam P.; Spallek, Heiko; Torres-Urquidy, Miguel H.; Hernandez, Pedro; Yuhaniak, Jeannie

2006-01-01

Objective: Measure the adoption and utilization of, opinions about, and attitudes toward clinical computing among general dentists in the United States. Design: Telephone survey of a random sample of 256 general dentists in active practice in the United States. Measurements: A 39-item telephone interview measuring practice characteristics and information technology infrastructure; clinical information storage; data entry and access; attitudes toward and opinions about clinical computing (features of practice management systems, barriers, advantages, disadvantages, and potential improvements); clinical Internet use; and attitudes toward the National Health Information Infrastructure. Results: The authors successfully screened 1,039 of 1,159 randomly sampled U.S. general dentists in active practice (89.6% response rate). Two hundred fifty-six (24.6%) respondents had computers at chairside and thus were eligible for this study. The authors successfully interviewed 102 respondents (39.8%). Clinical information associated with administration and billing, such as appointments and treatment plans, was stored predominantly on the computer; other information, such as the medical history and progress notes, primarily resided on paper. Nineteen respondents, or 1.8% of all general dentists, were completely paperless. Auxiliary personnel, such as dental assistants and hygienists, entered most data. Respondents adopted clinical computing to improve office efficiency and operations, support diagnosis and treatment, and enhance patient communication and perception. Barriers included insufficient operational reliability, program limitations, a steep learning curve, cost, and infection control issues. Conclusion: Clinical computing is being increasingly adopted in general dentistry. However, future research must address usefulness and ease of use, workflow support, infection control, integration, and implementation issues. PMID:16501177

Federated web-accessible clinical data management within an extensible neuroimaging database.

PubMed

Ozyurt, I Burak; Keator, David B; Wei, Dingying; Fennema-Notestine, Christine; Pease, Karen R; Bockholt, Jeremy; Grethe, Jeffrey S

2010-12-01

Managing vast datasets collected throughout multiple clinical imaging communities has become critical with the ever increasing and diverse nature of datasets. Development of data management infrastructure is further complicated by technical and experimental advances that drive modifications to existing protocols and acquisition of new types of research data to be incorporated into existing data management systems. In this paper, an extensible data management system for clinical neuroimaging studies is introduced: The Human Clinical Imaging Database (HID) and Toolkit. The database schema is constructed to support the storage of new data types without changes to the underlying schema. The complex infrastructure allows management of experiment data, such as image protocol and behavioral task parameters, as well as subject-specific data, including demographics, clinical assessments, and behavioral task performance metrics. Of significant interest, embedded clinical data entry and management tools enhance both consistency of data reporting and automatic entry of data into the database. The Clinical Assessment Layout Manager (CALM) allows users to create on-line data entry forms for use within and across sites, through which data is pulled into the underlying database via the generic clinical assessment management engine (GAME). Importantly, the system is designed to operate in a distributed environment, serving both human users and client applications in a service-oriented manner. Querying capabilities use a built-in multi-database parallel query builder/result combiner, allowing web-accessible queries within and across multiple federated databases. The system along with its documentation is open-source and available from the Neuroimaging Informatics Tools and Resource Clearinghouse (NITRC) site.

Stakeholder Engagement in a Patient-Reported Outcomes (PRO) Measure Implementation: A Report from the SAFTINet Practice-based Research Network (PBRN).

PubMed

Kwan, Bethany M; Sills, Marion R; Graham, Deborah; Hamer, Mika K; Fairclough, Diane L; Hammermeister, K E; Kaiser, Alicyn; de Jesus Diaz-Perez, Maria; Schilling, Lisa M

2016-01-01

Patient-reported outcome (PRO) measures offer value for clinicians and researchers, although priorities and value propositions can conflict. PRO implementation in clinical practice may benefit from stakeholder engagement methods to align research and clinical practice stakeholder perspectives. The objective is to demonstrate the use of stakeholder engagement in PRO implementation. Engaged stakeholders represented researchers and clinical practice representatives from the SAFTINet practice-based research network (PBRN). A stakeholder engagement process involving iterative analysis, deliberation, and decision making guided implementation of a medication adherence PRO measure (the Medication Adherence Survey [MAS]) for patients with hypertension and/or hyperlipidemia. Over 9 months, 40 of 45 practices (89%) implemented the MAS, collecting 3,247 surveys (mean = 72, median = 30, range: 0 - 416). Facilitators included: an electronic health record (EHR) with readily modifiable templates; existing staff, tools and workflows in which the MAS could be integrated (e.g., health risk appraisals, hypertension-specific visits, care coordinators); and engaged leadership and quality improvement teams. Stakeholder engagement appeared useful for promoting PRO measure implementation in clinical practice, in a way that met the needs of both researchers and clinical practice stakeholders. Limitations of this approach and opportunities for improving the PRO data collection infrastructure in PBRNs are discussed. © Copyright 2016 by the American Board of Family Medicine.

[Clinical research activity of the French cancer cooperative network: Overview and perspectives].

PubMed

Dubois, Claire; Morin, Franck; Moro-Sibilot, Denis; Langlais, Alexandra; Seitz, Jean-François; Girault, Cécile; Salles, Gilles; Haioun, Corinne; Deschaseaux, Pascal; Casassus, Philippe; Mathiot, Claire; Pujade-Lauraine, Éric; Votan, Bénédicte; Louvet, Christophe; Delpeut, Christine; Bardet, Étienne; Vintonenko, Nadejda; Hoang Xuan, Khê; Vo, Maryline; Michon, Jean; Milleron, Bernard

The French Cancer Plan 2014-2019 stresses the importance of strengthening collaboration between all stakeholders involved in the fight against cancer, including cancer cooperative groups and intergroups. This survey aimed to describe the basics characteristics and clinical research activity among the Cancer Cooperative Groups (Groupes coopérateurs en oncologie). The second objective was to identify facilitators and barriers to their research activity. A questionnaire was sent to all the clinicians involved in 2014 as investigators in a clinical trial sponsored by one of the ten members of the Cancer Cooperative Groups network. The questions were related to their profile, research activity and the infrastructure existing within their healthcare center to support clinical research and related compliance activities. In total, 366 investigators responded to our survey. The academic clinical trials sponsored by the Cancer Cooperative Groups represented an important part of the research activity of the investigators in France in 2014. These academic groups contributed to the opening of many research sites throughout all regions in France. Factors associated with a higher participation of investigators (more than 10 patients enrolled in a trial over a year) include the existing support of healthcare professionals (more than 2 clinical research associate (CRA) OR=11.16 [3.82-32.6] compared to none) and the practice of their research activity in a University Hospital Center (CHU) rather than a Hospital Center (CH) (OR=2.15 [1.20-3.83]). This study highlighted factors that can strengthen investigator clinical research activities and subsequently improve patient access to evidence-based new cancer therapies in France. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

The crisis in United States hospital emergency services.

PubMed

Harrison, Jeffrey P; Ferguson, Emily D

2011-01-01

Emergency services are critical for high-quality healthcare service provision to support acute illness, trauma and disaster response. The greater availability of emergency services decreases waiting time, improves clinical outcomes and enhances local community well being. This study aims to assess United States (U.S.) acute care hospital staffs ability to provide emergency medical services by evaluating the number of emergency departments and trauma centers. Data were obtained from the 2003 and 2007 American Hospital Association (AHA) annual surveys, which included over 5000 US hospitals and provided extensive information on their infrastructure and healthcare capabilities. U.S. acute care hospital numbers decreased by 59 or 1.1 percent from 2003 to 2007. Similarly, U.S. emergency rooms and trauma centers declined by 125, or 3 percent. The results indicate that US hospital staffs ability to respond to traumatic injury and disasters has declined. Therefore, US hospital managers need to increase their investment in emergency department beds as well as provide state-of-the-art clinical technology to improve emergency service quality. These investments, when linked to other clinical information systems and the electronic medical record, support further healthcare quality improvement. This research uses the AHA annual surveys,which represent self-reported data by individual hospital staff. However, the AHA expendssignificant resources to validate reported information and the annual survey data are widely used for hospital research. The declining US emergency rooms and trauma centers have negative implications for patients needing emergency services. More importantly, this research has significant policy implications because it documents a decline in the US emergency healthcare service infrastructure. This article has important information on US emergency service availability in the hospital industry.

Summary of NIH Medical-Surgical Emergency Research Roundtable held on April 30 to May 1, 2009.

PubMed

Kaji, Amy H; Lewis, Roger J; Beavers-May, Tony; Berg, Robert; Bulger, Eileen; Cairns, Charles; Callaway, Clifton; Camargo, Carlos A; Carcillo, Joseph; DeBiasi, Roberta; Diaz, Tania; Ducharme, Francine; Glickman, Seth; Heilpern, Katherine; Hickey, Robert; Hoek, Terry Vanden; Hollander, Judd; Janson, Susan; Jurkovich, Gregory; Kellermann, Arthur; Kingsmore, Stephen; Kline, Jeffrey; Kuppermann, Nathan; Lowe, Robert; McLario, David; Nathanson, Larry; Nichol, Graham; Peitzman, Andrew; Richardson, Lynne; Sanders, Arthur; Shah, Manish; Shapiro, Nathan; Silverman, Robert; Than, Martin; Wilber, Scott; Yealy, Donald M

2010-11-01

In 2003, the Institute of Medicine Committee on the Future of Emergency Care in the United States Health System convened and identified a crisis in emergency care in the United States, including a need to enhance the research base for emergency care. As a result, the National Institutes of Health (NIH) formed an NIH Task Force on Research in Emergency Medicine to enhance NIH support for emergency care research. Members of the NIH Task Force and academic leaders in emergency care participated in 3 roundtable discussions to prioritize current opportunities for enhancing and conducting emergency care research. The objectives of these discussions were to identify key research questions essential to advancing the scientific underpinnings of emergency care and to discuss the barriers and best means to advance research by exploring the role of research networks and collaboration between the NIH and the emergency care community. The Medical-Surgical Research Roundtable was convened on April 30 to May 1, 2009. Before the roundtable, the emergency care domains to be discussed were selected and experts in each of the fields were invited to participate in the roundtable. Domain experts were asked to identify research priorities and challenges and separate them into mechanistic, translational, and clinical categories. After the conference, the lists were circulated among the participants and revised to reach a consensus. Emergency care research is characterized by focus on the timing, sequence, and time sensitivity of disease processes and treatment effects. Rapidly identifying the phenotype and genotype of patients manifesting a specific disease process and the mechanistic reasons for heterogeneity in outcome are important challenges in emergency care research. Other research priorities include the need to elucidate the timing, sequence, and duration of causal molecular and cellular events involved in time-critical illnesses and injuries, and the development of treatments capable of halting or reversing them; the need for novel animal models; and the need to understand why there are regional differences in outcome for the same disease processes. Important barriers to emergency care research include a limited number of trained investigators and experienced mentors, limited research infrastructure and support, and regulatory hurdles. The science of emergency care may be advanced by facilitating the following: (1) training emergency care investigators with research training programs; (2) developing emergency care clinical research networks; (3) integrating emergency care research into Clinical and Translational Science Awards; (4) developing emergency care-specific initiatives within the existing structure of NIH institutes and centers; (5) involving emergency specialists in grant review and research advisory processes; (6) supporting learn-phase or small, clinical trials; and (7) performing research to address ethical and regulatory issues. Enhancing the research base supporting the care of medical and surgical emergencies will require progress in specific mechanistic, translational, and clinical domains; effective collaboration of academic investigators across traditional clinical and scientific boundaries; federal support of research in high-priority areas; and overcoming limitations in available infrastructure, research training, and access to patient populations. Copyright © 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

US EPA/ORD Condition Assessment Research for Drinking Water Conveyance Infrastructure

EPA Science Inventory

This presentation describes research on condition assessment for drinking water transmission and distribution systems that EPA is conducting under the U.S. Environmental Protection Agency’s Aging Water Infrastructure (AWI) Research Program. This research program will help U.S. ...

Hydrogen Infrastructure Testing and Research Facility

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

2017-04-10

Learn about the Hydrogen Infrastructure Testing and Research Facility (HITRF), where NREL researchers are working on vehicle and hydrogen infrastructure projects that aim to enable more rapid inclusion of fuel cell and hydrogen technologies in the market to meet consumer and national goals for emissions reduction, performance, and energy security. As part of NREL’s Energy Systems Integration Facility (ESIF), the HITRF is designed for collaboration with a wide range of hydrogen, fuel cell, and transportation stakeholders.

Mayo Clinic Zebrafish Facility Overview.

PubMed

Leveque, Ryan E; Clark, Karl J; Ekker, Stephen C

2016-07-01

The zebrafish (Danio rerio) is a premier nonmammalian vertebrate model organism. This small aquatic fish is utilized in multiple disciplines in the Mayo Clinic community and by many laboratories around the world because of its biological similarity to humans, its advanced molecular genetics, the elucidation of its genome sequence, and the ever-expanding and outstanding new biological tools now available to the zebrafish researcher. The Mayo Clinic Zebrafish Facility (MCZF) houses ∼2,000 tanks annotated using an in-house, Internet cloud-based bar-coding system tied to our established zfishbook.org web infrastructure. Paramecia are the primary food source for larval fish rearing, using a simplified culture protocol described herein. The MCZF supports the specific ongoing research in a variety of laboratories, while also serving as a local hub for new scientists as they learn to tap into the potential of this model system for understanding normal development, disease, and as models of health.

Facilities and Infrastructure FY 2017 Budget At-A-Glance

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

2016-03-01

The Facilities and Infrastructure Program includes EERE’s capital investments, operations and maintenance, and site-wide support of the National Renewable Energy Laboratory (NREL). It is the nation’s only national laboratory with a primary mission dedicated to the research, development and demonstration (RD&D) of energy efficiency, renewable energy and related technologies. EERE is NREL’s steward, primary client and sponsor of NREL’s designation as a Federally Funded Research and Development Center. The Facilities and Infrastructure (F&I) budget maintains NREL’s research and support infrastructure, ensures availability for EERE’s use, and provides a safe and secure workplace for employees.

The learning environment in professional doctorate and postgraduate dental education: a qualitative study.

PubMed

Subramanian, J; Thomson, W M

2017-11-01

Currently, there is a lack of studies focusing on professional doctoral students' and graduates' perceptions of their learning environment, in particular, using a qualitative approach to elicit in-depth information. This article aims to contribute to the existing body of knowledge by systematically exploring, critically analysing and getting a deeper understanding of professional doctorate dental students' and graduates' insights into effective and ineffective clinical and physical learning environment characteristics. The study included a total of 20 participants. Participants included 16 final-year Doctor of Clinical Dentistry (DClinDent) students and four dental specialists (graduates of the DClinDent programme). Semi-structured, individual interviews were used. Participants were asked to reflect upon and describe in detail their effective and ineffective learning environment experiences. The critical incident technique was used to guide the data collection. Data were analysed using a general inductive qualitative approach. Learning environment characteristics which participants associated with effective learning included the following: sufficient opportunities for comprehensive treatment planning; introduction to a number of patient treatment philosophies; a sufficient number of complex cases; clinically oriented research and assignment topics; a focus on clinical training in the programme generally; a research topic of a realistic depth and breadth, suitable for their 'specialist training' degree; and a well-resourced and updated physical infrastructure. On the other hand, most participants indicated that the absence of an adequate number of clinical cases, an overemphasis on research (as opposed to clinical practice) in the DClinDent programme and an 'outdated' physical infrastructure in the dental school clinics could hamper effective clinical learning. These findings contribute to the meaningful advancement of the literature on learning environment strategies through the exploration of (and in-depth qualitative insights into) what facilitated effective learning by New Zealand professional doctorate candidates and graduates. These findings provide a starting point for reflection by international academic directors, educational developers, curriculum planners, programme managers and clinical teachers in respect of the further development of the learning environment. Although the findings from this study may not be directly transferable to all international contexts, they have the potential to contribute to the further development of theory in this area. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Build infrastructure in publishing scientific journals to benefit medical scientists

PubMed Central

Dai, Ni; Xu, Dingyao; Zhong, Xiyao; Li, Li; Ling, Qibo

2014-01-01

There is urgent need for medical journals to optimize their publishing processes and strategies to satisfy the huge need for medical scientists to publish their articles, and then obtain better prestige and impact in scientific and research community. These strategies include optimizing the process of peer-review, utilizing open-access publishing models actively, finding ways of saving costs and getting revenue, smartly dealing with research fraud or misconduct, maintaining sound relationship with pharmaceutical companies, and managing to provide relevant and useful information for clinical practitioners and researchers. Scientists, publishers, societies and organizations need to work together to publish internationally renowned medical journals. PMID:24653634

Ensuring Support for Research and Quality Improvement (QI) Networks: Four Pillars of Sustainability-An Emerging Framework.

PubMed

Holve, Erin

2013-01-01

Multi-institutional research and quality improvement (QI) projects using electronic clinical data (ECD) hold great promise for improving quality of care and patient outcomes but typically require significant infrastructure investments both to initiate and maintain the project over its duration. Consequently, it is important for these projects to think holistically about sustainability to ensure their long-term success. Four "pillars" of sustainability are discussed based on the experiences of EDM Forum grantees and other research and QI networks. These include trust and value, governance, management, and financial and administrative support. Two "foundational considerations," adaptive capacity and policy levers, are also discussed.

Build infrastructure in publishing scientific journals to benefit medical scientists.

PubMed

Dai, Ni; Xu, Dingyao; Zhong, Xiyao; Li, Li; Ling, Qibo; Bu, Zhaode

2014-02-01

There is urgent need for medical journals to optimize their publishing processes and strategies to satisfy the huge need for medical scientists to publish their articles, and then obtain better prestige and impact in scientific and research community. These strategies include optimizing the process of peer-review, utilizing open-access publishing models actively, finding ways of saving costs and getting revenue, smartly dealing with research fraud or misconduct, maintaining sound relationship with pharmaceutical companies, and managing to provide relevant and useful information for clinical practitioners and researchers. Scientists, publishers, societies and organizations need to work together to publish internationally renowned medical journals.

Safety impacts of bicycle infrastructure: A critical review.

PubMed

DiGioia, Jonathan; Watkins, Kari Edison; Xu, Yanzhi; Rodgers, Michael; Guensler, Randall

2017-06-01

This paper takes a critical look at the present state of bicycle infrastructure treatment safety research, highlighting data needs. Safety literature relating to 22 bicycle treatments is examined, including findings, study methodologies, and data sources used in the studies. Some preliminary conclusions related to research efficacy are drawn from the available data and findings in the research. While the current body of bicycle safety literature points toward some defensible conclusions regarding the safety and effectiveness of certain bicycle treatments, such as bike lanes and removal of on-street parking, the vast majority treatments are still in need of rigorous research. Fundamental questions arise regarding appropriate exposure measures, crash measures, and crash data sources. This research will aid transportation departments with regard to decisions about bicycle infrastructure and guide future research efforts toward understanding safety impacts of bicycle infrastructure. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

EPA Research Highlights: EPA Studies Aging Water Infrastructure

EPA Science Inventory

The nation's extensive water infrastructure has the capacity to treat, store, and transport trillions of gallons of water and wastewater per day through millions of miles of pipelines. However, some infrastructure components are more than 100 years old, and as the infrastructure ...

Implementation of new clinical programs in the VHA healthcare system: the importance of early collaboration between clinical leadership and research.

PubMed

Wu, R Ryanne; Kinsinger, Linda S; Provenzale, Dawn; King, Heather A; Akerly, Patricia; Barnes, Lottie K; Datta, Santanu K; Grubber, Janet M; Katich, Nicholas; McNeil, Rebecca B; Monte, Robert; Sperber, Nina R; Atkins, David; Jackson, George L

2014-12-01

Collaboration between policy, research, and clinical partners is crucial to achieving proven quality care. The Veterans Health Administration has expended great efforts towards fostering such collaborations. Through this, we have learned that an ideal collaboration involves partnership from the very beginning of a new clinical program, so that the program is designed in a way that ensures quality, validity, and puts into place the infrastructure necessary for a reliable evaluation. This paper will give an example of one such project, the Lung Cancer Screening Demonstration Project (LCSDP). We will outline the ways that clinical, policy, and research partners collaborated in design, planning, and implementation in order to create a sustainable model that could be rigorously evaluated for efficacy and fidelity. We will describe the use of the Donabedian quality matrix to determine the necessary characteristics of a quality program and the importance of the linkage with engineering, information technology, and clinical paradigms to connect the development of an on-the-ground clinical program with the evaluation goal of a learning healthcare organization. While the LCSDP is the example given here, these partnerships and suggestions are salient to any healthcare organization seeking to implement new scientifically proven care in a useful and reliable way.

The European Research Infrastructure for Heritage Science (erihs)

NASA Astrophysics Data System (ADS)

Striova, J.; Pezzati, L.

2017-08-01

The European Research Infrastructure for Heritage Science (E-RIHS) entered the European strategic roadmap for research infrastructures (ESFRI Roadmap [1]) in 2016, as one of its six new projects. E-RIHS supports research on heritage interpretation, preservation, documentation and management. Both cultural and natural heritage are addressed: collections, artworks, buildings, monuments and archaeological sites. E-RIHS aims to become a distributed research infrastructure with a multi-level star-structure: facilities from single Countries will be organized in national nodes, coordinated by National Hubs. The E-RIHS Central Hub will provide the unique access point to all E-RIHS services through coordination of National Hubs. E-RIHS activities already started in some of its national nodes. In Italy the access to some E-RIHS services started in 2015. A case study concerning the diagnostic of a hypogea cave is presented.

Collecting, Integrating, and Disseminating Patient-Reported Outcomes for Research in a Learning Healthcare System

PubMed Central

Harle, Christopher A.; Lipori, Gloria; Hurley, Robert W.

2016-01-01

Introduction: Advances in health policy, research, and information technology have converged to increase the electronic collection and use of patient-reported outcomes (PROs). Therefore, it is important to share lessons learned in implementing PROs in research information systems. Case Description: The purpose of this case study is to describe a novel information system for electronic PROs and lessons learned in implementing that system to support research in an academic health center. The system incorporates freely available and commercial software and involves clinical and research workflows that support the collection, transformation, and research use of PRO data. The software and processes that comprise the system serve three main functions, (i) collecting electronic PROs in clinical care, (ii) integrating PRO data with non-patient generated clinical data, and (iii) disseminating data to researchers through the institution’s research informatics infrastructure, including the i2b2 (Informatics for Integrating Biology and the Bedside) system. Strategies: Our successful design and implementation was driven by three overarching strategies. First, we selected and implemented multiple interfaced technologies to support PRO collection, management, and research use. Second, we aimed to use standardized approaches to measuring PROs, sending PROs between systems, and disseminating PROs. Finally, we focused on using technologies and processes that aligned with existing clinical research information management strategies within our organization. Conclusion: These experiences and lessons may help future implementers and researchers enhance the scale and sustainable use of systems for research use of PROs. PMID:27563683

Collecting, Integrating, and Disseminating Patient-Reported Outcomes for Research in a Learning Healthcare System.

PubMed

Harle, Christopher A; Lipori, Gloria; Hurley, Robert W

2016-01-01

Advances in health policy, research, and information technology have converged to increase the electronic collection and use of patient-reported outcomes (PROs). Therefore, it is important to share lessons learned in implementing PROs in research information systems. The purpose of this case study is to describe a novel information system for electronic PROs and lessons learned in implementing that system to support research in an academic health center. The system incorporates freely available and commercial software and involves clinical and research workflows that support the collection, transformation, and research use of PRO data. The software and processes that comprise the system serve three main functions, (i) collecting electronic PROs in clinical care, (ii) integrating PRO data with non-patient generated clinical data, and (iii) disseminating data to researchers through the institution's research informatics infrastructure, including the i2b2 (Informatics for Integrating Biology and the Bedside) system. Our successful design and implementation was driven by three overarching strategies. First, we selected and implemented multiple interfaced technologies to support PRO collection, management, and research use. Second, we aimed to use standardized approaches to measuring PROs, sending PROs between systems, and disseminating PROs. Finally, we focused on using technologies and processes that aligned with existing clinical research information management strategies within our organization. These experiences and lessons may help future implementers and researchers enhance the scale and sustainable use of systems for research use of PROs.

Physician participation in clinical research and trials: issues and approaches

PubMed Central

Rahman, Sayeeda; Majumder, Md Anwarul Azim; Shaban, Sami F; Rahman, Nuzhat; Ahmed, Moslehuddin; Abdulrahman, Khalid Bin; D’Souza, Urban JA

2011-01-01

The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system-or organization-related as well as research-and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers. PMID:23745079

Researchers', Regulators', and Sponsors' Views on Pediatric Clinical Trials: A Multinational Study.

PubMed

Joseph, Pathma D; Craig, Jonathan C; Tong, Allison; Caldwell, Patrina H Y

2016-10-01

The last decade has seen dramatic changes in the regulatory landscape to support more trials involving children, but child-specific challenges and inequitable conduct across income regions persist. The goal of this study was to describe the attitudes and opinions of stakeholders toward trials in children, to inform additional strategies to promote more high-quality, relevant pediatric trials across the globe. Key informant semi-structured interviews were conducted with stakeholders (researchers, regulators, and sponsors) who were purposively sampled from low- to middle-income countries and high-income countries. The transcripts were thematically analyzed. Thirty-five stakeholders from 10 countries were interviewed. Five major themes were identified: addressing pervasive inequities (paucity of safety and efficacy data, knowledge disparities, volatile environment, double standards, contextual relevance, market-driven forces, industry sponsorship bias and prohibitive costs); contending with infrastructural barriers (resource constraints, dearth of pediatric trial expertise, and logistical complexities); navigating complex ethical and regulatory frameworks ("draconian" oversight, ambiguous requirements, exploitation, excessive paternalism and precariousness of coercion versus volunteerism); respecting uniqueness of children (pediatric research paradigms, child-appropriate approaches, and family-centered empowerment); and driving evidence-based child health (advocacy, opportunities, treatment access, best practices, and research prioritization). Stakeholders acknowledge that changes in the regulatory environment have encouraged more trials in children, but they contend that inequities and political, regulatory, and resource barriers continue to exist. Embedding trials as part of routine clinical care, addressing the unique needs of children, and streamlining regulatory approvals were suggested. Stakeholders recommended increasing international collaboration, establishing centralized trials infrastructure, and aligning research to child health priorities to encourage trials that address global child health care needs. Copyright © 2016 by the American Academy of Pediatrics.

Effect of a Clinical and Translational Science Award institute on grant funding in a major research university.

PubMed

Kabo, Felichism W; Mashour, George A

2017-04-01

Previous studies have examined the impact of Clinical and Translational Science Awards programs on other outcomes, but not on grant seeking. The authors examined the effects on grant seeking of the Michigan Institute for Clinical & Health Research (MICHR), a Clinical and Translational Science Awards institute at the University of Michigan. We assessed over 63,000 grant proposals submitted at the University of Michigan in the years 2002-2012 using data from the university and MICHR's Tracking Metrics and Reporting System. We used a retrospective, observational study of the dynamics of grant-seeking success and award funding. Heckman selection models were run to assess MICHR's relationship with a proposal's success (selection), and subsequently the award's size (outcome). Models were run for all proposals and for clinical and translational research (CTR) proposals alone. Other covariates included proposal classification, type of grant award, academic unit, and year. MICHR had a positive and statistically significant relationship with success for both proposal types. For all grants, MICHR was associated with a 29.6% increase in award size. For CTR grants, MICHR had a statistically nonsignificant relationship with award size. MICHR's infrastructure, created to enable and enhance CTR, has also created positive spillovers for a broader spectrum of research and grant seeking.

Investigator initiated IBD trials in the US: Facts, obstacles and answers

PubMed Central

Herfarth, Hans H; Jackson, Susan; Schliebe, Barbara G.; Martin, Christopher; Ivanova, Anastasia; Anton, Kristen; Sandler, Robert S; Long, Millie D; Isaacs, Kim L; Osterman, Mark T; Sands, Bruce E; Higgins, Peter D; Lewis, James D

2016-01-01

Investigator initiated randomized clinical trials (IITs) are the backbone of academic clinical research. IITs complement the large clinical studies sponsored by industry and address questions, which are usually not the main focus of a commercially directed research but have the purpose to confirm, improve or refute clinically important questions with regard to diagnostic and therapeutic approaches in patient care. The aim of this review is to illustrate the necessary steps to start and complete an IIT in the field of inflammatory bowel diseases (IBD) in the US. The initial milestones for an investigator include structuring a protocol, planning and building of the trial infrastructure, accurately estimating the costs of the trial and gauging the time span for recruitment. Once the trial has begun it is important to keep patient recruitment on target, monitor of the data quality, and document treatment emergent adverse events. This article provides a framework for the different phases of an IIT and outlines potential hurdles, which could hinder a successful execution. PMID:27598744

Software and hardware infrastructure for research in electrophysiology

PubMed Central

Mouček, Roman; Ježek, Petr; Vařeka, Lukáš; Řondík, Tomáš; Brůha, Petr; Papež, Václav; Mautner, Pavel; Novotný, Jiří; Prokop, Tomáš; Štěbeták, Jan

2014-01-01

As in other areas of experimental science, operation of electrophysiological laboratory, design and performance of electrophysiological experiments, collection, storage and sharing of experimental data and metadata, analysis and interpretation of these data, and publication of results are time consuming activities. If these activities are well organized and supported by a suitable infrastructure, work efficiency of researchers increases significantly. This article deals with the main concepts, design, and development of software and hardware infrastructure for research in electrophysiology. The described infrastructure has been primarily developed for the needs of neuroinformatics laboratory at the University of West Bohemia, the Czech Republic. However, from the beginning it has been also designed and developed to be open and applicable in laboratories that do similar research. After introducing the laboratory and the whole architectural concept the individual parts of the infrastructure are described. The central element of the software infrastructure is a web-based portal that enables community researchers to store, share, download and search data and metadata from electrophysiological experiments. The data model, domain ontology and usage of semantic web languages and technologies are described. Current data publication policy used in the portal is briefly introduced. The registration of the portal within Neuroscience Information Framework is described. Then the methods used for processing of electrophysiological signals are presented. The specific modifications of these methods introduced by laboratory researches are summarized; the methods are organized into a laboratory workflow. Other parts of the software infrastructure include mobile and offline solutions for data/metadata storing and a hardware stimulator communicating with an EEG amplifier and recording software. PMID:24639646

Software and hardware infrastructure for research in electrophysiology.

PubMed

Mouček, Roman; Ježek, Petr; Vařeka, Lukáš; Rondík, Tomáš; Brůha, Petr; Papež, Václav; Mautner, Pavel; Novotný, Jiří; Prokop, Tomáš; Stěbeták, Jan

2014-01-01

As in other areas of experimental science, operation of electrophysiological laboratory, design and performance of electrophysiological experiments, collection, storage and sharing of experimental data and metadata, analysis and interpretation of these data, and publication of results are time consuming activities. If these activities are well organized and supported by a suitable infrastructure, work efficiency of researchers increases significantly. This article deals with the main concepts, design, and development of software and hardware infrastructure for research in electrophysiology. The described infrastructure has been primarily developed for the needs of neuroinformatics laboratory at the University of West Bohemia, the Czech Republic. However, from the beginning it has been also designed and developed to be open and applicable in laboratories that do similar research. After introducing the laboratory and the whole architectural concept the individual parts of the infrastructure are described. The central element of the software infrastructure is a web-based portal that enables community researchers to store, share, download and search data and metadata from electrophysiological experiments. The data model, domain ontology and usage of semantic web languages and technologies are described. Current data publication policy used in the portal is briefly introduced. The registration of the portal within Neuroscience Information Framework is described. Then the methods used for processing of electrophysiological signals are presented. The specific modifications of these methods introduced by laboratory researches are summarized; the methods are organized into a laboratory workflow. Other parts of the software infrastructure include mobile and offline solutions for data/metadata storing and a hardware stimulator communicating with an EEG amplifier and recording software.

Building the informatics infrastructure for comparative effectiveness research (CER): a review of the literature.

PubMed

Lopez, Marianne Hamilton; Holve, Erin; Sarkar, Indra Neil; Segal, Courtney

2012-07-01

Technological advances in clinical informatics have made large amounts of data accessible and potentially useful for research. As a result, a burgeoning literature addresses efforts to bridge the fields of health services research and biomedical informatics. The Electronic Data Methods Forum review examines peer-reviewed literature at the intersection of comparative effectiveness research and clinical informatics. The authors are specifically interested in characterizing this literature and identifying cross-cutting themes and gaps in the literature. A 3-step systematic literature search was conducted, including a structured search of PubMed, manual reviews of articles from selected publication lists, and manual reviews of research activities based on prospective electronic clinical data. Two thousand four hundred thirty-five citations were identified as potentially relevant. Ultimately, a full-text review was performed for 147 peer-reviewed papers. One hundred thirty-two articles were selected for inclusion in the review. Of these, 88 articles are the focus of the discussion in this paper. Three types of articles were identified, including papers that: (1) provide historical context or frameworks for using clinical informatics for research, (2) describe platforms and projects, and (3) discuss issues, challenges, and applications of natural language processing. In addition, 2 cross-cutting themes emerged: the challenges of conducting research in the absence of standardized ontologies and data collection; and unique data governance concerns related to the transfer, storage, deidentification, and access to electronic clinical data. Finally, the authors identified several current gaps on important topics such as the use of clinical informatics for cohort identification, cloud computing, and single point access to research data.

Transportation security research : coordination needed in selecting and implementing infrastructure vulnerability assessments

DOT National Transportation Integrated Search

2003-05-01

The Department of Transportation's (DOT) Research and Special Programs Administration (RSPA) began research in to assess the vulnerabilities of the nation's transportation infrastructure and develop needed improvements in security in June 2001. The g...

The Role of Free/Libre and Open Source Software in Learning Health Systems.

PubMed

Paton, C; Karopka, T

2017-08-01

Objective: To give an overview of the role of Free/Libre and Open Source Software (FLOSS) in the context of secondary use of patient data to enable Learning Health Systems (LHSs). Methods: We conducted an environmental scan of the academic and grey literature utilising the MedFLOSS database of open source systems in healthcare to inform a discussion of the role of open source in developing LHSs that reuse patient data for research and quality improvement. Results: A wide range of FLOSS is identified that contributes to the information technology (IT) infrastructure of LHSs including operating systems, databases, frameworks, interoperability software, and mobile and web apps. The recent literature around the development and use of key clinical data management tools is also reviewed. Conclusions: FLOSS already plays a critical role in modern health IT infrastructure for the collection, storage, and analysis of patient data. The nature of FLOSS systems to be collaborative, modular, and modifiable may make open source approaches appropriate for building the digital infrastructure for a LHS. Georg Thieme Verlag KG Stuttgart.

Health Information Research Platform (HIReP)--an architecture pattern.

PubMed

Schreiweis, Björn; Schneider, Gerd; Eichner, Theresia; Bergh, Björn; Heinze, Oliver

2014-01-01

Secondary use or single source is still far from routine in healthcare, although lots of data are available either structured or unstructured. As data are stored in multiple systems, using them for biomedical research is difficult. Clinical data warehouses already help overcoming this issue, but currently they are only used for certain parts of biomedical research. A comprehensive research platform based on a generic architecture pattern could increase the benefits of existing data warehouses for both patient care and research by meeting two objectives: serving as a so called single point-of-truth and acting as a mediator between them strengthening interaction and close collaboration. Another effect is to reduce boundaries for the implementation of data warehouses. Taking further settings into account the architecture of a clinical data warehouse supporting patient care and biomedical research needs to be integrated with biomaterial banks and other sources. This work provides a solution conceptualizing a comprehensive architecture pattern of a Health Information Research Platform (HIReP) derived from use cases of the patient care and biomedical research domain. It serves as single IT infrastructure providing solutions for any type of use case.

Some recent advances of intelligent health monitoring systems for civil infrastructures in HIT

NASA Astrophysics Data System (ADS)

Ou, Jinping

2005-06-01

The intelligent health monitoring systems more and more become a technique for ensuring the health and safety of civil infrastructures and also an important approach for research of the damage accumulation or even disaster evolving characteristics of civil infrastructures, and attracts prodigious research interests and active development interests of scientists and engineers since a great number of civil infrastructures are planning and building each year in mainland China. In this paper, some recent advances on research, development nad implementation of intelligent health monitoring systems for civil infrastructuresin mainland China, especially in Harbin Institute of Technology (HIT), P.R.China. The main contents include smart sensors such as optical fiber Bragg grating (OFBG) and polivinyllidene fluoride (PVDF) sensors, fatigue life gauges, self-sensing mortar and carbon fiber reinforced polymer (CFRP), wireless sensor networks and their implementation in practical infrastructures such as offshore platform structures, hydraulic engineering structures, large span bridges and large space structures. Finally, the relative research projects supported by the national foundation agencies of China are briefly introduced.

LC Data QUEST: A Technical Architecture for Community Federated Clinical Data Sharing.

PubMed

Stephens, Kari A; Lin, Ching-Ping; Baldwin, Laura-Mae; Echo-Hawk, Abigail; Keppel, Gina A; Buchwald, Dedra; Whitener, Ron J; Korngiebel, Diane M; Berg, Alfred O; Black, Robert A; Tarczy-Hornoch, Peter

2012-01-01

The University of Washington Institute of Translational Health Sciences is engaged in a project, LC Data QUEST, building data sharing capacity in primary care practices serving rural and tribal populations in the Washington, Wyoming, Alaska, Montana, Idaho region to build research infrastructure. We report on the iterative process of developing the technical architecture for semantically aligning electronic health data in primary care settings across our pilot sites and tools that will facilitate linkages between the research and practice communities. Our architecture emphasizes sustainable technical solutions for addressing data extraction, alignment, quality, and metadata management. The architecture provides immediate benefits to participating partners via a clinical decision support tool and data querying functionality to support local quality improvement efforts. The FInDiT tool catalogues type, quantity, and quality of the data that are available across the LC Data QUEST data sharing architecture. These tools facilitate the bi-directional process of translational research.

LC Data QUEST: A Technical Architecture for Community Federated Clinical Data Sharing

PubMed Central

Stephens, Kari A.; Lin, Ching-Ping; Baldwin, Laura-Mae; Echo-Hawk, Abigail; Keppel, Gina A.; Buchwald, Dedra; Whitener, Ron J.; Korngiebel, Diane M.; Berg, Alfred O.; Black, Robert A.; Tarczy-Hornoch, Peter

2012-01-01

The University of Washington Institute of Translational Health Sciences is engaged in a project, LC Data QUEST, building data sharing capacity in primary care practices serving rural and tribal populations in the Washington, Wyoming, Alaska, Montana, Idaho region to build research infrastructure. We report on the iterative process of developing the technical architecture for semantically aligning electronic health data in primary care settings across our pilot sites and tools that will facilitate linkages between the research and practice communities. Our architecture emphasizes sustainable technical solutions for addressing data extraction, alignment, quality, and metadata management. The architecture provides immediate benefits to participating partners via a clinical decision support tool and data querying functionality to support local quality improvement efforts. The FInDiT tool catalogues type, quantity, and quality of the data that are available across the LC Data QUEST data sharing architecture. These tools facilitate the bi-directional process of translational research. PMID:22779052

Building research infrastructure in community health centers: a Community Health Applied Research Network (CHARN) report.

PubMed

Likumahuwa, Sonja; Song, Hui; Singal, Robbie; Weir, Rosy Chang; Crane, Heidi; Muench, John; Sim, Shao-Chee; DeVoe, Jennifer E

2013-01-01

This article introduces the Community Health Applied Research Network (CHARN), a practice-based research network of community health centers (CHCs). Established by the Health Resources and Services Administration in 2010, CHARN is a network of 4 community research nodes, each with multiple affiliated CHCs and an academic center. The four nodes (18 individual CHCs and 4 academic partners in 9 states) are supported by a data coordinating center. Here we provide case studies detailing how CHARN is building research infrastructure and capacity in CHCs, with a particular focus on how community practice-academic partnerships were facilitated by the CHARN structure. The examples provided by the CHARN nodes include many of the building blocks of research capacity: communication capacity and "matchmaking" between providers and researchers; technology transfer; research methods tailored to community practice settings; and community institutional review board infrastructure to enable community oversight. We draw lessons learned from these case studies that we hope will serve as examples for other networks, with special relevance for community-based networks seeking to build research infrastructure in primary care settings.

Building Research Infrastructure in Community Health Centers: A Community Health Applied Research Network (CHARN) Report

PubMed Central

Likumahuwa, Sonja; Song, Hui; Singal, Robbie; Weir, Rosy Chang; Crane, Heidi; Muench, John; Sim, Shao-Chee; DeVoe, Jennifer E.

2015-01-01

This article introduces the Community Health Applied Research Network (CHARN), a practice-based research network of community health centers (CHCs). Established by the Health Resources and Services Administration in 2010, CHARN is a network of 4 community research nodes, each with multiple affiliated CHCs and an academic center. The four nodes (18 individual CHCs and 4 academic partners in 9 states) are supported by a data coordinating center. Here we provide case studies detailing how CHARN is building research infrastructure and capacity in CHCs, with a particular focus on how community practice-academic partnerships were facilitated by the CHARN structure. The examples provided by the CHARN nodes include many of the building blocks of research capacity: communication capacity and “matchmaking” between providers and researchers; technology transfer; research methods tailored to community practice settings; and community institutional review board infrastructure to enable community oversight. We draw lessons learned from these case studies that we hope will serve as examples for other networks, with special relevance for community-based networks seeking to build research infrastructure in primary care settings. PMID:24004710

Cancer Treatment–Related Cardiotoxicity: Current State of Knowledge and Future Research Priorities

PubMed Central

Adhikari, Bishow; Brell, Joanna; Davis, Myrtle; Desvigne-Nickens, Patrice; Freedman, Andrew; Minasian, Lori; Force, Thomas; Remick, Scot C.

2014-01-01

Cardiotoxicity resulting from direct myocyte damage has been a known complication of cancer treatment for decades. More recently, the emergence of hypertension as a clinically significant side effect of several new agents has been recognized as adversely affecting cancer treatment outcomes. With cancer patients living longer, in part because of treatment advances, these adverse events have become increasingly important to address. However, little is known about the cardiovascular pathogenic mechanisms associated with cancer treatment and even less about how to optimally prevent and manage short- and long-term cardiovascular complications, leading to improved patient safety and clinical outcomes. To identify research priorities, allocate resources, and establish infrastructure required to address cardiotoxicity associated with cancer treatment, the National Cancer Institute (NCI) and National Heart, Lung and Blood Institute (NHLBI) sponsored a two-day workshop, “Cancer treatment–related cardiotoxicity: Understanding the current state of knowledge and future research priorities,” in March 2013 in Bethesda, MD. Participants included leading oncology and cardiology researchers and health professionals, patient advocates and industry representatives, with expertise ranging from basic to clinical science. Attendees were charged with identifying research opportunities to advance the understanding of cancer treatment–related cardiotoxicity across basic and clinical science. This commentary highlights the key discussion points and overarching recommendations from that workshop. PMID:25210198

Transit vehicle-to-infrastructure (V2I) applications : near term research and development : transit traveler information infrastructure mobility application : operational concept.

DOT National Transportation Integrated Search

2015-06-01

This document serves as an Operational Concept for the Transit Traveler Information Infrastructure Mobility Application. The purpose of this document is to provide an operational description of how the Transit Traveler Information Infrastructur...

Storing and using health data in a virtual private cloud.

PubMed

Regola, Nathan; Chawla, Nitesh V

2013-03-13

Electronic health records are being adopted at a rapid rate due to increased funding from the US federal government. Health data provide the opportunity to identify possible improvements in health care delivery by applying data mining and statistical methods to the data and will also enable a wide variety of new applications that will be meaningful to patients and medical professionals. Researchers are often granted access to health care data to assist in the data mining process, but HIPAA regulations mandate comprehensive safeguards to protect the data. Often universities (and presumably other research organizations) have an enterprise information technology infrastructure and a research infrastructure. Unfortunately, both of these infrastructures are generally not appropriate for sensitive research data such as HIPAA, as they require special accommodations on the part of the enterprise information technology (or increased security on the part of the research computing environment). Cloud computing, which is a concept that allows organizations to build complex infrastructures on leased resources, is rapidly evolving to the point that it is possible to build sophisticated network architectures with advanced security capabilities. We present a prototype infrastructure in Amazon's Virtual Private Cloud to allow researchers and practitioners to utilize the data in a HIPAA-compliant environment.

GREEN INFRASTRUCTURE RESEARCH PROGRAM: Rain Gardens

EPA Science Inventory

the National Risk Management Research Laboratory (NRMRL) rain garden evaluation is part of a larger collection of long-term research that evaluates a variety of stormwater management practices. The U.S. EPA recognizes the potential of rain gardens as a green infrastructure manag...

White Paper on Condition Assessment of Wastewater Collection Systems

EPA Science Inventory

The Office of Research and Development’s National Risk Management Research Laboratory has published this report in support of the Aging Water Infrastructure (AWI) Research Program, which directly supports the Office of Water’s Sustainable Water Infrastructure Initiative. Scienti...

Proceedings of the Inaugural Pediatric Dermatology Research Alliance (PeDRA) Conference

PubMed Central

Siegel, Dawn H.; Choate, Keith; Drolet, Beth A.; Frieden, Ilona J.; Teng, Joyce M.; Tom, Wynnis; Williams, Mary; Eichenfield, Lawrence F.; Paller, Amy S.

2014-01-01

Abstract/Statement of the problem Skin disease research involving children currently faces several major hurdles and as a result, many therapies are only available for off-label use in children and many of the most pressing clinical needs of our pediatric population remain unsolved. A strategic planning committee of the Society for Pediatric Dermatology (SPD) identified the need for an organized, inclusive research alliance to augment the resources of individual practitioners and pre-existing smaller collaborative groups and facilitate robust, multicenter basic, translational, and clinical research and therapeutic trials. A December 2011 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Roundtable on Pediatric Dermatology further detailed the therapeutic gaps and barriers to translation of scientific advances to clinical practice. Building on these forums, in July 2012, a group of interested investigators met in Monterey, CA to develop the infrastructure for collaborative pediatric skin research, now called the Pediatric Dermatology Research Alliance (PeDRA). The vision of PeDRA is to create sustainable collaborative research networks to better understand, prevent, treat and cure dermatologic diseases in children. From that starting point, subcommittees and expert members were added, stakeholders identified, and seed funding garnered, with the first PeDRA stand-alone research meeting* realized in Chicago, IL in October 2013. PMID:25318428

The ELIXIR channel in F1000Research.

PubMed

Blomberg, Niklas; Oliveira, Arlindo; Mons, Barend; Persson, Bengt; Jonassen, Inge

2015-01-01

ELIXIR, the European life science infrastructure for biological information, is a unique initiative to consolidate Europe's national centres, services, and core bioinformatics resources into a single, coordinated infrastructure. ELIXIR brings together Europe's major life-science data archives and connects these with national bioinformatics infrastructures  - the ELIXIR Nodes. This editorial introduces the ELIXIR channel in F1000Research; the aim of the channel is to collect and present ELIXIR's scientific and operational output, engage with the broad life science community and encourage discussion on proposed infrastructure solutions. Submissions will be assessed by the ELIXIR channel Advisory Board to ensure they are relevant to ELIXIR community, and subjected to F1000Research open peer review process.

The ELIXIR channel in F1000Research

PubMed Central

Blomberg, Niklas; Oliveira, Arlindo; Mons, Barend; Persson, Bengt; Jonassen, Inge

2016-01-01

ELIXIR, the European life science infrastructure for biological information, is a unique initiative to consolidate Europe’s national centres, services, and core bioinformatics resources into a single, coordinated infrastructure. ELIXIR brings together Europe’s major life-science data archives and connects these with national bioinformatics infrastructures  - the ELIXIR Nodes. This editorial introduces the ELIXIR channel in F1000Research; the aim of the channel is to collect and present ELIXIR’s scientific and operational output, engage with the broad life science community and encourage discussion on proposed infrastructure solutions. Submissions will be assessed by the ELIXIR channel Advisory Board to ensure they are relevant to ELIXIR community, and subjected to F1000Research open peer review process. PMID:26913192

Personalized health care and health information technology policy: an exploratory analysis.

PubMed

Wald, Jonathan S; Shapiro, Michael

2013-01-01

Personalized healthcare (PHC) is envisioned to enhance clinical practice decision-making using new genome-driven knowledge that tailors diagnosis, treatment, and prevention to the individual patient. In 2012, we conducted a focused environmental scan and informal interviews with fifteen experts to anticipate how PHC might impact health Information Technology (IT) policy in the United States. Findings indicatedthat PHC has a variable impact on current clinical practice, creates complex questions for providers, patients, and policy-makers, and will require a robust health IT infrastructure with advanced data architecture, clinical decision support, provider workflow tools, and re-use of clinical data for research. A number of health IT challenge areas were identified, along with five policy areas including: interoperable clinical decision support, standards for patient values and preferences, patient engagement, data transparency, and robust privacy and security.

Research training of Developmental-Behavioral Pediatrics fellows: a survey of fellowship directors by Developmental-Behavioral Pediatrics Research Network.

PubMed

Wiley, Susan; Schonfeld, David J; Fredstrom, Bridget; Huffman, Lynne

2013-01-01

To describe research training in Developmental-Behavioral Pediatrics (DBP) Fellowship Programs. Thirty-five US-accredited DBP fellowships were contacted through the Developmental-Behavioral Pediatrics Research Network to complete an online survey on scholarly work and research training. With an 83% response rate, responding programs represented 110 (87 filled) fellowship positions. External funding for fellowship positions was minimal (11 positions fully funded, 13 funded above 50% of cost). Structured research training included didactic lectures, web-based training, university courses, direct mentoring, journal clubs, and required reading. Of the 159 fellows described, spanning a 5-year training period, the majority chose projects relying on their own data collection (57%) rather than joining an existing research study and focused on clinical research (86%). Among 96 fellows with completed scholarly work, 29% were observational/epidemiological studies, 22% secondary analyses of large data sets, 16% community-based research, and 15% survey design. A limited number of fellows pursued basic science, meta-analysis/critical appraisal of the literature, or analysis of public policy. Barriers to successful fellow research are as follows: lack of time and money, challenges in balancing clinical demands and protected faculty research time, limited faculty research opportunities, time or expertise, and a lack of infrastructure for fellow research mentoring. The scholarly work of fellows in DBP fellowship programs has primarily focused on clinical research using observational/epidemiological research and secondary analysis of large data set. Barriers largely in faculty time and expertise for research mentoring and inadequate funding in programs that have high clinical demands and little resources for research efforts were noted.

INNOVATION AND RESEARCH FOR WATER INFRASTRUCTURE FOR THE 21ST CENTURY RESEARCH PLAN

EPA Science Inventory

This plan has been developed to provide the Office of Research and Development (ORD) with a guide for implementing a research program that addresses high priority needs of the Nation relating to its drinking water and wastewater infrastructure. By identifying these critical need...

Recruitment and retention strategies in longitudinal clinical studies with low-income populations.

PubMed

Nicholson, Lisa M; Schwirian, Patricia M; Klein, Elizabeth G; Skybo, Theresa; Murray-Johnson, Lisa; Eneli, Ihuoma; Boettner, Bethany; French, Gina M; Groner, Judith A

2011-05-01

Conducting longitudinal research studies with low-income and/or minority participants present a unique set of challenges and opportunities. To outline the specific strategies employed to successfully recruit and retain participants in a longitudinal study of nutritional anticipatory guidance during early childhood, conducted with a low-income, ethnically diverse, urban population of mothers. We describe recruitment and retention efforts made by the research team for the 'MOMS' Study (Making Our Mealtimes Special). The 'multilayered' approach for recruitment and retention included commitment of research leadership, piloting procedures, frequent team reporting, emphasis on participant convenience, incentives, frequent contact with participants, expanded budget, clinical staff buy-in, a dedicated phone line, and the use of research project branding and logos. Barriers to enrollment were not encountered in this project, despite recruiting from a low-income population with a large proportion of African-American families. Process evaluation with clinic staff demonstrated the perception of the MOMS staff was very positive. Participant retention rate was 75% and 64% at 6 months and 12 months post-recruitment, respectively. We attribute retention success largely to a coordinated effort between the research team and the infrastructure support at the clinical sites, as well as project branding and a dedicated phone line. Successful participant recruitment and retention approaches need to be specific and consistent with clinical staff buy in throughout the project. Published by Elsevier Inc.

Strengthening the Career Development of Clinical Translational Scientist Trainees: A Consensus Statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees

PubMed Central

Meyers, Frederick J.; Begg, Melissa D.; Fleming, Michael; Merchant, Carol

2012-01-01

Abstract  The challenges for scholars committed to successful careers in clinical and translational science are increasingly well recognized. The Education and Career Development (EdCD) of the national Clinical and Translational Science Award consortium gathered thought leaders to propose sustainable solutions and an agenda for future studies that would strengthen the infrastructure across the spectrum of pre‐ and postdoctoral, MD and PhD, scholars. Six consensus statements were prepared that include: (1) the requirement for career development of a qualitatively different investigator; (2) the implications of interdisciplinary science for career advancement including institutional promotion and tenure actions that were developed for discipline‐specific accomplishments; (3) the need for long‐term commitment of institutions to scholars; (4) discipline‐specific curricula are still required but curricula designed to promote team work and interdisciplinary training will promote innovation; (5) PhD trainees have many pathways to career satisfaction and success; and (6) a centralized infrastructure to enhance and reward mentoring is required. Several themes cut across all of the recommendations including team science, innovation, and sustained institutional commitment. Implied themes include an effective and diverse job force and the requirement for a well‐crafted public policy that supports continued investments in science education. Clin Trans Sci 2012; Volume #: 1–6 PMID:22507118

Spatial aspects of the research on tourist infrastructure with the use of the cartographic method on the basis of Roztoczański National Park

NASA Astrophysics Data System (ADS)

Kałamucki, Krzysztof; Kamińska, Anna; Buk, Dorota

2012-01-01

The aim of the research was to demonstrate changes in tourist trails and in the distribution of tourist infrastructure spots in the area of Roztoczański National Park in its vicinity. Another, equally important aim, was to check the usefulness of tourist infrastructure in both cartographic method of infrastructure research and in cartography of presentation methods. The research covered the region of Roztoczański National Park. The following elements of tourist infrastructure were selected for the analysis: linear elements (walking trails, education paths) and spot elements (accommodation, eating places and the accompanied basis). In order to recreate the state of infrastructure during the last 50 years, it was necessary to analyse the following source material: tourist maps issued as independent publications, maps issued as supplements to tour guides and aerial photography. The information from text sources was used, e.g. from tourist guides, leaflets and monographs. The temporal framework was defined as 50 years from the 1960's until 2009. This time range was divided into five 10-year periods. In order to present the state of tourist infrastructure, its spatial and qualitative changes, 6 maps were produces (maps of states and types of changes). The conducted spatial analyses and the interpretations of maps of states and changes in tourist infrastructure allowed to capture both qualitative and quantitative changes. It was stated that the changes in the trails were not regular. There were parts of trails that did not change for 40 years. There were also some that were constructed during the last decade. Presently, the area is densely covered with tourist trails and education paths. The measurements of lengths of tourist trails and their parts with regard to land cover and category of roads allowed to determine the character of trails and the scope of changes. The conducted analyses proved the usefulness of cartographic methods in researching tourist infrastructure in spatial and quantitative aspects.

Managing the interface between medical schools, hospitals, and clinical research.

PubMed

Gallin, J I; Smits, H L

1997-02-26

To review how academic health centers are coping with the changing environment of health care delivery with special emphasis on the impact of the changing health care system on clinical research. In response to Health and Human Services Secretary Donna Shalala's 1995 mandated review of the National Institutes of Health (NIH) Warren Grant Magnuson Clinical Center, an NIH review team visited 30 health facilities and government-owned organizations throughout the country. The review team determined what strategies are used by academic health centers to survive and thrive in the changing health care marketplace. The findings have implications for the NIH Clinical Center as well as academic health centers. Management strategies in successful academic health centers include streamlined governance structures whereby small groups of highly empowered group leaders allow institutions to move quickly and decisively; an active strategic planning process; close integration of hospital and medical school management; heavy investment in information systems; and new structures for patient care delivery. Successful centers are initiating discussions with third-party payers and are implementing new initiatives, such as establishing their own managed care organizations, purchasing physician practices, or owning hospitals. Other approaches include establishing revenue-generating centers for clinical research and new relations with industry. Attention to the infrastructure required to support the training and conduct of clinical research is essential for the future vitality of medical schools.

International Symposium on Grids and Clouds (ISGC) 2016

NASA Astrophysics Data System (ADS)

The International Symposium on Grids and Clouds (ISGC) 2016 will be held at Academia Sinica in Taipei, Taiwan from 13-18 March 2016, with co-located events and workshops. The conference is hosted by the Academia Sinica Grid Computing Centre (ASGC). The theme of ISGC 2016 focuses on“Ubiquitous e-infrastructures and Applications”. Contemporary research is impossible without a strong IT component - researchers rely on the existence of stable and widely available e-infrastructures and their higher level functions and properties. As a result of these expectations, e-Infrastructures are becoming ubiquitous, providing an environment that supports large scale collaborations that deal with global challenges as well as smaller and temporal research communities focusing on particular scientific problems. To support those diversified communities and their needs, the e-Infrastructures themselves are becoming more layered and multifaceted, supporting larger groups of applications. Following the call for the last year conference, ISGC 2016 continues its aim to bring together users and application developers with those responsible for the development and operation of multi-purpose ubiquitous e-Infrastructures. Topics of discussion include Physics (including HEP) and Engineering Applications, Biomedicine & Life Sciences Applications, Earth & Environmental Sciences & Biodiversity Applications, Humanities, Arts, and Social Sciences (HASS) Applications, Virtual Research Environment (including Middleware, tools, services, workflow, etc.), Data Management, Big Data, Networking & Security, Infrastructure & Operations, Infrastructure Clouds and Virtualisation, Interoperability, Business Models & Sustainability, Highly Distributed Computing Systems, and High Performance & Technical Computing (HPTC), etc.

Connectivity and Resilience: A Multidimensional Analysis of Infrastructure Impacts in the Southwestern Amazon

ERIC Educational Resources Information Center

Perz, Stephen G.; Shenkin, Alexander; Barnes, Grenville; Cabrera, Liliana; Carvalho, Lucas A.; Castillo, Jorge

2012-01-01

Infrastructure is a worldwide policy priority for national development via regional integration into the global economy. However, economic, ecological and social research draws contrasting conclusions about the consequences of infrastructure. We present a synthetic approach to the study of infrastructure, focusing on a multidimensional treatment…

Basic science faculty in surgical departments: advantages, disadvantages and opportunities.

PubMed

Chinoy, Mala R; Moskowitz, Jay; Wilmore, Douglas W; Souba, Wiley W

2005-01-01

The number of Ph.D. faculty in clinical departments now exceeds the number of Ph.D. faculty in basic science departments. Given the escalating pressures on academic surgeons to produce in the clinical arena, the recruitment and retention of high-quality Ph.D.s will become critical to the success of an academic surgical department. This success will be as dependent on the surgical faculty understanding the importance of the partnership as the success of the Ph.D. investigator. Tighter alignment among the various clinical and research programs and between surgeons and basic scientists will facilitate the generation of new knowledge that can be translated into useful products and services (thus improving care). To capitalize on what Ph.D.s bring to the table, surgery departments may need to establish a more formal research infrastructure that encourages the ongoing exchange of ideas and resources. Physically removing barriers between the research groups, encouraging the open exchange of techniques and observations and sharing core laboratories is characteristic of successful research teams. These strategies can meaningfully contribute to developing successful training program grants, program projects and bringing greater research recognition to the department of surgery.

Benefits and costs of integrating technology into undergraduate nursing programs.

PubMed

Glasgow, Mary Ellen Smith; Cornelius, Frances H

2005-01-01

Advances in technology over the last decade have resulted in increased opportunities for educators to become more innovative in classroom and clinical teaching. These innovations have allowed students and faculty to access essential clinical information at the point of care/need. By capitalizing on technologies such as personal digital assistants and course delivery shells, faculty and students have both portable and remote access to information that can guide practice and learning activities in clinical, classroom, and distance settings. For instance, a student can use a personal digital assistant to research a patient's new medication at the bedside, study course information, access references during class in response to a question, or download clinical materials from home. Although the benefits of having ready access to information seem obvious, there are costs and strategic planning activities associated with implementing these projects. Clearly, the objective of any academic nursing program is to develop skills among students so they can efficiently access information and use that information to guide their nursing practice. To do so, academic nursing administrators must have the forethought to envision how new technologies can support achieving this goal as well as the ability to put in place the infrastructure supports needed for success. This article presents a case study of how one institution developed the necessary infrastructure and garnished the appropriate resources to implement an ambitious technology initiative integrated throughout a large undergraduate nursing program. In addition, how the integration of technology, online and mobile, can enhance clinical learning will be discussed.

Women in EPOS: the role of women in a large pan-European Research Infrastructure for Solid Earth sciences

NASA Astrophysics Data System (ADS)

Calignano, Elisa; Freda, Carmela; Baracchi, Laura

2017-04-01

Women are outnumbered by men in geosciences senior research positions, but what is the situation if we consider large pan-European Research Infrastructures? With this contribution we want to show an analysis of the role of women in the implementation of the European Plate Observing System (EPOS): a planned research infrastructure for European Solid Earth sciences, integrating national and transnational research infrastructures to enable innovative multidisciplinary research. EPOS involves 256 national research infrastructures, 47 partners (universities and research institutes) from 25 European countries and 4 international organizations. The EPOS integrated platform demands significant coordination between diverse solid Earth disciplinary communities, national research infrastructures and the policies and initiatives they drive, geoscientists and information technologists. The EPOS architecture takes into account governance, legal, financial and technical issues and is designed so that the enterprise works as a single, but distributed, sustainable research infrastructure. A solid management structure is vital for the successful implementation and sustainability of EPOS. The internal organization relies on community-specific Working Packages (WPs), Transversal WPs in charge of the overall EPOS integration and implementation, several governing, executive and advisory bodies, a Project Management Office (PMO) and the Project Coordinator. Driven by the timely debate on gender balance and commitment of the European Commission to promote gender equality in research and innovation, we decided to conduct a mapping exercise on a project that crosses European national borders and that brings together diverse geoscience disciplines under one management structure. We present an analysis of women representation in decision-making positions in each EPOS Working Package (WP Leader, proxy, legal, financial and IT contact persons), in the Boards and Councils and in the PMO, together with statistics on women participation based on the project intranet, which counts more than 500 users. The analysis allows us not only to assess the gender balance in decision-making positions in a pan-European research infrastructure, but also to investigate how women's participation varies with different aspects of the project implementation (management, coordination, legal, financial or technical). Most of the women in EPOS are active geoscientists (academic or in national research institutes), or have a scientific background. By interviewing some of them we report also on how being involved in the project affects their careers. We believe this kind of analysis is an important starting point to promote awareness and achieve gender equality in research and innovation.

Monitoring and Benchmarking eHealth in the Nordic Countries.

PubMed

Nøhr, Christian; Koch, Sabine; Vimarlund, Vivian; Gilstad, Heidi; Faxvaag, Arild; Hardardottir, Gudrun Audur; Andreassen, Hege K; Kangas, Maarit; Reponen, Jarmo; Bertelsen, Pernille; Villumsen, Sidsel; Hyppönen, Hannele

2018-01-01

The Nordic eHealth Research Network, a subgroup of the Nordic Council of Ministers eHealth group, is working on developing indicators to monitor progress in availability, use and outcome of eHealth applications in the Nordic countries. This paper reports on the consecutive analysis of National eHealth policies in the Nordic countries from 2012 to 2016. Furthermore, it discusses the consequences for the development of indicators that can measure changes in the eHealth environment arising from the policies. The main change in policies is reflected in a shift towards more stakeholder involvement and intensified focus on clinical infrastructure. This change suggests developing indicators that can monitor understandability and usability of eHealth systems, and the use and utility of shared information infrastructure from the perspective of the end-users - citizens/patients and clinicians in particular.

Critical Infrastructure Protection II, The International Federation for Information Processing, Volume 290.

NASA Astrophysics Data System (ADS)

Papa, Mauricio; Shenoi, Sujeet

The information infrastructure -- comprising computers, embedded devices, networks and software systems -- is vital to day-to-day operations in every sector: information and telecommunications, banking and finance, energy, chemicals and hazardous materials, agriculture, food, water, public health, emergency services, transportation, postal and shipping, government and defense. Global business and industry, governments, indeed society itself, cannot function effectively if major components of the critical information infrastructure are degraded, disabled or destroyed. Critical Infrastructure Protection II describes original research results and innovative applications in the interdisciplinary field of critical infrastructure protection. Also, it highlights the importance of weaving science, technology and policy in crafting sophisticated, yet practical, solutions that will help secure information, computer and network assets in the various critical infrastructure sectors. Areas of coverage include: - Themes and Issues - Infrastructure Security - Control Systems Security - Security Strategies - Infrastructure Interdependencies - Infrastructure Modeling and Simulation This book is the second volume in the annual series produced by the International Federation for Information Processing (IFIP) Working Group 11.10 on Critical Infrastructure Protection, an international community of scientists, engineers, practitioners and policy makers dedicated to advancing research, development and implementation efforts focused on infrastructure protection. The book contains a selection of twenty edited papers from the Second Annual IFIP WG 11.10 International Conference on Critical Infrastructure Protection held at George Mason University, Arlington, Virginia, USA in the spring of 2008.

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project.

PubMed

Mosconi, Paola; Antes, Gerd; Barbareschi, Giorgio; Burls, Amanda; Demotes-Mainard, Jacques; Chalmers, Iain; Colombo, Cinzia; Garattini, Silvio; Gluud, Christian; Gyte, Gill; Mcllwain, Catherine; Penfold, Matt; Post, Nils; Satolli, Roberto; Valetto, Maria Rosa; West, Brian; Wolff, Stephanie

2016-01-12

The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe. Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence. The principal communication materials developed were: 1. A website ( http://ecranproject.eu ) in six languages, including a Media centre section to help journalists to disseminate information about the ECRAN project 2. An animated film about clinical trials, dubbed in the 23 official languages of the European Community, and an interactive tutorial 3. An inventory of resources, available in 23 languages, searchable by topic, author, and media type 4. Two educational games for young people, developed in six languages 5. Testing Treatments interactive in a dozen languages, including five official European Community languages 6. An interactive tutorial slide presentation testing viewers' knowledge about clinical trials Over a 2-year project, our multidisciplinary and multinational consortium was able to produce, and make freely available in many languages, new materials to promote public knowledge about the importance of independent and international clinical trials. Sustained funding for the ECRAN information platform could help to promote successful recruitment to independent clinical trials supported through the European Clinical Research Infrastructure Network.

Biobanking for Personalized Medicine.

PubMed

Liu, Angen; Pollard, Kai

2015-01-01

A biobank is an entity that collects, processes, stores, and distributes biospecimens and relevant data for use in basic, translational, and clinical research. Biobanking of high-quality human biospecimens such as tissue, blood and other bodily fluids along with associated patient clinical information provides a fundamental scientific infrastructure for personalized medicine. Identification of biomarkers that are specifically associated with particular medical conditions such as cancer, cardiovascular disease and neurological disorders are useful for early detection, prevention, and treatment of the diseases. The ability to determine individual tumor biomarkers and to use those biomarkers for disease diagnosis, prognosis and prediction of response to therapy is having a very significant impact on personalized medicine and is rapidly changing the way clinical care is conducted. As a critical requirement for personalized medicine is the availability of a large collection of patient samples with well annotated patient clinical and pathological data, biobanks thus play an important role in personalized medicine advancement. The goal of this chapter is to explore the role of biobanks in personalized medicine and discuss specific needs regarding biobank development for translational and clinical research, especially for personalized medicine advancement.

Public support for medical research in the 21st century.

PubMed

Smith, P M

2000-01-01

Key public policies that have contributed to the rise of modern medical research in the 20th Century are reviewed, focusing especially on the United States and the post-World War II period. Drawing on this history, the question is posed: "Are these policies sufficient to insure vigorous medical research in the 21st Century?" Although radical policy changes are not needed, several proposals for policy and medical research portfolio redirection are offered, including a rebalancing of public supported research in all fields of science that contribute to medical advances. Medical research must also invest in a national and international information infrastructure that will allow the linking of researchers, clinical experimenters, practicing physicians, and the public in ways heretofore not imagined. Medical researchers must be leaders and advocates for the whole research enterprise in the 21st Century.

Optimal infrastructure maintenance scheduling problem under budget uncertainty.

DOT National Transportation Integrated Search

2010-05-01

This research addresses a general class of infrastructure asset management problems. Infrastructure : agencies usually face budget uncertainties that will eventually lead to suboptimal planning if : maintenance decisions are made without taking the u...

EPA NRMRL green Infrastructure research

EPA Science Inventory

Green Infrastructure is an engineering approach to wet weather flow management that uses infiltration, evapotranspiration, capture and reuse to better mimic the natural drainage processes than traditional gray systems. Green technologies supplement gray infrastructure to red...

Aging Water Infrastructure

EPA Science Inventory

The Aging Water Infrastructure (AWI) research program is part of EPA’s larger effort called the Sustainable Water Infrastructure (SI) initiative. The SI initiative brings together drinking water and wastewater utility managers; trade associations; local watershed protection organ...

Collaborative Development of e-Infrastructures and Data Management Practices for Global Change Research

NASA Astrophysics Data System (ADS)

Samors, R. J.; Allison, M. L.

2016-12-01

An e-infrastructure that supports data-intensive, multidisciplinary research is being organized under the auspices of the Belmont Forum consortium of national science funding agencies to accelerate the pace of science to address 21st century global change research challenges. The pace and breadth of change in information management across the data lifecycle means that no one country or institution can unilaterally provide the leadership and resources required to use data and information effectively, or needed to support a coordinated, global e-infrastructure. The five action themes adopted by the Belmont Forum: 1. Adopt and make enforceable Data Principles that establish a global, interoperable e-infrastructure. 2. Foster communication, collaboration and coordination between the wider research community and Belmont Forum and its projects through an e-Infrastructure Coordination, Communication, & Collaboration Office. 3. Promote effective data planning and stewardship in all Belmont Forum agency-funded research with a goal to make it enforceable. 4. Determine international and community best practice to inform Belmont Forum research e-infrastructure policy through identification and analysis of cross-disciplinary research case studies. 5. Support the development of a cross-disciplinary training curriculum to expand human capacity in technology and data-intensive analysis methods. The Belmont Forum is ideally poised to play a vital and transformative leadership role in establishing a sustained human and technical international data e-infrastructure to support global change research. In 2016, members of the 23-nation Belmont Forum began a collaborative implementation phase. Four multi-national teams are undertaking Action Themes based on the recommendations above. Tasks include mapping the landscape, identifying and documenting existing data management plans, and scheduling a series of workshops that analyse trans-disciplinary applications of existing Belmont Forum projects to identify best practices and critical gaps that may be uniquely or best addressed by the Belmont Forum funding model. Concurrent work will define challenges in conducting international and interdisciplinary data management implementation plans and identify sources of relevant expertise and knowledge.

International Development of e-Infrastructures and Data Management Priorities for Global Change Research

NASA Astrophysics Data System (ADS)

Allison, M. L.; Gurney, R. J.

2015-12-01

An e-infrastructure that supports data-intensive, multidisciplinary research is needed to accelerate the pace of science to address 21st century global change challenges. Data discovery, access, sharing and interoperability collectively form core elements of an emerging shared vision of e-infrastructure for scientific discovery. The pace and breadth of change in information management across the data lifecycle means that no one country or institution can unilaterally provide the leadership and resources required to use data and information effectively, or needed to support a coordinated, global e-infrastructure. An 18-month long process involving ~120 experts in domain, computer, and social sciences from more than a dozen countries resulted in a formal set of recommendations to the Belmont Forum collaboration of national science funding agencies and others on what they are best suited to implement for development of an e-infrastructure in support of global change research, including: adoption of data principles that promote a global, interoperable e-infrastructure establishment of information and data officers for coordination of global data management and e-infrastructure efforts promotion of effective data planning determination of best practices development of a cross-disciplinary training curriculum on data management and curation The Belmont Forum is ideally poised to play a vital and transformative leadership role in establishing a sustained human and technical international data e-infrastructure to support global change research. The international collaborative process that went into forming these recommendations is contributing to national governments and funding agencies and international bodies working together to execute them.

Comparisons among Health Behavior Surveys: Implications for the Design of Informatics Infrastructures That Support Comparative Effectiveness Research.

PubMed

Yoon, Sunmoo; Wilcox, Adam B; Bakken, Suzanne

2013-01-01

To address the electronic health data fragmentation that is a methodological limitation of comparative effectiveness research (CER), the Washington Heights Inwood Informatics Infrastructure for Comparative Effectiveness Research (WICER) project is creating a patient-centered research data warehouse (RDW) by linking electronic clinical data (ECD) from New York Presbyterian Hospital's clinical data warehouse with ECD from ambulatory care, long-term care, and home health settings and the WICER community health survey (CHS). The purposes of the research were to identify areas of overlap between the WICER CHS and two other surveys that include health behavior data (the Behavioral Risk Factor Surveillance System (BRFSS) Survey and the New York City Community Health Survey (NYC CHS)) and to identify gaps in the current WICER RDW that have the potential to affect patient-centered CER. We compared items across the three surveys at the item and conceptual levels. We also compared WICER RDW (ECD and WICER CHS), BRFSS, and NYC CHS to the County Health Ranking framework. We found that 22 percent of WICER items were exact matches with BRFSS and that there were no exact matches between WICER CHS and NYC CHS items not also contained in BRFSS. The results suggest that BRFSS and, to a lesser extent, NYC CHS have the potential to serve as population comparisons for WICER CHS for some health behavior-related data and thus may be particularly useful for considering the generalizability of CER study findings. Except for one measure related to health behavior (motor vehicle crash deaths), the WICER RDW's comprehensive coverage supports the mortality, morbidity, and clinical care measures specified in the County Health Ranking framework but is deficient in terms of some socioeconomic factors and descriptions of the physical environment as captured in BRFSS. Linkage of these data in the WICER RDW through geocoding can potentially facilitate patient-centered CER that integrates important socioeconomic and physical environment influences on health outcomes. The research methods and findings may be relevant to others interested in either integrating health behavior data into RDWs to support patient-centered CER or conducting population-level comparisons.

From a Viewpoint of Clinical Settings: Pharmacoepidemiology as Reverse Translational Research (rTR).

PubMed

Kawakami, Junichi

2017-01-01

Clinical pharmacology and pharmacoepidemiology research may converge in practise. Pharmacoepidemiology is the study of pharmacotherapy and risk management in patient groups. For many drugs, adverse reaction(s) that were not seen and/or clarified during research and development stages have been reported in the real world. Pharmacoepidemiology can detect and verify adverse drug reactions as reverse translational research. Recently, development and effective use of medical information databases (MID) have been conducted in Japan and elsewhere for the purpose of post-marketing safety of drugs. The Ministry of Health, Labour and Welfare, Japan has been promoting the development of 10-million scale database in 10 hospitals and hospital groups as "the infrastructure project of medical information database (MID-NET)". This project enables estimation of the frequency of adverse reactions, the distinction between drug-induced reactions and basal health-condition changes, and usefulness verification of administrative measures of drug safety. However, because the database information is different from detailed medical records, construction of methodologies for the detection and evaluation of adverse reactions is required. We have been performing database research using medical information system in some hospitals to establish and demonstrate useful methods for post-marketing safety. In this symposium, we aim to discuss the possibility of reverse translational research from clinical settings and provide an introduction to our research.

Managing Critical Infrastructures C.I.M. Suite

ScienceCinema

Dudenhoeffer, Donald

2018-05-23

See how a new software package developed by INL researchers could help protect infrastructure during natural disasters, terrorist attacks and electrical outages. For more information about INL research, visit http://www.facebook.com/idahonationallaboratory.

Green Infrastructure Research and Demonstration at the Edison Environmental Center

EPA Science Inventory

This presentation will review the need for storm water control practices and will present a portion of the green infrastructure research and demonstration being performed at the Edison Environmental Center.

Satellite Communications for Aeronautical Applications: Recent research and Development Results

NASA Technical Reports Server (NTRS)

Kerczewski, Robert J.

2001-01-01

Communications systems have always been a critical element in aviation. Until recently, nearly all communications between the ground and aircraft have been based on analog voice technology. But the future of global aviation requires a more sophisticated "information infrastructure" which not only provides more and better communications, but integrates the key information functions (communications, navigation, and surveillance) into a modern, network-based infrastructure. Satellite communications will play an increasing role in providing information infrastructure solutions for aviation. Developing and adapting satellite communications technologies for aviation use is now receiving increased attention as the urgency to develop information infrastructure solutions grows. The NASA Glenn Research Center is actively involved in research and development activities for aeronautical satellite communications, with a key emphasis on air traffic management communications needs. This paper describes the recent results and status of NASA Glenn's research program.

Cancer Genomics: Integrative and Scalable Solutions in R / Bioconductor | Informatics Technology for Cancer Research (ITCR)

Cancer.gov

This proposal develops scalable R / Bioconductor software infrastructure and data resources to integrate complex, heterogeneous, and large cancer genomic experiments. The falling cost of genomic assays facilitates collection of multiple data types (e.g., gene and transcript expression, structural variation, copy number, methylation, and microRNA data) from a set of clinical specimens. Furthermore, substantial resources are now available from large consortium activities like The Cancer Genome Atlas (TCGA).

Development of a bipolar disorder biobank: differential phenotyping for subsequent biomarker analyses.

PubMed

Frye, Mark A; McElroy, Susan L; Fuentes, Manuel; Sutor, Bruce; Schak, Kathryn M; Galardy, Christine W; Palmer, Brian A; Prieto, Miguel L; Kung, Simon; Sola, Christopher L; Ryu, Euijung; Veldic, Marin; Geske, Jennifer; Cuellar-Barboza, Alfredo; Seymour, Lisa R; Mori, Nicole; Crowe, Scott; Rummans, Teresa A; Biernacka, Joanna M

2015-12-01

We aimed to establish a bipolar disorder biobank to serve as a resource for clinical and biomarker studies of disease risk and treatment response. Here, we describe the aims, design, infrastructure, and research uses of the biobank, along with demographics and clinical features of the first participants enrolled. Patients were recruited for the Mayo Clinic Bipolar Biobank beginning in July 2009. The Structured Clinical Interview for DSM-IV was used to confirm bipolar diagnosis. The Bipolar Biobank Clinical Questionnaire and Participant Questionnaire were designed to collect detailed demographic and clinical data, including clinical course of illness measures that would delineate differential phenotypes for subsequent analyses. Blood specimens were obtained from participants, and various aliquots were stored for future research. As of September 2014, 1363 participants have been enrolled in the bipolar biobank. Among these first participants, 69.0 % had a diagnosis of bipolar disorder type I. The group was 60.2 % women and predominantly white (90.6 %), with a mean (SD) age of 42.6 (14.9) years. Clinical phenotypes of the group included history of psychosis (42.3 %), suicide attempt (32.5 %), addiction to alcohol (39.1 %), addiction to nicotine (39.8 %), obesity (42.9 %), antidepressant-induced mania (31.7 %), tardive dyskinesia (3.2 %), and history of drug-related serious rash (5.7 %). Quantifying phenotypic patterns of illness beyond bipolar subtype can provide more detailed clinical disease characteristics for biomarker research, including genomic-risk studies. Future research can harness clinically useful biomarkers using state-of-the-art research technology to help stage disease burden and better individualize treatment selection for patients with bipolar disorder.

An Official American Thoracic Society Workshop Report: Climate Change and Human Health

PubMed Central

Pinkerton, Kent E.; Rom, William N.; Akpinar-Elci, Muge; Balmes, John R.; Bayram, Hasan; Brandli, Otto; Hollingsworth, John W.; Kinney, Patrick L.; Margolis, Helene G.; Martin, William J.; Sasser, Erika N.; Smith, Kirk R.; Takaro, Tim K.

2012-01-01

This document presents the proceedings from the American Thoracic Society Climate Change and Respiratory Health Workshop that was held on May 15, 2010, in New Orleans, Louisiana. The purpose of the one-day meeting was to address the threat to global respiratory health posed by climate change. Domestic and international experts as well as representatives of international respiratory societies and key U.S. federal agencies convened to identify necessary research questions concerning climate change and respiratory health and appropriate mechanisms and infrastructure needs for answering these questions. After much discussion, a breakout group compiled 27 recommendations for physicians, researchers, and policy makers. These recommendations are listed under main issues that the workshop participants deemed of key importance to respiratory health. Issues include the following: (1) the health impacts of climate change, with specific focus on the effect of heat waves, air pollution, and natural cycles; (2) mitigation and adaptation measures to be taken, with special emphasis on recommendations for the clinical and research community; (3) recognition of challenges specific to low-resource countries when coping with respiratory health and climate change; and (4) priority research infrastructure needs, with special discussion of international needs for cooperating with present and future environmental monitoring and alert systems. PMID:22421581

INNOVATION AND RESEARCH FOR WATER INFRASTRUCTURE IN THE 21ST CENTURY: U.S. EPA'S RESEARCH PLAN FOR GRAVITY SEWERS

EPA Science Inventory

The U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) has long recognized the need for research and development in the area of drinking water and wastewater infrastructure. Most recently in support of the Agency’s Sustainable Water Infrastructu...

INNOVATION AND RESEARCH FOR WATER INFRASTRUCTURE IN THE 21ST CENTURY: U.S. EPA’S RESEARCH PLANS FOR GRAVITY SEWERS

EPA Science Inventory

The U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) has long recognized the need for research and development in the area of drinking water and wastewater infrastructure. Most recently in support of the Agency’s Sustainable Water ...

Implementation Practice and Implementation Research: A Report from the Field

ERIC Educational Resources Information Center

Brekke, John S.; Phillips, Elizabeth; Pancake, Laura; O, Anne; Lewis, Jenebah; Duke, Jessica

2009-01-01

The Interventions and Practice Research Infrastructure Program (IPRISP) funding mechanism was introduced by the National Institute of Mental Health (NIMH) to bridge the gap between the worlds of services research and the usual care practice in the community. The goal was to build infrastructure that would provide a platform for research to…

Accelerators for society: succession of European infrastructural projects: CARE, EuCARD, TIARA, EuCARD2

NASA Astrophysics Data System (ADS)

Romaniuk, Ryszard S.

2013-10-01

Accelerator science and technology is one of a key enablers of the developments in the particle physic, photon physics and also applications in medicine and industry. The paper presents a digest of the research results in the domain of accelerator science and technology in Europe, shown during the realization of CARE (Coordinated Accelerator R&D), EuCARD (European Coordination of Accelerator R&D) and during the national annual review meeting of the TIARA - Test Infrastructure of European Research Area in Accelerator R&D. The European projects on accelerator technology started in 2003 with CARE. TIARA is an European Collaboration of Accelerator Technology, which by running research projects, technical, networks and infrastructural has a duty to integrate the research and technical communities and infrastructures in the global scale of Europe. The Collaboration gathers all research centers with large accelerator infrastructures. Other ones, like universities, are affiliated as associate members. TIARA-PP (preparatory phase) is an European infrastructural project run by this Consortium and realized inside EU-FP7. The paper presents a general overview of CARE, EuCARD and especially TIARA activities, with an introduction containing a portrait of contemporary accelerator technology and a digest of its applications in modern society. CARE, EuCARD and TIARA activities integrated the European accelerator community in a very effective way. These projects are expected very much to be continued.

Fabricating a UV-Vis and Raman Spectroscopy Immunoassay Platform.

PubMed

Hanson, Cynthia; Israelsen, Nathan D; Sieverts, Michael; Vargis, Elizabeth

2016-11-10

Immunoassays are used to detect proteins based on the presence of associated antibodies. Because of their extensive use in research and clinical settings, a large infrastructure of immunoassay instruments and materials can be found. For example, 96- and 384-well polystyrene plates are available commercially and have a standard design to accommodate ultraviolet-visible (UV-Vis) spectroscopy machines from various manufacturers. In addition, a wide variety of immunoglobulins, detection tags, and blocking agents for customized immunoassay designs such as enzyme-linked immunosorbent assays (ELISA) are available. Despite the existing infrastructure, standard ELISA kits do not meet all research needs, requiring individualized immunoassay development, which can be expensive and time-consuming. For example, ELISA kits have low multiplexing (detection of more than one analyte at a time) capabilities as they usually depend on fluorescence or colorimetric methods for detection. Colorimetric and fluorescent-based analyses have limited multiplexing capabilities due to broad spectral peaks. In contrast, Raman spectroscopy-based methods have a much greater capability for multiplexing due to narrow emission peaks. Another advantage of Raman spectroscopy is that Raman reporters experience significantly less photobleaching than fluorescent tags 1 . Despite the advantages that Raman reporters have over fluorescent and colorimetric tags, protocols to fabricate Raman-based immunoassays are limited. The purpose of this paper is to provide a protocol to prepare functionalized probes to use in conjunction with polystyrene plates for direct detection of analytes by UV-Vis analysis and Raman spectroscopy. This protocol will allow researchers to take a do-it-yourself approach for future multi-analyte detection while capitalizing on pre-established infrastructure.

National Study of Nursing Research Characteristics at Magnet®-Designated Hospitals.

PubMed

Pintz, Christine; Zhou, Qiuping Pearl; McLaughlin, Maureen Kirkpatrick; Kelly, Katherine Patterson; Guzzetta, Cathie E

2018-05-01

To describe the research infrastructure, culture, and characteristics of building a nursing research program in Magnet®-designated hospitals. Magnet recognition requires hospitals to conduct research and implement evidence-based practice (EBP). Yet, the essential characteristics of productive nursing research programs are not well described. We surveyed 181 nursing research leaders at Magnet-designated hospitals to assess the characteristics in their hospitals associated with research infrastructure, research culture, and building a nursing research program. Magnet hospitals provide most of the needed research infrastructure and have a culture that support nursing research. Higher scores for the 3 categories were found when hospitals had a nursing research director, a research department, and more than 10 nurse-led research studies in the past 5 years. While some respondents indicated their nurse executives and leaders support the enculturation of EBP and research, there continue to be barriers to full implementation of these characteristics in practice.

Building a personalized medicine infrastructure at a major cancer center.

PubMed

Meric-Bernstam, Funda; Farhangfar, Carol; Mendelsohn, John; Mills, Gordon B

2013-05-20

Our understanding of cancer biology is rapidly increasing, as is the availability and affordability of high throughput technologies for comprehensive molecular characterization of tumors and the individual's own genetic makeup. Thus, the time is right to implement personalized molecular medicine for all patients with cancer. Personalized approaches span the full cancer care spectrum from risk stratification to prevention, screening, therapy, and survivorship programs. Several molecular therapeutics have entered clinical trials creating a huge opportunity to couple genomic markers with this emerging drug tool kit. The number of patients managed in major cancer centers creates a challenge to the implementation of genomic technologies required to successfully deliver on the promise of personalized cancer care. This requires a major investment in infrastructure to facilitate rapid deployment of multiplex, cost-effective, and tissue-sparing assays relevant across multiple tumor lineages in the Clinical Laboratory Improvement Amendments (CLIA) environment. Efforts must be made to ensure that assays are accessible to patients most likely to be enrolled onto molecular-marker-driven trials and that the tests are billable and payable, which will make them accessible to a wide range of patients. As the number of patients and aberrations increase, it will become critical to provide decision support for genomic medicine. Institutional commitment is needed to optimize accessibility and quality of research biopsies and to facilitate novel personalized cancer therapy trials. This article will focus on the challenges and opportunities that accompany the building of infrastructure for personalized cancer therapy.

Optimizing health information technology's role in enabling comparative effectiveness research.

PubMed

Navathe, Amol S; Conway, Patrick H

2010-12-01

Health information technology (IT) is a key enabler of comparative effectiveness research (CER). Health IT standards for data sharing are essential to advancing the research data infrastructure, and health IT is critical to the next step of incorporating clinical data into data sources. Four key principles for advancement of CER are (1) utilization of data as a strategic asset, (2) leveraging public-private partnerships, (3) building robust, scalable technology platforms, and (4) coordination of activities across government agencies. To maximize the value of the resources, payers and providers must contribute data to initiatives, engage with government agencies on lessons learned, continue to develop new technologies that address key challenges, and utilize the data to improve patient outcomes and conduct research.

Population as a proxy for infrastructure in the determination of event response and recovery resource allocations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stamber, Kevin L.; Unis, Carl J.; Shirah, Donald N.

Research into modeling of the quantification and prioritization of resources used in the recovery of lifeline critical infrastructure following disruptive incidents, such as hurricanes and earthquakes, has shown several factors to be important. Among these are population density and infrastructure density, event effects on infrastructure, and existence of an emergency response plan. The social sciences literature has a long history of correlating the population density and infrastructure density at a national scale, at a country-to-country level, mainly focused on transportation networks. This effort examines whether these correlations can be repeated at smaller geographic scales, for a variety of infrastructure types,more » so as to be able to use population data as a proxy for infrastructure data where infrastructure data is either incomplete or insufficiently granular. Using the best data available, this effort shows that strong correlations between infrastructure density for multiple types of infrastructure (e.g. miles of roads, hospital beds, miles of electric power transmission lines, and number of petroleum terminals) and population density do exist at known geographic boundaries (e.g. counties, service area boundaries) with exceptions that are explainable within the social sciences literature. Furthermore, the correlations identified provide a useful basis for ongoing research into the larger resource utilization problem.« less

Population as a proxy for infrastructure in the determination of event response and recovery resource allocations

DOE PAGES

Stamber, Kevin L.; Unis, Carl J.; Shirah, Donald N.; ...

2016-04-01

Research into modeling of the quantification and prioritization of resources used in the recovery of lifeline critical infrastructure following disruptive incidents, such as hurricanes and earthquakes, has shown several factors to be important. Among these are population density and infrastructure density, event effects on infrastructure, and existence of an emergency response plan. The social sciences literature has a long history of correlating the population density and infrastructure density at a national scale, at a country-to-country level, mainly focused on transportation networks. This effort examines whether these correlations can be repeated at smaller geographic scales, for a variety of infrastructure types,more » so as to be able to use population data as a proxy for infrastructure data where infrastructure data is either incomplete or insufficiently granular. Using the best data available, this effort shows that strong correlations between infrastructure density for multiple types of infrastructure (e.g. miles of roads, hospital beds, miles of electric power transmission lines, and number of petroleum terminals) and population density do exist at known geographic boundaries (e.g. counties, service area boundaries) with exceptions that are explainable within the social sciences literature. Furthermore, the correlations identified provide a useful basis for ongoing research into the larger resource utilization problem.« less

Airborne biological hazards and urban transport infrastructure: current challenges and future directions.

PubMed

Nasir, Zaheer Ahmad; Campos, Luiza Cintra; Christie, Nicola; Colbeck, Ian

2016-08-01

Exposure to airborne biological hazards in an ever expanding urban transport infrastructure and highly diverse mobile population is of growing concern, in terms of both public health and biosecurity. The existing policies and practices on design, construction and operation of these infrastructures may have severe implications for airborne disease transmission, particularly, in the event of a pandemic or intentional release of biological of agents. This paper reviews existing knowledge on airborne disease transmission in different modes of transport, highlights the factors enhancing the vulnerability of transport infrastructures to airborne disease transmission, discusses the potential protection measures and identifies the research gaps in order to build a bioresilient transport infrastructure. The unification of security and public health research, inclusion of public health security concepts at the design and planning phase, and a holistic system approach involving all the stakeholders over the life cycle of transport infrastructure hold the key to mitigate the challenges posed by biological hazards in the twenty-first century transport infrastructure.

Ensuring Support for Research and Quality Improvement (QI) Networks: Four Pillars of Sustainability—An Emerging Framework

PubMed Central

Holve, Erin

2013-01-01

Multi-institutional research and quality improvement (QI) projects using electronic clinical data (ECD) hold great promise for improving quality of care and patient outcomes but typically require significant infrastructure investments both to initiate and maintain the project over its duration. Consequently, it is important for these projects to think holistically about sustainability to ensure their long-term success. Four “pillars” of sustainability are discussed based on the experiences of EDM Forum grantees and other research and QI networks. These include trust and value, governance, management, and financial and administrative support. Two “foundational considerations,” adaptive capacity and policy levers, are also discussed. PMID:25848557

Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders.

PubMed

Kim, Katherine K; Browe, Dennis K; Logan, Holly C; Holm, Roberta; Hack, Lori; Ohno-Machado, Lucila

2014-01-01

There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

What are the priorities for future success in critical care research in the UK? Report from a national stakeholder meeting.

PubMed

Walsh, Tim; Brett, Stephen J

2015-11-01

Critical care in the United Kingdom is now well-established in terms of professional status, standards of clinical practice and training, and national audit through professional bodies and government representation. Research is fundamental to the further development and maturation of the specialty, to develop new therapies and technologies, more efficient and effective service organisation, and to improve patient and family experience and outcomes. Critical care research has expanded rapidly in the UK, and now has established organisations and infrastructure to share and develop ideas, through the UK Critical Care Research Forum and similar meetings. In September 2014, the Intensive Care Foundation and Critical Care Leadership Forum hosted a research colloquium to reflect, in part, on achievements, but more importantly plan for the future. With an invited list of participants the meeting explored firstly - the practical delivery of clinical research and secondly - the future financing landscape, from both academic funders' and commercial developers' perspectives. The following article summarises the important 'take home' messages from this meeting and suggests key issues for future strategy.

Staff Clinicians | Center for Cancer Research

Cancer.gov

The Neuro-Oncology Branch (NOB), Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH) is seeking staff clinicians to provide high-quality patient care for individuals with primary central nervous system (CNS) malignancies.  The NOB is comprised of a multidisciplinary team of physicians, healthcare providers, and scientists who are dedicated to developing new therapies and improving outcomes for patients with primary brain and spinal cord tumors. The NOB is one of the first trans-institutional initiatives at the National Institutes of Health. The Branch is focused on developing an integrated clinical, translational, and basic research program that engages the strengths and resources of the National Cancer Institutes (NCI) and the National Institutes of Neurological Disorders and Stroke (NINDS) for the purpose of developing novel experimental therapeutics for individuals with primary central nervous system (CNS) malignancies. About NCI's Center for Cancer Research The Center for Cancer Research (CCR) is the intramural research component of the National Cancer Institute (NCI).  CCR’s enabling infrastructure facilitates clinical studies at the NIH Clinical Center, the world’s largest dedicated clinical research complex; provides extensive opportunities for collaboration; and allows scientists and clinicians to undertake high-risk, high-impact laboratory- and clinic-based investigations.  Investigators are supported by a wide array of intellectual, technological, and research resources, including surgical and pathology facilities, animal facilities, and dedicated, high-quality technology cores in areas such as imaging/microscopy, chemistry/purification, mass spectrometry, flow cytometry, genomics/DNA sequencing, transgenics and knock-out mice, arrays/molecular profiling, and human genetics/bioinformatics.  For an overview of CCR, please visit http://ccr.cancer.gov/.

Nucleus: A pilot project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Finnell, Joshua Eugene; Klein, Martin; Cain, Brian J.

2017-05-09

The proposal is to provide institutional infrastructure that facilitates management of research projects, research collaboration, and management, preservation, and discovery of data. Deploying such infrastructure will amplify the effectiveness, efficiency, and impact of research, as well as assist researchers in regards to compliance with both data management mandates and LANL security policy. This will facilitate discoverability of LANL research both within the lab and external to LANL.

Risk assessment framework on time impact: Infrastructure projects in soft soil during construction stage

NASA Astrophysics Data System (ADS)

Low, W. W.; Wong, K. S.; Lee, J. L.

2018-04-01

With the growth of economy and population, there is an increase in infrastructure construction projects. As such, it is unavoidable to have construction projects on soft soil. Without proper risk management plan, construction projects are vulnerable to different types of risks which will have negative impact on project’s time, cost and quality. Literature review showed that little or none of the research is focused on the risk assessment on the infrastructure project in soft soil. Hence, the aim of this research is to propose a risk assessment framework in infrastructure projects in soft soil during the construction stage. This research was focused on the impact of risks on project time and internal risk factors. The research method was Analytical Hierarchy Process and the sample population was experienced industry experts who have experience in infrastructure projects. Analysis was completed and result showed that for internal factors, the five most significant risks on time element are lack of special equipment, potential contractual disputes and claims, shortage of skilled workers, delay/lack of materials supply, and insolvency of contractor/sub-contractor. Results indicated that resources risk factor play a critical role on project time frame in infrastructure projects in soft soil during the construction stage.

Storing and Using Health Data in a Virtual Private Cloud

PubMed Central

Regola, Nathan

2013-01-01

Electronic health records are being adopted at a rapid rate due to increased funding from the US federal government. Health data provide the opportunity to identify possible improvements in health care delivery by applying data mining and statistical methods to the data and will also enable a wide variety of new applications that will be meaningful to patients and medical professionals. Researchers are often granted access to health care data to assist in the data mining process, but HIPAA regulations mandate comprehensive safeguards to protect the data. Often universities (and presumably other research organizations) have an enterprise information technology infrastructure and a research infrastructure. Unfortunately, both of these infrastructures are generally not appropriate for sensitive research data such as HIPAA, as they require special accommodations on the part of the enterprise information technology (or increased security on the part of the research computing environment). Cloud computing, which is a concept that allows organizations to build complex infrastructures on leased resources, is rapidly evolving to the point that it is possible to build sophisticated network architectures with advanced security capabilities. We present a prototype infrastructure in Amazon’s Virtual Private Cloud to allow researchers and practitioners to utilize the data in a HIPAA-compliant environment. PMID:23485880

The value of biomedical research training for veterinary anatomic and clinical pathologists.

PubMed

Sharkey, L C; Simpson, R M; Wellman, M L; Craig, L E; Birkebak, T A; Kock, N D; Miller, M A; Harris, R K; Munson, L

2012-07-01

Veterinary pathologists traditionally have been actively engaged in research as principal investigators and as collaborators. Pathologists frequently obtain advanced training in research; however, it appears that in the last 10 years there has been a reversal of a previous trend toward increasing numbers of pathologists obtaining PhD degrees. This has arisen despite an established shortage of veterinarians engaged in research. This article evaluates the benefits of research training for individual pathologists, including a wide spectrum of professional opportunities and additional skill development beyond that usually provided by diagnostic pathology training alone. Various training models are discussed, including combined and sequential diagnostic residency and research degree training as well as the nondegree research fellowship programs more commonly pursued in human medicine. Best-practice recommendations for program infrastructure, mentorship, time management, and a team approach to research and research training are advocated to facilitate the development of successful programs and to encourage a continued emphasis on integrated training for pathologists as both clinical diagnosticians and experimentalists. This article is intended to help prospective and active pathology trainees, their mentors, and educational administrators optimize opportunities to ensure the future vitality of veterinary pathologists, and their contributions, in basic and applied research.

Implementation of a deidentified federated data network for population-based cohort discovery

PubMed Central

Abend, Aaron; Mandel, Aaron; Geraghty, Estella; Gabriel, Davera; Wynden, Rob; Kamerick, Michael; Anderson, Kent; Rainwater, Julie; Tarczy-Hornoch, Peter

2011-01-01

Objective The Cross-Institutional Clinical Translational Research project explored a federated query tool and looked at how this tool can facilitate clinical trial cohort discovery by managing access to aggregate patient data located within unaffiliated academic medical centers. Methods The project adapted software from the Informatics for Integrating Biology and the Bedside (i2b2) program to connect three Clinical Translational Research Award sites: University of Washington, Seattle, University of California, Davis, and University of California, San Francisco. The project developed an iterative spiral software development model to support the implementation and coordination of this multisite data resource. Results By standardizing technical infrastructures, policies, and semantics, the project enabled federated querying of deidentified clinical datasets stored in separate institutional environments and identified barriers to engaging users for measuring utility. Discussion The authors discuss the iterative development and evaluation phases of the project and highlight the challenges identified and the lessons learned. Conclusion The common system architecture and translational processes provide high-level (aggregate) deidentified access to a large patient population (>5 million patients), and represent a novel and extensible resource. Enhancing the network for more focused disease areas will require research-driven partnerships represented across all partner sites. PMID:21873473

Implementation of a deidentified federated data network for population-based cohort discovery.

PubMed

Anderson, Nicholas; Abend, Aaron; Mandel, Aaron; Geraghty, Estella; Gabriel, Davera; Wynden, Rob; Kamerick, Michael; Anderson, Kent; Rainwater, Julie; Tarczy-Hornoch, Peter

2012-06-01

The Cross-Institutional Clinical Translational Research project explored a federated query tool and looked at how this tool can facilitate clinical trial cohort discovery by managing access to aggregate patient data located within unaffiliated academic medical centers. The project adapted software from the Informatics for Integrating Biology and the Bedside (i2b2) program to connect three Clinical Translational Research Award sites: University of Washington, Seattle, University of California, Davis, and University of California, San Francisco. The project developed an iterative spiral software development model to support the implementation and coordination of this multisite data resource. By standardizing technical infrastructures, policies, and semantics, the project enabled federated querying of deidentified clinical datasets stored in separate institutional environments and identified barriers to engaging users for measuring utility. The authors discuss the iterative development and evaluation phases of the project and highlight the challenges identified and the lessons learned. The common system architecture and translational processes provide high-level (aggregate) deidentified access to a large patient population (>5 million patients), and represent a novel and extensible resource. Enhancing the network for more focused disease areas will require research-driven partnerships represented across all partner sites.

Research Infrastructure and Scientific Collections: The Supply and Demand of Scientific Research

NASA Astrophysics Data System (ADS)

Graham, E.; Schindel, D. E.

2016-12-01

Research infrastructure is essential in both experimental and observational sciences and is commonly thought of as single-sited facilities. In contrast, object-based scientific collections are distributed in nearly every way, including by location, taxonomy, geologic epoch, discipline, collecting processes, benefits sharing rules, and many others. These diffused collections may have been amassed for a particular discipline, but their potential for use and impact in other fields needs to be explored. Through a series of cross-disciplinary activities, Scientific Collections International (SciColl) has explored and developed new ways in which the supply of scientific collections can meet the demand of researchers in unanticipated ways. From cross-cutting workshops on emerging infectious diseases and food security, to an online portal of collections, SciColl aims to illustrate the scope and value of object-based scientific research infrastructure. As distributed infrastructure, the full impact of scientific collections to the research community is a result of discovering, utilizing, and networking these resources. Examples and case studies from infectious disease research, food security topics, and digital connectivity will be explored.

A comprehensive framework for data quality assessment in CER.

PubMed

Holve, Erin; Kahn, Michael; Nahm, Meredith; Ryan, Patrick; Weiskopf, Nicole

2013-01-01

The panel addresses the urgent need to ensure that comparative effectiveness research (CER) findings derived from diverse and distributed data sources are based on credible, high-quality data; and that the methods used to assess and report data quality are consistent, comprehensive, and available to data consumers. The panel consists of representatives from four teams leveraging electronic clinical data for CER, patient centered outcomes research (PCOR), and quality improvement (QI) and seeks to change the current paradigm where data quality assessment (DQA) is performed "behind the scenes" using one-off project specific methods. The panelists will present their process of harmonizing existing models for describing and measuring clinical data quality and will describe a comprehensive integrated framework for assessing and reporting DQA findings. The collaborative project is supported by the Electronic Data Methods (EDM) Forum, a three-year grant from the Agency for Healthcare Research and Quality (AHRQ) to facilitate learning and foster collaboration across a set of CER, PCOR, and QI projects designed to build infrastructure and methods for collecting and analyzing prospective data from electronic clinical data .

Critical Infrastructure for Ocean Research and Societal Needs in 2030

NASA Astrophysics Data System (ADS)

Glickson, D.; Barron, E. J.; Fine, R. A.; Bellingham, J. G.; Boss, E.; Boyle, E. A.; Edwards, M.; Johnson, K. S.; Kelley, D. S.; Kite-Powell, H.; Ramberg, S. E.; Rudnick, D. L.; Schofield, O.; Tamburri, M.; Wiebe, P. H.; Wright, D. J.; Committee on an Ocean Infrastructure StrategyU. S. Ocean Research in 2030

2011-12-01

At the request of the Subcommittee on Ocean Science and Technology, an expert committee was convened by the National Research Council to identify major research questions anticipated to be at the forefront of ocean science in 2030, define categories of infrastructure that should be included in planning, provide advice on criteria and processes that could be used to set priorities, and recommend ways to maximize the value of investments in ocean infrastructure. The committee identified 32 future ocean research questions in four themes: enabling stewardship of the environment, protecting life and property, promoting economic vitality, and increasing fundamental scientific understanding. Many of the questions reflect challenging, multidisciplinary science questions that are clearly relevant now and are likely to take decades to solve. U.S. ocean research will require a growing suite of ocean infrastructure for a range of activities, such as high quality, sustained time series observations and autonomous monitoring at a broad range of spatial and temporal scales. A coordinated national plan for making future strategic investments will be needed and should be based upon known priorities and reviewed every 5-10 years. After assessing trends in ocean infrastructure and technology development, the committee recommended implementing a comprehensive, long-term research fleet plan in order to retain access to the sea; continuing U.S. capability to access fully and partially ice-covered seas; supporting innovation, particularly the development of biogeochemical sensors; enhancing computing and modeling capacity and capability; establishing broadly accessible data management facilities; and increasing interdisciplinary education and promoting a technically-skilled workforce. They also recommended that development, maintenance, or replacement of ocean research infrastructure assets should be prioritized in terms of societal benefit. Particular consideration should be given to usefulness for addressing important science questions; affordability, efficiency, and longevity; and ability to contribute to other missions or applications. Estimating the economic costs and benefits of each potential infrastructure investment using these criteria would allow funding of investments that produce the largest expected net benefit over time.

WATER INFRASTRUCTURE IN THE 21ST CENTURY: U.S. EPA’S RESEARCH PLANS FOR GRAVITY SEWERS

EPA Science Inventory

The U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) has long recognized the need for research and development in the area of drinking water and wastewater infrastructure. Most recently in support of the Agency’s Sustainable Water Infrastruct...

A green infrastructure experimental site for developing and evaluating models

EPA Science Inventory

The Ecosystems Research Division (ERD) of the U.S. EPA’s National Exposure Research Laboratory (NERL) in Athens, GA has a 14-acre urban watershed which has become an experimental research site for green infrastructure studies. About half of the watershed is covered by pervious la...

77 FR 20872 - Enabling a Secure Environment for Vehicle-to-Infrastructure Research Workshop; Notice of Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... DEPARTMENT OF TRANSPORTATION Enabling a Secure Environment for Vehicle-to-Infrastructure Research Workshop; Notice of Public Meeting AGENCY: ITS Joint Program Office, Research and Innovative Technology Administration, U.S. Department of Transportation. ACTION: Notice. The U.S. Department of Transportation (USDOT...

Designing a concept for an IT-infrastructure for an integrated research and treatment center.

PubMed

Stäubert, Sebastian; Winter, Alfred; Speer, Ronald; Löffler, Markus

2010-01-01

Healthcare and medical research in Germany are heading to more interconnected systems. New initiatives are funded by the German government to encourage the development of Integrated Research and Treatment Centers (IFB). Within an IFB new organizational structures and infrastructures for interdisciplinary, translational and trans-sectoral working relationship between existing rigid separated sectors are intended and needed. This paper describes how an IT-infrastructure of an IFB could look like, what major challenges have to be solved and what methods can be used to plan such a complex IT-infrastructure in the field of healthcare. By means of project management, system analyses, process models, 3LGM²-models and resource plans an appropriate concept with different views is created. This concept supports the information management in its enterprise architecture planning activities and implies a first step of implementing a connected healthcare and medical research platform.

Relevance of an academic GMP Pan-European vector infra-structure (PEVI).

PubMed

Cohen-Haguenauer, O; Creff, N; Cruz, P; Tunc, C; Aïuti, A; Baum, C; Bosch, F; Blomberg, P; Cichutek, K; Collins, M; Danos, O; Dehaut, F; Federspiel, M; Galun, E; Garritsen, H; Hauser, H; Hildebrandt, M; Klatzmann, D; Merten, O W; Montini, E; O'Brien, T; Panet, A; Rasooly, L; Scherman, D; Schmidt, M; Schweitzer, M; Tiberghien, P; Vandendriessche, T; Ziehr, H; Ylä-Herttuala, S; von Kalle, C; Gahrton, G; Carrondo, M

2010-12-01

In the past 5 years, European investigators have played a major role in the development of clinical gene therapy. The provision of substantial funds by some individual member states to construct GMP facilities makes it an opportune time to network available gene therapy GMP facilities at an EU level. The integrated coordination of GMP production facilities and human skills for advanced gene and genetically-modified (GM) cell therapy, can dramatically enhance academic-led "First-in-man" gene therapy trials. Once proof of efficacy is gathered, technology can be transferred to the private sector which will take over further development taking advantage of knowledge and know-how. Complex technical challenges require existing production facilities to adapt to emerging technologies in a coordinated manner. These include a mandatory requirement for the highest quality of production translating gene-transfer technologies with pharmaceutical-grade GMP processes to the clinic. A consensus has emerged on the directions and priorities to adopt, applying to advanced technologies with improved efficacy and safety profiles, in particular AAV, lentivirus-based and oncolytic vectors. Translating cutting-edge research into "First-in-man" trials require that pre-normative research is conducted which aims to develop standard assays, processes and candidate reference materials. This research will help harmonise practices and quality in the production of GMP vector lots and GM-cells. In gathering critical expertise in Europe and establish conditions for interoperability, the PEVI infrastructure will contribute to the demands of the advanced therapy medicinal products* regulation and to both health and quality of life of EU-citizens.

Perspective: Integrating research into surgical residency education: lessons learned from orthopaedic surgery.

PubMed

Atesok, Kivanc I; Hurwitz, Shepard R; Egol, Kenneth A; Ahn, Jaimo; Owens, Brett D; Crosby, Lynn A; Pellegrini, Vincent D

2012-05-01

Orthopaedic research has advanced tremendously in parallel with accelerated progress in medical science. Possession of a fundamental understanding of basic and clinical science has become more essential than previously for orthopaedic surgeons to be able to translate advances in research into clinical practice. The number of medical graduates with prior education in scientific research who choose to pursue careers in orthopaedic surgery is small. Therefore, it is important that a core of research education be included during residency training to ensure the continued advancement of the clinical practice of orthopaedics. The authors examine some of the challenges to a comprehensive research experience during residency, including deficient priority, inadequate institutional infrastructure, financial strain on residency budgets, restricted time, and an insufficient number of mentors to encourage and guide residents to become clinician-scientists. They also present some strategies to overcome these challenges, including development and expansion of residency programs with clinician-scientist pathways, promotion of financial sources, and enhancement of opportunities for residents to interact with mentors who can serve as role models. Successful integration of research education into residency programs will stimulate future orthopaedic surgeons to develop the critical skills to lead musculoskeletal research, comprehend related discoveries, and translate them into patient care. Lessons learned from incorporating research training within orthopaedic residency programs will have broad application across medical specialties-in both primary and subspecialty patient care.

Outcomes of Australian rural clinical schools: a decade of success building the rural medical workforce through the education and training continuum.

PubMed

Greenhill, Jennene A; Walker, Judi; Playford, Denese

2015-01-01

The establishment of the rural clinical schools funded through the Commonwealth Department of Health and Ageing (now Department of Health) Rural Clinical Training and Support program over a decade ago has been a significant policy initiative in Australian rural health. This article explores the impacts of this policy initiative and presents the wide range of educational innovations contextualised to each rural community they serve. This article reviews the achievements of the Australian rural clinical and regional medical schools (RCS/RMS) through semi-structured interviews with the program directors or other key informants. The questions and responses were analysed according to the funding parameters to ascertain the numbers of students, types of student placements and range of activities undertaken by each university program. Sixteen university medical schools have established 18 rural programs, creating an extensive national network of RCS and RMS in every state and territory. The findings reveal extensive positive impacts on rural and regional communities, curriculum innovation in medical education programs and community engagement activities. Teaching facilities, information technology, video-conferencing and student accommodation have brought new infrastructure to small rural towns. Rural clinicians are thriving on new opportunities for education and research. Clinicians continue to deliver clinical services and some have taken on formal academic positions, reducing professional isolation, improving the quality of care and their job satisfaction. This strategy has created many new clinical academics in rural areas, which has retained and expanded the clinical workforce. A total of 1224 students are provided with high-quality learning experiences for long-term clinical placements. These placements consist of a year or more in primary care, community and hospital settings across hundreds of rural and remote areas. Many programs offer longitudinal integrated clerkships; others offer block rotations in general practice and specialist clinics. Nine universities established programs prior to 2004, and these well-established programs are finding graduates who are returning to rural practice. Universities are required to have 25% of the students from a rural background. University admission policies have changed to encourage more applications from rural students. This aspect of the policy implements the extensive research evidence that rural-origin students are more likely to become rural practitioners. Additional capacity for research in RCS has influenced the rural health agenda in fields including epidemiology, population health, Aboriginal health, aged care, mental health and suicide prevention, farming families and climate change. There are strong research partnerships with rural workforce agencies, research centres for early career researchers and PhD students. The RCS policy initiative has vastly increased opportunities for medical students to have long-term clinical placements in rural health services. Over a decade since the policy has been implemented, graduates are being attracted to rural practice because they have positive learning experiences, good infrastructure and support within rural areas. The study shows the RCS initiative sets the stage for a sustainable future Australian rural medical workforce now requiring the development of a seamless rural clinical training pipeline linking undergraduate and postgraduate medical education.

New Geodetic Infrastructure for Australia: The NCRIS / AuScope Geospatial Component

NASA Astrophysics Data System (ADS)

Tregoning, P.; Watson, C. S.; Coleman, R.; Johnston, G.; Lovell, J.; Dickey, J.; Featherstone, W. E.; Rizos, C.; Higgins, M.; Priebbenow, R.

2009-12-01

In November 2006, the Australian Federal Government announced AUS15.8M in funding for geospatial research infrastructure through the National Collaborative Research Infrastructure Strategy (NCRIS). Funded within a broader capability area titled ‘Structure and Evolution of the Australian Continent’, NCRIS has provided a significant investment across Earth imaging, geochemistry, numerical simulation and modelling, the development of a virtual core library, and geospatial infrastructure. Known collectively as AuScope (www.auscope.org.au), this capability area has brought together Australian’s leading Earth scientists to decide upon the most pressing scientific issues and infrastructure needs for studying Earth systems and their impact on the Australian continent. Importantly and at the same time, the investment in geospatial infrastructure offers the opportunity to raise Australian geodetic science capability to the highest international level into the future. The geospatial component of AuScope builds onto the AUS15.8M of direct funding through the NCRIS process with significant in-kind and co-investment from universities and State/Territory and Federal government departments. The infrastructure to be acquired includes an FG5 absolute gravimeter, three gPhone relative gravimeters, three 12.1 m radio telescopes for geodetic VLBI, a continent-wide network of continuously operating geodetic quality GNSS receivers, a trial of a mobile SLR system and access to updated cluster computing facilities. We present an overview of the AuScope geospatial capability, review the current status of the infrastructure procurement and discuss some examples of the scientific research that will utilise the new geospatial infrastructure.

Cloud Environment Automation: from infrastructure deployment to application monitoring

NASA Astrophysics Data System (ADS)

Aiftimiei, C.; Costantini, A.; Bucchi, R.; Italiano, A.; Michelotto, D.; Panella, M.; Pergolesi, M.; Saletta, M.; Traldi, S.; Vistoli, C.; Zizzi, G.; Salomoni, D.

2017-10-01

The potential offered by the cloud paradigm is often limited by technical issues, rules and regulations. In particular, the activities related to the design and deployment of the Infrastructure as a Service (IaaS) cloud layer can be difficult to apply and time-consuming for the infrastructure maintainers. In this paper the research activity, carried out during the Open City Platform (OCP) research project [1], aimed at designing and developing an automatic tool for cloud-based IaaS deployment is presented. Open City Platform is an industrial research project funded by the Italian Ministry of University and Research (MIUR), started in 2014. It intends to research, develop and test new technological solutions open, interoperable and usable on-demand in the field of Cloud Computing, along with new sustainable organizational models that can be deployed for and adopted by the Public Administrations (PA). The presented work and the related outcomes are aimed at simplifying the deployment and maintenance of a complete IaaS cloud-based infrastructure.

ACTRIS Aerosol, Clouds and Trace Gases Research Infrastructure

NASA Astrophysics Data System (ADS)

Pappalardo, Gelsomina

2018-04-01

The Aerosols, Clouds and Trace gases Research Infrastructure (ACTRIS) is a distributed infrastructure dedicated to high-quality observation of aerosols, clouds, trace gases and exploration of their interactions. It will deliver precision data, services and procedures regarding the 4D variability of clouds, short-lived atmospheric species and the physical, optical and chemical properties of aerosols to improve the current capacity to analyse, understand and predict past, current and future evolution of the atmospheric environment.

The Emerging Information Infrastructure: Players, Issues, Technology, and Strategies. Proceedings of Part I of the Meeting of the Association of Research Libraries (123rd, Arlington, Virginia, October 20-22, 1993).

ERIC Educational Resources Information Center

Mogge, Dru, Ed.; And Others

The topic of the 123rd meeting of the Association of Research Libraries (ARL) is the information infrastructure. The ARL is seeking to influence the policies that will form the backbone of the emerging information infrastructure. The first session concentrated on government roles and initiatives and included the following papers: "Opening…

Nuclear Energy Infrastructure Database Fitness and Suitability Review

DOE Office of Scientific and Technical Information (OSTI.GOV)

Heidrich, Brenden

In 2014, the Deputy Assistant Secretary for Science and Technology Innovation (NE-4) initiated the Nuclear Energy-Infrastructure Management Project by tasking the Nuclear Science User Facilities (NSUF) to create a searchable and interactive database of all pertinent NE supported or related infrastructure. This database will be used for analyses to establish needs, redundancies, efficiencies, distributions, etc. in order to best understand the utility of NE’s infrastructure and inform the content of the infrastructure calls. The NSUF developed the database by utilizing data and policy direction from a wide variety of reports from the Department of Energy, the National Research Council, themore » International Atomic Energy Agency and various other federal and civilian resources. The NEID contains data on 802 R&D instruments housed in 377 facilities at 84 institutions in the US and abroad. A Database Review Panel (DRP) was formed to review and provide advice on the development, implementation and utilization of the NEID. The panel is comprised of five members with expertise in nuclear energy-associated research. It was intended that they represent the major constituencies associated with nuclear energy research: academia, industry, research reactor, national laboratory, and Department of Energy program management. The Nuclear Energy Infrastructure Database Review Panel concludes that the NSUF has succeeded in creating a capability and infrastructure database that identifies and documents the major nuclear energy research and development capabilities across the DOE complex. The effort to maintain and expand the database will be ongoing. Detailed information on many facilities must be gathered from associated institutions added to complete the database. The data must be validated and kept current to capture facility and instrumentation status as well as to cover new acquisitions and retirements.« less

Conducting clinical trials in Singapore.

PubMed

Woo, K T

1999-04-01

All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

Preventing Obesity in the Military Community (POMC): The Development of a Clinical Trials Research Network

PubMed Central

Spieker, Elena A.; Sbrocco, Tracy; Theim, Kelly R.; Maurer, Douglas; Johnson, Dawn; Bryant, Edny; Bakalar, Jennifer L.; Schvey, Natasha A.; Ress, Rachel; Seehusen, Dean; Klein, David A.; Stice, Eric; Yanovski, Jack A.; Chan, Linda; Gentry, Shari; Ellsworth, Carol; Hill, Joanne W.; Tanofsky-Kraff, Marian; Stephens, Mark B.

2015-01-01

Obesity impacts the U.S. military by affecting the health and readiness of active duty service members and their families. Preventing Obesity in Military Communities (POMC) is a comprehensive research program within Patient Centered Medical Homes (PCMHs) in three Military Training Facilities. This paper describes three pilot randomized controlled trials that target critical high risk periods for unhealthy weight gain from birth to young adulthood: (1) pregnancy and early infancy (POMC-Mother-Baby), (2) adolescence (POMC-Adolescent), and (3) the first tour of duty after boot camp (POMC-Early Career). Each study employs a two-group randomized treatment or prevention program with follow up. POMC offers a unique opportunity to bring together research and clinical expertise in obesity prevention to develop state-of-the-art programs within PCMHs in Military Training Facilities. This research builds on existing infrastructure that is expected to have immediate clinical benefits to DoD and far-reaching potential for ongoing collaborative work. POMC may offer an economical approach for widespread obesity prevention, from conception to young adulthood, in the U.S. military as well as in civilian communities. PMID:25648176

Walking behavior on Lapangan Merdeka district in Medan city

NASA Astrophysics Data System (ADS)

Zahrah, W.; Mandai, A. J. O.; Nasution, A. D.

2018-03-01

Lapangan Merdeka district in Medan City is an area with a lot of functions and activities. Pedestrians in this area pose particular behavior for walking. Such behavior can be formed due to certain factors. This study aimed to identify the behavior and motivation of walking, as well as knowing the perception of pedestrians on pedestrian facilities and infrastructures. This research is a qualitative descriptive study. This research was conducted in five streets that have pedestrian lanes by collecting data through observation of pedestrian facilities and infrastructures, as well as the distribution of questionnaires to investigate the characteristics of pedestrians, the behavior and motivation of walking, and perceptions of pedestrian facilities and infrastructure. The research found that the behavior of pedestrians when walking are different on certain characteristics of pedestrians as well as the specific conditions of facilities and infrastructures. The most dominant motivation when walking in this area is easy transportation access. The results of the perception of pedestrians also show that pedestrian facilities and infrastructure are good in this area.

Increasing the resilience and security of the United States' power infrastructure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Happenny, Sean F.

2015-08-01

The United States' power infrastructure is aging, underfunded, and vulnerable to cyber attack. Emerging smart grid technologies may take some of the burden off of existing systems and make the grid as a whole more efficient, reliable, and secure. The Pacific Northwest National Laboratory (PNNL) is funding research into several aspects of smart grid technology and grid security, creating a software simulation tool that will allow researchers to test power infrastructure control and distribution paradigms by utilizing different smart grid technologies to determine how the grid and these technologies react under different circumstances. Understanding how these systems behave in real-worldmore » conditions will lead to new ways to make our power infrastructure more resilient and secure. Demonstrating security in embedded systems is another research area PNNL is tackling. Many of the systems controlling the U.S. critical infrastructure, such as the power grid, lack integrated security and the aging networks protecting them are becoming easier to attack.« less

Final report for the Integrated and Robust Security Infrastructure (IRSI) laboratory directed research and development project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hutchinson, R.L.; Hamilton, V.A.; Istrail, G.G.

1997-11-01

This report describes the results of a Sandia-funded laboratory-directed research and development project titled {open_quotes}Integrated and Robust Security Infrastructure{close_quotes} (IRSI). IRSI was to provide a broad range of commercial-grade security services to any software application. IRSI has two primary goals: application transparency and manageable public key infrastructure. IRSI must provide its security services to any application without the need to modify the application to invoke the security services. Public key mechanisms are well suited for a network with many end users and systems. There are many issues that make it difficult to deploy and manage a public key infrastructure. IRSImore » addressed some of these issues to create a more manageable public key infrastructure.« less

Herbal medicine research and global health: an ethical analysis.

PubMed

Tilburt, Jon C; Kaptchuk, Ted J

2008-08-01

Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. Significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. However, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. By "cross-training" investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health.

Security Policy and Infrastructure in the Context of a Multi-Centeric Information System Dedicated to Autism Spectrum Disorder.

PubMed

Ben Said, Mohamed; Robel, Laurence; Golse, Bernard; Jais, Jean Philippe

2017-01-01

Autism spectrum disorders (ASD) are complex neuro-developmental disorders affecting children in their early age. The diagnosis of ASD relies on multidisciplinary investigations, in psychiatry, neurology, genetics, electrophysiology, neuro-imagery, audiology and ophthalmology. In order to support clinicians, researchers and public health decision makers, we designed an information system dedicated to ASD, called TEDIS. TEDIS was designed to manage systematic, exhaustive and continuous multi-centric patient data collection via secured Internet connections. In this paper, we present the security policy and security infrastructure we developed to protect ASD' patients' clinical data and patients' privacy. We tested our system on 359 ASD patient records in a local secured intranet environment and showed that the security system is functional, with a consistent, transparent and safe encrypting-decrypting behavior. It is ready for deployment in the nine ASD expert assessment centers in the Ile de France district.

CAEP 2014 Academic Symposium: "How to make research succeed in your emergency department: How to develop and train career researchers in emergency medicine".

PubMed

Perry, Jeffrey J; Snider, Carolyn E; Artz, Jennifer D; Stiell, Ian G; Shaeri, Sedigheh; McLeod, Shelley; Le Sage, Natalie; Hohl, Corinne; Calder, Lisa A; Vaillancourt, Christian; Holroyd, Brian; Hollander, Judd E; Morrison, Laurie J

2015-05-01

We sought to 1) identify best practices for training and mentoring clinician researchers, 2) characterize facilitators and barriers for Canadian emergency medicine researchers, and 3) develop pragmatic recommendations to improve and standardize emergency medicine postgraduate research training programs to build research capacity. We performed a systematic review of MEDLINE and Embase using search terms relevant to emergency medicine research fellowship/graduate training. We conducted an email survey of all Canadian emergency physician researchers. The Society for Academic Emergency Medicine (SAEM) research fellowship program was analysed, and other similar international programs were sought. An expert panel reviewed these data and presented recommendations at the Canadian Association of Emergency Physicians (CAEP) 2014 Academic Symposium. We refined our recommendations based on feedback received. Of 1,246 potentially relevant citations, we included 10 articles. We identified five key themes: 1) creating training opportunities; 2) ensuring adequate protected time; 3) salary support; 4) infrastructure; and 5) mentorship. Our survey achieved a 72% (67/93) response rate. From these responses, 42 (63%) consider themselves clinical researchers (i.e., spend a significant proportion of their career conducting research). The single largest constraint to conducting research was funding. Factors felt to be positive contributors to a clinical research career included salary support, research training (including an advanced graduate degree), mentorship, and infrastructure. The SAEM research fellowship was the only emergency medicine research fellowship program identified. This 2-year program requires approval of both the teaching centre and each applying fellow. This program requires training in 15 core competencies, manuscript preparation, and submission of a large grant to a national peer-review funding organization. We recommend that the CAEP Academic Section create a process to endorse research fellowship/graduate training programs. These programs should include two phases: Phase I: Research fellowship/graduate training would include an advanced research university degree and 15 core learning areas. Phase II: research consolidation involves a further 1-3 years with an emphasis on mentorship and scholarship production. It is anticipated that clinician scientists completing Phase I and Phase II training at a CAEP Academic Section-endorsed site(s) will be independent researchers with a higher likelihood of securing external peer-reviewed funding and be able to have a meaningful external impact in emergency medicine research.

Raising the Bar on External Research Funding: Infrastructure and Strategies for Enhancing Faculty Productivity

ERIC Educational Resources Information Center

Chval, Kathryn B.; Nossaman, Larry D.

2014-01-01

Administrators seek faculty who have the expertise to secure external funding to support their research agenda. Administrators also seek strategies to support and enhance faculty productivity across different ranks. In this manuscript, we describe the infrastructure we established and strategies we implemented to enhance the research enterprise at…

The importance of international collaboration for rare diseases research: a European perspective

PubMed Central

Julkowska, D; Austin, C P; Cutillo, C M; Gancberg, D; Hager, C; Halftermeyer, J; Jonker, A H; Lau, L P L; Norstedt, I; Rath, A; Schuster, R; Simelyte, E; van Weely, S

2017-01-01

Over the last two decades, important contributions were made at national, European and international levels to foster collaboration into rare diseases research. The European Union (EU) has put much effort into funding rare diseases research, encouraging national funding organizations to collaborate together in the E-Rare program, setting up European Reference Networks for rare diseases and complex conditions, and initiating the International Rare Diseases Research Consortium (IRDiRC) together with the National Institutes of Health in the USA. Co-ordination of the activities of funding agencies, academic researchers, companies, regulatory bodies, and patient advocacy organizations and partnerships with, for example, the European Research Infrastructures maximizes the collective impact of global investments in rare diseases research. This contributes to accelerating progress, for example, in faster diagnosis through enhanced discovery of causative genes, better understanding of natural history of rare diseases through creation of common registries and databases and boosting of innovative therapeutic approaches. Several examples of funded pre-clinical and clinical gene therapy projects show that integration of multinational and multidisciplinary expertize generates new knowledge and can result in multicentre gene therapy trials. International collaboration in rare diseases research is key to improve the life of people living with a rare disease. PMID:28440796

The importance of international collaboration for rare diseases research: a European perspective.

PubMed

Julkowska, D; Austin, C P; Cutillo, C M; Gancberg, D; Hager, C; Halftermeyer, J; Jonker, A H; Lau, L P L; Norstedt, I; Rath, A; Schuster, R; Simelyte, E; van Weely, S

2017-09-01

Over the last two decades, important contributions were made at national, European and international levels to foster collaboration into rare diseases research. The European Union (EU) has put much effort into funding rare diseases research, encouraging national funding organizations to collaborate together in the E-Rare program, setting up European Reference Networks for rare diseases and complex conditions, and initiating the International Rare Diseases Research Consortium (IRDiRC) together with the National Institutes of Health in the USA. Co-ordination of the activities of funding agencies, academic researchers, companies, regulatory bodies, and patient advocacy organizations and partnerships with, for example, the European Research Infrastructures maximizes the collective impact of global investments in rare diseases research. This contributes to accelerating progress, for example, in faster diagnosis through enhanced discovery of causative genes, better understanding of natural history of rare diseases through creation of common registries and databases and boosting of innovative therapeutic approaches. Several examples of funded pre-clinical and clinical gene therapy projects show that integration of multinational and multidisciplinary expertize generates new knowledge and can result in multicentre gene therapy trials. International collaboration in rare diseases research is key to improve the life of people living with a rare disease.

Improving Care And Research Electronic Data Trust Antwerp (iCAREdata): a research database of linked data on out-of-hours primary care.

PubMed

Colliers, Annelies; Bartholomeeusen, Stefaan; Remmen, Roy; Coenen, Samuel; Michiels, Barbara; Bastiaens, Hilde; Van Royen, Paul; Verhoeven, Veronique; Holmgren, Philip; De Ruyck, Bernard; Philips, Hilde

2016-05-04

Primary out-of-hours care is developing throughout Europe. High-quality databases with linked data from primary health services can help to improve research and future health services. In 2014, a central clinical research database infrastructure was established (iCAREdata: Improving Care And Research Electronic Data Trust Antwerp, www.icaredata.eu ) for primary and interdisciplinary health care at the University of Antwerp, linking data from General Practice Cooperatives, Emergency Departments and Pharmacies during out-of-hours care. Medical data are pseudonymised using the services of a Trusted Third Party, which encodes private information about patients and physicians before data is sent to iCAREdata. iCAREdata provides many new research opportunities in the fields of clinical epidemiology, health care management and quality of care. A key aspect will be to ensure the quality of data registration by all health care providers. This article describes the establishment of a research database and the possibilities of linking data from different primary out-of-hours care providers, with the potential to help to improve research and the quality of health care services.

Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials.

PubMed

Moler, Frank W; Silverstein, Faye S; Meert, Kathleen L; Clark, Amy E; Holubkov, Richard; Browning, Brittan; Slomine, Beth S; Christensen, James R; Dean, J Michael

2013-09-01

To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Multicenter randomized controlled trials. Pediatric intensive care and cardiac ICUs in the United States and Canada. Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Therapeutic hypothermia or therapeutic normothermia. From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.

Overview of Ongoing NRMRL GI Research

EPA Science Inventory

This presentation is an overview of ongoing NRMRL Green Infrastructure research and addresses the question: What do we need to know to present a cogent estimate of the value of Green Infrastructure? Discussions included are: stormwater well study, rain gardens and permeable su...

The biobanking research infrastructure BBMRI_CZ: a critical tool to enhance translational cancer research.

PubMed

Holub, P; Greplova, K; Knoflickova, D; Nenutil, R; Valik, D

2012-01-01

We introduce the national research biobanking infrastructure, BBMRI_CZ. The infrastructure has been founded by the Ministry of Education and became a partner of the European biobanking infrastructure BBMRI.eu. It is designed as a network of individual biobanks where each biobank stores samples obtained from associated healthcare providers. The biobanks comprise long term storage (various types of tissues classified by diagnosis, serum at surgery, genomic DNA and RNA) and short term storage (longitudinally sampled patient sera). We discuss the operation workflow of the infrastructure that needs to be the distributed system: transfer of the samples to the biobank needs to be accompanied by extraction of data from the hospital information systems and this data must be stored in a central index serving mainly for sample lookup. Since BBMRI_CZ is designed solely for research purposes, the data is anonymised prior to their integration into the central BBMRI_CZ index. The index is then available for registered researchers to seek for samples of interest and to request the samples from biobank managers. The paper provides an overview of the structure of data stored in the index. We also discuss monitoring system for the biobanks, incorporated to ensure quality of the stored samples.

Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings.

PubMed

Mtove, George; Kimani, Joshua; Kisinza, William; Makenga, Geofrey; Mangesho, Peter; Duparc, Stephan; Nakalembe, Miriam; Phiri, Kamija S; Orrico, Russell; Rojo, Ricardo; Vandenbroucke, Pol

2018-03-22

Multinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials. During the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the "Sponsoring Entities" for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs. Engagement with key stakeholders at international and national levels enabled the Sponsoring Entities to address challenges by aligning the study design with the requirements of health and regulatory agencies and to understand and address healthcare infrastructure needs prior to trial initiation. Local stakeholder engagement, including community members, study participants, and family enabled the investigators to address challenges by ensuring that study design and conduct were adapted to local considerations and ensuring accurate information about the study aims was shared with the public. ClinicalTrials.gov, ID: NCT01103063 . Registered on 7 April 2010.

Bricks-and-mortar and patient safety culture.

PubMed

Brandis, Susan; Schleimer, Stephanie; Rice, John

2017-06-19

Purpose Building a new hospital requires a major investment in capital infrastructure. The purpose of this paper is to investigate the impact of bricks-and-mortar on patient safety culture before and two years after the move of a large tertiary hospital to a greenfield site. The difference in patient safety perceptions between clinical and non-clinical staff is also explored. Design/methodology/approach This research uses data collected from the same workforce across two time periods (2013 and 2015) in a large Australian healthcare service. Validated surveys of patient safety culture ( n=306 and 246) were analysed using descriptive and inferential statistics. Findings Using two-way analysis of variance, the authors found that perceived patient safety culture remains unchanged for staff despite a major relocation and upgrade of services and different perceptions of patient safety culture between staff groups remains the same throughout change. Practical implications A dramatic change in physical context, such as moving an entire hospital, made no measurable impact on perceived patient safety culture by major groups of staff. Improving patient safety culture requires more than investment in buildings and infrastructure. Understanding differences in professional perspectives of patient safety culture may inform organisational management approaches, and enhance the targeting of specific strategies. Originality/value The authors believe this to be the first empirically based paper that investigates the impact of a large investment into hospital capital and a subsequent relocation of services on clinical and non-clinical staff perceptions of patient safety culture.

Rural Oregon community perspectives: introducing community-based participatory research into a community health coalition.

PubMed

Young-Lorion, Julia; Davis, Melinda M; Kirks, Nancy; Hsu, Anna; Slater, Jana Kay; Rollins, Nancy; Aromaa, Susan; McGinnis, Paul

2013-01-01

The Community Health Improvement Partnership (CHIP) model has supported community health development in more than 100 communities nationally. In 2011, four rural Oregon CHIPs collaborated with investigators from the Oregon Rural Practice-based Research Network (ORPRN), a component of the Oregon Clinical and Translational Research Institute (OCTRI), to obtain training on research methods, develop and implement pilot research studies on childhood obesity, and explore matches with academic partners. This article summarizes the experiences of the Lincoln County CHIP, established in 2003, as it transitioned from CHIP to Community Health Improvement and Research Partnership (CHIRP). Our story and lessons learned may inform rural community-based health coalitions and academicians who are engaged in or considering Community-based participatory research (CBPR) partnerships. Utilizing existing infrastructure and relationships in community and academic settings provides an ideal starting point for rural, bidirectional research partnerships.

Sustainability considerations for health research and analytic data infrastructures.

PubMed

Wilcox, Adam; Randhawa, Gurvaneet; Embi, Peter; Cao, Hui; Kuperman, Gilad J

2014-01-01

The United States has made recent large investments in creating data infrastructures to support the important goals of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER), with still more investment planned. These initial investments, while critical to the creation of the infrastructures, are not expected to sustain them much beyond the initial development. To provide the maximum benefit, the infrastructures need to be sustained through innovative financing models while providing value to PCOR and CER researchers. Based on our experience with creating flexible sustainability strategies (i.e., strategies that are adaptive to the different characteristics and opportunities of a resource or infrastructure), we define specific factors that are important considerations in developing a sustainability strategy. These factors include assets, expansion, complexity, and stakeholders. Each factor is described, with examples of how it is applied. These factors are dimensions of variation in different resources, to which a sustainability strategy should adapt. We also identify specific important considerations for maintaining an infrastructure, so that the long-term intended benefits can be realized. These observations are presented as lessons learned, to be applied to other sustainability efforts. We define the lessons learned, relating them to the defined sustainability factors as interactions between factors. Using perspectives and experiences from a diverse group of experts, we define broad characteristics of sustainability strategies and important observations, which can vary for different projects. Other descriptions of adaptive, flexible, and successful models of collaboration between stakeholders and data infrastructures can expand this framework by identifying other factors for sustainability, and give more concrete directions on how sustainability can be best achieved.

European environmental research infrastructures are going for common 30 years strategy

NASA Astrophysics Data System (ADS)

Asmi, Ari; Konjin, Jacco; Pursula, Antti

2014-05-01

Environmental Research infrastructures are facilities, resources, systems and related services that are used by research communities to conduct top-level research. Environmental research is addressing processes at very different time scales, and supporting research infrastructures must be designed as long-term facilities in order to meet the requirements of continuous environmental observation, measurement and analysis. This longevity makes the environmental research infrastructures ideal structures to support the long-term development in environmental sciences. ENVRI project is a collaborative action of the major European (ESFRI) Environmental Research Infrastructures working towards increased co-operation and interoperability between the infrastructures. One of the key products of the ENVRI project is to combine the long-term plans of the individual infrastructures towards a common strategy, describing the vision and planned actions. The envisaged vision for environmental research infrastructures toward 2030 is to support the holistic understanding of our planet and it's behavior. The development of a 'Standard Model of the Planet' is a common ambition, a challenge to define an environmental standard model; a framework of all interactions within the Earth System, from solid earth to near space. Indeed scientists feel challenged to contribute to a 'Standard Model of the Planet' with data, models, algorithms and discoveries. Understanding the Earth System as an interlinked system requires a systems approach. The Environmental Sciences are rapidly moving to become a one system-level science. Mainly since modern science, engineering and society are increasingly facing complex problems that can only be understood in the context of the full overall system. The strategy of the supporting collaborating research infrastructures is based on developing three key factors for the Environmental Sciences: the technological, the cultural and the human capital. The technological capital development concentrates on improving the capacities to measure, observe, preserve and compute. This requires staff, technologies, sensors, satellites, floats, software to integrate and to do analysis and modeling, including data storage, computing platforms and networks. The cultural capital development addresses issues such as open access to data, rules, licenses, citation agreements, IPR agreements, technologies for machine-machine interaction, workflows, metadata, and RI community on the policy level. Human capital actions are based on anticipated need of specialists, including data scientists and 'generalists' that oversee more than just their own discipline. Developing these, as interrelated services, should help the scientific community to enter innovative and large projects contributing to a 'Standard Model of the Planet'. To achieve the overall goal, ENVRI will publish a set of action items that contains intermediate aims, bigger and smaller steps to work towards the development of the 'Standard Model of the Planet' approach. This timeline of actions can used as reference and 'common denominator' in defining new projects and research programs. Either within the various environmental scientific disciplines or when cooperating among these disciplines or even when outreaching towards other disciplines like social sciences, physics/chemistry, medical/life sciences etc.

Challenges of Identifying Clinically Actionable Genetic Variants for Precision Medicine

PubMed Central

2016-01-01

Advances in genomic medicine have the potential to change the way we treat human disease, but translating these advances into reality for improving healthcare outcomes depends essentially on our ability to discover disease- and/or drug-associated clinically actionable genetic mutations. Integration and manipulation of diverse genomic data and comprehensive electronic health records (EHRs) on a big data infrastructure can provide an efficient and effective way to identify clinically actionable genetic variants for personalized treatments and reduce healthcare costs. We review bioinformatics processing of next-generation sequencing (NGS) data, bioinformatics infrastructures for implementing precision medicine, and bioinformatics approaches for identifying clinically actionable genetic variants using high-throughput NGS data and EHRs. PMID:27195526

Capacity evaluation and infrastructure planning techniques for heterogeneous railway traffic under structured, flexible and mixed operations.

DOT National Transportation Integrated Search

2017-01-22

The objective of this study is to develop new railway capacity evaluation tools and infrastructure planning techniques to address infrastructure or operations planning challenges under different operating styles. Three main research questions will be...

Field Evaluation of Innovative Wastewater Collection System Condition Assessment Technologies

EPA Science Inventory

As part of an effort to address aging infrastructure needs, the U.S. Environmental Protection Agency (USEPA) initiated research under the Aging Water Infrastructure program, part of the USEPA Office of Water’s Sustainable Infrastructure Initiative. This presentation discusses fi...

76 FR 34286 - ITS Joint Program Office; Webinar on Connected Vehicle Infrastructure Deployment Analysis Report...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-13

... Deployment Analysis Report Review; Notice of Public Meeting AGENCY: Research and Innovative Technology... discuss the Connected Vehicle Infrastructure Deployment Analysis Report. The webinar will provide an... and Transportation Officials (AASHTO) Connected Vehicle Infrastructure Deployment Analysis Report...

Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.

PubMed

Linde, Peter G; Archdeacon, Patrick; Breyer, Matthew D; Ibrahim, Tod; Inrig, Jula K; Kewalramani, Reshma; Lee, Celeste Castillo; Neuland, Carolyn Y; Roy-Chaudhury, Prabir; Sloand, James A; Meyer, Rachel; Smith, Kimberly A; Snook, Jennifer; West, Melissa; Falk, Ronald J

2016-07-01

Innovation in kidney diseases is not commensurate with the effect of these diseases on human health and mortality or innovation in other key therapeutic areas. A primary cause of the dearth in innovation is that kidney diseases disproportionately affect a demographic that is largely disenfranchised, lacking sufficient advocacy, public attention, and funding. A secondary and likely consequent cause is that the existing infrastructure supporting nephrology research pales in comparison with those for other internal medicine specialties, especially cardiology and oncology. Citing such inequities, however, is not enough. Changing the status quo will require a coordinated effort to identify and redress the existing deficits. Specifically, these deficits relate to the need to further develop and improve the following: understanding of the disease mechanisms and pathophysiology, patient engagement and activism, clinical trial infrastructure, and investigational clinical trial designs as well as coordinated efforts among critical stakeholders. This paper identifies potential solutions to these barriers, some of which are already underway through the Kidney Health Initiative. The Kidney Health Initiative is unique and will serve as a current and future platform from which to overcome these barriers to innovation in nephrology. Copyright © 2016 by the American Society of Nephrology.

Use of health information technology to advance evidence-based care: lessons from the VA QUERI program.

PubMed

Hynes, Denise M; Weddle, Timothy; Smith, Nina; Whittier, Erika; Atkins, David; Francis, Joseph

2010-01-01

As the Department of Veterans Affairs (VA) Health Services Research and Development Service's Quality Enhancement Research Initiative (QUERI) has progressed, health information technology (HIT) has occupied a crucial role in implementation research projects. We evaluated the role of HIT in VA QUERI implementation research, including HIT use and development, the contributions implementation research has made to HIT development, and HIT-related barriers and facilitators to implementation research. Key informants from nine disease-specific QUERI Centers. Documentation analysis of 86 implementation project abstracts followed up by semi-structured interviews with key informants from each of the nine QUERI centers. We used qualitative and descriptive analyses. We found: (1) HIT provided data and information to facilitate implementation research, (2) implementation research helped to further HIT development in a variety of uses including the development of clinical decision support systems (23 of 86 implementation research projects), and (3) common HIT barriers to implementation research existed but could be overcome by collaborations with clinical and administrative leadership. Our review of the implementation research progress in the VA revealed interdependency on an HIT infrastructure and research-based development. Collaboration with multiple stakeholders is a key factor in successful use and development of HIT in implementation research efforts and in advancing evidence-based practice.

Semantic querying of relational data for clinical intelligence: a semantic web services-based approach

PubMed Central

2013-01-01

Background Clinical Intelligence, as a research and engineering discipline, is dedicated to the development of tools for data analysis for the purposes of clinical research, surveillance, and effective health care management. Self-service ad hoc querying of clinical data is one desirable type of functionality. Since most of the data are currently stored in relational or similar form, ad hoc querying is problematic as it requires specialised technical skills and the knowledge of particular data schemas. Results A possible solution is semantic querying where the user formulates queries in terms of domain ontologies that are much easier to navigate and comprehend than data schemas. In this article, we are exploring the possibility of using SADI Semantic Web services for semantic querying of clinical data. We have developed a prototype of a semantic querying infrastructure for the surveillance of, and research on, hospital-acquired infections. Conclusions Our results suggest that SADI can support ad-hoc, self-service, semantic queries of relational data in a Clinical Intelligence context. The use of SADI compares favourably with approaches based on declarative semantic mappings from data schemas to ontologies, such as query rewriting and RDFizing by materialisation, because it can easily cope with situations when (i) some computation is required to turn relational data into RDF or OWL, e.g., to implement temporal reasoning, or (ii) integration with external data sources is necessary. PMID:23497556

BORDERLINE RESECTABLE PANCREATIC CANCER: Need for Standardization and Methods for Optimal Clinical Trial Design

PubMed Central

Katz, Matthew HG; Marsh, Robert; Herman, Joseph M.; Shi, Qian; Collison, Eric; Venook, Alan; Kindler, Hedy; Alberts, Steven; Philip, Philip; Lowy, Andrew M.; Pisters, Peter; Posner, Mitchell; Berlin, Jordan; Ahmad, Syed A.

2017-01-01

Methodological limitations of prior studies have prevented progress in the treatment of patients with borderline resectable pancreatic adenocarcinoma. Shortcomings have included the absence of staging and treatment standards and pre-existing biases with regard to the use of neoadjuvant therapy and the role of vascular resection at pancreatectomy. In this manuscript, we will review limitations of studies of borderline resectable PDAC reported to date, highlight important controversies related to this disease stage, emphasize the research infrastructure necessary for its future study, and present a recently-approved Intergroup pilot study (Alliance A0201101) that will provide a foundation upon which subsequent well-designed clinical trials can be performed. PMID:23435609

Improving the Research Infrastructure at U.S. Universities and Colleges. Hearing before the Committee on Science and Technology. U.S. House of Representatives, Ninety-Eighth Congress, Second Session.

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. House Committee on Science and Technology.

The state of university science and engineering research capabilities is considered. Attention is directed to the need for improving and enhancing the research infrastructure, including support for instrumentation, buildings, and other related research facilities. U.S. universities and colleges are encountering severe facilities and…

Successfully accelerating translational research at an academic medical center: the University of Michigan-Coulter translational research partnership program.

PubMed

Pienta, Kenneth J

2010-12-01

Translational research encompasses the effective movement of new knowledge and discoveries into new approaches for prevention, diagnosis, and treatment of disease. There are many roadblocks to successful bench to bedside research, but few have received as much recent attention as the "valley of death". The valley of death refers to the lack of funding and support for research that moves basic science discoveries into diagnostics, devices, and treatments in humans, and is ascribed to be the result of companies unwilling to fund research development that may not result in a drug or device that will be utilized in the clinic and conversely, the fact that researchers have no access to the funding needed to carry out preclinical and early clinical development to demonstrate potential efficacy in humans. The valley of death also exists because bridging the translational gap is dependent on successfully managing an additional four risks: scientific, intellectual property, market, and regulatory. The University of Michigan (UM) has partnered with the Wallace H. Coulter Foundation (CF) to create a model providing an infrastructure to overcome these risks. This model is easily adoptable to other academic medical centers (AMCs). © 2010 Wiley Periodicals, Inc.

URBAN INFRASTRUCTURE RESEARCH PLAN WATER AND WASTEWATER ISSUES

EPA Science Inventory

As we approach the twenty-first century, we should be considering where we are today and where the consequences of our actions will place us tomorrow. This is especially true in the management of our aging and growing infrastructure. Infrastructure facilitates movement of people ...

Use of community engagement strategies to increase research participation in practice-based research networks (PBRNs).

PubMed

Spears, William; Tsoh, Janice Y; Potter, Michael B; Weller, Nancy; Brown, Anthony E; Campbell-Voytal, Kimberly; Getrich, Christina M; Sussman, Andrew L; Pascoe, John; Neale, Anne Victoria

2014-01-01

Practice-based research networks (PBRNs) are increasingly encouraged to use community engagement approaches. The extent to which PBRNs engage clinic and community partners in strategies to recruit and retain participants from their local communities (specifically racial/ethnic communities) is the focus of this study. The design was a cross-sectional survey of PBRN directors in the United States. Survey respondents indicated whether their research network planned for, implemented, and has capacity for activities that engage clinic and community partners in 7 recommended strategies organized into study phases, called the cycle of trust. The objectives of the national survey were to (1) describe the extent to which PBRNs across the United States routinely implement the strategies recommended for recruiting diverse patient groups and (2) identify factors associated with implementing the recommended strategies. The survey response rate was 63%. Activities that build trust often are used more with clinic partners than with community partners. PBRNs that adopt engagement strategies when working with clinic and community partners have less difficulty in recruiting diverse populations. Multivariate analysis showed that the targeting racial/ethnic communities for study recruitment, Clinical and Translational Science Award affiliation, and planning to use community engagement strategies were independent correlates of PBRN implementation of the recommended strategies. PBRNs that successfully engage racial/ethnic communities as research partners use community engagement strategies. New commitments are needed to support PBRN researchers in developing relationships with the communities in which their patients live. Stable PBRN infrastructure funding that appreciates the value of maintaining community engagement between funded studies is critical to the research enterprise that values translating research findings into generalizable care models for patients in the community. © Copyright 2014 by the American Board of Family Medicine.

Building Research Infrastructure in Schools of Social Work: A University Perspective

ERIC Educational Resources Information Center

Videka, Lynn; Blackburn, James A.; Moran, James R.

2008-01-01

This article addresses strategies for research infrastructure development in social work by building on the profession's work of the past two decades and by drawing on the experiences of the larger university environment. The article provides a set of recommendations for the next generation of social work research, which is likely to be highly…

Scientific/Technical Report Bioenergetics Research Initiative Award number-DE-FG02-05ER64092

DOE Office of Scientific and Technical Information (OSTI.GOV)

Trappe, Scott A

2009-12-04

General Project Overview and Final Technical Report This equipment grant was utilized to enhance the infrastructure of the Human Performance Laboratory at Ball State University. The laboratories primary focus is human based exercise physiology conducting research in the areas of sports performance, aging and exercise, unloading (space flight and bed rest), pediatric exercise and clinical exercise physiology. The main equipment supported by this grant was an ultrasound unit for cardiac and skeletal muscle imaging at the whole organ level, microscope system for micro imaging of skeletal muscle tissue, running treadmill for energy expenditure assessment, autoclave for sterilization, and upgrade tomore » our dual x–ray absorptiometry (DEXA) system that was utilized for body composition measurements. The equipment was involved in several human metabolic and skeletal muscle research projects as highlighted above. In particular, this equipment served a support role for other large–scale clinical projects funded by the National Institutes of Health (NIH), National Aeronautics and Space Administration (NASA), and corporate sponsors.« less

Big Data and the Future of Radiology Informatics.

PubMed

Kansagra, Akash P; Yu, John-Paul J; Chatterjee, Arindam R; Lenchik, Leon; Chow, Daniel S; Prater, Adam B; Yeh, Jean; Doshi, Ankur M; Hawkins, C Matthew; Heilbrun, Marta E; Smith, Stacy E; Oselkin, Martin; Gupta, Pushpender; Ali, Sayed

2016-01-01

Rapid growth in the amount of data that is electronically recorded as part of routine clinical operations has generated great interest in the use of Big Data methodologies to address clinical and research questions. These methods can efficiently analyze and deliver insights from high-volume, high-variety, and high-growth rate datasets generated across the continuum of care, thereby forgoing the time, cost, and effort of more focused and controlled hypothesis-driven research. By virtue of an existing robust information technology infrastructure and years of archived digital data, radiology departments are particularly well positioned to take advantage of emerging Big Data techniques. In this review, we describe four areas in which Big Data is poised to have an immediate impact on radiology practice, research, and operations. In addition, we provide an overview of the Big Data adoption cycle and describe how academic radiology departments can promote Big Data development. Copyright © 2016 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

[The Competence Network Parkinson (CNP)].

PubMed

Oertel, Wolfgang H; Deuschl, Guenther; Eggert, Karla

2016-04-01

The Competence Network Parkinson (CNP) is a research infrastructure for disease-oriented translational and clinical research in the field of Parkinson syndromes (PS). It was initiated in 1999 and funded until 2008 by the German Ministry for Education and Research (BMBF). The CNP created a highly frequented website with information on PS for the general public and for experts. The CNP designed and established one of the first electronic internet-based data entry systems (secuTrial®) - fulfilling the legal standards of data safety and security - a material bank for genetic research on Parkinson's disease (PD), implemented and investigated new methods for early diagnosis of PD and related atypical PS including in vivo dopamine transporter imaging (DAT SPECT), established the German Parkinson Study Group (GPS-Pharma) with 40 certified trial centres for pharmacotherapeutical trials and the German interdisciplinary Parkinson Study Group (neurology and neurosurgery) for deep brain stimulation (GPS-DBS), and carried out several pharmacoeconomic and health care studies on PD in Germany. Sustainability of the infrastructure CNP has in part been achieved in form of the GPS-Pharma and the GPS-DBS, as well as in the German Study Group on REM Sleep Behaviour Disorder (RBD), a prodromal phase of PD. Part of the CNP activities, such as genetic research and research on cohorts of PD patients, have been incorporated into the German Center for Neurodegenerative Disorders (DZNE). Furthermore, topics such as health care research are funded within projects of the EU research program. The article describes problems in setting up a competence network from scratch and contains recommendations how to avoid them in the future.

Health services research and data linkages: issues, methods, and directions for the future.

PubMed

Bradley, Cathy J; Penberthy, Lynne; Devers, Kelly J; Holden, Debra J

2010-10-01

Research on pressing health services and policy issues requires access to complete, accurate, and timely patient and organizational data. This paper describes how administrative and health records (including electronic medical records) can be linked for comparative effectiveness and health services research. We categorize the major agents (i.e., who owns and controls data and who carries out the data linkage) into three areas: (1) individual investigators; (2) government sponsored linked data bases; and (3) public-private partnerships that facilitate linkage of data owned by private organizations. We describe challenges that may be encountered in the linkage process, and the benefits of combining secondary databases with primary qualitative and quantitative sources. We use cancer care research to illustrate our points. To fill the gaps in the existing data infrastructure, additional steps are required to foster collaboration among institutions, researchers, and public and private components of the health care sector. Without such effort, independent researchers, governmental agencies, and nonprofit organizations are likely to continue building upon a fragmented and costly system with limited access. Discussion. Without the development and support for emerging information technologies across multiple health care settings, the potential for data collected for clinical and transactional purposes to benefit the research community and, ultimately, the patient population may go unrealized. The current environment is characterized by budget and technical challenges, but investments in data infrastructure are arguably cost-effective given the need to reform our health care system and to monitor the impact of health reform initiatives. © Health Research and Educational Trust.

[Maintainance of a research tissue bank. (Infra)structural and quality aspects].

PubMed

Schmitt, S; Kynast, K; Schirmacher, P; Herpel, E

2015-11-01

The availability of high quality human tissue samples and access to associated histopathological and clinical data are essential for biomedical research. Therefore, it is necessary to establish quality assured tissue biobanks that provide high quality tissue samples for research purposes. This entails quality concerns referring not only to the biomaterial specimen itself but encompassing all procedures related to biobanking, including the implementation of structural components, e.g. ethical and legal guidelines, quality management documentation as well as data and project management and information technology (IT) administration. Moreover, an integral aspect of tissue biobanks is the quality assured evaluation of every tissue specimen that is stored in a tissue biobank and used for projects to guarantee high quality assured biomaterial.

Information Technology Support for Clinical Genetic Testing within an Academic Medical Center.

PubMed

Aronson, Samuel; Mahanta, Lisa; Ros, Lei Lei; Clark, Eugene; Babb, Lawrence; Oates, Michael; Rehm, Heidi; Lebo, Matthew

2016-01-20

Academic medical centers require many interconnected systems to fully support genetic testing processes. We provide an overview of the end-to-end support that has been established surrounding a genetic testing laboratory within our environment, including both laboratory and clinician facing infrastructure. We explain key functions that we have found useful in the supporting systems. We also consider ways that this infrastructure could be enhanced to enable deeper assessment of genetic test results in both the laboratory and clinic.

Investigations into Gravitational Wave Emission from Compact Body Inspiral Into Massive Black Holes

NASA Technical Reports Server (NTRS)

Hughes, Scott A.

2004-01-01

Much of the grant's support (and associated time) was used in developmental activity, building infrastructure for the core of the work that the grant supports. Though infrastructure development was the bulk of the activity supported this year, important progress was made in research as well. The two most important "infrastructure" items were in computing hardware and personnel. Research activities were primarily focused on improving and extending. Hughes' Teukolsky-equation-based gravitational-wave generator. Several improvements have been incorporated into this generator.

Building the National Information Infrastructure in K-12 Education: A Comprehensive Survey of Attitudes towards Linking Both Sides of the Desk. A Report of the Global Telecommunications Infrastructure Research Project. Research Report Series.

ERIC Educational Resources Information Center

Pereira, Francis; And Others

This survey was designed to elicit the perceptions of the members of the educational community on four issues concerning the NII (National Information Infrastructure), and to test whether these visions of the NII were shared by educators. The issues were: (1) the benefits of the NII to the education sector and specifically whether the NII will be…

Toxocariasis: a silent threat with a progressive public health impact.

PubMed

Chen, Jia; Liu, Quan; Liu, Guo-Hua; Zheng, Wen-Bin; Hong, Sung-Jong; Sugiyama, Hiromu; Zhu, Xing-Quan; Elsheikha, Hany M

2018-06-13

Toxocariasis is a neglected parasitic zoonosis that afflicts millions of the pediatric and adolescent populations worldwide, especially in impoverished communities. This disease is caused by infection with the larvae of Toxocara canis and T. cati, the most ubiquitous intestinal nematode parasite in dogs and cats, respectively. In this article, recent advances in the epidemiology, clinical presentation, diagnosis and pharmacotherapies that have been used in the treatment of toxocariasis are reviewed. Over the past two decades, we have come far in our understanding of the biology and epidemiology of toxocariasis. However, lack of laboratory infrastructure in some countries, lack of uniform case definitions and limited surveillance infrastructure are some of the challenges that hindered the estimation of global disease burden. Toxocariasis encompasses four clinical forms: visceral, ocular, covert and neural. Incorrect or misdiagnosis of any of these disabling conditions can result in severe health consequences and considerable medical care spending. Fortunately, multiple diagnostic modalities are available, which if effectively used together with the administration of appropriate pharmacologic therapies, can minimize any unnecessary patient morbidity. Although progress has been made in the management of toxocariasis patients, there remains much work to be done. Implementation of new technologies and better understanding of the pathogenesis of toxocariasis can identify new diagnostic biomarkers, which may help in increasing diagnostic accuracy. Also, further clinical research breakthroughs are needed to develop better ways to effectively control and prevent this serious disease.

The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems.

PubMed

Kirkpatrick, Beth D; Colgate, E Ross; Mychaleckyj, Josyf C; Haque, Rashidul; Dickson, Dorothy M; Carmolli, Marya P; Nayak, Uma; Taniuchi, Mami; Naylor, Caitlin; Qadri, Firdausi; Ma, Jennie Z; Alam, Masud; Walsh, Mary Claire; Diehl, Sean A; Petri, William A

2015-04-01

Oral vaccines appear less effective in children in the developing world. Proposed biologic reasons include concurrent enteric infections, malnutrition, breast milk interference, and environmental enteropathy (EE). Rigorous study design and careful data management are essential to begin to understand this complex problem while assuring research subject safety. Herein, we describe the methodology and lessons learned in the PROVIDE study (Dhaka, Bangladesh). A randomized clinical trial platform evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of EE and additional exploratory variables. Methods for the enrollment and 2-year follow-up of a 700 child birth cohort are described, including core laboratory, safety, regulatory, and data management practices. Intense efforts to standardize clinical, laboratory, and data management procedures in a developing world setting provide clinical trials rigor to all outcomes. Although this study infrastructure requires extensive time and effort, it allows optimized safety and confidence in the validity of data gathered in complex, developing country settings. © The American Society of Tropical Medicine and Hygiene.

Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency.

PubMed

Larson, Gregg S; Baseler, Beth R; Hoover, Marie L; Pierson, Jerome F; Tegli, Jemee K; Johnson, Melvin P; Kieh, Mark W S; McNay, Laura A; Njoh, Wissedi Sio

2017-07-01

Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health.

Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency

PubMed Central

Larson, Gregg S.; Baseler, Beth R.; Hoover, Marie L.; Pierson, Jerome F.; Tegli, Jemee K.; Johnson, Melvin P.; Kieh, Mark W. S.; McNay, Laura A.; Njoh, Wissedi Sio

2017-01-01

Abstract. Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health. PMID:28719299

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

PubMed

Weinfurt, Kevin P; Hernandez, Adrian F; Coronado, Gloria D; DeBar, Lynn L; Dember, Laura M; Green, Beverly B; Heagerty, Patrick J; Huang, Susan S; James, Kathryn T; Jarvik, Jeffrey G; Larson, Eric B; Mor, Vincent; Platt, Richard; Rosenthal, Gary E; Septimus, Edward J; Simon, Gregory E; Staman, Karen L; Sugarman, Jeremy; Vazquez, Miguel; Zatzick, Douglas; Curtis, Lesley H

2017-09-18

The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped. To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design. In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs. A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

NHERI: Advancing the Research Infrastructure of the Multi-Hazard Community

NASA Astrophysics Data System (ADS)

Blain, C. A.; Ramirez, J. A.; Bobet, A.; Browning, J.; Edge, B.; Holmes, W.; Johnson, D.; Robertson, I.; Smith, T.; Zuo, D.

2017-12-01

The Natural Hazards Engineering Research Infrastructure (NHERI), supported by the National Science Foundation (NSF), is a distributed, multi-user national facility that provides the natural hazards research community with access to an advanced research infrastructure. Components of NHERI are comprised of a Network Coordination Office (NCO), a cloud-based cyberinfrastructure (DesignSafe-CI), a computational modeling and simulation center (SimCenter), and eight Experimental Facilities (EFs), including a post-disaster, rapid response research facility (RAPID). Utimately NHERI enables researchers to explore and test ground-breaking concepts to protect homes, businesses and infrastructure lifelines from earthquakes, windstorms, tsunamis, and surge enabling innovations to help prevent natural hazards from becoming societal disasters. When coupled with education and community outreach, NHERI will facilitate research and educational advances that contribute knowledge and innovation toward improving the resiliency of the nation's civil infrastructure to withstand natural hazards. The unique capabilities and coordinating activities over Year 1 between NHERI's DesignSafe-CI, the SimCenter, and individual EFs will be presented. Basic descriptions of each component are also found at https://www.designsafe-ci.org/facilities/. Additionally to be discussed are the various roles of the NCO in leading development of a 5-year multi-hazard science plan, coordinating facility scheduling and fostering the sharing of technical knowledge and best practices, leading education and outreach programs such as the recent Summer Institute and multi-facility REU program, ensuring a platform for technology transfer to practicing engineers, and developing strategic national and international partnerships to support a diverse multi-hazard research and user community.

Gatekeepers for Pragmatic Clinical Trials

PubMed Central

Whicher, Danielle M.; Miller, Jennifer E.; Dunham, Kelly M.; Joffe, Steven

2015-01-01

To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g., clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the United States clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This manuscript provides a framework to help guide gatekeepers’ decision-making related to the use of resources for pragmatic clinical trials. These include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers’ decisions, including protection from harm and maximization of benefits, (2) advancement of organizational mission and values, and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers’ actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding the use of limited and valuable resources. PMID:26374683

Towards Building a Bridge between Community Engagement in Research (CEnR) and Comparative Effectiveness Research (CER).

PubMed

Ahmed, Syed M; Nelson, David; Kissack, Anne; Franco, Zeno; Whittle, Jeff; Kotchen, Theodore; Meurer, John R; Morzinski, Jeffrey; Brandenburg, Terry

2015-04-01

A major national priority is establishing an effective infrastructure for translation of scientific discoveries into the community. Knowledge and practice continue to accelerate in health research yet healthcare recommendation adoption remains slow for practitioners, patients, and communities. Two areas of research placed in the later stages of the translational research spectrum, Community Engagement in Research and Comparative Effectiveness Research, are ideal for approaching this challenge collaboratively. The Clinical and Translational Science Institute of Southeastern Wisconsin convened academics and community-based organizations familiar with these fields of research in a 1-day workshop to establish an initial dialogue on similarities and differences with a goal of exploring ways to operationalize a collective effort. Participants represented four academic institutions and twelve other healthcare and community-based service organizations. Primary fields of study included community engaged research, comparative effectiveness research, psychology, clinical research, administration, nursing, public health, education, and other professionals. This initial report outlines the results of this diverse discussion and provides insights into the priorities, diverging issues, and areas for future examination and practice. Key discoveries reveal clear crosscutting issues, value in philosophical and provocative discussions among investigators, a need for practice and lessons learned, and bidirectional exchange with community representation. © 2014 Wiley Periodicals, Inc.

The Knowledge Program: an Innovative, Comprehensive Electronic Data Capture System and Warehouse

PubMed Central

Katzan, Irene; Speck, Micheal; Dopler, Chris; Urchek, John; Bielawski, Kay; Dunphy, Cheryl; Jehi, Lara; Bae, Charles; Parchman, Alandra

2011-01-01

Data contained in the electronic health record (EHR) present a tremendous opportunity to improve quality-of-care and enhance research capabilities. However, the EHR is not structured to provide data for such purposes: most clinical information is entered as free text and content varies substantially between providers. Discrete information on patients’ functional status is typically not collected. Data extraction tools are often unavailable. We have developed the Knowledge Program (KP), a comprehensive initiative to improve the collection of discrete clinical information into the EHR and the retrievability of data for use in research, quality, and patient care. A distinct feature of the KP is the systematic collection of patient-reported outcomes, which is captured discretely, allowing more refined analyses of care outcomes. The KP capitalizes on features of the Epic EHR and utilizes an external IT infrastructure distinct from Epic for enhanced functionality. Here, we describe the development and implementation of the KP. PMID:22195124

An organizational intervention to influence evidence-informed decision making in home health nursing.

PubMed

Gifford, Wendy; Lefebre, Nancy; Davies, Barbara

2014-01-01

The aims of this study were to field test and evaluate a series of organizational strategies to promote evidence-informed decision making (EIDM) by nurse managers and clinical leaders in home healthcare. EIDM is central to delivering high-quality and effective healthcare. Barriers exist and organizational strategies are needed to support EIDM. Management and clinical leaders from 4 units participated in a 20-week organization-focused intervention. Preintervention (n = 32) and postintervention (n = 17) surveys and semistructured interviews (n = 15) were completed. Statistically significant increases were found on 4 of 31 survey items reflecting an increased organizational capacity for participants to acquire and apply research evidence in decision making. Support from designated facilitators with advanced skills in finding, appraising, and applying research was the highest rated intervention strategy. Results are useful to inform the development of organizational infrastructures to increase EIDM capacity in community-based healthcare organizations.

The RD-Connect Registry & Biobank Finder: a tool for sharing aggregated data and metadata among rare disease researchers.

PubMed

Gainotti, Sabina; Torreri, Paola; Wang, Chiuhui Mary; Reihs, Robert; Mueller, Heimo; Heslop, Emma; Roos, Marco; Badowska, Dorota Mazena; de Paulis, Federico; Kodra, Yllka; Carta, Claudio; Martìn, Estrella Lopez; Miller, Vanessa Rangel; Filocamo, Mirella; Mora, Marina; Thompson, Mark; Rubinstein, Yaffa; Posada de la Paz, Manuel; Monaco, Lucia; Lochmüller, Hanns; Taruscio, Domenica

2018-05-01

In rare disease (RD) research, there is a huge need to systematically collect biomaterials, phenotypic, and genomic data in a standardized way and to make them findable, accessible, interoperable and reusable (FAIR). RD-Connect is a 6 years global infrastructure project initiated in November 2012 that links genomic data with patient registries, biobanks, and clinical bioinformatics tools to create a central research resource for RDs. Here, we present RD-Connect Registry & Biobank Finder, a tool that helps RD researchers to find RD biobanks and registries and provide information on the availability and accessibility of content in each database. The finder concentrates information that is currently sparse on different repositories (inventories, websites, scientific journals, technical reports, etc.), including aggregated data and metadata from participating databases. Aggregated data provided by the finder, if appropriately checked, can be used by researchers who are trying to estimate the prevalence of a RD, to organize a clinical trial on a RD, or to estimate the volume of patients seen by different clinical centers. The finder is also a portal to other RD-Connect tools, providing a link to the RD-Connect Sample Catalogue, a large inventory of RD biological samples available in participating biobanks for RD research. There are several kinds of users and potential uses for the RD-Connect Registry & Biobank Finder, including researchers collaborating with academia and the industry, dealing with the questions of basic, translational, and/or clinical research. As of November 2017, the finder is populated with aggregated data for 222 registries and 21 biobanks.

A primer on precision medicine informatics.

PubMed

Sboner, Andrea; Elemento, Olivier

2016-01-01

In this review, we describe key components of a computational infrastructure for a precision medicine program that is based on clinical-grade genomic sequencing. Specific aspects covered in this review include software components and hardware infrastructure, reporting, integration into Electronic Health Records for routine clinical use and regulatory aspects. We emphasize informatics components related to reproducibility and reliability in genomic testing, regulatory compliance, traceability and documentation of processes, integration into clinical workflows, privacy requirements, prioritization and interpretation of results to report based on clinical needs, rapidly evolving knowledge base of genomic alterations and clinical treatments and return of results in a timely and predictable fashion. We also seek to differentiate between the use of precision medicine in germline and cancer. © The Author 2015. Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

Capacity for research in minority health: the need for infrastructure plus will.

PubMed

Pearson, T A

2001-11-01

Cardiovascular mortality has continued to decline, but racial disparities in cardiovascular diseases (CVD) continue to grow. To build the capacity to address these racial disparities, two things will be required. First, a research and policy infrastructure must be in place to provide guidance on what to do and how to do it. Second, the will to implement and activate this infrastructure must be present at the community and policy-making levels. The Jackson Heart Study is an example of a research infrastructure with the economic resources, scientific expertise, and technical manpower required to monitor, organize, assess, and follow a cohort of individuals over time to study the burden, natural history, predictive factors, and level of care for CVD in an African American community. The creation of will within the community for CVD research may require additional strategies than in the majority community, such as community organization and local policy development. These additional efforts at the community level should create a fertile environment to develop research and, ultimately, test strategies for reducing national disparities in cardiovascular health.

Transforming Our Cities: High-Performance Green Infrastructure (WERF Report INFR1R11)

EPA Science Inventory

The objective of this project is to demonstrate that the highly distributed real-time control (DRTC) technologies for green infrastructure being developed by the research team can play a critical role in transforming our nation’s urban infrastructure. These technologies include a...

Software Reuse Methods to Improve Technological Infrastructure for e-Science

NASA Technical Reports Server (NTRS)

Marshall, James J.; Downs, Robert R.; Mattmann, Chris A.

2011-01-01

Social computing has the potential to contribute to scientific research. Ongoing developments in information and communications technology improve capabilities for enabling scientific research, including research fostered by social computing capabilities. The recent emergence of e-Science practices has demonstrated the benefits from improvements in the technological infrastructure, or cyber-infrastructure, that has been developed to support science. Cloud computing is one example of this e-Science trend. Our own work in the area of software reuse offers methods that can be used to improve new technological development, including cloud computing capabilities, to support scientific research practices. In this paper, we focus on software reuse and its potential to contribute to the development and evaluation of information systems and related services designed to support new capabilities for conducting scientific research.

Sustaining Research Networks: the Twenty-Year Experience of the HMO Research Network

PubMed Central

Steiner, John F.; Paolino, Andrea R.; Thompson, Ella E.; Larson, Eric B.

2014-01-01

Purpose: As multi-institutional research networks assume a central role in clinical research, they must address the challenge of sustainability. Despite its importance, the concept of network sustainability has received little attention in the literature, and the sustainability strategies of durable scientific networks have not been described. Innovation: The Health Maintenance Organization Research Network (HMORN) is a consortium of 18 research departments in integrated health care delivery systems with over 15 million members in the United States and Israel. The HMORN has coordinated federally funded scientific networks and studies since 1994. This case study describes the HMORN approach to sustainability, proposes an operational definition of network sustainability, and identifies 10 essential elements that can enhance sustainability. Credibility: The sustainability framework proposed here is drawn from prior publications on organizational issues by HMORN investigators and from the experience of recent HMORN leaders and senior staff. Conclusion and Discussion: Network sustainability can be defined as (1) the development and enhancement of shared research assets to facilitate a sequence of research studies in a specific content area or multiple areas, and (2) a community of researchers and other stakeholders who reuse and develop those assets. Essential elements needed to develop the shared assets of a network include: network governance; trustworthy data and processes for sharing data; shared knowledge about research tools; administrative efficiency; physical infrastructure; and infrastructure funding. The community of researchers within a network is enhanced by: a clearly defined mission, vision and values; protection of human subjects; a culture of collaboration; and strong relationships with host organizations. While the importance of these elements varies based on the membership and goals of a network, this framework for sustainability can enhance strategic planning within the network and can guide relationships with external stakeholders. PMID:25848605

The NWRA Classification Infrastructure: description and extension to the Discriminant Analysis Flare Forecasting System (DAFFS)

NASA Astrophysics Data System (ADS)

Leka, K. D.; Barnes, Graham; Wagner, Eric

2018-04-01

A classification infrastructure built upon Discriminant Analysis (DA) has been developed at NorthWest Research Associates for examining the statistical differences between samples of two known populations. Originating to examine the physical differences between flare-quiet and flare-imminent solar active regions, we describe herein some details of the infrastructure including: parametrization of large datasets, schemes for handling "null" and "bad" data in multi-parameter analysis, application of non-parametric multi-dimensional DA, an extension through Bayes' theorem to probabilistic classification, and methods invoked for evaluating classifier success. The classifier infrastructure is applicable to a wide range of scientific questions in solar physics. We demonstrate its application to the question of distinguishing flare-imminent from flare-quiet solar active regions, updating results from the original publications that were based on different data and much smaller sample sizes. Finally, as a demonstration of "Research to Operations" efforts in the space-weather forecasting context, we present the Discriminant Analysis Flare Forecasting System (DAFFS), a near-real-time operationally-running solar flare forecasting tool that was developed from the research-directed infrastructure.

Behavioral and social sciences at the National Institutes of Health: Methods, measures, and data infrastructures as a scientific priority.

PubMed

Riley, William T

2017-01-01

The National Institutes of Health Office of Behavioral and Social Sciences Research (OBSSR) recently released its strategic plan for 2017-2021. This plan focuses on three equally important strategic priorities: 1) improve the synergy of basic and applied behavioral and social sciences research, 2) enhance and promote the research infrastructure, methods, and measures needed to support a more cumulative and integrated approach to behavioral and social sciences research, and 3) facilitate the adoption of behavioral and social sciences research findings in health research and in practice. This commentary focuses on scientific priority two and future directions in measurement science, technology, data infrastructure, behavioral ontologies, and big data methods and analytics that have the potential to transform the behavioral and social sciences into more cumulative, data rich sciences that more efficiently build on prior research. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Resilience in social insect infrastructure systems

PubMed Central

2016-01-01

Both human and insect societies depend on complex and highly coordinated infrastructure systems, such as communication networks, supply chains and transportation networks. Like human-designed infrastructure systems, those of social insects are regularly subject to disruptions such as natural disasters, blockages or breaks in the transportation network, fluctuations in supply and/or demand, outbreaks of disease and loss of individuals. Unlike human-designed systems, there is no deliberate planning or centralized control system; rather, individual insects make simple decisions based on local information. How do these highly decentralized, leaderless systems deal with disruption? What factors make a social insect system resilient, and which factors lead to its collapse? In this review, we bring together literature on resilience in three key social insect infrastructure systems: transportation networks, supply chains and communication networks. We describe how systems differentially invest in three pathways to resilience: resistance, redirection or reconstruction. We suggest that investment in particular resistance pathways is related to the severity and frequency of disturbance. In the final section, we lay out a prospectus for future research. Human infrastructure networks are rapidly becoming decentralized and interconnected; indeed, more like social insect infrastructures. Human infrastructure management might therefore learn from social insect researchers, who can in turn make use of the mature analytical and simulation tools developed for the study of human infrastructure resilience. PMID:26962030

DOE Office of Scientific and Technical Information (OSTI.GOV)

National Research Council

The United States has jurisdiction over 3.4 million square miles of ocean expanse greater than the land area of all fifty states combined. This vast marine area offers researchers opportunities to investigate the ocean's role in an integrated Earth system, but also presents challenges to society, including damaging tsunamis and hurricanes, industrial accidents, and outbreaks of waterborne diseases. The 2010 Gulf of Mexico Deepwater Horizon oil spill and 2011 Japanese earthquake and tsunami are vivid reminders that a broad range of infrastructure is needed to advance our still-incomplete understanding of the ocean. The National Research Council (NRC)'s Ocean Studies Boardmore » was asked by the National Science and Technology Council's Subcommittee on Ocean Science and Technology, comprised of 25 U.S. government agencies, to examine infrastructure needs for ocean research in the year 2030. This request reflects concern, among a myriad of marine issues, over the present state of aging and obsolete infrastructure, insufficient capacity, growing technological gaps, and declining national leadership in marine technological development; issues brought to the nation's attention in 2004 by the U.S. Commission on Ocean Policy. A 15-member committee of experts identified four themes that encompass 32 future ocean research questions enabling stewardship of the environment, protecting life and property, promoting economic vitality, and increasing fundamental scientific understanding. Many of the questions in the report (e.g., sea level rise, sustainable fisheries, the global water cycle) reflect challenging, multidisciplinary science questions that are clearly relevant today, and are likely to take decades of effort to solve. As such, U.S. ocean research will require a growing suite of ocean infrastructure for a range of activities, such as high quality, sustained time series observations or autonomous monitoring at a broad range of spatial and temporal scales. Consequently, a coordinated national plan for making future strategic investments becomes an imperative to address societal needs. Such a plan should be based upon known priorities and should be reviewed every 5-10 years to optimize the federal investment. The committee examined the past 20 years of technological advances and ocean infrastructure investments (such as the rise in use of self-propelled, uncrewed, underwater autonomous vehicles), assessed infrastructure that would be required to address future ocean research questions, and characterized ocean infrastructure trends for 2030. One conclusion was that ships will continue to be essential, especially because they provide a platform for enabling other infrastructure autonomous and remotely operated vehicles; samplers and sensors; moorings and cabled systems; and perhaps most importantly, the human assets of scientists, technical staff, and students. A comprehensive, long-term research fleet plan should be implemented in order to retain access to the sea. The current report also calls for continuing U.S. capability to access fully and partially ice-covered seas; supporting innovation, particularly the development of biogeochemical sensors; enhancing computing and modeling capacity and capability; establishing broadly accessible data management facilities; and increasing interdisciplinary education and promoting a technically-skilled workforce. The committee also provided a framework for prioritizing future investment in ocean infrastructure. They recommend that development, maintenance, or replacement of ocean research infrastructure assets should be prioritized in terms of societal benefit, with particular consideration given to usefulness for addressing important science questions; affordability, efficiency, and longevity; and ability to contribute to other missions or applications. These criteria are the foundation for prioritizing ocean research infrastructure investments by estimating the economic costs and benefits of each potential infrastructure investment, and funding those investments that collectively produce the largest expected net benefit over time. While this type of process is clearly subject to budget constraints, it could quantify the often informal evaluation of linkages between infrastructure, ocean research, the value of information produced, societal objectives, and economic benefits. Addressing the numerous complex science questions facing the entire ocean research enterprise in 2030 from government to academia, industry to nonprofits, local to global scale represents a major challenge, requiring collaboration across the breadth of the ocean sciences community and nearly seamless coordination between ocean-related federal agencies.« less

75 FR 54915 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Sensory System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

... DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993--Sensory System for Critical Infrastructure Defect Recognition, Visualization and... Critical Infrastructure Defect Recognition, Visualization and Failure Prediction ('Sensory System'') has...

Research Challenges in Water Infrastructure Condition Assessment, Rehabilitation and System Optimization – The U.S. Perspective

EPA Science Inventory

This presentation first provides an overview of U.S.EPA research activities on water infrastructure condition assessment, system rehabilitation, and asset management. It then describes in detail specific activities in pipe leak detection, water conservation and the advanced wate...

Sustainability Considerations for Health Research and Analytic Data Infrastructures

PubMed Central

Wilcox, Adam; Randhawa, Gurvaneet; Embi, Peter; Cao, Hui; Kuperman, Gilad J.

2014-01-01

Introduction: The United States has made recent large investments in creating data infrastructures to support the important goals of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER), with still more investment planned. These initial investments, while critical to the creation of the infrastructures, are not expected to sustain them much beyond the initial development. To provide the maximum benefit, the infrastructures need to be sustained through innovative financing models while providing value to PCOR and CER researchers. Sustainability Factors: Based on our experience with creating flexible sustainability strategies (i.e., strategies that are adaptive to the different characteristics and opportunities of a resource or infrastructure), we define specific factors that are important considerations in developing a sustainability strategy. These factors include assets, expansion, complexity, and stakeholders. Each factor is described, with examples of how it is applied. These factors are dimensions of variation in different resources, to which a sustainability strategy should adapt. Summary Observations: We also identify specific important considerations for maintaining an infrastructure, so that the long-term intended benefits can be realized. These observations are presented as lessons learned, to be applied to other sustainability efforts. We define the lessons learned, relating them to the defined sustainability factors as interactions between factors. Conclusion and Next Steps: Using perspectives and experiences from a diverse group of experts, we define broad characteristics of sustainability strategies and important observations, which can vary for different projects. Other descriptions of adaptive, flexible, and successful models of collaboration between stakeholders and data infrastructures can expand this framework by identifying other factors for sustainability, and give more concrete directions on how sustainability can be best achieved. PMID:25848610

Effects of a significant New Madrid Seismic Zone event on oil and natural gas pipelines and their cascading effects to critical infrastructures

NASA Astrophysics Data System (ADS)

Fields, Damon E.

Critical Infrastructure Protection (CIP) is a construct that relates preparedness and responsiveness to natural or man-made disasters that involve vulnerable assets deemed essential for the functioning of our economy and society. Infrastructure systems (power grids, bridges, airports, etc.) are vulnerable to disastrous types of events--natural or man-made. Failures of these systems can have devastating effects on communities and entire regions. CIP relates our willingness, ability, and capability to defend, mitigate, and re-constitute those assets that succumb to disasters affecting one or more infrastructure sectors. This qualitative research utilized ethnography and employed interviews with subject matter experts (SMEs) from various fields of study regarding CIP with respect to oil and natural gas pipelines in the New Madrid Seismic Zone. The study focused on the research question: What can be done to mitigate vulnerabilities in the oil and natural gas infrastructures, along with the potential cascading effects to interdependent systems, associated with a New Madrid fault event? The researcher also analyzed National Level Exercises (NLE) and real world events, and associated After Action Reports (AAR) and Lessons Learned (LL) in order to place a holistic lens across all infrastructures and their dependencies and interdependencies. Three main themes related to the research question emerged: (a) preparedness, (b) mitigation, and (c) impacts. These themes comprised several dimensions: (a) redundancy, (b) node hardening, (c) education, (d) infrastructure damage, (e) cascading effects, (f) interdependencies, (g) exercises, and (h) earthquake readiness. As themes and dimensions are analyzed, they are considered against findings in AARs and LL from previous real world events and large scale exercise events for validation or rejection.

MillionTreesNYC, Green infrastructure, and urban ecology: building a research agenda

Treesearch

Jacqueline W.T. Lu; Megan Shane; Erika Svendsen; Lindsay Campbell; Cristiana Fragola; Marianne Krasny; Gina Lovasl; David Maddox; Simon McDonnell; P. Timon McPhearson; Franco Montalto; Andrew Newman; Ellen Pehek; Ruth A. Rae; Richard Stedman; Keith G. Tidball; Lynne Westphal; Tom Whitlow

2009-01-01

MillionTreesNYC is a citywide, public-private initiative with an ambitious goal: to plant and care for one million new trees across New York City's five boroughs by 2017. The Spring 2009 workshop MillionTreesNYC, Green Infrastructure, and Urban Ecology: Building a Research Agenda brought together more than 100 researchers, practitioners and New York City...

The Infrastructure of Open Educational Resources

ERIC Educational Resources Information Center

Smith, Marshall S.; Wang, Phoenix M.

2007-01-01

The success of OER is likely to depend on a flexible, extendable infrastructure that will meet the challenges of an evolving World Wide Web. In this article, the authors examine three key dimensions of this infrastructure--technical, legal/cultural/social/political, and research--and discuss possible directions for development. (Contains 1 table…

77 FR 43416 - ITS Industry Forum on Connected Vehicles: Moving From Research Towards Implementation; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-24

..., Vehicle-to-Infrastructure, and Testing programs; along with a special session discussing lessons learned... evolving in terms of a robust Vehicle-to- Infrastructure environment, and identify what we have learned... wireless communication between vehicles, infrastructure, and personal communications devices to [[Page...

Optimizing Estimates of Impervious Cover and Riparian Zone Condition in New England Watersheds: A Green Infrastructure Analysis.

EPA Science Inventory

Under EPA’s Green Infrastructure Initiative, a variety of research activities are underway to evaluate the effectiveness of green infrastructure in mitigating the effects of urbanization and stormwater impacts on stream biota and habitat. Effectiveness of both site-scale st...

An Architecture for the Integration of Clinical Data from a PEHR in a Regional Research Platform.

PubMed

Schreiweis, Björn; Bronsch, Tobias; Stein, Katharina E; Nöst, Stefan; Aguduri, Lakshmi S; Brandner, Antje; Pensold, Peter; Weiss, Nicolas; Yüksekogul, Nilay; Bergh, Björn; Heinze, Oliver

2016-01-01

Making clinical information available for research is not only relevant for healthcare institutions, but also for regional EHRs, as cross-sectorial information can be made accessible. In the INFOPAT (INFOrmation technology for PATient-oriented health care in the Rhine-Neckar metropolitan region) project we are thus implementing both, a regional personal cross-enterprise electronic health record (PEHR) and a regional research platform (RRP) based on information from the PEHR. IHE profiles are implemented to achieve interoperability between healthcare institutions electronic medical records (EMR) and PEHR on the one hand, as well as PEHR and RRP on the other hand. The use case for the RRP is cross-sectorial quality assessment and improvement for colorectal cancer based on a quality indicator (QI) approach including patients' perspectives. For semantic interoperability the responses are transferred in the form of HL7 CDA L2 documents. The resulting architecture for a RRP shows that implementing a PEHR in combination with a RRP based on international communication standards is possible. Also IHE XDS can be used for integration of patient care and biomedical research infrastructures.

Digital liver biopsy: Bio-imaging of fatty liver for translational and clinical research.

PubMed

Mancini, Marcello; Summers, Paul; Faita, Francesco; Brunetto, Maurizia R; Callea, Francesco; De Nicola, Andrea; Di Lascio, Nicole; Farinati, Fabio; Gastaldelli, Amalia; Gridelli, Bruno; Mirabelli, Peppino; Neri, Emanuele; Salvadori, Piero A; Rebelos, Eleni; Tiribelli, Claudio; Valenti, Luca; Salvatore, Marco; Bonino, Ferruccio

2018-02-27

The rapidly growing field of functional, molecular and structural bio-imaging is providing an extraordinary new opportunity to overcome the limits of invasive liver biopsy and introduce a "digital biopsy" for in vivo study of liver pathophysiology. To foster the application of bio-imaging in clinical and translational research, there is a need to standardize the methods of both acquisition and the storage of the bio-images of the liver. It can be hoped that the combination of digital, liquid and histologic liver biopsies will provide an innovative synergistic tri-dimensional approach to identifying new aetiologies, diagnostic and prognostic biomarkers and therapeutic targets for the optimization of personalized therapy of liver diseases and liver cancer. A group of experts of different disciplines (Special Interest Group for Personalized Hepatology of the Italian Association for the Study of the Liver, Institute for Biostructures and Bio-imaging of the National Research Council and Bio-banking and Biomolecular Resources Research Infrastructure) discussed criteria, methods and guidelines for facilitating the requisite application of data collection. This manuscript provides a multi-Author review of the issue with special focus on fatty liver.

Gait biomechanics in the era of data science.

PubMed

Ferber, Reed; Osis, Sean T; Hicks, Jennifer L; Delp, Scott L

2016-12-08

Data science has transformed fields such as computer vision and economics. The ability of modern data science methods to extract insights from large, complex, heterogeneous, and noisy datasets is beginning to provide a powerful complement to the traditional approaches of experimental motion capture and biomechanical modeling. The purpose of this article is to provide a perspective on how data science methods can be incorporated into our field to advance our understanding of gait biomechanics and improve treatment planning procedures. We provide examples of how data science approaches have been applied to biomechanical data. We then discuss the challenges that remain for effectively using data science approaches in clinical gait analysis and gait biomechanics research, including the need for new tools, better infrastructure and incentives for sharing data, and education across the disciplines of biomechanics and data science. By addressing these challenges, we can revolutionize treatment planning and biomechanics research by capitalizing on the wealth of knowledge gained by gait researchers over the past decades and the vast, but often siloed, data that are collected in clinical and research laboratories around the world. Copyright © 2016 Elsevier Ltd. All rights reserved.

Modeling track access charge to enhance railway industry performance

NASA Astrophysics Data System (ADS)

Berawi, Mohammed Ali; Miraj, Perdana; Berawi, Abdur Rohim Boy; Susantono, Bambang; Leviakangas, Pekka; Radiansyah, Hendra

2017-11-01

Indonesia attempts to improve nation's competitiveness by increasing the quality and the availability of railway network. However, the infrastructure improperly managed by the operator in terms of the technical issue. One of the reasons for this problem is an unbalanced value of infrastructure charge. In 2000's track access charge and infrastructure maintenance and operation for Indonesia railways are equal and despite current formula of the infrastructure charge, issues of transparency and accountability still in question. This research aims to produce an alternative scheme of track access charge by considering marginal cost plus markup (MC+) approach. The research combines qualitative and quantitative method through an in-depth interview and financial analysis. The result will generate alternative formula of infrastructure charge in Indonesia's railway industry. The simulation also conducted to estimate track access charge for the operator and to forecast government support in terms of subsidy. The result is expected to enhance railway industry performance and competitiveness.

Collaborative Paradigm of Preventive, Personalized, and Precision Medicine With Point-of-Care Technologies.

PubMed

Dhawan, Atam P

2016-01-01

Recent advances in biosensors, medical instrumentation, and information processing and communication technologies (ICT) have enabled significant improvements in healthcare. However, these technologies have been mainly applied in clinical environments, such as hospitals and healthcare facilities, under managed care by well-trained and specialized individuals. The global challenge of providing quality healthcare at affordable cost leads to the proposed paradigm of P reventive, Personalized, and Precision Medicine that requires a seamless use of technology and infrastructure support for patients and healthcare providers at point-of-care (POC) locations including homes, semi or pre-clinical facilities, and hospitals. The complexity of the global healthcare challenge necessitates strong collaborative interdisciplinary synergies involving all stakeholder groups including academia, federal research institutions, industry, regulatory agencies, and clinical communities. It is critical to evolve with collaborative efforts on the translation of research to technology development toward clinical validation and potential healthcare applications. This special issue is focused on technology innovation and translational research for POC applications with potential impact in improving global healthcare in the respective areas. Some of these papers were presented at the NIH-IEEE Strategic Conference on Healthcare Innovations and POC Technologies for Precision Medicine (HI-POCT) held at the NIH on November 9-10, 2015. The papers included in the Special Issue provide a spectrum of critical issues and collaborative resources on translational research of advanced POC devices and ICT into global healthcare environment.

Institutional shared resources and translational cancer research.

PubMed

De Paoli, Paolo

2009-06-29

The development and maintenance of adequate shared infrastructures is considered a major goal for academic centers promoting translational research programs. Among infrastructures favoring translational research, centralized facilities characterized by shared, multidisciplinary use of expensive laboratory instrumentation, or by complex computer hardware and software and/or by high professional skills are necessary to maintain or improve institutional scientific competitiveness. The success or failure of a shared resource program also depends on the choice of appropriate institutional policies and requires an effective institutional governance regarding decisions on staffing, existence and composition of advisory committees, policies and of defined mechanisms of reporting, budgeting and financial support of each resource. Shared Resources represent a widely diffused model to sustain cancer research; in fact, web sites from an impressive number of research Institutes and Universities in the U.S. contain pages dedicated to the SR that have been established in each Center, making a complete view of the situation impossible. However, a nation-wide overview of how Cancer Centers develop SR programs is available on the web site for NCI-designated Cancer Centers in the U.S., while in Europe, information is available for individual Cancer centers. This article will briefly summarize the institutional policies, the organizational needs, the characteristics, scientific aims, and future developments of SRs necessary to develop effective translational research programs in oncology.In fact, the physical build-up of SRs per se is not sufficient for the successful translation of biomedical research. Appropriate policies to improve the academic culture in collaboration, the availability of educational programs for translational investigators, the existence of administrative facilitations for translational research and an efficient organization supporting clinical trial recruitment and management represent essential tools, providing solutions to overcome existing barriers in the development of translational research in biomedical research centers.

Institutional shared resources and translational cancer research

PubMed Central

De Paoli, Paolo

2009-01-01

The development and maintenance of adequate shared infrastructures is considered a major goal for academic centers promoting translational research programs. Among infrastructures favoring translational research, centralized facilities characterized by shared, multidisciplinary use of expensive laboratory instrumentation, or by complex computer hardware and software and/or by high professional skills are necessary to maintain or improve institutional scientific competitiveness. The success or failure of a shared resource program also depends on the choice of appropriate institutional policies and requires an effective institutional governance regarding decisions on staffing, existence and composition of advisory committees, policies and of defined mechanisms of reporting, budgeting and financial support of each resource. Shared Resources represent a widely diffused model to sustain cancer research; in fact, web sites from an impressive number of research Institutes and Universities in the U.S. contain pages dedicated to the SR that have been established in each Center, making a complete view of the situation impossible. However, a nation-wide overview of how Cancer Centers develop SR programs is available on the web site for NCI-designated Cancer Centers in the U.S., while in Europe, information is available for individual Cancer centers. This article will briefly summarize the institutional policies, the organizational needs, the characteristics, scientific aims, and future developments of SRs necessary to develop effective translational research programs in oncology. In fact, the physical build-up of SRs per se is not sufficient for the successful translation of biomedical research. Appropriate policies to improve the academic culture in collaboration, the availability of educational programs for translational investigators, the existence of administrative facilitations for translational research and an efficient organization supporting clinical trial recruitment and management represent essential tools, providing solutions to overcome existing barriers in the development of translational research in biomedical research centers. PMID:19563639

RMS: a platform for managing cross-disciplinary and multi-institutional research project collaboration.

PubMed

Luo, Jake; Apperson-Hansen, Carolyn; Pelfrey, Clara M; Zhang, Guo-Qiang

2014-11-30

Cross-institutional cross-disciplinary collaboration has become a trend as researchers move toward building more productive and innovative teams for scientific research. Research collaboration is significantly changing the organizational structure and strategies used in the clinical and translational science domain. However, due to the obstacles of diverse administrative structures, differences in area of expertise, and communication barriers, establishing and managing a cross-institutional research project is still a challenging task. We address these challenges by creating an integrated informatics platform to reduce the barriers to biomedical research collaboration. The Request Management System (RMS) is an informatics infrastructure designed to transform a patchwork of expertise and resources into an integrated support network. The RMS facilitates investigators' initiation of new collaborative projects and supports the management of the collaboration process. In RMS, experts and their knowledge areas are categorized and managed structurally to provide consistent service. A role-based collaborative workflow is tightly integrated with domain experts and services to streamline and monitor the life-cycle of a research project. The RMS has so far tracked over 1,500 investigators with over 4,800 tasks. The research network based on the data collected in RMS illustrated that the investigators' collaborative projects increased close to 3 times from 2009 to 2012. Our experience with RMS indicates that the platform reduces barriers for cross-institutional collaboration of biomedical research projects. Building a new generation of infrastructure to enhance cross-disciplinary and multi-institutional collaboration has become an important yet challenging task. In this paper, we share the experience of developing and utilizing a collaborative project management system. The results of this study demonstrate that a web-based integrated informatics platform can facilitate and increase research interactions among investigators.