Science.gov

Sample records for clinic researchers discover

  1. Discovering Related Clinical Concepts Using Large Amounts of Clinical Notes.

    PubMed

    Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren

    2016-01-01

    The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases. PMID:27656096

  2. Discovering Related Clinical Concepts Using Large Amounts of Clinical Notes

    PubMed Central

    Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren

    2016-01-01

    The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases. PMID:27656096

  3. Discovering Related Clinical Concepts Using Large Amounts of Clinical Notes.

    PubMed

    Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren

    2016-01-01

    The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases.

  4. Discovering Related Clinical Concepts Using Large Amounts of Clinical Notes

    PubMed Central

    Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren

    2016-01-01

    The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases.

  5. Genetics Research Discovered in a Bestseller | Poster

    Cancer.gov

    By Nancy Parrish, Staff Writer One morning in early January, Amar Klar sat down at his computer and found an e-mail with a curious message from a colleague. While reading a bestselling novel, The Marriage Plot by Jeffrey Eugenides, his colleague, a professor at Princeton University, found a description of research on yeast genetics that was surprisingly similar to Klar’s early research. Even the laboratory in the novel was reminiscent of Cold Spring Harbor Laboratory, where Klar had conducted his research.

  6. Discovering cancer biomarkers from clinical samples by protein microarrays.

    PubMed

    Hu, Bin; Niu, Xin; Cheng, Li; Yang, Li-Na; Li, Qing; Wang, Yang; Tao, Sheng-Ce; Zhou, Shu-Min

    2015-02-01

    Cancer biomarkers are of potential use in early cancer diagnosis, anticancer therapy development, and monitoring the responses to treatments. Protein-based cancer biomarkers are major forms in use, as they are much easier to be monitored in body fluids or tissues. For cancer biomarker discovery, high-throughput techniques such as protein microarrays hold great promises, because they are capable of global unbiased monitoring but with a miniaturized format. In doing so, novel and cancer type specific biomarkers can be systematically discovered at an affordable cost. In this review, we give a relatively complete picture on protein microarrays applied to clinical samples for cancer biomarker discovery, and conclude this review with the future perspectives. PMID:25523829

  7. Clinical Research and Clinical Trials

    MedlinePlus

    ... you can get involved. Doing your own clinical research project? Then select the Guidance for Clinical Researchers link to learn more about the NICHD's clinical research processes and policies. Last Reviewed: 03/06/2012 ...

  8. Lipidomics applications for discovering biomarkers of diseases in clinical chemistry.

    PubMed

    Zhao, Ying-Yong; Cheng, Xian-long; Lin, Rui-Chao

    2014-01-01

    Lipids are the fundamental components of biological membranes as well as the metabolites of organisms. Lipids play diverse and important roles in biologicals. The lipid imbalance is closely associated with numerous human lifestyle-related diseases, such as atherosclerosis, obesity, diabetes, and Alzheimer's disease. Lipidomics or lipid profiling is a system-based study of all lipids aiming at comprehensive analysis of lipids in the biological system. Lipidomics has been accepted as a lipid-related research tool in lipid biochemistry, clinical biomarker discovery, disease diagnosis, and in understanding disease pathology. Lipidomics will not only provide insights into the specific functions of lipid species in health and disease, but will also identify potential biomarkers for establishing preventive or therapeutic programs for human diseases. This review presents an overview of lipidomics followed by in-depth discussion of its application to the study of human diseases, including extraction methods of lipids, analytical technologies, data analysis, and clinical research in cancer, neuropsychiatric disease, cardiovascular disease, kidney disease, and respiratory disease. We describe the current status of the identification of metabolic biomarkers in different diseases. We also discuss the lipidomics for the future perspectives and their potential problems. The application of lipidomics in clinical studies may provide new insights into lipid profiling and pathophysiological mechanisms.

  9. Sir Alexander Fleming: Scottish researcher who discovered penicillin.

    PubMed

    Ligon, B Lee

    2004-01-01

    The discovery and development of penicillin changed the entire direction of approaches to treating infectious diseases and saved the lives of millions of people. Indeed, the development of penicillin was a watershed event in the battle against infectious diseases, and the individual who discovered it, Sir Alexander Fleming, remains a prominent individual in the annals of medical history. This article focuses primarily on the personal life of Alexander Fleming, an individual who had a remarkable diversity of interests and who made many contributions to science and medicine.

  10. Research Areas - Clinical Trials

    Cancer.gov

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  11. Discovering Letters and Sounds. Research in Practice Series

    ERIC Educational Resources Information Center

    Topfer; Christine

    2007-01-01

    The Research in Practice Series has been developed to provide practical, easy to read, up-to-date information and support to a growing national readership of early childhood workers. Letters and sounds are the foundation blocks for communication -- the pathway to success in school and life. Topfer explains how to use games and activities involving…

  12. Surprising the Writer: Discovering Details through Research and Reading.

    ERIC Educational Resources Information Center

    Broaddus, Karen; Ivey, Gay

    2002-01-01

    Describes how students parallel the process of author Megan McDonald in conducting research and collecting information to provide ideas for the form and content of their writing. Notes that guiding students to record and organize information in a graphic format helps them to transfer those interesting details to new types of writing. (SG)

  13. Clinical Research Methodology 2: Observational Clinical Research.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.

  14. Mining a clinical data warehouse to discover disease-finding associations using co-occurrence statistics.

    PubMed

    Cao, Hui; Markatou, Marianthi; Melton, Genevieve B; Chiang, Michael F; Hripcsak, George

    2005-01-01

    This paper applies co-occurrence statistics to discover disease-finding associations in a clinical data warehouse. We used two methods, chi2 statistics and the proportion confidence interval (PCI) method, to measure the dependence of pairs of diseases and findings, and then used heuristic cutoff values for association selection. An intrinsic evaluation showed that 94 percent of disease-finding associations obtained by chi2 statistics and 76.8 percent obtained by the PCI method were true associations. The selected associations were used to construct knowledge bases of disease-finding relations (KB-chi2, KB-PCI). An extrinsic evaluation showed that both KB-chi2 and KB-PCI could assist in eliminating clinically non-informative and redundant findings from problem lists generated by our automated problem list summarization system.

  15. Mining a clinical data warehouse to discover disease-finding associations using co-occurrence statistics

    PubMed Central

    Cao, Hui; Markatou, Marianthi; Melton, Genevieve B.; Chiang, Michael F.; Hripcsak, George

    2005-01-01

    This paper applies co-occurrence statistics to discover disease-finding associations in a clinical data warehouse. We used two methods, χ2 statistics and the proportion confidence interval (PCI) method, to measure the dependence of pairs of diseases and findings, and then used heuristic cutoff values for association selection. An intrinsic evaluation showed that 94 percent of disease-finding associations obtained by χ2 statistics and 76.8 percent obtained by the PCI method were true associations. The selected associations were used to construct knowledge bases of disease-finding relations (KB-χ2, KB-PCI). An extrinsic evaluation showed that both KB-χ2 and KB-PCI could assist in eliminating clinically non-informative and redundant findings from problem lists generated by our automated problem list summarization system. PMID:16779011

  16. Discovering Inexpensive, Effective Catalysts for Solar Energy Conversion: An Authentic Research Laboratory Experience

    ERIC Educational Resources Information Center

    Shaner, Sarah E.; Hooker, Paul D.; Nickel, Anne-Marie; Leichtfuss, Amanda R.; Adams, Carissa S.; de la Cerda, Dionisia; She, Yuqi; Gerken, James B.; Pokhrel, Ravi; Ambrose, Nicholas J.; Khaliqi, David; Stahl, Shannon S.; Schuttlefield Christus, Jennifer D.

    2016-01-01

    Electrochemical water oxidation is a major focus of solar energy conversion efforts. A new laboratory experiment has been developed that utilizes real-time, hands-on research to discover catalysts for solar energy conversion. The HARPOON, or Heterogeneous Anodes Rapidly Perused for Oxygen Overpotential Neutralization, experiment allows an array of…

  17. Developing a clinical research career.

    PubMed

    Nicholson, Caroline

    The National Institute for Health Research helps to promote clinical research careers for health professionals working in clinical practice, and has developed a structure to support new researchers. This article explains how nurses can get involved in clinical research and the support available to them. PMID:27491187

  18. Rare Diseases Clinical Research Network

    MedlinePlus

    ... RDCRN? Aims of the Rare Diseases Clinical Research Network Contact Us RDCRN Members Login Accessibility Disclaimer The Rare Diseases Clinical Research Network is an initiative of the Office of Rare ...

  19. Gaining approval for clinical research.

    PubMed

    Cobb, Vanessa; Srinivasan, Neil; Lambiase, Pier

    2016-07-01

    Set-up and delivery of a clinical research project can be complicated and difficult. This article introduces the regulatory processes involved in gaining approval for clinical research and discusses the obstacles that may be encountered. PMID:27388381

  20. Research ethics for clinical researchers.

    PubMed

    Harnett, John D; Neuman, Richard

    2015-01-01

    This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.

  1. Research &Discover: A Pipeline of the Next Generation of Earth System Scientists

    NASA Astrophysics Data System (ADS)

    Hurtt, G. C.; Einaudi, F.; Moore, B.; Salomonson, V.; Campbell, J.

    2006-12-01

    In 2002, the University of New Hampshire (UNH) and NASA Goddard Space Flight Center (GSFC) started the educational initiative Research &Discover with the goals to: (i) recruit outstanding young scientists into research careers in Earth science and Earth remote sensing (broadly defined), and (ii) support Earth science graduate students enrolled at UNH through a program of collaborative partnerships with GSFC scientists and UNH faculty. To meet these goals, the program consists of a linked set of educational opportunities that begins with a paid summer research internship at UNH for students following their Junior year of college, and is followed by a second paid summer internship at GSFC for students following their Senior year of college. These summer internships are then followed by two-year fellowship opportunities at UNH for graduate studies jointly supervised by UNH faculty and GSFC scientists. After 5 years of implementation, the program has awarded summer research internships to 22 students, and graduate research fellowships to 6 students. These students have produced more than 78 scientific research presentations, 5 undergraduate theses, 2 Masters theses, and 4 peer-reviewed publications. More than 80% of alums are actively pursuing careers in Earth sciences now. In the process, the program has engaged 19 faculty from UNH and 15 scientists from GSFC as advisors/mentors. New collaborations between these scientists have resulted in new joint research proposals, and the development, delivery, and assessment of a new course in Earth System Science at UNH. Research &Discover represents an educational model of collaboration between a national lab and university to create a pipeline of the next generation of Earth system scientists.

  2. Career pathways in research: clinical research.

    PubMed

    Kenkre, J E; Foxcroft, D R

    This article, the second in a series on career pathways, informs readers of the knowledge they require to conduct clinical therapeutic trials to recognised standards. Many nurses start their careers in research as clinical research nurses. The skills and knowledge they develop through conducting multi-centre studies gives them an excellent grounding in the discipline, organisation and management of research.

  3. Clinical research in allied health.

    PubMed

    Selker, L G

    1994-01-01

    Allied health professionals in nutrition and medical dietetics, occupational therapy, physical therapy, and speech-language pathology and audiology play both unique and key cross-cutting roles in the furtherance of clinical research. Clinical research in nutrition and medical dietetics uniquely focuses on food nutrient intake and the metabolic utilization of nutrients. Clinical research in occupational therapy has a special focus on the relationship of impairment to disability, the adaptation to disability and the maximization of function. Physical therapy clinical research uniquely targets movement dysfunction and its evaluation and treatment within the context of quality and effective care. Clinical research in speech-language pathology and audiology is singular in its focus on deafness and hearing disorders, voice, speech, language and related disorders, and intersections among these and other neurological and physical conditions. Thus, all of these disciplines are making unique contributions to clinical research. Clinical research in these allied health professions is much more than the above specific foci. Inasmuch as these disciplines are rooted in practice, their contributions to research are inherently clinical. Many, if not most, of these contributions represent further validations of clinical practice or its underlying knowledge base. This means that, at a macro level, clinical research in allied health is very much "applied" research. Within allied health clinical research, this emphasis is redoubled at the "person," or individual level, where considerable attention is given to concepts of function and effectiveness. Clinical research in allied health has played a key cross-cutting role through its emphasis on collaboration. Possibly due to their professional maturation within multidisciplinary academic units, allied health professionals have demonstrated a level of comfort with multidisciplinary and interdisciplinary collaborations unique within many

  4. Clinical research before informed consent.

    PubMed

    Miller, Franklin G

    2014-06-01

    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  5. Clinical research: a globalized network.

    PubMed

    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.

  6. Personal Computers in Clinical Research

    PubMed Central

    McAlister, Neil; Andrews, David

    1984-01-01

    Personal computers have proved useful in several identifiable areas of clinical research support. However, they have limitations. Popular microcomputer systems typically fail to meet all of the traditional data processing requirements of serious clinical investigators — usually because of software restrictions. Objective evaluation of the strengths and weaknesses of these small systems, and particularly of their software, ensures effective use of research budgets and personnel. An analysis of clinical research needs that personal computers serve well, and of those that they serve poorly, is therefore presented.

  7. Insurance in clinical research

    PubMed Central

    Ghooi, Ravindra B.; Divekar, Deepa

    2014-01-01

    Aims and Objectives: Sponsors need to pay for management of all serious adverse events suffered by subjects in a clinical trial and to compensate for injuries or deaths related to the trial. This study examines if insurance policies of trials, cover all contingencies that require reimbursement or compensation. Materials and Methods: Insurance policies of trials submitted to Sahyadri Hospitals between January 2013 and December 2013 were studied, with respect to the policy period, the limit of liability, deductibles, and preconditions if any. Results: All the policies studied had some deficiencies, in one respect or the other and none had a provision to pay full compensation if required. Some insurers have put in preconditions that could jeopardize the payment of compensation to subjects. Conclusions: Insurances are complicated documents, and need to be critically examined by the ethics committee before approval of the study documents. PMID:25276622

  8. Yoga clinical research review.

    PubMed

    Field, Tiffany

    2011-02-01

    In this paper recent research is reviewed on the effects of yoga poses on psychological conditions including anxiety and depression, on pain syndromes, cardiovascular, autoimmune and immune conditions and on pregnancy. Further, the physiological effects of yoga including decreased heartrate and blood pressure and the physical effects including weight loss and increased muscle strength are reviewed. Finally, potential underlying mechanisms are proposed including the stimulation of pressure receptors leading to enhanced vagal activity and reduced cortisol. The reduction in cortisol, in turn, may contribute to positive effects such as enhanced immune function and a lower prematurity rate.

  9. Promise and Pragmatism in Clinical Microbiome Research.

    PubMed

    Ajami, Nadim J; Hutchinson, Diane S; Petrosino, Joseph F

    2015-01-01

    The evolution of human microbiome research has lead to a systems biology approach that encompasses multidisciplinary investigations. The implementation of next generation sequencing technologies has allowed researchers to study unculturable organisms, discover novel ones, and provide insights into the role of the human microbiome in health and disease. When these approaches are applied to large-scale longitudinal studies designed to interrogate the association of the microbiome with specific clinical outcomes, the development of new therapeutics and diagnostics intended to modulate or detect changes in microbiome composition to improve human health are born. We are just starting to unravel the role of the microbiome in a wide-variety of diseases, and while some of it appears to be related to causation and provide opportunities for intervention, a good dose of pragmatism is warranted as the field is still in its infancy.

  10. Aspergillus pragensis sp. nov. discovered during molecular reidentification of clinical isolates belonging to Aspergillus section Candidi

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The identity of nine clinical isolates from Czech patients presumably belonging to Aspergillus section Candidi based on morphology of colonies was revised using sequences of ß-tubulin, calmodulin, and internal transcribed spacer (ITS) rDNA. The set of isolates included six isolates from suspected (n...

  11. Methodology Rigor in Clinical Research

    PubMed Central

    Yang, Lynda J-S.; Chang, Kate W-C.; Chung, Kevin C.

    2012-01-01

    Background Methodology rigor increases the quality of clinical research by encouraging freedom from the biases inherent in clinical studies. As randomized controlled studies (clinical trial design) are rarely applicable to surgical research, we address the commonly used observational study designs and methodologies by presenting guidelines for rigor. Methods Review of study designs including cohort, case-control, and cross-sectional studies and case series/reports, as well as biases and confounders of study design. Results Details about biases and confounders at each study stage, study characteristics, rigor checklists, and published literature examples for each study design are summarized and presented in this report. Conclusions For those surgeons interested in pursuing clinical research, mastery of the principles of methodology rigor is imperative in of the context of evidence-based medicine and widespread publication of clinical studies. Knowledge of the study designs, their appropriate application, and strictly adhering to study design methods can provide high-quality evidence to serve as the basis for rational clinical decision-making. PMID:22634695

  12. Discovering and annotating fish early life-stage (FELS) adverse outcome pathways: Putting the research strategy into practice

    EPA Science Inventory

    In May 2012, a HESI-sponsored expert workshop yielded a proposed research strategy for systematically discovering, characterizing, and annotating fish early life-stage (FELS) adverse outcome pathways (AOPs) as well as prioritizing AOP development in light of current restrictions ...

  13. Aspergillus pragensis sp. nov. discovered during molecular reidentification of clinical isolates belonging to Aspergillus section Candidi.

    PubMed

    Hubka, Vit; Lyskova, Pavlina; Frisvad, Jens C; Peterson, Stephen W; Skorepova, Magdalena; Kolarik, Miroslav

    2014-08-01

    The identity of nine clinical isolates recovered from Czech patients and presumptively identified as Aspergillus sp. section Candidi based on colony morphology was revised using sequences of β-tubulin, calmodulin gene sequence, and internal transcribed spacer rDNA. Six isolates were from suspected and proven onychomycosis, one from otitis externa, and two associated with probable invasive aspergillosis. The results showed that one Aspergillus candidus isolate was the cause of otitis externa, and both isolates obtained from sputa of patients with probable invasive aspergillosis were reidentified as A. carneus (sect. Terrei) and A. flavus (sect. Flavi). Three isolates from nail scrapings were identified as A. tritici, a verified agent of nondermatophyte onychomycosis. One isolate from toenail was determined to be A. candidus and the two isolates belonged to a hitherto undescribed species, Aspergillus pragensis sp. nov. This species is well supported by phylogenetic analysis based on β-tubulin and calmodulin gene and is distinguishable from other members of sect. Candidi by red-brown reverse on malt extract agar, slow growth on Czapek-Dox agar and inability to grow at 37°C. A secondary metabolite analysis was also provided with comparison of metabolite spectrum to other species. Section Candidi now encompasses five species for which a dichotomous key based on colony characteristics is provided. All clinical isolates were tested for susceptibilities to selected antifungal agents using the Etest and disc diffusion method. Overall sect. Candidi members are highly susceptible to common antifungals.

  14. Dive and Discover: Bringing Oceanographic Research into the Classroom and to the General Public

    NASA Astrophysics Data System (ADS)

    Fornari, D. J.; Fino, D.; Humphris, S. E.; Fruth, L. L.; Dean, S.

    2001-12-01

    We have developed the "Dive and Discover" web site for use in classrooms and for the general public to provide near real-time, daily access to oceanographic research expeditions, particularly those using deep submergence vehicles operated by Woods Hole Oceanographic Institution. The site was one of five science sites nominated for a 2001 Webby Award, was selected by Scientific American as one of the top five sites in the category of earth and environmental science, and was one of Eisenhower National Clearinghouse's "digital dozen" for science resources. The web site consists of two major components. A series of educational modules provide both general educational information about the oceans and the people that study them, as well as cruise-specific information about the natural systems being studied, the participating scientists, and the data and sample-collecting methodologies and technologies being used. The second component consists of modules that allow access to near real-time updates of the progress of the cruise, images of seafloor features and animals, samples of data being collected and used on board, and general information about life on board. In addition, a Mail Buoy provides e-mail access for students to ask questions of the scientists on board the ship during the course of the expedition. COSI Toledo have a linked Educator's Companion that gives access to COSI project management tips, background information, activities, correlations to national science education standards, assessment tools, and a vast array of resources to assist educators in using the web site. We have worked with teachers and students from all over the United States to test, evaluate, and refine the web site during five cruises in the Pacific and Indian Oceans over the last two years. These cruises focused on various problems associated with mid-ocean ridge volcanism, and the chemical, physical and biological processes associated with seafloor hydrothermal activity. Our intention

  15. Can research influence clinical practice?

    PubMed

    Jiménez, Juan Pablo

    2007-06-01

    After briefly reviewing the unfavourable reception accorded empirical research by parts of the psychoanalytic community, as well as some of the benefits to clinical practice of analysts being involved in research activities, the author examines whether the findings of process and outcome research in psychotherapy and psychoanalysis can help identify the most appropriate forms of intervention for producing therapeutic change, given the specific condition of the patient and the relationship that the individual establishes with the analyst. He argues that research findings can influence clinical practice on various levels and in different areas, and goes on to examine a number of related issues: the specificity of therapeutic interventions versus the relevance of common curative factors; the dyadic conception of technique and ways of understanding the therapeutic action of the treatment alliance; and the strategic or heuristic conception in psychoanalytic therapy. Finally, the author presents clinical material with the aim of illustrating how the knowledge acquired through research can be applied to psychoanalytic treatment. PMID:17537698

  16. New restriction enzymes discovered from Escherichia coli clinical strains using a plasmid transformation method.

    PubMed

    Kasarjian, Julie K A; Iida, Masatake; Ryu, Junichi

    2003-03-01

    The presence of restriction enzymes in bacterial cells has been predicted by either classical phage restriction-modification (R-M) tests, direct in vitro enzyme assays or more recently from bacterial genome sequence analysis. We have applied phage R-M test principles to the transformation of plasmid DNA and established a plasmid R-M test. To validate this test, six plasmids that contain BamHI fragments of phage lambda DNA were constructed and transformed into Escherichia coli strains containing known R-M systems including: type I (EcoBI, EcoAI, Eco124I), type II (HindIII) and type III (EcoP1I). Plasmid DNA with a single recognition site showed a reduction of relative efficiency of transformation (EOT = 10(-1)-10(-2)). When multiple recognition sites were present, greater reductions in EOT values were observed. Once established in the cell, the plasmids were subjected to modification (EOT = 1.0). We applied this test to screen E.coli clinical strains and detected the presence of restriction enzymes in 93% (14/15) of cells. Using additional subclones and the computer program, RM Search, we identified four new restriction enzymes, Eco377I, Eco585I, Eco646I and Eco777I, along with their recognition sequences, GGA(8N)ATGC, GCC(6N)TGCG, CCA(7N)CTTC, and GGA(6N)TATC, respectively. Eco1158I, an isoschizomer of EcoBI, was also found in this study.

  17. Statistical Research on the Bioactivity of New Marine Natural Products Discovered during the 28 Years from 1985 to 2012

    PubMed Central

    Hu, Yiwen; Chen, Jiahui; Hu, Guping; Yu, Jianchen; Zhu, Xun; Lin, Yongcheng; Chen, Shengping; Yuan, Jie

    2015-01-01

    Every year, hundreds of new compounds are discovered from the metabolites of marine organisms. Finding new and useful compounds is one of the crucial drivers for this field of research. Here we describe the statistics of bioactive compounds discovered from marine organisms from 1985 to 2012. This work is based on our database, which contains information on more than 15,000 chemical substances including 4196 bioactive marine natural products. We performed a comprehensive statistical analysis to understand the characteristics of the novel bioactive compounds and detail temporal trends, chemical structures, species distribution, and research progress. We hope this meta-analysis will provide useful information for research into the bioactivity of marine natural products and drug development. PMID:25574736

  18. Evolution of neurotoxins: from research modalities to clinical realities.

    PubMed

    Kostrzewa, Richard M

    2009-01-01

    In the 1950s, the discovery of anti-nerve growth factor, an immunotoxin stunting sympathetic neural development, signaled the advent of neurotoxins as research modalities. Other selective neurotoxins were discovered in rapid succession. In the 1960s, 6-hydroxydopamine and 6-hydroxydopa were shown to destroy noradrenergic and dopaminergic nerves. Excitotoxins (glutamate, aspartate, and analogs) were discovered in the 1970s. DSP-4 [N-(2-chloroethyl)-N-ethyl-2-bromobenzylamine] proved to be selective for noradrenergic destruction, while 5,6- and 5,7-dihydroxytryptamines were relatively selective for serotonin neurons. Additional neurotoxins were discovered, but it was MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine) that predominated neurotoxicity research in the 1980s. Eventually, Clostridium botulinum neurotoxin (BoNT), discovered as a "poisonous" principle in the late 1800s, resurfaced in purified and standardized forms as a clinically useful drug. Neurotoxins represent chemical tools, useful not only for discerning neuronal mechanisms and animal modeling of neurological disorders, but also for their use in medicine and potential as treatments for medical disorders. This unit reviews the early discovery of neurotoxins, describes categories of neurotoxins, and finally characterizes their usefulness--first as research tools, and eventually as clinical therapeutic agents.

  19. Clinical Epidemiology Unit - overview of research areas

    Cancer.gov

    Clinical Epidemiology Unit (CEU) conducts etiologic research with potential clinical and public health applications, and leads studies evaluating population-based early detection and cancer prevention strategies

  20. Discover Earth

    NASA Technical Reports Server (NTRS)

    Steele, Colleen

    1998-01-01

    Discover Earth is a NASA-sponsored project for teachers of grades 5-12, designed to: (1) enhance understanding of the Earth as an integrated system; (2) enhance the interdisciplinary approach to science instruction; and (3) provide classroom materials that focus on those goals. Discover Earth is conducted by the Institute for Global Environmental Strategies in collaboration with Dr. Eric Barron, Director, Earth System Science Center, The Pennsylvania State University; and Dr. Robert Hudson, Chair, the Department of Meteorology, University of Maryland at College Park. The enclosed materials: (1) represent only part of the Discover Earth materials; (2) were developed by classroom teachers who are participating in the Discover Earth project; (3) utilize an investigative approach and on-line data; and (4) can be effectively adjusted to classrooms with greater/without technology access. The Discover Earth classroom materials focus on the Earth system and key issues of global climate change including topics such as the greenhouse effect, clouds and Earth's radiation balance, surface hydrology and land cover, and volcanoes and climate change. All the materials developed to date are available on line at (http://www.strategies.org) You are encouraged to submit comments and recommendations about these materials to the Discover Earth project manager, contact information is listed below. You are welcome to duplicate all these materials.

  1. Clinical and Technical Phosphoproteomic Research

    PubMed Central

    2011-01-01

    An encouraging approach for the diagnosis and effective therapy of immunological pathologies, which would include cancer, is the identification of proteins and phosphorylated proteins. Disease proteomics, in particular, is a potentially useful method for this purpose. A key role is played by protein phosphorylation in the regulation of normal immunology disorders and targets for several new cancer drugs and drug candidates are cancer cells and protein kinases. Protein phosphorylation is a highly dynamic process. The functioning of new drugs is of major importance as is the selection of those patients who would respond best to a specific treatment regime. In all major aspects of cellular life signalling networks are key elements which play a major role in inter- and intracellular communications. They are involved in diverse processes such as cell-cycle progression, cellular metabolism, cell-cell communication and appropriate response to the cellular environment. A whole range of networks that are involved in the regulation of cell development, differentiation, proliferation, apoptosis, and immunologic responses is contained in the latter. It is so necessary to understand and monitor kinase signalling pathways in order to understand many immunology pathologies. Enrichment of phosphorylated proteins or peptides from tissue or bodily fluid samples is required. The application of technologies such as immunoproteomic techniques, phosphoenrichments and mass spectrometry (MS) is crucial for the identification and quantification of protein phosphorylation sites in order to advance in clinical research. Pharmacodynamic readouts of disease states and cellular drug responses in tumour samples will be provided as the field develops. We aim to detail the current and most useful techniques with research examples to isolate and carry out clinical phosphoproteomic studies which may be helpful for immunology and cancer research. Different phosphopeptide enrichment and quantitative

  2. [Discovering pathways for health research in dealing with the social movement].

    PubMed

    Smeke, E L

    1993-01-01

    This article is about methodology for scientific research in health, where the researcher is an important part of the object of investigation. The implementation of a broad-based Health Reform in Brazil depends on the involvement of users. It is important to guarantee these social rights. Many experiences sharing this concern are going on in this country. Still, research on the relationship between institutional work in health and the Social Movement lacks a predefined methodology. Therefore, the main objectives of this study are the following: to contribute to the discussion of possible ways of approaching the mechanisms of relationships between health and users of health services, and to collaborate with the development of the citizenship process. This work was done through theoretical research on participatory methodology and "action-based research". The following aspects are particularly important: definition of the object of study, self-positioning by the researcher, subjective explanations, documentary surveys and interviews for case studies, and feedback to theory. Finally, the author concludes that this methodology allows for an understanding of some mechanisms that explain the relationship between macro- and micro-structural analyses. In addition, one also observes a maturation process in the research protagonists.

  3. Qualitative research in clinical epidemiology.

    PubMed

    Gregory, Deborah M; Way, Christine Y

    2015-01-01

    This chapter has been written to specifically address the usefulness of qualitative research for the practice of clinical epidemiology. The methods of grounded theory to facilitate understanding of human behavior and construction of monitoring scales for use in quantitative studies are discussed. In end-stage renal disease patients receiving long-term hemodialysis, a qualitative study used grounded theory to generate a multilayered classification system, which culminated in a substantive theory on living with end-stage renal disease and hemodialysis. The qualitative data base was re-visited for the purpose of scale development and led to the Patient Perception of Hemodialysis Scale (PPHS). The quantitative study confirmed that the PPHS was psychometrically valid and reliable and supported the major premises of the substantive theory. PMID:25694318

  4. Qualitative research in clinical epidemiology.

    PubMed

    Gregory, Deborah M; Way, Christine Y

    2015-01-01

    This chapter has been written to specifically address the usefulness of qualitative research for the practice of clinical epidemiology. The methods of grounded theory to facilitate understanding of human behavior and construction of monitoring scales for use in quantitative studies are discussed. In end-stage renal disease patients receiving long-term hemodialysis, a qualitative study used grounded theory to generate a multilayered classification system, which culminated in a substantive theory on living with end-stage renal disease and hemodialysis. The qualitative data base was re-visited for the purpose of scale development and led to the Patient Perception of Hemodialysis Scale (PPHS). The quantitative study confirmed that the PPHS was psychometrically valid and reliable and supported the major premises of the substantive theory.

  5. Principles for the ethical analysis of clinical and translational research

    PubMed Central

    Gelfond, Jonathan A. L.; Heitman, Elizabeth; Pollock, Brad H.; Klugman, Craig M.

    2013-01-01

    Statistical analysis is a cornerstone of the scientific method and evidence-based medicine, and statisticians serve an increasingly important role in clinical and translational research by providing objective evidence concerning the risks and benefits of novel therapeutics. Researchers rely on statistics and informatics as never before to generate and test hypotheses and to discover patterns of disease hidden within overwhelming amounts of data. Too often, clinicians and biomedical scientists are not adequately proficient in statistics to analyze data or interpret results, and statistical expertise may not be properly incorporated within the research process. We argue for the ethical imperative of statistical standards, and we present ten nontechnical principles that form a conceptual framework for the ethical application of statistics in clinical and translational research. These principles are drawn from the literature on the ethics of data analysis and the American Statistical Association Ethical Guidelines for Statistical Practice. PMID:21751225

  6. Discovering Deserts.

    ERIC Educational Resources Information Center

    Braus, Judy, Ed.

    1985-01-01

    Ranger Rick's NatureScope is a creative education series dedicated to inspiring in children an understanding and appreciation of the natural world while developing the skills they will need to make responsible decisions about the environment. The topic of this issue is "Discovering Deserts." Contents are organized into the following sections: (1)…

  7. Discovering "What's Innovative": The Challenge of Evaluating Education Research and Development Efforts

    ERIC Educational Resources Information Center

    Yin, Robert K.; Hackett, Edward J.; Chubin, Daryl E.

    2008-01-01

    National Science Foundation's (NSF's) MSP Program seeks foremost "to improve student outcomes in high-quality mathematics and science by all students, at all pre-K-12 levels". The MSP Program, consisting of a portfolio of funded projects, in part positions itself as a research and development (R&D) program. This study has addressed the need to…

  8. Island Explorations: Discovering Effects of Environmental Research-Based Lab Activities on Analytical Chemistry Students

    ERIC Educational Resources Information Center

    Tomasik, Janice Hall; LeCaptain, Dale; Murphy, Sarah; Martin, Mary; Knight, Rachel M.; Harke, Maureen A.; Burke, Ryan; Beck, Kara; Acevedo-Polakovich, I. David

    2014-01-01

    Motivating students in analytical chemistry can be challenging, in part because of the complexity and breadth of topics involved. Some methods that help encourage students and convey real-world relevancy of the material include incorporating environmental issues, research-based lab experiments, and service learning projects. In this paper, we…

  9. Clinical research and the development of medical therapeutics.

    PubMed

    Antman, Elliott M

    2014-01-01

    Clinical research plays a central role in the development of medical therapeutics, but the current system is estimated to take 10-15 years from initial discovery to regulatory approval, at a cost of approximately US$1 billion. Contrast the paths by which 2 anticoagulant options for atrial fibrillation were discovered and ultimately established as treatment options in clinical medicine. Warfarin was discovered by serendipity and compared with placebo in relatively small trials; this was associated with a low cost of development. The new oral anticoagulants were synthesized to provide highly specific, targeted inhibition of critical steps in the coagulation system. They were compared with warfarin for prevention of stroke and systemic embolic events in large, phase 3 trials; this resulted in very expensive development programs. Neither of these paths is desirable for future development of therapeutics. We need to focus on innovative approaches at the preclinical level (systems approach, greater use of inducible pluripotent stem cells, use of novel bioengineering platforms) and clinical trial level (adaptive design, greater use of new and emerging technology). Focusing on disruptive innovations for development of medical therapeutics has the potential to bring us closer to the goal of precision medicine where safer, more effective treatments are discovered in a more efficient system. PMID:24837573

  10. [Clinical research XXIV. From clinical judgment to ethics in research on humans].

    PubMed

    Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O

    2014-01-01

    Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.

  11. Translational Bioinformatics and Clinical Research (Biomedical) Informatics.

    PubMed

    Sirintrapun, S Joseph; Zehir, Ahmet; Syed, Aijazuddin; Gao, JianJiong; Schultz, Nikolaus; Cheng, Donavan T

    2016-03-01

    Translational bioinformatics and clinical research (biomedical) informatics are the primary domains related to informatics activities that support translational research. Translational bioinformatics focuses on computational techniques in genetics, molecular biology, and systems biology. Clinical research (biomedical) informatics involves the use of informatics in discovery and management of new knowledge relating to health and disease. This article details 3 projects that are hybrid applications of translational bioinformatics and clinical research (biomedical) informatics: The Cancer Genome Atlas, the cBioPortal for Cancer Genomics, and the Memorial Sloan Kettering Cancer Center clinical variants and results database, all designed to facilitate insights into cancer biology and clinical/therapeutic correlations.

  12. Translational Bioinformatics and Clinical Research (Biomedical) Informatics.

    PubMed

    Sirintrapun, S Joseph; Zehir, Ahmet; Syed, Aijazuddin; Gao, JianJiong; Schultz, Nikolaus; Cheng, Donavan T

    2015-06-01

    Translational bioinformatics and clinical research (biomedical) informatics are the primary domains related to informatics activities that support translational research. Translational bioinformatics focuses on computational techniques in genetics, molecular biology, and systems biology. Clinical research (biomedical) informatics involves the use of informatics in discovery and management of new knowledge relating to health and disease. This article details 3 projects that are hybrid applications of translational bioinformatics and clinical research (biomedical) informatics: The Cancer Genome Atlas, the cBioPortal for Cancer Genomics, and the Memorial Sloan Kettering Cancer Center clinical variants and results database, all designed to facilitate insights into cancer biology and clinical/therapeutic correlations.

  13. Measuring Clinical Significance in Rehabilitation Research

    ERIC Educational Resources Information Center

    Johnson, Erica K.; Dow, Christian; Lynch, Ruth T.; Hermann, Bruce P.

    2006-01-01

    Measurement of clinically significant change is critical for rehabilitation research because it can enhance the credibility of rehabilitation efforts and guide evidence-based practices. The practical appeal of clinically significant change is that it can bridge research and clinical practice by focusing on individual rather than group differences.…

  14. Discover Earth

    NASA Technical Reports Server (NTRS)

    1997-01-01

    Discover Earth is a NASA-funded project for teachers of grades 5-12 who want to expand their knowledge of the Earth system, and prepare to become master teachers who promote Earth system science in their own schools, counties, and throughout their state. Participants from the following states are invited to apply: Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, and Washington, DC. Teachers selected for the project participate in a two-week summer workshop conducted at the University of Maryland, College Park; develop classroom-ready materials during the workshop for broad dissemination; conduct a minimum of two peer training activities during the coming school year; and participate in other enrichment/education opportunities as available and desired. Discover Earth is a team effort that utilizes expertise from a range of contributors, and balances science content with hands-on classroom applications.

  15. Discover Earth

    NASA Technical Reports Server (NTRS)

    Steele, Colleen

    1996-01-01

    Discover Earth is a NASA-funded project for teachers of grades 5-12 who want to expand their knowledge of the Earth system, and prepare to become master teachers who promote Earth system science in their own schools, counties, and throughout their state. Participants from the following states are invited to apply: Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, and Washington, DC. Teachers selected for the project participate in a two-week summer workshop conducted at the University of Maryland, College Park; develop classroom-ready materials during the workshop for broad dissemination; conduct a minimum of two peer training activities during the coming school year; and participate in other enrichment/education opportunities as available and desired. Discover Earth is a team effort that utilizes expertise from a range of contributors, and balances science content with hands-on classroom applications.

  16. Learning from experience: Using action research to discover consumer needs in post-seclusion debriefing.

    PubMed

    Ryan, Rob; Happell, Brenda

    2009-04-01

    Approximately 16% of consumers are secluded during an inpatient admission. Despite the harmful psychological consequences resulting from the use of physical force, restraint, control, and temporary sequestration of therapeutic communication, there is little evidence of nursing practices to support consumers who are secluded. This paper will outline the findings from an action research project examining post-seclusion debriefing practice. A series of focus groups was undertaken with mental health nurses (MHN) and consumer consultants (CC) to investigate current practice, identify consumer/clinician preferences, and scope future practice possibilities. The findings suggest that CC need assistance in dealing with the negative feelings evoked by seclusion. MHN use a range of approaches for debriefing; however, these sometimes do not meet consumer preferences. MHN focus on explaining why seclusion happened and how to avoid it. While mitigation is a critical issue, CC want more emotional support from debriefing. MHN saw the possibility of using the debriefing to support consumers' transit from seclusion to high-dependency status and then to low-dependency status. Opinions raised regarding the potential for CC to have a role in debriefing were divided. The findings will be used to inform the development of a consumer debriefing training program for MHN and CC.

  17. Clinical nursing research: you can do it!

    PubMed

    Zadinsky, J K; Broome, M E

    1989-01-01

    Nurses can use clinical nursing research to strengthen the knowledge base of their practice and to develop effective nursing interventions. When planning and implementing their studies, nurses must anticipate and deal with important issues concerning the realities of clinical nursing research. These issues include developing the research question, planning for an optimal sample size, passing the Institutional Review Committee, managing conflicts between clinical and research roles, selecting instruments to measure the variables, collecting data in a clinical setting, analyzing and interpreting the data, funding the proposed study, and ensuring administrative support.

  18. Best practice & research in anaesthesiology issue on new approaches in clinical research ethics in clinical research.

    PubMed

    Schwenzer, Karen J

    2011-12-01

    The history of ethics in clinical research parallels the history of abuse of human beings. The Nuremberg Code, Declaration of Helsinki, and the Belmont Report laid the foundations for modern research ethics. In the United States, the OHRP and the FDA provide guidelines for the ethical conduct of research. Investigators should be familiar with regulations concerning informed consent, doing research in vulnerable populations, and protection of privacy.

  19. Clinical research: what do patients understand?

    PubMed

    Erlen, J A

    2000-01-01

    An increasing amount of clinical research is being conducted to test the efficacy and effectiveness of new medications, therapies, and medical procedures. These studies often require that patients be invited to be subjects. However, what do patients really understand whenever they are asked to participate in clinical research? Are patients aware that research is clearly different from treatment? Are they aware that their participation in research is to benefit future patients? Despite the desire of clinical agencies to support research, there is the concern about how they can best protect the rights of patients who are subjects in this research. The author briefly discusses clinical research, patients as vulnerable subjects, the therapeutic misconception, and informed consent. In addition, recommendations are provided to help assure that the rights of patients who are research subjects are protected.

  20. Providing semantic interoperability between clinical care and clinical research domains.

    PubMed

    Laleci, Gokce Banu; Yuksel, Mustafa; Dogac, Asuman

    2013-03-01

    Improving the efficiency with which clinical research studies are conducted can lead to faster medication innovation and decreased time to market for new drugs. To increase this efficiency, the parties involved in a regulated clinical research study, namely, the sponsor, the clinical investigator and the regulatory body, each with their own software applications, need to exchange data seamlessly. However, currently, the clinical research and the clinical care domains are quite disconnected because each use different standards and terminology systems. In this article, we describe an initial implementation of the Semantic Framework developed within the scope of SALUS project to achieve interoperability between the clinical research and the clinical care domains. In our Semantic Framework, the core ontology developed for semantic mediation is based on the shared conceptual model of both of these domains provided by the BRIDG initiative. The core ontology is then aligned with the extracted semantic models of the existing clinical care and research standards as well as with the ontological representations of the terminology systems to create a model of meaning for enabling semantic mediation. Although SALUS is a research and development effort rather than a product, the current SALUS knowledge base contains around 4.7 million triples representing BRIDG DAM, HL7 CDA model, CDISC standards and several terminology ontologies. In order to keep the reasoning process within acceptable limits without sacrificing the quality of mediation, we took an engineering approach by developing a number of heuristic mechanisms. The results indicate that it is possible to build a robust and scalable semantic framework with a solid theoretical foundation for achieving interoperability between the clinical research and clinical care domains.

  1. Providing semantic interoperability between clinical care and clinical research domains.

    PubMed

    Laleci, Gokce Banu; Yuksel, Mustafa; Dogac, Asuman

    2013-03-01

    Improving the efficiency with which clinical research studies are conducted can lead to faster medication innovation and decreased time to market for new drugs. To increase this efficiency, the parties involved in a regulated clinical research study, namely, the sponsor, the clinical investigator and the regulatory body, each with their own software applications, need to exchange data seamlessly. However, currently, the clinical research and the clinical care domains are quite disconnected because each use different standards and terminology systems. In this article, we describe an initial implementation of the Semantic Framework developed within the scope of SALUS project to achieve interoperability between the clinical research and the clinical care domains. In our Semantic Framework, the core ontology developed for semantic mediation is based on the shared conceptual model of both of these domains provided by the BRIDG initiative. The core ontology is then aligned with the extracted semantic models of the existing clinical care and research standards as well as with the ontological representations of the terminology systems to create a model of meaning for enabling semantic mediation. Although SALUS is a research and development effort rather than a product, the current SALUS knowledge base contains around 4.7 million triples representing BRIDG DAM, HL7 CDA model, CDISC standards and several terminology ontologies. In order to keep the reasoning process within acceptable limits without sacrificing the quality of mediation, we took an engineering approach by developing a number of heuristic mechanisms. The results indicate that it is possible to build a robust and scalable semantic framework with a solid theoretical foundation for achieving interoperability between the clinical research and clinical care domains. PMID:23008263

  2. Clinical Psychology: A Research and Development Model.

    ERIC Educational Resources Information Center

    Broskowski, Anthony

    The purpose of this paper is to present a clinical research and development (R and D) model along with the rationale for its implementation and a sample training program for clinical psychologists. Although it may be possible to correct some problems by a clearer restatement of the scientist-professional model, a new model of clinical R and D has…

  3. Career pathways in research: clinical practice.

    PubMed

    Foxcroft, K J

    This article, the first in a five-part series on career pathways, discusses the facility for nurses to develop their clinical expertise to consultant level, which is an exciting development on the career pathway for nurses in clinical practice. The introduction of consultant nurses has re-emphasised the need for experienced leadership in research and practice development in clinical settings.

  4. Methodology in clinical sleep research.

    PubMed

    Rosa, A; Poyares, D; Moraes, W; Cintra, F

    2007-05-01

    This review presents traditional and cutting-edge interventions in sleep research, including descriptions of the relationship of rapid eye movement-non-rapid eye movement sleep with the autonomous nervous system, and dream research methodology. Although sleep and dreaming are overlapping and non- separable phenomena, they are not typically addressed simultaneously in the scientific sleep research literature. Therefore, a more extensive overview of dream research has been included with a focus on objective dream content analysis and the theory of neurocognitive analysis. A bridge is made between dream content analysis and current sleep research methodologies.

  5. [Women, forgotten by clinical research].

    PubMed

    Potterat, M M; Monnin, Y; Pechère, A; Guessous, I

    2015-09-23

    For years, women were underrepresented in clinical studies. But the effect of many drugs differ among women and men, due to pharmacokinetic and pharmacodynamic differences. As a result, there is a lack of information on therapeutic or adverse effets of drugs and, more generally, a lack of knowledge on diseases, leading more frequently to sub-optimal medical care in women. This underrepresentation is due to various factors, including the social role of women or ethical issues about pregnancy. The need for adequate representation of women in clinical studies is a social as well as medical concern, that implies political and legal changes. PMID:26591785

  6. Autism: Clinical and Research Issues.

    ERIC Educational Resources Information Center

    Accardo, Pasquale J., Ed.; Magnusen, Christy, Ed.; Capute, Arnold J., Ed.

    This text examines the characteristics that define autism: impairments in communication; abnormal social development; and clinically significant odd behaviors. Specific chapters include: (1) Neural Mechanisms in Autism (Andrew W. Zimmerman and Barry Gordon); (2) Epidemiology of Autism and Other Pervasive Developmental Disorders: Current…

  7. Clinical research in anthroposophic medicine.

    PubMed

    Hamre, Harald Johan; Kiene, Helmut; Kienle, Gunver Sophia

    2009-01-01

    Anthroposophic medicine includes special medications and special artistic and physical therapies. More than 200 clinical studies of varying design and quality have been conducted on anthroposophic treatment. Half of these studies concern anthroposophic mistletoe therapy for cancer. Clinical effects of mistletoe products include improvement of quality of life, reduction of side effects from chemotherapy and radiation, and possibly increased survival. Apart from cancer therapy, the largest studies of anthroposophic treatment have been 2 naturalistic system evaluations: In German outpatients with mental, musculoskeletal, respiratory, and other chronic conditions, anthroposophic treatment was followed by sustained improvements of symptoms and quality of life. In primary care patients from 4 European countries and the United States treated for acute respiratory and ear infections by anthroposophic or conventional physicians, anthroposophic treatment was associated with reduced use of antibiotics and antipyretics, quicker recovery, and fewer adverse reactions; these differences remained after adjustment for relevant baseline differences.

  8. Discovering Technicolor

    NASA Astrophysics Data System (ADS)

    Andersen, J. R.; Antipin, O.; Azuelos, G.; Del Debbio, L.; Del Nobile, E.; Di Chiara, S.; Hapola, T.; Järvinen, M.; Lowdon, P. J.; Maravin, Y.; Masina, I.; Nardecchia, M.; Pica, C.; Sannino, F.

    2011-09-01

    We provide a pedagogical introduction to extensions of the Standard Model in which the Higgs is composite. These extensions are known as models of dynamical electroweak symmetry breaking or, in brief, Technicolor. Material covered includes: motivations for Technicolor, the construction of underlying gauge theories leading to minimal models of Technicolor, the comparison with electroweak precision data, the low-energy effective theory, the spectrum of the states common to most of the Technicolor models, the decays of the composite particles and the experimental signals at the Large Hadron Collider. The level of the presentation is aimed at readers familiar with the Standard Model but who have little or no prior exposure to Technicolor. Several extensions of the Standard Model featuring a composite Higgs can be reduced to the effective Lagrangian introduced in the text. We establish the relevant experimental benchmarks for Vanilla, Running, Walking, and Custodial Technicolor, and a natural fourth family of leptons, by laying out the framework to discover these models at the Large Hadron Collider.

  9. Training needs of clinical research associates.

    PubMed

    Ajay, Samyuktha; Bhatt, Arun

    2010-10-01

    Clinical research is a relatively new field in our country that has seen very rapid growth in the last few years. Availability of personnel appropriately trained to the specific requirements of the role they will perform in clinical research is critical for capacity expansion. Our study attempts to understand the specific areas of knowledge and skills that are important for the role of a clinical research associate. The survey was conducted among clinical research professionals from industry and academia who had more than five years of clinical research experience and held important decision making positions in clinical research (stakeholders). The survey questionnaire was designed as a matrix of various clinical research roles on the y-axis and six knowledge modules and eight skills on the x-axis. Respondents were asked to rate the importance of the knowledge /skills to the role of clinical research associates on a three point scale. In discussing results, a significant response was considered to be 50% or greater positive response from the total group. The significant findings were that general, ethics and clinical trial execution modules were rated as critical for the role of clinical research associate. Regulatory module was rated as important for the role. The other significant responses were that three of the sub-topics in the methodology module - framing a research proposal/protocol and experimental design, designing case report forms and EDCs and conducting PK studies - were rated as important and one sub topic in the data management and statistics module was rated as not important. All the skills except leadership skills were rated as critical for the role. The findings of our survey were in general on the lines of expectations of performance of the role. The general, ethics and clinical trial execution modules are critical knowledge areas for the role of a clinical research associate. No clear trends emerged for some of the other modules. Leadership

  10. Discovering treatment pattern in Traditional Chinese Medicine clinical cases by exploiting supervised topic model and domain knowledge.

    PubMed

    Yao, Liang; Zhang, Yin; Wei, Baogang; Wang, Wei; Zhang, Yuejiao; Ren, Xiaolin; Bian, Yali

    2015-12-01

    In Traditional Chinese Medicine (TCM), the prescription is the crystallization of clinical experience of doctors, which is the main way to cure diseases in China for thousands of years. Clinical cases, on the other hand, describe how doctors diagnose and prescribe. In this paper, we propose a framework which mines treatment patterns in TCM clinical cases by exploiting supervised topic model and TCM domain knowledge. The framework can reflect principle rules in TCM and improve function prediction of a new prescription. We evaluate our method on 3090 real world TCM clinical cases. The experiment validates the effectiveness of our method.

  11. Tremelimumab: research and clinical development

    PubMed Central

    Comin-Anduix, Begoña; Escuin-Ordinas, Helena; Ibarrondo, Francisco Javier

    2016-01-01

    The immune checkpoint therapy is a relatively recent strategy that aims to tweak the immune system to effectively attack cancer cells. The understanding of the immune responses and their regulation at the intracellular level and the development of fully humanized monoclonal antibodies are the pillars of an approach that could elicit durable clinical responses and even remission in some patients with cancer. Most of the immune checkpoints that regulate the T-cell responses (activation and inhibition) operate through proteins present on the cytoplasmic membrane of the immune cells. Therefore, specific antibodies capable of blocking the inhibitory signals should lead to unrestrained immune responses that supersede the inhibitory mechanisms, which are naturally present in the tumor microenviroment. The best-known and most successful targets for immune checkpoint therapy are the cytotoxic T-lymphocyte antigen-4 and programmed cell death-1 coreceptors. Tremelimumab (CP-675,206) is a fully humanized monoclonal antibody specific for cytotoxic T-lymphocyte antigen-4, which has been successfully used to treat patients with metastatic melanoma and some other cancers. Although still a work in progress, the use of tremelimumab as an immune checkpoint therapeutic agent is a promising approach alone or in combination with other anticancer drugs. Here, we review the use of this antibody in a number of clinical trials against solid tumors. PMID:27042127

  12. Retooling institutional support infrastructure for clinical research.

    PubMed

    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

    2016-05-01

    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 divert 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 similar transition.

  13. Retooling institutional support infrastructure for clinical research.

    PubMed

    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

    2016-05-01

    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 divert 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 similar transition. PMID:27125563

  14. CLARA: an integrated clinical research administration system.

    PubMed

    Bian, Jiang; Xie, Mengjun; Hogan, William; Hutchins, Laura; Topaloglu, Umit; Lane, Cheryl; Holland, Jennifer; Wells, Thomas

    2014-10-01

    Administration of human subject research is complex, involving not only the institutional review board but also many other regulatory and compliance entities within a research enterprise. Its efficiency has a direct and substantial impact on the conduct and management of clinical research. In this paper, we report on the Clinical Research Administration (CLARA) platform developed at the University of Arkansas for Medical Sciences. CLARA is a comprehensive web-based system that can streamline research administrative tasks such as submissions, reviews, and approval processes for both investigators and different review committees on a single integrated platform. CLARA not only helps investigators to meet regulatory requirements but also provides tools for managing other clinical research activities including budgeting, contracting, and participant schedule planning.

  15. CLARA: an integrated clinical research administration system

    PubMed Central

    Bian, Jiang; Xie, Mengjun; Hogan, William; Hutchins, Laura; Topaloglu, Umit; Lane, Cheryl; Holland, Jennifer; Wells, Thomas

    2014-01-01

    Administration of human subject research is complex, involving not only the institutional review board but also many other regulatory and compliance entities within a research enterprise. Its efficiency has a direct and substantial impact on the conduct and management of clinical research. In this paper, we report on the Clinical Research Administration (CLARA) platform developed at the University of Arkansas for Medical Sciences. CLARA is a comprehensive web-based system that can streamline research administrative tasks such as submissions, reviews, and approval processes for both investigators and different review committees on a single integrated platform. CLARA not only helps investigators to meet regulatory requirements but also provides tools for managing other clinical research activities including budgeting, contracting, and participant schedule planning. PMID:24778201

  16. Clinical Translational Research Hits the Road

    PubMed Central

    Bonuck, Karen A.; Lischewski, Jennifer; Brittner, Mindy

    2009-01-01

    Translating evidence-based research into practice requires data from clinical trials in real world settings. This paper presents “lessons learned” from the implementation of an RCT of breastfeeding promotion interventions at two busy, urban, prenatal care sites. Data were obtained via direct observations, qualitative interviews, and study statistics. Primary challenges include: time and space burdens, “research vs. service” mission conflict, and the provider learning curve for conducting interventions. Primary facilitators include: researcher presence for enhancing rapport with participants and staff, site staff labeling of both the research interview and intervention as “value added time,” and the ability of research staff to assist the clinic beyond the scope of the clinical trial. Specific suggestions are given for building collaborative bonds between the research team, clinicians, administrators, and staff in busy urban practices. PMID:19523539

  17. Ganetespib: research and clinical development

    PubMed Central

    Jhaveri, Komal; Modi, Shanu

    2015-01-01

    Under stressful conditions, the heat shock protein 90 (HSP90) molecular chaperone protects cellular proteins (client proteins) from degradation via the ubiquitin-proteasome pathway. HSP90 expression is upregulated in cancers, and this contributes to the malignant phenotype of increased proliferation and decreased apoptosis and maintenance of metastatic potential via conservation of its client proteins, including human epidermal growth factor receptor 2, anaplastic lymphoma kinase, androgen receptor, estrogen receptor, Akt, Raf-1, cell cycle proteins, and B-cell lymphoma 2 among others. Hence, inhibition of HSP90 leads to the simultaneous degradation of its many clients, thereby disrupting multiple oncogenic signaling cascades. This has sparked tremendous interest in the development of HSP90 inhibitors as an innovative anticancer strategy. Based on the wealth of compelling data from preclinical studies, a number of HSP90 inhibitors have entered into clinical testing. However, despite enormous promise and anticancer activity reported to date, none of the HSP90 inhibitors in development has been approved for cancer therapy, and the full potential of this class of agents is yet to be realized. This article provides a review on ganetespib, a small molecule HSP90 inhibitor that is currently under evaluation in a broad range of cancer types in combination with other therapeutic agents with the hope of further enhancing its efficacy and overcoming drug resistance. Based on our current understanding of the complex HSP90 machinery combined with the emerging data from these key clinical trials, ganetespib has the potential to be the first-in-class HSP90 inhibitor to be approved as a new anticancer therapy. PMID:26244021

  18. [False innovations in clinical research].

    PubMed

    Garattini, Silvio; Bertele', Vittorio

    2006-11-01

    Pharmaceutical innovation is actually poorer than it seems, largely because of "false" innovations. Various factors help create an image of novelty in the pharmaceutical area. These factors act throughout the research and development process and in the post-marketing stages affecting the selection of study hypotheses, the adoption of the appropriate study methodology, and the interpretation and publication of results. Each of these steps may be diverted from the priority objective of patients' interest and shifted towards to the defence of the drugs companies' commercial interests. Regulators, NHS, physicians and patients must be vigilant to recognise and get rid of false innovations which can prevent the use of more effective and safer drugs and waste resources useful for effective treatments in other areas. Rewarding this lack of innovation discourages research for excellence and reduces the competitiveness of the pharmaceutical industry. PMID:17252717

  19. [False innovations in clinical research].

    PubMed

    Garattini, Silvio; Bertele', Vittorio

    2006-11-01

    Pharmaceutical innovation is actually poorer than it seems, largely because of "false" innovations. Various factors help create an image of novelty in the pharmaceutical area. These factors act throughout the research and development process and in the post-marketing stages affecting the selection of study hypotheses, the adoption of the appropriate study methodology, and the interpretation and publication of results. Each of these steps may be diverted from the priority objective of patients' interest and shifted towards to the defence of the drugs companies' commercial interests. Regulators, NHS, physicians and patients must be vigilant to recognise and get rid of false innovations which can prevent the use of more effective and safer drugs and waste resources useful for effective treatments in other areas. Rewarding this lack of innovation discourages research for excellence and reduces the competitiveness of the pharmaceutical industry.

  20. Clinical anatomy research in a research-driven anatomy department.

    PubMed

    Jones, D Gareth; Dias, G J; Mercer, S; Zhang, M; Nicholson, H D

    2002-05-01

    Clinical anatomy is too often viewed as a discipline that reiterates the wisdom of the past, characterized more by description of what is known than by active investigation and critical analysis of hypotheses and ideas. Various misconceptions follow from an acceptance of this premise: the teaching of clinical anatomists is textbook based, there is no clinical anatomy research worthy of the name, and any research that does exist fails to utilize modern technology and does not stand comparison with serious biomedical research as found in cell and molecular biology. The aim of this paper is to challenge each of these contentions by reference to ongoing clinical research studies within this department. It is argued that all teaching (including that of clinical anatomy) should be research-informed and that the discipline of clinical anatomy should have at its base a vigorous research ethos driven by clinically related problems. In interacting with physicians, the role of the clinical anatomist should be to promulgate a questioning scientific spirit, with its willingness to test and challenge accepted anatomic dicta. PMID:11948960

  1. Coping Strategies in Psychiatric Clinical Research.

    ERIC Educational Resources Information Center

    Kraemer, Helena Chmura

    1981-01-01

    A broad range of strategies in sampling, measurement, design, execution, implementation, and analysis are examined. Specific strategies are suggested that tend to be successful in the real world of psychiatric clinical research. (Author)

  2. Privacy and confidentiality in clinical research.

    PubMed

    Holder, A R

    1990-01-01

    The information contained in clinical research records is often highly sensitive and personal. This article describes some of the issues that can arise with respect to preserving the confidentiality of these records.

  3. Ultrasound imaging in research and clinical medicine.

    PubMed

    Schellpfeffer, Michael A

    2013-06-01

    The use of ultrasound imaging in clinical obstetrics continues to grow at an almost exponential rate. Ultrasound imaging in developmental biology has only begun to be used to enhance the traditional methodologies to study the developing embryo/fetus. The various modalities of ultrasound imaging are reviewed as they apply to current uses in clinical obstetrics and developmental biologic research. New modalities are also discussed in both clinical obstetrics and developmental biologic research as well as the current limitations of ultrasound imaging faced in both of these fields. PMID:23897593

  4. Research misconduct among clinical trial staff.

    PubMed

    Redman, Barbara K; Templin, Thomas N; Merz, Jon F

    2006-07-01

    Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations. PMID:16909150

  5. Collaborations in Proteomics Research - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The National Cancer Institute (NCI), through the Office of Cancer Clinical Proteomics Research (OCCPR), has signed two Memorandums of Understanding (MOUs) in the sharing of proteomics reagents and protocols

  6. [Social aspect of clinical research in Poland].

    PubMed

    Masełbas, Wojciech; Czarkowski, Marek

    2007-12-01

    Each year more than 400 new clinical studies are registered in Poland. They gather above 50.000 of study participants. Social opinion on clinical trials is an important factor. The paper presents the review of actual opinions on clinical research in Poland. It provides the description of standards of protection of study participants, benefits and risks related to the participation in clinical research and the role of media in creating and influencing of the social perception of clinical trials. Results of conducted questionnaire studies imply that Poles correctly identify and assess the risk of participation in clinical experiments. The primary reason for the participation seams to be the possibility to help other patients, contribution to the progress of science and standards of medical care and potential benefits for other sufferers. The need of testing the safety and efficacy of the new medication in man is generally well recognized. At the same time a substantial part of the society is concerned with the possible corruption of investigators and unethical behaviour of sponsors. The social perception of clinical research in Poland is in majority of analyzed parameters not substantially different from opinions in other member states of EU. However, the medical society should be more active in influencing and changing some negative impressions.

  7. Ethics in clinical research: the Indian perspective.

    PubMed

    Sanmukhani, J; Tripathi, C B

    2011-03-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward. PMID:22303053

  8. Statistics in clinical research: Important considerations

    PubMed Central

    Barkan, Howard

    2015-01-01

    Statistical analysis is one of the foundations of evidence-based clinical practice, a key in conducting new clinical research and in evaluating and applying prior research. In this paper, we review the choice of statistical procedures, analyses of the associations among variables and techniques used when the clinical processes being examined are still in process. We discuss methods for building predictive models in clinical situations, and ways to assess the stability of these models and other quantitative conclusions. Techniques for comparing independent events are distinguished from those used with events in a causal chain or otherwise linked. Attention then turns to study design, to the determination of the sample size needed to make a given comparison, and to statistically negative studies. PMID:25566715

  9. How do researchers decide early clinical trials?

    PubMed

    Grankvist, Hannah; Kimmelman, Jonathan

    2016-06-01

    Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research.

  10. Current clinical research environment: focus on psychiatry.

    PubMed

    Dainesi, Sonia Mansoldo; Elkis, Helio

    2007-09-01

    The introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area.

  11. "Ethics and Clinical Research" in Biographical Perspective.

    PubMed

    Lederer, Susan E

    2016-01-01

    Henry K. Beecher (1904-1976) played an important role in the development of bioethics. His 1966 article "Ethics and Clinical Research" in the New England Journal of Medicine intensified concern about the welfare of patients participating in clinical research, and his leadership in the 1968 Harvard Ad Hoc Committee on Brain Death redefined the determination of death. Beecher deserves, and even demands, explanation and explication. This essay offers a biographical perspective on the Harvard professor. In addition to his early life and education in both Kansas and Boston, the essay explores how Beecher's experiences in World War II and in the new geopolitical realities of the Cold War shaped his views about the ethical dilemmas of clinical research. PMID:27499482

  12. Incidentally discovered goblet cell carcinoid clinically presenting as acute intestinal obstruction: a case report with review of literature.

    PubMed

    Afroz, Nishat; Shamim, Nida; Sofi, Lateef Ahmed; Rizvi, Syed Amjad Ali

    2014-01-01

    Goblet cell carcinoid (GCC) is a rare variant of carcinoid tumor that exclusively involves the appendix. It usually occurs in 5th-6th decade with the most common clinical presentation being acute appendicitis. The natural history of this tumor is intermediate between carcinoids and adenocarcinomas. We here report a case of GCC diagnosed incidentally in a patient presenting with acute intestinal obstruction. Ultrasonographic examination supported the clinical diagnosis of acute intestinal obstruction, following which the patient underwent laparotomy and resection of ileum along with appendix was done. On gross pathological examination, a nodular growth was present on the tip and body of appendix that was yellow in color with a semi-solid to mucoid consistency on cut section. On microscopy, lakes of mucin with few acinar structures floating in them were seen. The submucosa as well as serosa were infiltrated by clusters of goblet cells and well-formed acini, with little atypia. Glands and nests were positive for periodic acid Schiff and immunohistochemistry showed focal chromogranin positivity in glandular structures, thereby confirming the diagnosis of GCC. Although the prognosis of GCC is better than adenocarcinomas, it is one of the carcinoids having a poorer outcome when compared with other variants of carcinoid tumor. Therefore, it is important to rule out other differential diagnoses of goblet cell carcinoid, the most important being mucinous adenocarcinomas. PMID:24739849

  13. 78 FR 66992 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... specialties within the general areas of biomedical, behavioral, and clinical science research. The...

  14. 76 FR 66367 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... medical specialties within the general areas of biomedical, behavioral and clinical science research....

  15. 76 FR 19188 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... medical specialties within the general areas of biomedical, behavioral and clinical science research....

  16. 78 FR 22622 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-16

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... medical specialties within the general areas of biomedical, behavioral and clinical science research....

  17. 77 FR 23810 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-20

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Biomedical Laboratory Research and Development and Clinical Science Research and Development Services... areas of biomedical, behavioral and clinical science research. The panel meetings will be open to...

  18. Clinical nurse specialists driving research and practice through Research Roundtables.

    PubMed

    Harne-Britner, Sarah; Schafer, Deborah J

    2009-01-01

    Providing patient care based on the best evidence is a priority for healthcare institutions across the country to improve practice and patient outcomes. Creating a culture of evidence-based practice (EBP) within an organization can be a challenging task. Literature has identified numerous barriers to EBP including negative attitudes and perceptions among nurses and lack of organizational support, time, resources, and confidence with these skills. Creating programs that help nurses appreciate the value and importance of nursing research for practice can be an effective approach in changing the culture. Research Roundtable is a collaborative partnership between a healthcare system and a baccalaureate nursing program to promote EBP and research skills in nurses and nursing students. Initial goals of the program focused on increasing the nurses' knowledge base of the research process and applying research to actual clinical problems. Over the course of 3 years, Roundtable evolved from development and implementation of research projects to concentrating on the identification of clinical problems that could be analyzed and solved through the use of EBP processes. The program has resulted in the completion of research studies, implementation of practice changes based on evidence uncovered in group work, and the approval of research projects in data collection phases. The positive impacts of Roundtable have been identified at the level of the staff nurse and the organization as a whole. This article describes the role of the clinical nurse specialist in the development and implementation of the Research Roundtable. PMID:19858901

  19. Clinical Research Careers: Reports from a NHLBI Pediatric Heart Network Clinical Research Skills Development Conference

    PubMed Central

    Lai, Wyman W.; Richmond, Marc; Li, Jennifer S.; Saul, J. Philip; Mital, Seema; Colan, Steven D.; Newburger, Jane W.; Sleeper, Lynn A.; McCrindle, Brain W.; Minich, L. LuAnn; Goldmuntz, Elizabeth; Marino, Bradley S.; Williams, Ismee A.; Pearson, Gail D.; Evans, Frank; Scott, Jane D.; Cohen, Meryl S.

    2013-01-01

    Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health-National Heart, Lung, and Blood Institute (NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators. PMID:21167335

  20. Budgeting, funding, and managing clinical research projects.

    PubMed

    Hatfield, Elizabeth; Dicks, Elizabeth; Parfrey, Patrick

    2009-01-01

    Large, integrated multidisciplinary teams have become recognized as an efficient means by which to drive innovation and discovery in clinical research. This chapter describes how to budget and fund these large studies and effectively manage the large, often dispersed teams involved. Sources of funding are identified; budget development, justification, reporting, financial governance, and accountability are described; in addition to the creation and management of the multidisciplinary team that will implement the research plan. PMID:19160746

  1. Clinical research in pediatric organ transplantation.

    PubMed

    Azeka, Estela; Saavedra, Laura Castillo; Fregni, Felipe

    2014-01-01

    Solid organ transplantation has greatly improved survival in children with end-stage disease, becoming one of the main treatment options in this population. Nonetheless, there are significant challenges associated with validating and optimizing the effects of these interventions in clinical trials. Therefore, we reviewed the main issues related to conducting clinical transplantation research in children. We divided these challenges into three different categories: (i) challenges related to surgical techniques and anesthetic procedures, (ii) challenges related to post-transplant care and (iii) challenges specific to a particular population group and disease type. Some of the observed burdens for clinical research in this field are related to the limitations of conducting studies with a placebo or sham procedure, determining the standard of care for a control group, low prevalence of cases, ethical concerns related to use of a placebo control group and lack of generalizability from animal studies and clinical trials conducted in adult populations. To overcome some of these barriers, it is necessary to utilize alternative clinical trial designs, such as observational studies or non-inferiority trials, and to develop multicenter collaborations to increase the recruitment rate. In conclusion, the lack of robust data related to pediatric transplantation remains problematic, and further clinical trials are needed to develop more efficacious and safer treatments. PMID:24860862

  2. Modeling Flowsheet Data for Clinical Research

    PubMed Central

    Johnson, Steven G.; Byrne, Matthew D.; Christie, Beverly; Delaney, Connie W.; LaFlamme, Anne; Park, Jung In; Pruinelli, Lisiane; Sherman, Suzan G.; Speedie, Stuart; Westra, Bonnie L.

    2015-01-01

    Health care data included in clinical data repositories (CDRs) are increasingly used for quality reporting, business analytics and research; however, extended clinical data from interprofessional practice are seldom included. With the increasing emphasis on care coordination across settings, CDRs need to include data from all clinicians and be harmonized to understand the impact of their collaborative efforts on patient safety, effectiveness and efficiency. This study characterizes the extended clinical data derived from EHR flowsheet data that is available in the University of Minnesota’s CDR and describes a process for creating an ontology that organizes that data so that it is more useful and accessible to researchers. The process is illustrated using a pressure ulcer ontology and compares ease of finding concepts in i2b2 for different data organization approaches. The challenges of the manual process and difficulties combining similar concepts are discussed. PMID:26306244

  3. Modeling Flowsheet Data for Clinical Research.

    PubMed

    Johnson, Steven G; Byrne, Matthew D; Christie, Beverly; Delaney, Connie W; LaFlamme, Anne; Park, Jung In; Pruinelli, Lisiane; Sherman, Suzan G; Speedie, Stuart; Westra, Bonnie L

    2015-01-01

    Health care data included in clinical data repositories (CDRs) are increasingly used for quality reporting, business analytics and research; however, extended clinical data from interprofessional practice are seldom included. With the increasing emphasis on care coordination across settings, CDRs need to include data from all clinicians and be harmonized to understand the impact of their collaborative efforts on patient safety, effectiveness and efficiency. This study characterizes the extended clinical data derived from EHR flowsheet data that is available in the University of Minnesota's CDR and describes a process for creating an ontology that organizes that data so that it is more useful and accessible to researchers. The process is illustrated using a pressure ulcer ontology and compares ease of finding concepts in i2b2 for different data organization approaches. The challenges of the manual process and difficulties combining similar concepts are discussed.

  4. Clinical and Experimental Research Utilizing the DACL.

    ERIC Educational Resources Information Center

    Strickland, Bonnie R.

    Since the development of the Lubin Depression Adjective Check Lists (DACL) in 1965, researchers have used this instrument in many empirical and clinical studies. Scores on the DACL have correlated with other measures of depression and have also been related to personal characteristics of depressed individuals. The DACL has been used in studies to…

  5. Single Case Research Results as Clinical Outcomes

    ERIC Educational Resources Information Center

    Parker, Richard I.; Hagan-Burke, Shanna

    2007-01-01

    The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, "proportion of variance" ("R"[superscript 2],…

  6. Be a Partner in Clinical Research

    MedlinePlus

    ... part of the U.S. Department of Health and Human Services Latest Issue This Issue Features Be a Partner in Clinical Research Better Check Your Bowels Health Capsules Are You at Risk for Alcohol-Medication Interactions? Measles: Preventable with Vaccines Featured Website: National Center ...

  7. [AGIKO (Clinical Research Fellow); a training model aimed at enhancement of clinical scientific research].

    PubMed

    van Rees-Wortelboer, M M; Lamberts, S W; Klasen, E C

    1997-06-21

    The enhancement of clinical scientific research in the Netherlands is being stimulated to a substantial extent by the introduction and stimulation of a training model aimed at the combined training of physicians to both a general practitioner or specialist and a clinical researcher, the AGIKO (Clinical Research Fellow). The model has been recognized by the Central College for Recognition and Registration of Medical Specialists. Extra stimulation by the section Medical Sciences of the Netherlands Organization for Scientific Research (MW-NWO) makes it possible to appoint AGIKOs on second or third flows of funds but also within the first flow of funds. During the last two years, 25 AGIKO applications from ten medical specialisms have been approved. The AGIKO model may help to meet (expected) needs for future clinical-medical research workers in specific research areas.

  8. The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research.

    PubMed

    Berry, Donald A

    2015-05-01

    Clinical trials are the final links in the chains of knowledge and for determining the roles of therapeutic advances. Unfortunately, in an important sense they are the weakest links. This article describes two designs that are being explored today: platform trials and basket trials. Both are attempting to merge clinical research and clinical practice.

  9. [The research protocol II: study designs in clinical research].

    PubMed

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    In clinical research that takes place in health-care areas, most of the studies are performed with human beings as research subjects. The main objectives of these studies are to know the characteristics of one or more groups, the behavior of human diseases, the etiology or causes of diseases, to identify the best diagnostic tools, or to establish the best treatment for a condition or disease in particular. Additionally, some studies are classified as basic bio-medical research; in these investigations, the subjects of study are laboratory animals, tissues, cells, or molecules. In general terms, the objectives of these studies are to understand the physiology, pathogenesis, or biological mechanisms that could explain functions or alterations in one or more systems or body organs. This article will only address clinical research designs.

  10. Fetal cardiac interventions: clinical and experimental research

    PubMed Central

    Humuruola, Gulimila

    2016-01-01

    Fetal cardiac interventions for congenital heart diseases may alleviate heart dysfunction, prevent them evolving into hypoplastic left heart syndrome, achieve biventricular outcome and improve fetal survival. Candidates for clinical fetal cardiac interventions are now restricted to cases of critical aortic valve stenosis with evolving hypoplastic left heart syndrome, pulmonary atresia with an intact ventricular septum and evolving hypoplastic right heart syndrome, and hypoplastic left heart syndrome with an intact or highly restrictive atrial septum as well as fetal heart block. The therapeutic options are advocated as prenatal aortic valvuloplasty, pulmonary valvuloplasty, creation of interatrial communication and fetal cardiac pacing. Experimental research on fetal cardiac intervention involves technical modifications of catheter-based cardiac clinical interventions and open fetal cardiac bypass that cannot be applied in human fetuses for the time being. Clinical fetal cardiac interventions are plausible for midgestation fetuses with the above-mentioned congenital heart defects. The technical success, biventricular outcome and fetal survival are continuously being improved in the conditions of the sophisticated multidisciplinary team, equipment, techniques and postnatal care. Experimental research is laying the foundations and may open new fields for catheter-based clinical techniques. In the present article, the clinical therapeutic options and experimental fetal cardiac interventions are described. PMID:27279868

  11. Fetal cardiac interventions: clinical and experimental research.

    PubMed

    Yuan, Shi-Min; Humuruola, Gulimila

    2016-01-01

    Fetal cardiac interventions for congenital heart diseases may alleviate heart dysfunction, prevent them evolving into hypoplastic left heart syndrome, achieve biventricular outcome and improve fetal survival. Candidates for clinical fetal cardiac interventions are now restricted to cases of critical aortic valve stenosis with evolving hypoplastic left heart syndrome, pulmonary atresia with an intact ventricular septum and evolving hypoplastic right heart syndrome, and hypoplastic left heart syndrome with an intact or highly restrictive atrial septum as well as fetal heart block. The therapeutic options are advocated as prenatal aortic valvuloplasty, pulmonary valvuloplasty, creation of interatrial communication and fetal cardiac pacing. Experimental research on fetal cardiac intervention involves technical modifications of catheter-based cardiac clinical interventions and open fetal cardiac bypass that cannot be applied in human fetuses for the time being. Clinical fetal cardiac interventions are plausible for midgestation fetuses with the above-mentioned congenital heart defects. The technical success, biventricular outcome and fetal survival are continuously being improved in the conditions of the sophisticated multidisciplinary team, equipment, techniques and postnatal care. Experimental research is laying the foundations and may open new fields for catheter-based clinical techniques. In the present article, the clinical therapeutic options and experimental fetal cardiac interventions are described. PMID:27279868

  12. The Ontology of Clinical Research (OCRe): An Informatics Foundation for the Science of Clinical Research

    PubMed Central

    Sim, Ida; Tu, Samson W.; Carini, Simona; Lehmann, Harold P.; Pollock, Brad H.; Peleg, Mor; Wittkowski, Knut M.

    2013-01-01

    To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes — the science of clinical research — are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe’s modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study’s scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. PMID:24239612

  13. Clinical Research Trials | NIH MedlinePlus the Magazine

    MedlinePlus

    ... of this page please turn Javascript on. Clinical Research Trials Past Issues / Summer 2012 Table of Contents Let the Opportunities to Join A Clinical Study Find You How does clinical research work? Visit our website and click on New ...

  14. How can we improve clinical research in clinical practice with better research outcome?

    PubMed

    Woo, Keng Thye; Wong, Kok Seng; Lee, Evan J C; Chan, Choong Meng

    2011-11-01

    This paper explains some of the difficulties doctors face when taking up a career in research. It describes the efforts by the government and the Ministry of Health (MOH) to nurture the Clinician Scientist Programme. The nature of research and the mindset of clinicians who are passionate about research are explored and the reasons which drive some of them to pursue a research career. It discusses the need to have structured training for research and how continuing research education is necessary for the researcher. The paper discusses the goals for research and how we can achieve better research outcomes and the importance of good mentorship. It suggests ways to engage more doctors in research in the restructured hospitals by overcoming some of the problems they encounter. Finally, it relates the Biomedical Science initiative of the government through the National Research Foundation and the various programmes in Translational Clinical Research available for clinicians who are keen on a research career.

  15. Linking Clinical Research Data to Population Databases

    PubMed Central

    Edelman, Linda S.; Guo, Jia-Wen; Fraser, Alison; Beck, Susan L.

    2014-01-01

    Background Most clinical nursing research is limited to funded study periods. Researchers can study relationships between study measures and long-term outcomes if clinical research data can be linked to population databases. Objectives The objective was to describe feasibility of linking research participant data to data from population databases in order to study long-term poststudy outcomes. As an exemplar, participants were linked from a completed oncology nursing research trial to outcomes data in two state population databases. Methods Participant data from a previously completed symptom management study were linked to the Utah Population Database and the Utah Emergency Department Database. The final dataset contained demographic, cancer diagnosis and treatment, and baseline data from the oncology study linked to poststudy long-term outcomes from the population databases. Results One hundred twenty-nine of 144 (89.6%) study participants were linked to their individual data in the population databases. Of those, 73% were linked to hospitalization records, 60% to emergency department visit records, and 28% were identified as having died. Discussion Study participant data were successfully linked to population databases data to describe poststudy emergency department visit and hospitalization numbers and mortality. The results suggest that data linkage success can be improved if researchers include linkage and human subjects protection plans related to linkage in the initial study design. PMID:24165220

  16. Reengineering Clinical Research Science: A Focus on Translational Research

    ERIC Educational Resources Information Center

    Ferrell, Courtney B.

    2009-01-01

    The burden of disease in the United States is high. Mental illness is currently the leading cause of disease burden among 15- to 44-year-olds. This phenomenon is occurring despite the many advances that have been made in clinical research. Several efficacious interventions are available to treat many of these disorders; however, they are greatly…

  17. Standard operating procedures for clinical research departments.

    PubMed

    Kee, Ashley Nichole

    2011-01-01

    A set of standard operating procedures (SOPs) provides a clinical research department with clear roles, responsibilities, and processes to ensure compliance, accuracy, and timeliness of data. SOPs also serve as a standardized training program for new employees. A practice may have an employee that can assist in the development of SOPs. There are also consultants that specialize in working with a practice to develop and write practice-specific SOPs. Making SOPs a priority will save a practice time and money in the long run and make the research practice more attractive to corporate study sponsors.

  18. [Ear keloid and clinical research progress].

    PubMed

    Du, Guangyuan; Zhu, Jiang

    2014-04-01

    Keloid refers to the damaged skin due to excessive fibroblast proliferation. Ear is one predilection site. The pathogenesis of ear keloid is not very clear, and the treatment is also varied. Surgery, postoperative radiotherapy and laser treatment, steroid hormones, pressure therapy are the basic treatment methods. Integrated application of a variety of treatments, classification research and new materials using revealed the prospect for the treatment of the disease. This thesis reviews literature about ear keloid in recent 10 years, and introduces this disease and clinical research progress.

  19. Current clinical research in orthodontics: a perspective.

    PubMed

    Baumrind, Sheldon

    2006-10-01

    This essay explores briefly the approach of the Craniofacial Research Instrumentation Laboratory to the systematic and rigorous investigation of the usual outcome of orthodontic treatment in the practices of experienced clinicians. CRIL's goal is to produce a shareable electronic database of reliable, valid, and representative data on clinical practice as an aid in the production of an improved environment for truly evidence-based orthodontic treatment.

  20. Negotiation skills for clinical research professionals

    PubMed Central

    Hake, Sanjay; Shah, Tapankumar

    2011-01-01

    Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors. PMID:21897886

  1. Negotiation skills for clinical research professionals.

    PubMed

    Hake, Sanjay; Shah, Tapankumar

    2011-07-01

    Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors. PMID:21897886

  2. Multi-institutional Collaboration to Promote Undergraduate Clinical Research Nursing.

    PubMed

    Garner, Shelby L; Spencer, Becky; Beal, Claudia C

    2016-01-01

    Clinical research nursing is distinct from nursing research and includes the coordination and delivery of care for patients enrolled in clinical research trials. An innovative elective in clinical research nursing was developed collaboratively by stakeholders at a university, research institute, and national organization to provide experiential learning for undergraduate nursing students. The multi-institutional collaborative process, course overview, and precepted experience are described.

  3. [Clinical research I. The importance of the research design].

    PubMed

    Talavera, Juan O

    2011-01-01

    The endeavor of clinical research to study a group of patients is to make a diagnosis, estimate the prognosis and prove a treatment. For this purpose is used the scientific method: 1) the architectural arrangement, which can be divided into cause-effect and the process of research; 2) the methodological approach, which includes controlled clinical trials, cohorts, case control, and cross-sectional designs; 3) the goal-oriented approach, in which studies on diagnostic tests, prognosis, treatment and risk or causal factors are grouped. The designs mentioned above are considered primary studies; it means that the information was obtained directly from the subjects studied. There is a second category of studies, which uses information obtained from the primary studies. This is the reason why they are considered as secondary or integrative studies.

  4. Measuring informant discrepancies in clinical child research.

    PubMed

    De Los Reyes, Andres; Kazdin, Alan E

    2004-09-01

    Discrepancies among informants' ratings of child psychopathology have important implications for diagnosis, assessment, and treatment. Typically, parents and children complete measures (e.g., self-report checklists, diagnostic instruments) to assess child dysfunction. Ratings gathered from these sources reveal relatively little agreement on the nature and extent of the child's social, emotional, and behavioral problems. This article reviews and illustrates the most frequently used methods of measuring informant discrepancies in the clinical child literature (i.e., raw difference, standardized difference, and residual difference scores) and outlines key considerations to influence their selection. The authors conclude that frequently used methods of measuring informant discrepancies are not interchangeable and recommend that future investigations examining informant discrepancies in clinical child research use the standardized difference score as their measure of informant discrepancies.

  5. Applying Research on Family Violence to Clinical Practice.

    ERIC Educational Resources Information Center

    Gelles, Richard J.

    1982-01-01

    Considers whether research on family violence can be applied to clinical practice. Suggests limitations of the knowledge base constrain the application of research on family violence to clinical work, and certain aspects of the research paradigm also limit the transfer of research knowledge to clinical practice. (Author)

  6. Clinical Research Strategies for Fructose Metabolism12

    PubMed Central

    Laughlin, Maren R.; Bantle, John P.; Havel, Peter J.; Parks, Elizabeth; Klurfeld, David M.; Teff, Karen; Maruvada, Padma

    2014-01-01

    Fructose and simple sugars are a substantial part of the western diet, and their influence on human health remains controversial. Clinical studies in fructose nutrition have proven very difficult to conduct and interpret. NIH and USDA sponsored a workshop on 13–14 November 2012, “Research Strategies for Fructose Metabolism,” to identify important scientific questions and parameters to be considered while designing clinical studies. Research is needed to ascertain whether there is an obesogenic role for fructose-containing sugars via effects on eating behavior and energy balance and whether there is a dose threshold beyond which these sugars promote progression toward diabetes and liver and cardiovascular disease, especially in susceptible populations. Studies tend to fall into 2 categories, and design criteria for each are described. Mechanistic studies are meant to validate observations made in animals or to elucidate the pathways of fructose metabolism in humans. These highly controlled studies often compare the pure monosaccharides glucose and fructose. Other studies are focused on clinically significant disease outcomes or health behaviors attributable to amounts of fructose-containing sugars typically found in the American diet. These are designed to test hypotheses generated from short-term mechanistic or epidemiologic studies and provide data for health policy. Discussion brought out the opinion that, although many mechanistic questions concerning the metabolism of monosaccharide sugars in humans remain to be addressed experimentally in small highly controlled studies, health outcomes research meant to inform health policy should use large, long-term studies using combinations of sugars found in the typical American diet rather than pure fructose or glucose. PMID:24829471

  7. Clinical research strategies for fructose metabolism.

    PubMed

    Laughlin, Maren R; Bantle, John P; Havel, Peter J; Parks, Elizabeth; Klurfeld, David M; Teff, Karen; Maruvada, Padma

    2014-05-01

    Fructose and simple sugars are a substantial part of the western diet, and their influence on human health remains controversial. Clinical studies in fructose nutrition have proven very difficult to conduct and interpret. NIH and USDA sponsored a workshop on 13-14 November 2012, "Research Strategies for Fructose Metabolism," to identify important scientific questions and parameters to be considered while designing clinical studies. Research is needed to ascertain whether there is an obesogenic role for fructose-containing sugars via effects on eating behavior and energy balance and whether there is a dose threshold beyond which these sugars promote progression toward diabetes and liver and cardiovascular disease, especially in susceptible populations. Studies tend to fall into 2 categories, and design criteria for each are described. Mechanistic studies are meant to validate observations made in animals or to elucidate the pathways of fructose metabolism in humans. These highly controlled studies often compare the pure monosaccharides glucose and fructose. Other studies are focused on clinically significant disease outcomes or health behaviors attributable to amounts of fructose-containing sugars typically found in the American diet. These are designed to test hypotheses generated from short-term mechanistic or epidemiologic studies and provide data for health policy. Discussion brought out the opinion that, although many mechanistic questions concerning the metabolism of monosaccharide sugars in humans remain to be addressed experimentally in small highly controlled studies, health outcomes research meant to inform health policy should use large, long-term studies using combinations of sugars found in the typical American diet rather than pure fructose or glucose.

  8. Putting Research Findings into Clinical Practice

    PubMed Central

    Bhargava, Deepa; Al-Lawatia, Zainab; Al-Abri, Rashid; Bhargava, Kamlesh

    2012-01-01

    Objectives: A perception exists that clinicians in Oman are reluctant to adopt evidence-based practice (EBP). This pilot study was undertaken to study the feasibility of using EBP pathways at the point of care in otorhinolaryngology head and neck surgery. The ultimate aim was to facilitate EBP with the probability of developing a new system for implementing research findings/translational research at the clinical point of care. Methods: A cross-sectional prospective questionnaire pilot survey of clinicians at Sultan Qaboos University Hospital (SQUH), Oman, a tertiary care medical centre, was undertaken. Respondents included 135 physicians and surgeons with between 3 months and 25 years of clinical experience and included personnel ranging from interns to senior consultants, in areas ranging from primary care to specialist care. Results: Of those polled, 90% (95% confidence interval (CI) 85–95%) either strongly agreed or agreed that evidence-based practice protocols (EBPP) could help in decision making. A total of 87.4% of participants (95% CI 81.8–93%) either strongly agreed or agreed that EBPPs can improve clinical outcomes; 91.8% of participants (95% CI 87.2–96.4%) would use and apply EBPP in day-to-day care if they were available at the point of care and embedded in the hospital information system. Conclusions: The perception that clinicians at SQUH are reluctant to adopt EBP is incorrect. The introduction of EBP pathways is very feasible at the primary care level. Institutional support for embedding EBP in hospital information systems is needed as well as further outcome research to assess the improvement in quality of care. PMID:22548137

  9. Whose Stories Matter? Re-Vising, Reflecting and Re-Discovering a Researcher's Embodied Experience as a Narrative Inquirer

    ERIC Educational Resources Information Center

    McMahon, Jenny; McGannon, Kerry R.

    2016-01-01

    This paper centres on one researcher's narrative inquiry of embodied experience. The purpose of this paper is to initiate and extend dialogue which highlights potential possibilities and limitations for those researchers and participants who choose to engage with the narrative inquiry approach. Of special concern are four points or evocations that…

  10. Neonatal networks: clinical research and quality improvement.

    PubMed

    Profit, Jochen; Soll, Roger F

    2015-12-01

    Worldwide, neonatal networks have been formed to address both the research and quality improvement agenda of neonatal-perinatal medicine. Neonatal research networks have led the way in conducting many of the most important clinical trials of the last 25 years, including studies of cooling for hypoxic-ischemic encephalopathy, delivery room management with less invasive support, and oxygen saturation targeting. As we move into the future, increasing numbers of these networks are tackling quality improvement initiatives as a priority of their collaboration. Neonatal quality improvement networks have been in the forefront of the quality movement in medicine and, in the 21st century, have contributed to many of the reported improvements in care. In the coming years, building and maintaining this community of care is critical to the success of neonatal-perinatal medicine.

  11. Clinical Trials: A Crucial Key to Human Health Research

    MedlinePlus

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...

  12. Clinical Assay Development Support - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The NCI’s Division of Cancer Treatment and Diagnosis and the Cancer Diagnosis Program announce a request for applications for the Clinical Assay Development Program (CADP) for investigators seeking clinical assay development and validation resources.

  13. DISCOVER-AQ

    Atmospheric Science Data Center

    2015-01-07

    ... of satellites to monitor air quality for public health and environmental benefit. Through targeted airborne and ground-based observations, ... Relevant Documents:  DISCOVER-AQ - Airborne Science Data for Atmospheric Composition DISCOVER-AQ - NASA Earth ...

  14. Novartis School Lab: bringing young people closer to the world of research and discovering the excitement of science.

    PubMed

    Michel, Christiane Röckl; Standke, Gesche; Naef, Reto

    2012-01-01

    The Novartis School Lab (http://www.novartis.ch/schullabor) is an institution with an old tradition. The School Lab reaches about 5000 students through internal courses and an additional 5000 children at public science events where they can enjoy hands-on science in disciplines of biomedical research. The subjects range from chemistry, physics, molecular biology and genetics to toxicology and medical topics. The Novartis School Lab offers a variety of activities for youngsters aged 10-20 ranging from lab courses for school classes, continuing education for teachers and development of teaching kits, support for individual research projects to outreach for public science events. Innovation and adaptation to changes of current needs are essential aspects for the Novartis School Lab. Ongoing activities to shape the Novartis Biomedical Learning Lab include design of new teaching experiments, exploration into additional disciplines of biomedical science and the creation of a fascinating School Lab of the future.

  15. Antidepressants and psychotherapy: a clinical research review

    PubMed Central

    Frank, Ellen; Novick, Danielle; Kupfer, David J.

    2005-01-01

    This review focuses on information concerning antidepressants and psychotherapy in the treatement of both acute and chronic forms of unipolar depression in the English language literature. In it, we address the use of combination therapy, both from the outset of treatment and in a variety of sequences, ie, we examine the potential advantages of adding a targeted psychotherapy to an incompletely effective pharmacotherapy and the potential advantages of adding pharmacotherapy to an incompletely effective psychotherapy The number of research reports available to address these questions is small relative to their importance for clinical practice. There is a clear need for more information about the relative efficacy of pharmacotherapy-psychotherapy combinations or sequences versus either pharmacotherapy or psychotherapy provided as monotherapies. PMID:16156384

  16. Tissue engineering: from research to dental clinics

    PubMed Central

    Rosa, Vinicius; Bona, Alvaro Della; Cavalcanti, Bruno Neves; Nör, Jacques Eduardo

    2013-01-01

    Tissue engineering is an interdisciplinary field that combines the principles of engineering, material and biological sciences toward the development of therapeutic strategies and biological substitutes that restore, maintain, replace or improve biological functions. The association of biomaterials, stem cells, growth and differentiation factors have yielded the development of new treatment opportunities in most of the biomedical areas, including Dentistry. The objective of this paper is to present the principles underlying tissue engineering and the current scenario, the challenges and the perspectives of this area in Dentistry. Significance The growth of tissue engineering as a research field have provided a novel set of therapeutic strategies for biomedical applications. The emerging knowledge arisen from studies in the dental area may translate into new methods for caring or improving the alternatives used to treat patients in the daily clinic. PMID:22240278

  17. Rheumatoid Arthritis: The Stride from Research to Clinical Practice

    PubMed Central

    Chung, Ill-Min; Ketharnathan, Sarada; Thiruvengadam, Muthu; Rajakumar, Govindasamy

    2016-01-01

    Over 70 different genetic variants with a significant association with rheumatoid arthritis (RA) have been discovered. Anti-citrullination protein antibodies (ACPA)-positive RA variants are more well-defined than their ACPA-negative counterparts. The human leukocyte antigen, HLA-DRB1 locus remains the prime suspect in anti-citrullination protein antibodies (ACPA)—positive RA. Different HLA-DRB1 alleles are linked to RA susceptibility across different ethnicities. With evolving techniques, like genome-wide association studies (GWAS) and single nucleotide polymorphism (SNP) arrays, more non-HLA susceptibility loci have been identified for both types of RA. However, the functional significance of only a handful of these variants is known. Their roles include increasing susceptibility to RA or in determining the speed at which the disease progresses. Additionally, a couple of variations are associated with protection from RA. Defining such clear-cut biological functions can aid in the clinical diagnosis and treatment of RA. Recent research has focused on the implication of microRNAs, with miR-146a widely studied. In addition to disease susceptibility, genetic variations that influence the efficacy and toxicity of anti-RA agents have also been identified. Polymorphisms in the MTHFR gene influence the effectiveness of methotrexate, the first line of therapy in RA. Larger studies are, however, needed to identify potential biomarkers for early disease identification and monitoring disease progression. PMID:27338350

  18. Herbal Medicine Today: Clinical and Research Issues

    PubMed Central

    Gori, Luigi

    2007-01-01

    Herbal medicine is the use of medicinal plants for prevention and treatment of diseases: it ranges from traditional and popular medicines of every country to the use of standardized and tritated herbal extracts. Generally cultural rootedness enduring and widespread use in a Traditional Medical System may indicate safety, but not efficacy of treatments, especially in herbal medicine where tradition is almost completely based on remedies containing active principles at very low and ultra low concentrations, or relying on magical-energetic principles. In the age of globalization and of the so-called ‘plate world’, assessing the ‘transferability’ of treatments between different cultures is not a relevant goal for clinical research, while are the assessment of efficacy and safety that should be based on the regular patterns of mainstream clinical medicine. The other black box of herbal-based treatments is the lack of definite and complete information about the composition of extracts. Herbal derived remedies need a powerful and deep assessment of their pharmacological qualities and safety that actually can be realized by new biologic technologies like pharmacogenomic, metabolomic and microarray methology. Because of the large and growing use of natural derived substances in all over the world, it is not wise to rely also on the tradition or supposed millenarian beliefs; explanatory and pragmatic studies are useful and should be considered complementary in the acquisition of reliable data both for health caregiver and patients. PMID:18227931

  19. Clinical misconceptions dispelled by epidemiological research.

    PubMed

    Kannel, W B

    1995-12-01

    The epidemiological approach to investigation of cardiovascular disease was innovated in 1948 by Ancel Keys' Seven Countries Study and T.R. Dawber's Framingham Heart Study. Conducted in representative samples of the general population, these investigations provided an undistorted perception of the clinical spectrum of cardiovascular disease, its incidence and prognosis, the lifestyles and personal attributes that predispose to cardiovascular disease, and clues to pathogenesis. The many insights gained corrected numerous widely held misconceptions derived from clinical studies. It was learned, for example, that the adverse consequences of hypertension do not derive chiefly from the diastolic pressure, left ventricular hypertrophy was not an incidental compensatory phenomenon, and small amounts of proteinuria were more than orthostatic trivia. Exercise was considered dangerous for cardiovascular disease candidates; smoking, cholesterol, and a fatty diet were regarded as questionable promoters of atherosclerosis. The entities of sudden death and unrecognized myocardial infarction were not widely appreciated as prominent features of coronary disease, and the disabling and lethal nature of cardiac failure and atrial fibrillation was underestimated. It took epidemiological research to coin the term "risk factor" and dispel the notion that cardiovascular disease must have a single origin. Epidemiological investigation provided health professionals with multifactorial risk profiles to more efficiently target candidates for cardiovascular disease for preventive measures. Clinicians now look to epidemiological research to provide definitive information about possible predisposing factors for cardiovascular disease and preventive measures that are justified. As a result, clinicians are less inclined to regard usual or average values as acceptable and are more inclined to regard optimal values as "normal." Cardiovascular events are coming to be regarded as a medical failure

  20. Multi-institutional Collaboration to Promote Undergraduate Clinical Research Nursing.

    PubMed

    Garner, Shelby L; Spencer, Becky; Beal, Claudia C

    2016-01-01

    Clinical research nursing is distinct from nursing research and includes the coordination and delivery of care for patients enrolled in clinical research trials. An innovative elective in clinical research nursing was developed collaboratively by stakeholders at a university, research institute, and national organization to provide experiential learning for undergraduate nursing students. The multi-institutional collaborative process, course overview, and precepted experience are described. PMID:26164323

  1. Decline of clinical research in academic medical centers.

    PubMed

    Meador, Kimford J

    2015-09-29

    Marked changes in US medical school funding began in the 1960s with progressively increasing revenues from clinical services. The growth of clinical revenues slowed in the mid-1990s, creating a funding crisis for US academic health care centers, who responded by having their faculty increase their clinical duties at the expense of research activities. Surveys document the resultant stresses on the academic clinician researcher. The NIH provides greater funding for basic and translational research than for clinical research, and the new Patient-Centered Outcomes Research Institute is inadequately funded to address the scope of needed clinical research. An increasing portion of clinical research is funded by industry, which leaves many important clinical issues unaddressed. There is an inadequate supply of skilled clinical researchers and a lack of external support for clinical research. The impact on the academic environment in university medical centers is especially severe on young faculty, who have a shrinking potential to achieve successful academic careers. National health care research funding policies should encourage the right balance of life-science investigations. Medical universities need to improve and highlight education on clinical research for students, residents, fellows, and young faculty. Medical universities also need to provide appropriate incentives for clinical research. Without training to ensure an adequate supply of skilled clinical researchers and a method to adequately fund clinical research, discoveries from basic and translational research cannot be clinically tested and affect patient care. Thus, many clinical problems will continue to be evaluated and treated with inadequate or even absent evidence-based knowledge.

  2. Decline of clinical research in academic medical centers

    PubMed Central

    2015-01-01

    Marked changes in US medical school funding began in the 1960s with progressively increasing revenues from clinical services. The growth of clinical revenues slowed in the mid-1990s, creating a funding crisis for US academic health care centers, who responded by having their faculty increase their clinical duties at the expense of research activities. Surveys document the resultant stresses on the academic clinician researcher. The NIH provides greater funding for basic and translational research than for clinical research, and the new Patient-Centered Outcomes Research Institute is inadequately funded to address the scope of needed clinical research. An increasing portion of clinical research is funded by industry, which leaves many important clinical issues unaddressed. There is an inadequate supply of skilled clinical researchers and a lack of external support for clinical research. The impact on the academic environment in university medical centers is especially severe on young faculty, who have a shrinking potential to achieve successful academic careers. National health care research funding policies should encourage the right balance of life-science investigations. Medical universities need to improve and highlight education on clinical research for students, residents, fellows, and young faculty. Medical universities also need to provide appropriate incentives for clinical research. Without training to ensure an adequate supply of skilled clinical researchers and a method to adequately fund clinical research, discoveries from basic and translational research cannot be clinically tested and affect patient care. Thus, many clinical problems will continue to be evaluated and treated with inadequate or even absent evidence-based knowledge. PMID:26156509

  3. A win/win solution for FGD-gypsum: researches discover beneficial applications for by-product in agriculture

    SciTech Connect

    Ramsier, C.; Norton, D.

    2006-07-01

    Research at the Ohio State University and the USDA-ARS National Soil Erosion Research Lab at Purdue University has uncovered some viable new reasons for using FGD-gypsum as a regular part of production agriculture. Work has centered on FGD gypsum or calcium sulfite and to a much lesser extent on fly ash. Researchers have found three agronomically valuable functions of these materials. First, and most obvious, is the fertilizer value of these materials. Gypsum applications to the soil surface provide the rainfall with an alternative source of electrolyte which prevents soil crushing, thus keeping the soil open and permeable to rainwater and air. Gypsum is more effective than liming materials atremediation of sub-soil acidity by detoxifying the excess exchangeable aluminium, which causes low pH. One proven way to sequester carbon is to fix it as organic matter in soil. 90% of the carbon in roots is converted to soil organic matter, whereas 90% of surface residue is oxide and the carbon returned to the atmosphere. Therefore, more carbon is sequestered by increasing root growth. Improved soil water management also reduces nitrous oxide emissions from soils. The utility's world is improved since the highest quality and lowest cost material is generated by an emission control scrubber as FGD-gypsum. There are more than 175 million crop acres in the US alone. Each acre would require 0.5 ton per year to prevent surface sealing. This means that the potential for FGD-gypsum use is more than 80 million tons per year. 4 photos.

  4. NCI Researchers Discover Exceptionally Potent Antibodies with Potential for Prophylaxis and Therapy of MERS-Coronavirus Infections | Poster

    Cancer.gov

    By Andrea Frydl, Contributing Writer In a recent article published in the Journal of Virology, Tianlei Ying, Ph.D., Dimiter Dimitrov, Ph.D., and their colleagues in the Laboratory of Experimental Immunology (LEI), Cancer and Inflammation Program, NCI Center for Cancer Research, reported the identification of three human monoclonal antibodies (m336, m337, and m338) that target the part of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) that is responsible for binding to its receptor. These antibodies are exceptionally potent inhibitors of MERS-CoV infection and also provide a basis for creating a future MERS-CoV vaccine.

  5. How to Conduct Clinical Qualitative Research on the Patient's Experience

    ERIC Educational Resources Information Center

    Chenail, Ronald J.

    2011-01-01

    From a perspective of patient-centered healthcare, exploring patients' (a) preconceptions, (b) treatment experiences, (c) quality of life, (d) satisfaction, (e) illness understandings, and (f) design are all critical components in improving primary health care and research. Utilizing qualitative approaches to discover patients' experiences can…

  6. Science, technology, and innovation: nursing responsibilities in clinical research.

    PubMed

    Grady, Christine; Edgerly, Maureen

    2009-12-01

    Clinical research is a systematic investigation of human biology, health, or illness involving human beings. It builds on laboratory and animal studies and often involves clinical trials, which are specifically designed to test the safety and efficacy of interventions in humans. Nurses are critical to the conduct of ethical clinical research and face clinical, ethical, and regulatory challenges in research in many diverse roles. Understanding and addressing the ethical challenges that complicate clinical research is integral to upholding the moral commitment that nurses make to patients, including protecting their rights and ensuring their safety as patients and as research participants. PMID:19850183

  7. Metapsychological and clinical issues in psychosomatics research.

    PubMed

    Press, Jacques

    2016-02-01

    The author starts by treating the general epistemological problems inherent to research and emphasizes that all investigation takes place between two poles: a creative pole and one that is defensive in relation to the unknown and formlessness. In the psychosomatic field, an additional difficulty resides in the western dualistic vision of the relationship between psyche and soma which influences our way of thinking about the body as well as about otherness. The author continues by exploring Pierre Marty's psychosomatic model. Its psychosomatic monism is revolutionary but incomplete and creates a distance with the other, the somatizing patient, resulting in a medically oriented nosology symptomatic of the impossibility to think about some of the most important aspects of counter-transference. With the help of clinical material, the author considers these unthought aspects and some of their theoretical implications, particularly the way of understanding the negative often so prevalent with these patients. Based on these reflections as well as Freud's on beyond the pleasure principle and Winnicott's theorization on the fear of breakdown, the author suggests some directions for research. Somatic illness might occur when the attempts at filling the cracks created by a breakdown are unsuccessful.

  8. China makes an impressive breakthrough in avian influenza virus research - Discovering the "heart" of avian infl uenza virus.

    PubMed

    Li, Y G; Wu, J F; Li, X

    2009-02-01

    The successive appearance of strains of epizootic avian influenza A virus with the subtype H5N1 in China has attracted considerable concern from the public and Chinese authorities. According to the latest WHO estimates as of February 2, 2009, the number of H5N1 virus deaths in China totaled 25, second only to Indonesia and Viet Nam (http://www.who.int/csr/disease/avian_influenza/country/cases_table_2009_02_02/en/index.html). The H5N1 virus is highly contagious among birds and is fatal when transmitted to humans, though the means by which this occurs is still unknown. Owing to the possible variation of the H5N1 prototype virus, together with the fact that it has the propensity to exchange genes with influenza viruses from other species, humans have no natural immunity to the virus. Despite years of efforts, the exact pathogenesis of H5N1 transmission to humans is still not completely clear, nor is potential human-tohuman transmission as could lead to an epidemic or even worldwide pandemic (Enserink M. Science. 2009; 323:324). Unfortunately, current antiviral treatment and therapeutic measures cannot effectively overcome this virulent virus that causes highly pathogenic avian influenza (HPAI). Researchers from around the world are working to study the virology of influenza viruses, including their methods of infiltration, replication, and transcription, to elucidate the mechanisms of unremitting viral infection in terms of aspects such as the virus, host, and environment. These researchers are also working to identify potential molecular targets related to H5N1 for anti-influenza drug intervention. A recent H5N1-related study from China provides encouraging information. According to the People's Daily (Renmin Ribao), a newspaper out of Beijing, professor Liu Yingfang, academician Rao Zihe, and fellow researchers from more than 6 research centers, including the Institute of Biophysics Chinese Academy of Sciences, Nankai University, and Tsinghua University, have

  9. [Clinical research=design*measurements*statistical analyses].

    PubMed

    Furukawa, Toshiaki

    2012-06-01

    A clinical study must address true endpoints that matter for the patients and the doctors. A good clinical study starts with a good clinical question. Formulating a clinical question in the form of PECO can sharpen one's original question. In order to perform a good clinical study one must have a knowledge of study design, measurements and statistical analyses: The first is taught by epidemiology, the second by psychometrics and the third by biostatistics.

  10. 75 FR 57833 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-22

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit..., behavioral and clinical science research. The panel meetings will be open to the public for approximately...

  11. 76 FR 79273 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Eligibility of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... biomedical, behavioral, and clinical science research. The panel meeting will be open to the public...

  12. 75 FR 23847 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and ] Development Services Scientific Merit.... Clinical Research Program June 9, 2010 *VA Central Office. Oncology June 10-11, 2010....... L'Enfant...

  13. 78 FR 28292 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Research and Development and Clinical Science Research and Development Services Scientific Merit Review... areas of biomedical, behavioral and clinical science research. The panel meetings will be open to...

  14. 77 FR 64598 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Biomedical Laboratory Research and Development and Clinical Science Research and Development Services..., behavioral and clinical science research. The panel meetings will be open to the public for approximately...

  15. 76 FR 1212 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Eligibility of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... areas of biomedical, behavioral and clinical science research. The panel meeting will be open to...

  16. Clinical research training of Peruvian neurologists: a baseline assessment

    PubMed Central

    Navarro-Chumbes, Gian Carlos; Montano-Torres, Silvia Margarita; Díaz-Vásquez, Alberto; Zunt, Joseph Raymond

    2010-01-01

    In Peru, despite a strong clinical research infrastructure in Lima, and Masters degree programs in epidemiology at three universities, few neurologists participate in clinical research. It was our objective to identify perceived needs and opportunities for increasing clinical research capacity and training opportunities for Peruvian neurologists. We conducted a descriptive, cross-sectional survey of Peruvian neurologists in Lima and Arequipa, Peru. Forty-eight neurologists completed written surveys and oral interviews. All neurologists reported interest in clinical research, but noted that lack of time and financial resources limited their ability to participate. Although most neurologists had received some training in epidemiology and research design as medical students or residents, the majority felt these topics were not adequately covered. Neurologists in Arequipa noted international funding for clinical research was uncommon outside the capital city of Lima. We concluded that clinical research is important to Peruvian neurologists. The three main barriers to increased participation in clinical research identified by neurologists were insufficient training in clinical research methodology, meager funding opportunities, and lack of dedicated time to participate in clinical research. Distance learning holds promise as a method for providing additional training in clinical research methodology, especially for neurologists who may have difficulty traveling to larger cities for additional training. PMID:21577342

  17. Binge eating disorder: from clinical research to clinical practice.

    PubMed

    Goracci, Arianna; Casamassima, Francesco; Iovieno, Nadia; di Volo, Silvia; Benbow, Jim; Bolognesi, Simone; Fagiolini, Andrea

    2015-01-01

    This case report describes the clinical course of a young woman suffering from binge eating disorder (BED) associated with obesity. It illustrates the efficacy of different medications in the treatment of BED and related conditions and is followed by the comments and clinical observations of 2 practicing psychiatrists. The issues described in this paper have important clinical implications and are topical, given that BED is now recognized as a specific disorder in the new Diagnostic and Statistical Manual of Mental Disorders, fifth edition classification system, but neither the US Food and Drug Administration nor any other regulatory agency has yet approved a drug for treatment of this disease, despite its very prevalent and disabling nature. Growing evidence from the fields of psychopathology and neurobiology, including preclinical and clinical studies, converges to support the idea that "overeating" has much in common with other behavioral addictions, and substance abuse treatment agents may show promise for the treatment of BED.

  18. [Source data management in clinical researches].

    PubMed

    Ho, Effie; Yao, Chen; Zhang, Zi-bao; Liu, Yu-xiu

    2015-11-01

    Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management. PMID:26911026

  19. 76 FR 24974 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... following four panels of the Joint Biomedical Laboratory Research and Development and Clinical Science... clinical science research. The panel meetings will be open to the public for approximately one hour at...

  20. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... following three panels of the Joint Biomedical Laboratory Research and Development and Clinical Science..., behavioral and clinical science research. The panel meetings will be open to the public for approximately...

  1. What Else Should I Know about Clinical Research?

    MedlinePlus

    ... to have the potential risks, benefits, alternatives, and responsibilities of the clinical research explained to them before ... informed about the potential risks, benefits, alternatives, and responsibilities of the clinical trial before they agree to ...

  2. A Division of Research in an Academic Clinical Department.

    ERIC Educational Resources Information Center

    Traystman, Richard J.

    1982-01-01

    Discusses in general the importance of a research division, whether basic or clinical, in an academic setting and factors to consider in establishing one. Uses John Hopkins' newly created research division for Anesthesiology and Critical Care Medicine to specifically address funding and intra- and interdepartmental clinical research programs. (DC)

  3. Clinical research in medical schools: seizing the opportunity.

    PubMed

    Meyer, R E; Griner, P F; Weissman, J

    1998-01-01

    Academic medical centers (AMCs) face challenges to the achievement of their potential in clinical research. These challenges include reduced support of research from clinical revenue, cultural impediments to clinical research within the traditional value system of research-intensive AMCs, and potential problems of patient access to clinical research in intensive managed care environments. This article considers options to strengthen clinical research that have been developed at some medical centers. While much attention is being directed to the expansion of clinical trials in many AMCs, this effort needs to be linked to a cohesive strategy for clinical research being conducted in an academic environment. The article also addresses the subject of training and career development. It concludes with the opinion that the "crisis" in clinical research in academic medical centers provides the opportunity to define, more explicitly, the nature and scope of the investment in clinical research, and to define strategies that will bring added value to knowledge generated from basic research and to the teaching and patient care missions of these centers.

  4. Symposium on research advances in clinical PET. Final performance report

    SciTech Connect

    J. Michael McGehee

    1992-01-01

    The Institute for Clinical PET and the U.S. Department of Energy (DOE) co-sponsored a symposium entitled 'Research in PET: International and Institutional Perspectives' that highlighted the activities of many leading investigators in the U.S. and throughout the world. Research programs at the DOE were discussed as were potential directions of PET research. International as well as institutional perspectives on PET research were presented. This symposium was successful in reaching those interested in research advances of clinical PET.

  5. Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy.

    PubMed

    Hadi, Muhammad Abdul; José Closs, S

    2016-06-01

    The use of qualitative research methodology is well established for data generation within healthcare research generally and clinical pharmacy research specifically. In the past, qualitative research methodology has been criticized for lacking rigour, transparency, justification of data collection and analysis methods being used, and hence the integrity of findings. Demonstrating rigour in qualitative studies is essential so that the research findings have the "integrity" to make an impact on practice, policy or both. Unlike other healthcare disciplines, the issue of "quality" of qualitative research has not been discussed much in the clinical pharmacy discipline. The aim of this paper is to highlight the importance of rigour in qualitative research, present different philosophical standpoints on the issue of quality in qualitative research and to discuss briefly strategies to ensure rigour in qualitative research. Finally, a mini review of recent research is presented to illustrate the strategies reported by clinical pharmacy researchers to ensure rigour in their qualitative research studies.

  6. Advances in clinical research methodology for pain clinical trials.

    PubMed

    Farrar, John T

    2010-11-01

    Pain is a ubiquitous phenomenon, but the experience of pain varies considerably from person to person. Advances in understanding of the growing number of pathophysiologic mechanisms that underlie the generation of pain and the influence of the brain on the experience of pain led to the investigation of numerous compounds for treating pain. Improved knowledge of the subjective nature of pain, the variations in the measurement of pain, the mind-body placebo effect and the impact of differences in the conduct of a clinical trial on the outcome have changed approaches to design and implement studies. Careful consideration of how these concepts affect the choice of study population, the randomization and blinding process, the measurement and collection of data, and the analysis and interpretation of results should improve the quality of clinical trials for potential pain therapies.

  7. A plea for pragmatism in clinical research ethics.

    PubMed

    Brendel, David H; Miller, Franklin G

    2008-04-01

    Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.

  8. Construction of databases: advances and significance in clinical research.

    PubMed

    Long, Erping; Huang, Bingjie; Wang, Liming; Lin, Xiaoyu; Lin, Haotian

    2015-12-01

    Widely used in clinical research, the database is a new type of data management automation technology and the most efficient tool for data management. In this article, we first explain some basic concepts, such as the definition, classification, and establishment of databases. Afterward, the workflow for establishing databases, inputting data, verifying data, and managing databases is presented. Meanwhile, by discussing the application of databases in clinical research, we illuminate the important role of databases in clinical research practice. Lastly, we introduce the reanalysis of randomized controlled trials (RCTs) and cloud computing techniques, showing the most recent advancements of databases in clinical research. PMID:27215009

  9. Fraud and misconduct in clinical research: A concern

    PubMed Central

    Gupta, Ashwaria

    2013-01-01

    Fraud and misconduct in clinical research is widespread. Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines being available, unavailability of internationally harmonized framework for managing research fraud and misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud could be of various types and due to various reasons. Whatever the circumstances be, any fraud should be dealt with strictly and regulations should be in place to prevent its occurrence. PMID:23833741

  10. 77 FR 20489 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-04

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Biomedical Laboratory Research and Development and Clinical Science Research and Development Services... science research. The panel meetings will be open to the public for approximately one-half hour at...

  11. Electronic health records: new opportunities for clinical research.

    PubMed

    Coorevits, P; Sundgren, M; Klein, G O; Bahr, A; Claerhout, B; Daniel, C; Dugas, M; Dupont, D; Schmidt, A; Singleton, P; De Moor, G; Kalra, D

    2013-12-01

    Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role. Whilst EHRs used for routine clinical care have some limitations at present, as discussed in this review, new improved systems and emerging research infrastructures are being developed to ensure that EHRs can be used for secondary purposes such as clinical research, including the design and execution of clinical trials for new medicines. EHR systems should be able to exchange information through the use of recently published international standards for their interoperability and clinically validated information structures (such as archetypes and international health terminologies), to ensure consistent and more complete recording and sharing of data for various patient groups. Such systems will counteract the obstacles of differing clinical languages and styles of documentation as well as the recognized incompleteness of routine records. Here, we discuss some of the legal and ethical concerns of clinical research data reuse and technical security measures that can enable such research while protecting privacy. In the emerging research landscape, cooperation infrastructures are being built where research projects can utilize the availability of patient data from federated EHR systems from many different sites, as well as in international multilingual settings. Amongst several initiatives described, the EHR4CR project offers a promising method for clinical research. One of the first achievements of this project was the development of a protocol feasibility prototype which is used for finding patients eligible for clinical trials from multiple sources. PMID:23952476

  12. Unusual clinical presentation of cutaneous malignant melanoma metastatic to the parotid gland; initially discovered by fine needle aspiration: case report and review of literature.

    PubMed

    Elshenawy, Yasmin; Youngberg, George; Al-Abbadi, Mousa A

    2011-05-01

    We report a case of malignant melanoma (MM) metastatic to the parotid gland, initially discovered on fine needle aspiration (FNA). The patient presented with a mass in the parotid gland area with previous history only significant for prostatic carcinoma. The initial FNA impression was melanoma. The smears were hypercellular with bloody necrotic background. The cells were epithelioid with mild nuclear atypia. Discrete cytoplasmic pigmentation was seen. No lymphoglandular bodies were noticed. Fragments of benign salivary gland were also identified. The cytological diagnosis of MM triggered onsite thorough physical examination for potential primary, where a scalp pigmented lesion was discovered hidden by overlying covering hair. Our differential diagnosis included melanoma, metastatic carcinoma, and lymphoma. Further work up for melanoma with S100, HMB45, and Mart 1 confirmed our top differential diagnosis. We emphasize thorough physical examination in such circumstances, and the importance of onsite evaluation guiding clinicians looking for primary.

  13. On improving research methodology in clinical trials.

    PubMed

    Berger, Vance W; Matthews, J Rosser; Grosch, Eric N

    2008-06-01

    Research plays a vital role within biomedicine. Scientifically appropriate research provides a basis for appropriate medical decisions; conversely, inappropriate research may lead to flawed ;best medical practices' which, when followed, contribute to avoidable morbidity and mortality. Although an all-encompassing definition of ;appropriate medical research' is beyond the scope of this article, the concept clearly entails (among other things) that research methods be continually revised and updated as better methods become available. Despite the advent of evidence-based medicine, many research methods have become ;standard' even though there are legitimate scientific reasons to question the conclusions reached by such methods. We first illustrate prominent examples of inappropriate (yet regimented) research methods that are in widespread use. Second, as a way to improve the situation, we suggest a model of research that relies on standardized statistical analyses that individual researchers must consider as a default, but are free to challenge when they can marshal sufficient scientific evidence to demonstrate that the challenge is warranted. Third, we characterize the current system as analogous to ;unnatural selection' in the biological world and argue that our proposed model of research will enable ;natural' to replace ;unnatural' selection in the choice of research methodologies. Given the pervasiveness of inappropriate research methods, we believe that there are strong scientific and ethical reasons to create such a system, that, if properly designed, will both facilitate creativity and ensure methodological rigor while protecting the public at large from the threats posed by poor medical treatment decisions resulting from flawed research methodology.

  14. [Organisation of clinical research in France: the new missions of inter-regional delegations for clinical research].

    PubMed

    Jaillon, Patrice

    2008-05-01

    The organisation of clinical research in French teaching hospitals has been profoundly modified over the past 15 years. The first call for clinical research projects was made by the Ministry of Health in 1993. This Hospital Program for Clinical Research was created by the public welfare system, a situation unique in Europe and the USA at the time. Every year since 1993, new clinical research projects have been supported through this program. In 2007, more than 14 million euros was provided for clinical research in oncology more than 21 million euros for clinical research in other fields, and more than 11 million euros through interregional grants. Overall, more than 50 million euros will be provided in 2008 to support clinical research with public sponsorship in French teaching hospitals. Major organisational changes were made to support this unprecedented financial effort in favor of clinical research. In each of the 29 French teaching hospitals, a Delegation for Clinical Research (DRC) was created to promote public sponsorship of clinical trials, to monitor these trials, to guarantee that Good Clinical Practices are respected, and to control the financial aspects of research projects. Clinical Research Assistants were recruited by DRC to monitor clinical trials. Clinical Investigation Centers (CIC) were organized in conjunction with teaching hospitals and with the French biomedical research council (INSERM). Today, there are 54 CICs located in 23 teaching hospitals, conducting clinical trials and other research in epidemiology and biotechnology. In May 2005, seven interregional delegations for clinical research (DIRC) were created to coordinate these activities on a regional basis. The aim was to improve scientific collaboration between teaching hospitals in a given region, to organize the training of clinical investigators and technicians, and to support the development of clinical trial monitoring, quality assurance, and pharmacovigilance. A 2006 survey of

  15. [Organisation of clinical research in France: the new missions of inter-regional delegations for clinical research].

    PubMed

    Jaillon, Patrice

    2008-05-01

    The organisation of clinical research in French teaching hospitals has been profoundly modified over the past 15 years. The first call for clinical research projects was made by the Ministry of Health in 1993. This Hospital Program for Clinical Research was created by the public welfare system, a situation unique in Europe and the USA at the time. Every year since 1993, new clinical research projects have been supported through this program. In 2007, more than 14 million euros was provided for clinical research in oncology more than 21 million euros for clinical research in other fields, and more than 11 million euros through interregional grants. Overall, more than 50 million euros will be provided in 2008 to support clinical research with public sponsorship in French teaching hospitals. Major organisational changes were made to support this unprecedented financial effort in favor of clinical research. In each of the 29 French teaching hospitals, a Delegation for Clinical Research (DRC) was created to promote public sponsorship of clinical trials, to monitor these trials, to guarantee that Good Clinical Practices are respected, and to control the financial aspects of research projects. Clinical Research Assistants were recruited by DRC to monitor clinical trials. Clinical Investigation Centers (CIC) were organized in conjunction with teaching hospitals and with the French biomedical research council (INSERM). Today, there are 54 CICs located in 23 teaching hospitals, conducting clinical trials and other research in epidemiology and biotechnology. In May 2005, seven interregional delegations for clinical research (DIRC) were created to coordinate these activities on a regional basis. The aim was to improve scientific collaboration between teaching hospitals in a given region, to organize the training of clinical investigators and technicians, and to support the development of clinical trial monitoring, quality assurance, and pharmacovigilance. A 2006 survey of

  16. The Nephrology Clinical Research Nurse Role: Potential Role Conflicts.

    PubMed

    Micklos, Lisa

    2016-01-01

    Clinical research nursing is becoming more visible to nephrology professionals. As more nephrology practices and units are participating in clinical trials, clinical research nursing is gaining interest as a career niche among nephrology nurses. This unique specialty requires that nephrology clinical nurse nurses (CRNs) reconcile the roles of nurse as caregiver and nurse as researcher, which may result in a role conflict. Nephrology nurses should be aware that they may experience this role conflict when transitioning from patient care to a position as a clinical research nurse. These nurses can rely on the American Nurses Association's Code of Ethics for Nurses and the Oncology Nursing Society's Oncology Clinical Trials Nurse Competencies to help reconcile the potential role conflict. PMID:27501633

  17. Using Computerized Clinical Nursing Data Bases for Nursing Research.

    ERIC Educational Resources Information Center

    Nail, Lillian M.; Lange, Linda L.

    1996-01-01

    Addresses the recognition of differences between clinical and research data in using computerized clinical nursing databases and the issues of privacy and confidentiality for patients whose records are involved. Describes procedures for assessing the quality and usability of these data for nursing research. (SK)

  18. A framework for workflow-based clinical research billing disambiguation.

    PubMed

    Payne, Philip R O; Borlawsky, Tara; Kamal, Jyoti; Saltz, Joel H

    2007-10-11

    Medicare received authorization in 2000 to reimburse for routine costs incurred in association with patients participating in clinical research. However, we hypothesize that the inability to accurately differentiate standard from investigational care has resulted in under-coding of potentially reimbursable clinical events. To address this problem, we have initiated the development of a methodology for constructing computational clinical workflow models that can be employed to aid in the disambiguation of routine versus research costs.

  19. History of Neural Stem Cell Research and Its Clinical Application.

    PubMed

    Takagi, Yasushi

    2016-01-01

    "Once development was ended…in the adult centers, the nerve paths are something fixed and immutable. Everything may die, nothing may be regenerated," wrote Santiago Ramón y Cajal, a Spanish neuroanatomist and Nobel Prize winner and the father of modern neuroscience. This statement was the central dogma in neuroscience for a long time. However, in the 1960s, neural stem cells (NSCs) were discovered. Since then, our knowledge about NSCs has continued to grow. This review focuses on our current knowledge about NSCs and their surrounding microenvironment. In addition, the clinical application of NSCs for the treatment of various central nervous system diseases is also summarized. PMID:26888043

  20. Translation of clinical research into practice: defining the clinician scientist.

    PubMed

    Khanna, Niharika; Nesbitt, Laquandra; Roghmann, Mary-Claire; Tacket, Carol

    2009-06-01

    Family medicine has evolved into a specialty deeply rooted in clinical service. Because of high demands for clinical practice productivity, family physicians have drifted away from participation in scientific inquiry. There is even an effort in some institutions to reinvent family medicine as a community-based ambulatory specialty, resulting in a further "disconnect" between research and family physicians. A new movement for the efficient translation of laboratory science into clinical applications in the community supports the need for trained community-based clinician scientists. This translational science seeks to take the findings from bench research and clinical trials and study their introduction and dissemination into community-based clinical practice. There is an opportunity for family physicians to become involved in translational research. But, to develop a cadre of translational researchers within the family medicine community, education programs need to train and develop those researchers. Residency education may be an ideal time to begin that training and development.

  1. Clinical Research Methodology 3: Randomized Controlled Trials.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  2. 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

  3. Maximizing the clinical utility of comparative effectiveness research.

    PubMed

    Umscheid, C A

    2010-12-01

    Providers, consumers, payers, and policy makers are awash in choices when it comes to medical decision making and need better evidence to inform their decisions. Large federal investments in comparative effectiveness research (CER) aim to fill this need. But how do we ensure the clinical utility of CER? Here, I define comparative effectiveness and clinical utility, outline metrics to evaluate clinical utility, and suggest methods for maximizing the clinical utility of CER for the various stakeholders.

  4. [Clinical research XXIII. From clinical judgment to meta-analyses].

    PubMed

    Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Noyola-Castillo, Maura E; Talavera, Juan O

    2014-01-01

    Systematic reviews (SR) are studies made in order to ask clinical questions based on original articles. Meta-analysis (MTA) is the mathematical analysis of SR. These analyses are divided in two groups, those which evaluate the measured results of quantitative variables (for example, the body mass index -BMI-) and those which evaluate qualitative variables (for example, if a patient is alive or dead, or if he is healing or not). Quantitative variables generally use the mean difference analysis and qualitative variables can be performed using several calculations: odds ratio (OR), relative risk (RR), absolute risk reduction (ARR) and hazard ratio (HR). These analyses are represented through forest plots which allow the evaluation of each individual study, as well as the heterogeneity between studies and the overall effect of the intervention. These analyses are mainly based on Student's t test and chi-squared. To take appropriate decisions based on the MTA, it is important to understand the characteristics of statistical methods in order to avoid misinterpretations.

  5. [Clinical research XXI. From the clinical judgment to survival analysis].

    PubMed

    Rivas-Ruiz, Rodolfo; Pérez-Rodríguez, Marcela; Palacios, Lino; Talavera, Juan O

    2014-01-01

    Decision making in health care implies knowledge of the clinical course of the disease. Knowing the course allows us to estimate the likelihood of occurrence of a phenomenon at a given time or its duration. Within the statistical models that allow us to have a summary measure to estimate the time of occurrence of a phenomenon in a given population are the linear regression (the outcome variable is continuous and normally distributed -time to the occurrence of the event-), logistic regression (outcome variable is dichotomous, and it is evaluated at one single interval), and survival curves (outcome event is dichotomous, and it can be evaluated at multiple intervals). The first reference we have of this type of analysis is the work of the astronomer Edmond Halley, an English physicist and mathematician, famous for the calculation of the appearance of the comet orbit, recognized as the first periodic comet (1P/Halley's Comet). Halley also contributed in the area of health to estimate the mortality rate for a Polish population. The survival curve allows us to estimate the probability of an event occurring at different intervals. Also, it leds us to estimate the median survival time of any phenomenon of interest (although the used term is survival, the outcome does not need to be death, it may be the occurrence of any other event).

  6. [Clinical research XXI. From the clinical judgment to survival analysis].

    PubMed

    Rivas-Ruiz, Rodolfo; Pérez-Rodríguez, Marcela; Palacios, Lino; Talavera, Juan O

    2014-01-01

    Decision making in health care implies knowledge of the clinical course of the disease. Knowing the course allows us to estimate the likelihood of occurrence of a phenomenon at a given time or its duration. Within the statistical models that allow us to have a summary measure to estimate the time of occurrence of a phenomenon in a given population are the linear regression (the outcome variable is continuous and normally distributed -time to the occurrence of the event-), logistic regression (outcome variable is dichotomous, and it is evaluated at one single interval), and survival curves (outcome event is dichotomous, and it can be evaluated at multiple intervals). The first reference we have of this type of analysis is the work of the astronomer Edmond Halley, an English physicist and mathematician, famous for the calculation of the appearance of the comet orbit, recognized as the first periodic comet (1P/Halley's Comet). Halley also contributed in the area of health to estimate the mortality rate for a Polish population. The survival curve allows us to estimate the probability of an event occurring at different intervals. Also, it leds us to estimate the median survival time of any phenomenon of interest (although the used term is survival, the outcome does not need to be death, it may be the occurrence of any other event). PMID:24878091

  7. Research Guides Mayo Clinic's Recruitment, Retention Efforts.

    ERIC Educational Resources Information Center

    Nayar, Veena R.; Morrey, Michael A.; Schneider, Kenneth J.; Purrington, Anne W.; Wilshusen, Laurie L.; Mullen, Michael P.; Seltman, Kent D.

    2001-01-01

    Discusses a collaborative study between Mayo Clinic's departments of human resources and marketing to identify the factors that influence candidates' decisions to accept or decline job offers and the reasons behind staff resignations. Study aimed to increase the effectiveness of employee recruitment advertising, streamline its interviewing…

  8. Data management by using R: big data clinical research series.

    PubMed

    Zhang, Zhongheng

    2015-11-01

    Electronic medical record (EMR) system has been widely used in clinical practice. Instead of traditional record system by hand writing and recording, the EMR makes big data clinical research feasible. The most important feature of big data research is its real-world setting. Furthermore, big data research can provide all aspects of information related to healthcare. However, big data research requires some skills on data management, which however, is always lacking in the curriculum of medical education. This greatly hinders doctors from testing their clinical hypothesis by using EMR. To make ends meet, a series of articles introducing data management techniques are put forward to guide clinicians to big data clinical research. The present educational article firstly introduces some basic knowledge on R language, followed by some data management skills on creating new variables, recoding variables and renaming variables. These are very basic skills and may be used in every project of big data research.

  9. Data management by using R: big data clinical research series

    PubMed Central

    2015-01-01

    Electronic medical record (EMR) system has been widely used in clinical practice. Instead of traditional record system by hand writing and recording, the EMR makes big data clinical research feasible. The most important feature of big data research is its real-world setting. Furthermore, big data research can provide all aspects of information related to healthcare. However, big data research requires some skills on data management, which however, is always lacking in the curriculum of medical education. This greatly hinders doctors from testing their clinical hypothesis by using EMR. To make ends meet, a series of articles introducing data management techniques are put forward to guide clinicians to big data clinical research. The present educational article firstly introduces some basic knowledge on R language, followed by some data management skills on creating new variables, recoding variables and renaming variables. These are very basic skills and may be used in every project of big data research. PMID:26697463

  10. A survey of patients' attitudes to clinical research.

    PubMed

    Desmond, A; Stanton, A; Maher, V; Crean, P; Feely, J; Sullivan, P

    2011-04-01

    Every year hundreds of patients voluntarily participate in clinical trials across Ireland. However, little research has been done as to how patients find the experience. This survey was conducted in an attempt to ascertain clinical trial participants' views on their experience of participating in a clinical trial and to see and how clinical trial participation can be improved. One hundred and sixty-six clinical trial participants who had recently completed a global phase IV cardiovascular endpoint clinical trial were sent a 3-page questionnaire. Ninety-one (91%) respondents found the experience of participating in a clinical trial a good one with 85 (84.16%) respondents saying they would recommend participating in a clinical trial to a friend or relative and eighty-five (87.63%) respondents feeling they received better healthcare because they had participated in a clinical trial.

  11. On using people merely as a means in clinical research.

    PubMed

    van der Graaf, Rieke; van Delden, Johannes J M

    2012-02-01

    It is often argued that clinical research should not violate the Kantian principle that people must not be used merely as a means for the purposes of others. At first sight, the practice of clinical research itself, however, seems to violate precisely this principle: clinical research is often beneficial to future people rather than to participants; even if participants benefit, all things considered, they are exposed to discomforts which are absent both in regular care for their diseases and in other areas of daily life. Therefore, in this paper we will consider whether people are used merely as a means by being enrolled in clinical research. On the basis of recent studies of Kantian scholars we will argue that clinical research is compatible with the Kantian principle if the conditions of possible consent and end-sharing have been met. Participants are not used merely as a means if they have sufficient reasons to consent to being enrolled in clinical research and can share the ends of the researchers who use them. Moreover, we will claim that even if people are used merely as a means by participating in clinical research, it may not always be morally wrong to use them in this way. PMID:20377571

  12. Reflections on clinical research in sub-Saharan Africa.

    PubMed

    Kuepfer, Irene; Burri, Christian

    2009-07-15

    The urgent need for new, safe and sustainable interventions against diseases that disproportionally affect the poor is finally receiving global attention and the funding landscape for development projects has significantly improved during the past decade. For the development of new drug and vaccine candidates, clinical trials have become the most important tool to assess their safety and efficacy. Recently, there has been a seismic shift in the number of clinical trials conducted in resource-limited settings. We discuss the current framework of clinical research in sub-Saharan Africa, from building product pipelines to the capacities needed for the conduct of trials according the harmonised Good Clinical Practice (GCP) ICH E6 guideline. We place emphasis on clinical research in neglected tropical diseases which still frequently has to be conducted with limited financial, logistical and human resources. Given those short-comings we recommend minimum standards needed at the local, national and sponsor levels to provide GCP-compliant clinical research.

  13. [Clinical Research Progress on Transformed Lymphoma -Review].

    PubMed

    Wang, Bing-Jie; Cen, Xi-Nan; Ren, Han-Yun

    2016-08-01

    Histologic transformation (HT) is a frequent event in the clinical course of patients with indolent lymphoma with dismal outcome. The diagnosis of HT is based on clinical manifestation, PET-CT and pathologic biopsy, and the latter is a golden standard for HT. There are contradictory data about the impact of initial management on the risk of transformation. Patients who present with HT did not receive R-CHOP or chemotherapy-naive, should receive this regimen. For the subset of patients received R-CHOP prior to HT, the second line chemotherapy for DLBCL should be adopted. Consolidation with HDT-ASCT should be considered for the suitable young patients. The radio-immunotherapy and novel drugs showed a bright perspective for the patients with HT. PMID:27531806

  14. Information Technology for Clinical, Translational and Comparative Effectiveness Research

    PubMed Central

    Choquet, R.

    2014-01-01

    Summary Objectives To select and summarize key contributions to current research in the field of Clinical Research Informatics (CRI). Method: A bibliographic search using a combination of MeSH and free terms search over PubMed was performed followed by a blinded review. Results The review process resulted in the selection of four papers illustrating various aspects of current research efforts in the area of CRI. The first paper tackles the challenge of extracting accurate phenotypes from Electronic Healthcare Records (EHRs). Privacy protection within shared de-identified, patient-level research databases is the focus of the second selected paper. Two other papers exemplify the growing role of formal representation of clinical data - in metadata repositories - and knowledge – in ontologies - for supporting the process of reusing data for clinical research. Conclusions The selected articles demonstrate how concrete platforms are currently achieving interoperability across clinical research and care domains and have reached the evaluation phase. When EHRs linked to genetic data have the potential to shift the research focus from research driven patient recruitment to phenotyping in large population, a key issue is to lower patient re-identification risks for biomedical research databases. Current research illustrates the potential of knowledge engineering to support, in the coming years, the scientific lifecycle of clinical research. PMID:25123747

  15. Ramucirumab: preclinical research and clinical development.

    PubMed

    Aprile, Giuseppe; Rijavec, Erika; Fontanella, Caterina; Rihawi, Karim; Grossi, Francesco

    2014-01-01

    Ramucirumab (IMC-1121B, LY3009806), a fully humanized monoclonal antibody directed against the extracellular domain of vascular endothelial growth factor receptor 2 (VEGFR-2), is a new therapeutic option that selectively inhibits the human VEGFR-2 with a much greater affinity than its natural ligands. Based on the promising results of both preclinical and early clinical studies, ramucirumab has been tested in different tumor types either alone or in combination with chemotherapy. While it has recently been granted its first US Food and Drug Administration approval for use as a single agent in patients with advanced or metastatic gastric cancer or gastroesophageal junction carcinoma, its role for metastatic breast cancer or advanced non-small-cell lung cancer is still debated. The aims of this review are to recall and discuss the most significant preclinical and clinical studies that led to the development of ramucirumab and to present the results of the randomized clinical trials that have tested its efficacy in different malignancies, including gastric and lung cancer.

  16. Ramblings from the trenches: a clinical perspective on thanatological research.

    PubMed

    Wolfe, B; Jordan, J R

    2000-01-01

    Is thanatological research helpful in clinical practice, or do clinicians feel researchers are from some "other planet"? Written from the perspective of two practicing clinicians, this article explores the problems and potential of research to enhance clinical practice in end-of-life and bereavement care. Using a case example as a starting point, the article highlights important choice points where good research could assist the clinician. It also discusses several domains of theory and research where advances in knowledge are likely to be particularly helpful to caregivers "in the trenches." Finally, some of the barriers to dissemination of new information to practitioners are described, and suggestions for reducing these barriers are discussed.

  17. From Laboratory Research to a Clinical Trial

    PubMed Central

    Keevil, C. William; Salgado, Cassandra D.; Schmidt, Michael G.

    2015-01-01

    Objective: This is a translational science article that discusses copper alloys as antimicrobial environmental surfaces. Bacteria die when they come in contact with copper alloys in laboratory tests. Components made of copper alloys were also found to be efficacious in a clinical trial. Background: There are indications that bacteria found on frequently touched environmental surfaces play a role in infection transmission. Methods: In laboratory testing, copper alloy samples were inoculated with bacteria. In clinical trials, the amount of live bacteria on the surfaces of hospital components made of copper alloys, as well as those made from standard materials, was measured. Finally, infection rates were tracked in the hospital rooms with the copper components and compared to those found in the rooms containing the standard components. Results: Greater than a 99.9% reduction in live bacteria was realized in laboratory tests. In the clinical trials, an 83% reduction in bacteria was seen on the copper alloy components, when compared to the surfaces made from standard materials in the control rooms. Finally, the infection rates were found to be reduced by 58% in patient rooms with components made of copper, when compared to patients' rooms with components made of standard materials. Conclusions: Bacteria die on copper alloy surfaces in both the laboratory and the hospital rooms. Infection rates were lowered in those hospital rooms containing copper components. Thus, based on the presented information, the placement of copper alloy components, in the built environment, may have the potential to reduce not only hospital-acquired infections but also patient treatment costs. PMID:26163568

  18. Clinical Research Informatics: Recent Advances and Future Directions

    PubMed Central

    2015-01-01

    Summary Objectives To summarize significant developments in Clinical Research Informatics (CRI) over the past two years and discuss future directions. Methods Survey of advances, open problems and opportunities in this field based on exploration of current literature. Results Recent advances are structured according to three use cases of clinical research: Protocol feasibility, patient identification/recruitment and clinical trial execution. Discussion CRI is an evolving, dynamic field of research. Global collaboration, open metadata, content standards with semantics and computable eligibility criteria are key success factors for future developments in CRI. PMID:26293865

  19. [Conflicts of interests in clinical research in primary health care].

    PubMed

    González-de Paz, L; Navarro-Rubio, M D; Sisó-Almirall, A

    2014-03-01

    Conflicts of interests between professionals and patients in biomedical research, is an ethical problem. None of the laws in Spain mention whether the clinical researcher has to clarify to participants the reasons why it proposes them to participate in a clinical trial. In this article, conflicts of interests in research are discussed in the context of primary healthcare. In this area conflicts of interests might alter the confidence between patients and healthcare professionals. Finally, we suggest some practical strategies that can help participants make the decision to participate in a clinical trial more willingly and freely.

  20. Clinical research nursing: a critical resource in the national research enterprise.

    PubMed

    Hastings, Clare E; Fisher, Cheryl A; McCabe, Margaret A; Allison, J; Brassil, D; Offenhartz, M; Browning, S; DeCandia, E; Medina, R; Duer-Hefele, J; McClary, K; Mullen, N; Ottosen, M; Britt, S; Sanchez, T; Turbini, V

    2012-01-01

    Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to more quickly deliver prevention strategies, treatments and cures based on scientific innovations to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings, and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing. PMID:22172370

  1. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences

    ERIC Educational Resources Information Center

    National Academies Press, 2011

    2011-01-01

    Comprehensive research and a highly-trained workforce are essential for the improvement of health and health care both nationally and internationally. During the past 40 years the National Research Services Award (NRSA) Program has played a large role in training the workforce responsible for dramatic advances in the understanding of various…

  2. Frequently Asked Questions about Clinical Research

    MedlinePlus

    ... the molecular basis of human genetic diseases, and creating new technologies to accelerate further genetic research. NHGRI investigators are working to uncover the genetic components of common disorders such as cancer, diabetes, and heart disease, as well as less common conditions such ...

  3. Clinical Assessment Research with Older Adults.

    ERIC Educational Resources Information Center

    La Rue, Asenath; Markee, Taryn

    1995-01-01

    Methodological issues in geropsychological assessment research are discussed and illustrated through recent investigations. Cross-sectional studies are needed to extend and diversify age norms, and short-term longitudinal studies should be planned to assess the predictive validity of test outcomes and diagnostic profiles of older adults. (SLD)

  4. Transforming Research Management Systems at Mayo Clinic

    ERIC Educational Resources Information Center

    Smith, Steven C.; Gronseth, Darren L.

    2011-01-01

    In order for research programs at academic medical centers and universities to survive and thrive in the increasingly challenging economic, political and regulatory environment, successful transformation is extremely important. Transformation and quality management techniques are increasingly well established in medical practice organizations. In…

  5. Integrative data analysis in clinical psychology research.

    PubMed

    Hussong, Andrea M; Curran, Patrick J; Bauer, Daniel J

    2013-01-01

    Integrative data analysis (IDA), a novel framework for conducting the simultaneous analysis of raw data pooled from multiple studies, offers many advantages including economy (i.e., reuse of extant data), power (i.e., large combined sample sizes), the potential to address new questions not answerable by a single contributing study (e.g., combining longitudinal studies to cover a broader swath of the lifespan), and the opportunity to build a more cumulative science (i.e., examining the similarity of effects across studies and potential reasons for dissimilarities). There are also methodological challenges associated with IDA, including the need to account for sampling heterogeneity across studies, to develop commensurate measures across studies, and to account for multiple sources of study differences as they impact hypothesis testing. In this review, we outline potential solutions to these challenges and describe future avenues for developing IDA as a framework for studies in clinical psychology.

  6. Integrative Data Analysis in Clinical Psychology Research

    PubMed Central

    Hussong, Andrea M.; Curran, Patrick J.; Bauer, Daniel J.

    2013-01-01

    Integrative Data Analysis (IDA), a novel framework for conducting the simultaneous analysis of raw data pooled from multiple studies, offers many advantages including economy (i.e., reuse of extant data), power (i.e., large combined sample sizes), the potential to address new questions not answerable by a single contributing study (e.g., combining longitudinal studies to cover a broader swath of the lifespan), and the opportunity to build a more cumulative science (i.e., examining the similarity of effects across studies and potential reasons for dissimilarities). There are also methodological challenges associated with IDA, including the need to account for sampling heterogeneity across studies, to develop commensurate measures across studies, and to account for multiple sources of study differences as they impact hypothesis testing. In this review, we outline potential solutions to these challenges and describe future avenues for developing IDA as a framework for studies in clinical psychology. PMID:23394226

  7. 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

  8. CRC Clinical Trials Management System (CTMS): An Integrated Information Management Solution for Collaborative Clinical Research

    PubMed Central

    Payne, Philip R.O.; Greaves, Andrew W.; Kipps, Thomas J.

    2003-01-01

    The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) consists of 9 geographically distributed sites conducting a program of research including both basic science and clinical components. To enable the CRC’s clinical research efforts, a system providing for real-time collaboration was required. CTMS provides such functionality, and demonstrates that the use of novel data modeling, web-application platforms, and management strategies provides for the deployment of an extensible, cost effective solution in such an environment. PMID:14728471

  9. Collaboration - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    Despite great strides in proteomics and the growing number of articles citing the discovery of potential biomarkers, the actual rate of introduction of Food and Drug Administration (FDA) approved protein analytes has been relatively unchanged over the past 10 years. One of reasons for the lack of new protein-based biomarkers approved has been a lack of information and understanding by the proteomics research community to the regulatory process used by the FDA.

  10. Ethics of Cancer Gene Transfer Clinical Research.

    PubMed

    Kimmelman, Jonathan

    2015-01-01

    Translation of cancer gene transfer confronts many familiar-and some distinctive-ethical challenges. In what follows, I survey three major ethical dimensions of cancer gene transfer development. Subheading 1 centers on the ethics of planning, designing, and reporting animal studies. Subheading 2 describes basic elements of human subjects protection as pertaining to cancer gene transfer. In Subheading 3, I describe how cancer gene transfer researchers have obligations to downstream consumers of the evidence they produce.

  11. Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

    PubMed

    Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

    2015-12-01

    The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

  12. Lightest exoplanet yet discovered

    NASA Astrophysics Data System (ADS)

    2009-04-01

    Well-known exoplanet researcher Michel Mayor today announced the discovery of the lightest exoplanet found so far. The planet, "e", in the famous system Gliese 581, is only about twice the mass of our Earth. The team also refined the orbit of the planet Gliese 581 d, first discovered in 2007, placing it well within the habitable zone, where liquid water oceans could exist. These amazing discoveries are the outcome of more than four years of observations using the most successful low-mass-exoplanet hunter in the world, the HARPS spectrograph attached to the 3.6-metre ESO telescope at La Silla, Chile. ESO PR Photo 15a/09 Artist's impression of Gliese 581 e ESO PR Photo 15b/09 A planet in the habitable zone ESO PR Video 15a/09 ESOcast 6 ESO PR Video 15b/09 VNR A-roll ESO PR Video 15c/09 Zoom-in on Gliese 581 e ESO PR Video 15d/09 Artist's impression of Gliese 581 e ESO PR Video 15e/09 Artist's impression of Gliese 581 d ESO PR Video 15f/09 Artist's impression of Gliese 581 system ESO PR Video 15g/09 The radial velocity method ESO PR Video 15h/09 Statement in English ESO PR Video 15i/09 Statement in French ESO PR Video 15j/09 La Silla Observatory "The holy grail of current exoplanet research is the detection of a rocky, Earth-like planet in the ‘habitable zone' -- a region around the host star with the right conditions for water to be liquid on a planet's surface", says Michel Mayor from the Geneva Observatory, who led the European team to this stunning breakthrough. Planet Gliese 581 e orbits its host star - located only 20.5 light-years away in the constellation Libra ("the Scales") -- in just 3.15 days. "With only 1.9 Earth-masses, it is the least massive exoplanet ever detected and is, very likely, a rocky planet", says co-author Xavier Bonfils from Grenoble Observatory. Being so close to its host star, the planet is not in the habitable zone. But another planet in this system appears to be. From previous observations -- also obtained with the HARPS spectrograph

  13. Letter from the Director - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The NCI's Clinical Proteomic Technologies for Cancer (CPTC) initiative has made tremendous progress knocking down barriers to the field which is indicative of both the dedication to the highest quality of research by its investigators and commitment to open standards.

  14. Progress through Collaboration - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The National Cancer Institute (NCI), through the Office of Cancer Clinical Proteomics Research (OCCPR), has signed two Memorandums of Understanding (MOUs) in the areas of sharing proteomics reagents and protocols and also in regulatory science.

  15. Cyclotrons for clinical and biomedical research with PET

    SciTech Connect

    Wolf, A.P.

    1987-01-01

    The purpose of this commentary is to present some background material on cyclotrons and other particle accelerators particularly with a view toward the considerations behind acquiring and installing such a machine for purely clinical and/or biomedical research use.

  16. Clinical Research Trials and You: Questions and Answers

    MedlinePlus

    ... volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses. Informed Consent Informed consent is the process of learning the key facts about a clinical trial before ...

  17. A Five-Phase Model for Clinical-Outcome Research

    ERIC Educational Resources Information Center

    Robey, Randall R.

    2004-01-01

    Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and…

  18. Infrastructure resources for clinical research in amyotrophic lateral sclerosis.

    PubMed

    Sherman, Alexander V; Gubitz, Amelie K; Al-Chalabi, Ammar; Bedlack, Richard; Berry, James; Conwit, Robin; Harris, Brent T; Horton, D Kevin; Kaufmann, Petra; Leitner, Melanie L; Miller, Robert; Shefner, Jeremy; Vonsattel, Jean Paul; Mitsumoto, Hiroshi

    2013-05-01

    Clinical trial networks, shared clinical databases, and human biospecimen repositories are examples of infrastructure resources aimed at enhancing and expediting clinical and/or patient oriented research to uncover the etiology and pathogenesis of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease that leads to the paralysis of voluntary muscles. The current status of such infrastructure resources, as well as opportunities and impediments, were discussed at the second Tarrytown ALS meeting held in September 2011. The discussion focused on resources developed and maintained by ALS clinics and centers in North America and Europe, various clinical trial networks, U.S. government federal agencies including the National Institutes of Health (NIH), the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC), and several voluntary disease organizations that support ALS research activities. Key recommendations included 1) the establishment of shared databases among individual ALS clinics to enhance the coordination of resources and data analyses; 2) the expansion of quality-controlled human biospecimen banks; and 3) the adoption of uniform data standards, such as the recently developed Common Data Elements (CDEs) for ALS clinical research. The value of clinical trial networks such as the Northeast ALS (NEALS) Consortium and the Western ALS (WALS) Consortium was recognized, and strategies to further enhance and complement these networks and their research resources were discussed.

  19. Review of the Registration in the Clinical Research Information Service

    PubMed Central

    2016-01-01

    Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement. PMID:26770030

  20. Found in translation: Integrating laboratory and clinical oncology research

    PubMed Central

    Wagner, H

    2008-01-01

    Translational research in medicine aims to inform the clinic and the laboratory with the results of each other’s work, and to bring promising and validated new therapies into clinical application. While laudable in intent, this is complicated in practice and the current state of translational research in cancer shows both striking success stories and examples of the numerous potential obstacles as well as opportunities for delays and errors in translation. This paper reviews the premises, promises, and problems of translational research with a focus on radiation oncology and suggests opportunities for improvements in future research design. PMID:21611010

  1. Discovering Mendeleev's Model.

    ERIC Educational Resources Information Center

    Sterling, Donna

    1996-01-01

    Presents an activity that introduces the historical developments in science that led to the discovery of the periodic table and lets students experience scientific discovery firsthand. Enables students to learn about patterns among the elements and experience how scientists analyze data to discover patterns and build models. (JRH)

  2. Discovering the Artist Within.

    ERIC Educational Resources Information Center

    Hamill, Sam

    1999-01-01

    Describes a personal artistic struggle against heroin addiction, advising teachers of the difficulty of working to discover and express one's developing self. Considers the effect of poetry and philosophy on the developing creative process. Provides samples of the author's own poetry to demonstrate creative development, as an example to Montessori…

  3. [Computerized system validation of clinical researches].

    PubMed

    Yan, Charles; Chen, Feng; Xia, Jia-lai; Zheng, Qing-shan; Liu, Daniel

    2015-11-01

    Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means. PMID:26911028

  4. Diabetes research in jeopardy: the extinction of clinical diabetes researchers.

    PubMed

    Rossini, Aldo A; Greiner, Dale L

    2007-04-01

    Finding a cure for an autoimmune disease, such as diabetes, must be viewed as a marathon. Although there are occasional quick sprints forward on the road to discovery, the bulk of research is carried out steadily over time. Over the years, researchers have made progressive strides toward a cure, but our field is now facing a crisis. We need youthful researchers with fresh new perspectives to carry on the work started by forerunners in the field. In fact, many young people never get the opportunity to work in a scientific field. Of those who do choose to study science, after receiving a bachelor's degree in that field, only 4% eventually receive their doctorate. There are many reasons for the abrupt end of the academic path for these students. Perhaps they are stymied in their education, frustrated by the lack of grant support and mentorship provided to young scientists. On average, a scientist receives his or her first NIH R01 award at the age of 43 years. Moreover, many young researchers lack the mentorship they seek from more established scientists. This hurdle can be overcome by providing young scientists the ability to work unreservedly with other mature scientists. Ideally, a Diabetes Research Center needs to be geared toward facilitating collaboration and free exchange of ideas to promote the maturation of young scientists. Additionally, this environment, can offer young scientists the resources that would otherwise be unavailable to them. This concept is fundamental to creating more experienced and prolific scientists in the field of diabetes.

  5. Clinical implications of neuroscience research in PTSD.

    PubMed

    van der Kolk, Bessel A

    2006-07-01

    The research showing how exposure to extreme stress affects brain function is making important contributions to understanding the nature of traumatic stress. This includes the notion that traumatized individuals are vulnerable to react to sensory information with subcortically initiated responses that are irrelevant, and often harmful, in the present. Reminders of traumatic experiences activate brain regions that support intense emotions, and decrease activation in the central nervous system (CNS) regions involved in (a) the integration of sensory input with motor output, (b) the modulation of physiological arousal, and (c) the capacity to communicate experience in words. Failures of attention and memory in posttraumatic stress disorder (PTSD) interfere with the capacity to engage in the present: traumatized individuals "lose their way in the world." This article discusses the implications of this research by suggesting that effective treatment needs to involve (a) learning to tolerate feelings and sensations by increasing the capacity for interoception, (b) learning to modulate arousal, and (c) learning that after confrontation with physical helplessness it is essential to engage in taking effective action.

  6. 76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Research and Development Officer through the Director of the Clinical Science Research and...

  7. 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. PMID:23919369

  8. 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

    Rosenblum, Daniel

    2013-01-01

    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. PMID:23919369

  9. Institutional review board (IRB) and ethical issues in clinical research

    PubMed Central

    2012-01-01

    Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward. PMID:22323947

  10. Clinical diabetes research using data mining: a Canadian perspective.

    PubMed

    Shah, Baiju R; Lipscombe, Lorraine L

    2015-06-01

    With the advent of the digitization of large amounts of information and the computer power capable of analyzing this volume of information, data mining is increasingly being applied to medical research. Datasets created for administration of the healthcare system provide a wealth of information from different healthcare sectors, and Canadian provinces' single-payer universal healthcare systems mean that data are more comprehensive and complete in this country than in many other jurisdictions. The increasing ability to also link clinical information, such as electronic medical records, laboratory test results and disease registries, has broadened the types of data available for analysis. Data-mining methods have been used in many different areas of diabetes clinical research, including classic epidemiology, effectiveness research, population health and health services research. Although methodologic challenges and privacy concerns remain important barriers to using these techniques, data mining remains a powerful tool for clinical research.

  11. Pediatric Acupuncture: A Review of Clinical Research

    PubMed Central

    Nicolaou, Colette D.; Belmont, Katharine A.; Katz, Aaron R.; Benaron, Daniel M.; Yu, Wendy

    2009-01-01

    Practiced in China for more than 2000 years, acupuncture has recently gained increased attention in the United States as an alternative treatment approach for a variety of medical conditions. Despite its growing prevalence and anecdotal reports of success among pediatric populations, few empirically based studies have assessed the efficacy of acupuncture for children and adolescents. This article presents a review of the current literature, including a systematic appraisal of the methodological value of each study and a discussion of potential benefits and adverse effects of acupuncture. While acupuncture holds great promise as a treatment modality for diverse pediatric conditions, a significant amount of additional research is necessary to establish an empirical basis for the incorporation of acupuncture into standard care. PMID:18955306

  12. Leveraging dialog systems research to assist biomedical researchers' interrogation of Big Clinical Data.

    PubMed

    Hoxha, Julia; Weng, Chunhua

    2016-06-01

    The worldwide adoption of electronic health records (EHR) promises to accelerate clinical research, which lies at the heart of medical advances. However, the interrogation of such Big Data by clinical researchers can be laborious and error-prone, involving iterative and ineffective communication of data requests to data analysts. Research on this communication process is rare. There also exists no contemporary system that offers intelligent solutions to assist clinical researchers in their quest for clinical data. In this article, we first provide a detailed characterization of the challenges encountered in this communication space. Second, we identify promising synergies between fields studying human-to-human and human-machine communication that can shed light on biomedical data query mediation. We propose a mixed-initiative dialog-based approach to support autonomous clinical data access and recommend needed technology development and communication study for accelerating clinical research.

  13. Leveraging dialog systems research to assist biomedical researchers' interrogation of Big Clinical Data.

    PubMed

    Hoxha, Julia; Weng, Chunhua

    2016-06-01

    The worldwide adoption of electronic health records (EHR) promises to accelerate clinical research, which lies at the heart of medical advances. However, the interrogation of such Big Data by clinical researchers can be laborious and error-prone, involving iterative and ineffective communication of data requests to data analysts. Research on this communication process is rare. There also exists no contemporary system that offers intelligent solutions to assist clinical researchers in their quest for clinical data. In this article, we first provide a detailed characterization of the challenges encountered in this communication space. Second, we identify promising synergies between fields studying human-to-human and human-machine communication that can shed light on biomedical data query mediation. We propose a mixed-initiative dialog-based approach to support autonomous clinical data access and recommend needed technology development and communication study for accelerating clinical research. PMID:27067901

  14. Treatment of Opioid Dependent Pregnant Women: Clinical and Research Issues

    PubMed Central

    Jones, H.E.; Martin, P.R.; Heil, S.H.; Stine, S.M.; Kaltenbach, K.; Selby, P.; Coyle, M.G.; O’Grady, K.E.; Arria, A.M.; Fischer, G.

    2008-01-01

    This paper addresses common questions that clinicians face when treating pregnant women with opioid dependence. Guidance is provided to aid clinical decision-making, based on both research evidence and the collective clinical experience of the authors which include investigators in the Maternal Opioid Treatment: Human Experimental Research (MOTHER) project. MOTHER is a double-blind, double-dummy, flexible–dosing, parallel-group clinical trial examining the comparative safety and efficacy of methadone and buprenorphine for the opioid dependence treatment among pregnant women and their neonates. The paper begins with a discussion of appropriate assessment during pregnancy, and then addresses clinical management stages, including maintenance medication selection, induction and stabilization, opioid agonist medication management before, during and after delivery, pain management, breast-feeding, and transfer to aftercare. Lastly, other important clinical issues including managing co-occurring psychiatric disorders and medication interactions are discussed. PMID:18248941

  15. Aortic function: from the research laboratory to the clinic.

    PubMed

    Boudoulas, Konstantinos Dean; Vlachopoulos, Charalambos; Raman, Subha V; Sparks, Elizabeth A; Triposciadis, Filippos; Stefanadis, Christodoulos; Boudoulas, Harisios

    2012-01-01

    For many years, much of the pioneering research on aortic function was carried out by a small group of investigators frequently working away from the clinical environment in the research laboratory. The evaluation of aortic function using aortic pulse wave velocity, aortic distensibility, or other practical indices had yet to reach clinical threshold. It was necessary for the clinicians to take over and to apply these indices to the clinic. In this Odyssey, the work by the basic scientist was important to define the fundamental mechanisms of aortic function; however, it was the vision of the clinical investigator who recognized the importance of aortic function and introduced it into clinical practice. In the near future, the clinical investigator will introduce aortic function in daily clinical practice as the measurement of left ventricular function is used today. A close collaboration between the clinical and the basic investigator will be necessary in order to define the molecular mechanisms related to aortic wall synthesis and degradation of collagen and elastin. Application of these findings by the clinical investigator may help to delay or prevent aortic dysfunction related to aging or other conditions and diseases.

  16. E-recruitment based clinical research: notes for Research Ethics Committees/Institutional Review Boards.

    PubMed

    Refolo, P; Sacchini, D; Minacori, R; Daloiso, V; Spagnolo, A G

    2015-01-01

    Patient recruitment is a critical point of today's clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.

  17. History of Neural Stem Cell Research and Its Clinical Application

    PubMed Central

    TAKAGI, Yasushi

    2016-01-01

    “Once development was ended…in the adult centers, the nerve paths are something fixed and immutable. Everything may die, nothing may be regenerated,” wrote Santiago Ramón y Cajal, a Spanish neuroanatomist and Nobel Prize winner and the father of modern neuroscience. This statement was the central dogma in neuroscience for a long time. However, in the 1960s, neural stem cells (NSCs) were discovered. Since then, our knowledge about NSCs has continued to grow. This review focuses on our current knowledge about NSCs and their surrounding microenvironment. In addition, the clinical application of NSCs for the treatment of various central nervous system diseases is also summarized. PMID:26888043

  18. Discovering the Solar System

    NASA Astrophysics Data System (ADS)

    Jones, Barrie W.

    1999-04-01

    Discovering the Solar System Barrie W. Jones The Open University, Milton Keynes, UK Discovering the Solar System is a comprehensive, up-to-date account of the Solar System and of the ways in which the various bodies have been investigated and modelled. The approach is thematic, with sequences of chapters on the interiors of planetary bodies, on their surfaces, and on their atmospheres. Within each sequence there is a chapter on general principles and processes followed by one or two chapters on specific bodies. There is also an introductory chapter, a chapter on the origin of the Solar System, and a chapter on asteroids, comets and meteorites. Liberally illustrated with diagrams, black and white photographs and colour plates, Discovering the Solar System also features: * tables of essential data * question and answers within the text * end of section review questions with answers and comments Discovering the Solar System is essential reading for all undergraduate students for whom astronomy or planetary science are components of their degrees, and for those at a more advanced level approaching the subject for the first time. It will also be of great interest to non-specialists with a keen interest in astronomy. A small amount of scientific knowledge is assumed plus familiarity with basic algebra and graphs. There is no calculus. Praise for this book includes: ".certainly qualifies as an authoritative text. The author clearly has an encyclopedic knowledge of the subject." Meteorics and Planetary Science ".liberally doused with relevant graphs, tables, and black and white figures of good quality." EOS, Transactions of the American Geophysical Union ".one of the best books on the Solar System I have seen. The general accuracy and quality of the content is excellent." Journal of the British Astronomical Association

  19. Sex and Gender: Critical Variables in Pre-Clinical and Clinical Medical Research.

    PubMed

    Morselli, Eugenia; Frank, Aaron P; Santos, Roberta S; Fátima, Luciana A; Palmer, Biff F; Clegg, Deborah J

    2016-08-01

    In this Essay, we discuss the critical need to incorporate sex and gender in pre-clinical and clinical research to enhance our understanding of the mechanisms by which metabolic processes differ by sex and gender. This knowledge will allow for development of personalized medicine which will optimize therapies specific for individuals. PMID:27508869

  20. Re-thinking clinical research training in residency

    PubMed Central

    O’Brien, Jennifer; D’Eon, Marcel

    2014-01-01

    Background There are good reasons to train clinician researchers, including a lack of translational and patient centered research, a decline in physicians choosing academic careers, the need for physicians who are able to critically appraise research, and accreditation requirements. However, why are we insisting that residents engage in original clinical research? Discussion This paper is structured around three questions: 1) Is mandating original research the answer? 2) What ought to be the central purpose of research training? And 3) What are the alternatives to original clinical research? The successful development of clinician-scientists involves many more factors than resident research training. While invoking social accountability and public welfare, we argue for considering the opportunity cost of resident research training. We question the focus on original resident research and challenge medical educators to encourage research training aimed steadfastly at public good in the local setting. Finally, we offer preliminary suggestions for how to move forward. Conclusions We conclude that medical educators should critically re-think our programs to develop resident researchers. If it is worthwhile to require original research projects during residency, then we must consider the priorities of local settings to best serve the public interest. PMID:26451223

  1. Using Clinical Data, Hypothesis Generation Tools and PubMed Trends to Discover the Association between Diabetic Retinopathy and Antihypertensive Drugs

    SciTech Connect

    Senter, Katherine G; Sukumar, Sreenivas R; Patton, Robert M; Chaum, Ed

    2015-01-01

    Diabetic retinopathy (DR) is a leading cause of blindness and common complication of diabetes. Many diabetic patients take antihypertensive drugs to prevent cardiovascular problems, but these drugs may have unintended consequences on eyesight. Six common classes of antihypertensive drug are angiotensin converting enzyme (ACE) inhibitors, alpha blockers, angiotensin receptor blockers (ARBs), -blockers, calcium channel blockers, and diuretics. Analysis of medical history data might indicate which of these drugs provide safe blood pressure control, and a literature review is often used to guide such analyses. Beyond manual reading of relevant publications, we sought to identify quantitative trends in literature from the biomedical database PubMed to compare with quantitative trends in the clinical data. By recording and analyzing PubMed search results, we found wide variation in the prevalence of each antihypertensive drug in DR literature. Drug classes developed more recently such as ACE inhibitors and ARBs were most prevalent. We also identified instances of change-over-time in publication patterns. We then compared these literature trends to a dataset of 500 diabetic patients from the UT Hamilton Eye Institute. Data for each patient included class of antihypertensive drug, presence and severity of DR. Graphical comparison revealed that older drug classes such as diuretics, calcium channel blockers, and -blockers were much more prevalent in the clinical data than in the DR and antihypertensive literature. Finally, quantitative analysis of the dataset revealed that patients taking -blockers were statistically more likely to have DR than patients taking other medications, controlling for presence of hypertension and year of diabetes onset. This finding was concerning given the prevalence of -blockers in the clinical data. We determined that clinical use of -blockers should be minimized in diabetic patients to prevent retinal damage.

  2. Common data elements for clinical research in Friedreich's ataxia.

    PubMed

    Lynch, David R; Pandolfo, Massimo; Schulz, Jorg B; Perlman, Susan; Delatycki, Martin B; Payne, R Mark; Shaddy, Robert; Fischbeck, Kenneth H; Farmer, Jennifer; Kantor, Paul; Raman, Subha V; Hunegs, Lisa; Odenkirchen, Joanne; Miller, Kristy; Kaufmann, Petra

    2013-02-01

    To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements, which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich's ataxia (FRDA), a neurological disorder that involves multiple organ systems. To develop FRDA common data elements, FRDA experts formed a working group and subgroups to define elements in the following: ataxia and performance measures; biomarkers; cardiac and other clinical outcomes; and demographics, laboratory tests, and medical history. The basic development process included identification of international experts in FRDA clinical research, meeting by teleconference to develop a draft of standardized common data elements recommendations, vetting of recommendations across the subgroups, and dissemination of recommendations to the research community for public comment. The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The subgroups' recommendations are classified as core, supplemental, or exploratory. Template case report forms were created for many of the core tests. The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new, ongoing studies will be assessed in an ongoing fashion to define their utility in FRDA.

  3. 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

  4. Improving International Research with Clinical Specimens: 5 Achievable Objectives

    PubMed Central

    LaBaer, Joshua

    2012-01-01

    Our increased interest in translational research has created a large demand for blood, tissue and other clinical samples, which find use in a broad variety of research including genomics, proteomics, and metabolomics. Hundreds of millions of dollars have been invested internationally on the collection, storage and distribution of samples. Nevertheless, many researchers complain in frustration about their inability to obtain relevant and/or useful samples for their research. Lack of access to samples, poor condition of samples, and unavailability of appropriate control samples have slowed our progress in the study of diseases and biomarkers. In this editorial, I focus on five major challenges that thwart clinical sample use for translational research and propose near term objectives to address them. They include: (1) defining our biobanking needs; (2) increasing the use of and access to standard operating procedures; (3) mapping inter-observer differences for use in normalizing diagnoses; (4) identifying natural internal protein controls; and (5) redefining the clinical sample paradigm by building partnerships with the public. In each case, I believe that we have the tools at hand required to achieve the objective within 5 years. Potential paths to achieve these objectives are explored. However we solve these problems, the future of proteomics depends on access to high quality clinical samples, collected under standardized conditions, accurately annotated and shared under conditions that promote the research we need to do. PMID:22998582

  5. Clinical Research Priorities in Adult Congenital Heart Disease

    PubMed Central

    Cotts, Timothy; Khairy, Paul; Opotowsky, Alexander R.; John, Anitha S.; Valente, Anne Marie; Zaidi, Ali N.; Cook, Stephen C.; Aboulhosn, Jamil; Ting, Jennifer Grando; Gurvitz, Michelle; Landzberg, Michael J.; Verstappen, Amy; Kay, Joseph; Earing, Michael; Franklin, Wayne; Kogon, Brian; Broberg, Craig S.

    2014-01-01

    Background Adult congenital heart disease (ACHD) clinicians are hampered by the paucity of data to inform clinical decision-making. The objective of this study was to identify priorities for clinical research in ACHD. Methods A list of 45 research questions was developed by the Alliance for Adult Research in Congenital Cardiology (AARCC), compiled into a survey, and administered to ACHD providers. Patient input was sought via the Adult Congenital Heart Association at community meetings and online forums. The 25 top questions were sent to ACHD providers worldwide via an online survey. Each question was ranked based on perceived priority and weighted based on time spent in ACHD care. The top 10 topics identified are presented and discussed. Results The final online survey yielded 139 responses. Top priority questions related to tetralogy of Fallot (timing of pulmonary valve replacement and criteria for primary prevention ICDs), patients with systemic right ventricles (determining the optimal echocardiographic techniques for measuring right ventricular function, and indications for tricuspid valve replacement and primary prevention ICDs), and single ventricle/Fontan patients (role of pulmonary vasodilators, optimal anticoagulation, medical therapy for preservation of ventricular function, treatment for protein losing enteropathy). In addition, establishing criteria to refer ACHD patients for cardiac transplantation was deemed a priority. Conclusions The ACHD field is in need of prospective research to address fundamental clinical questions. It is hoped that this methodical consultation process will inform researchers and funding organizations about clinical research topics deemed to be of high priority. PMID:24411207

  6. Using computerized clinical nursing data bases for nursing research.

    PubMed

    Nail, L M; Lange, L L

    1996-01-01

    Computerized clinical nursing data bases (CCNDBs) have significant potential as sources of data for research on the processes and outcomes of nursing care. The emergence of nurse-managed practice sites, in which patient care is driven predominantly by nurses' decisions, has prompted renewed interest in using data from these practices to answer questions that are important to nurses. The purpose of this article is to articulate strategies for using CCNDBs for nursing research. Recognition of the differences between clinical and research data bases is essential. The steps involved in obtaining and using computerized clinical data can be grouped into three phases: (1) locating and accessing CCNDBs, (2) assessing the content and quality of the data, and (3) extracting and analyzing the data. Processes involved in phase 1 include determining the research question, identifying eligible CCNDBs, negotiating access to the CCNDB, and ensuring the privacy and confidentiality of subjects. In phase 2 the processes include determining the content of the candidate CCNDBs, assessing the quality of the data in candidate CCNDBs, and determining the technical usability of data in candidate CCNDBs. Phase 3 involves mapping CCNDB data elements to research variables; determining data and record selection criteria; writing and implementing a query to select the desired records; designing a data base and record structure for research variables; performing analytic procedures on the research data; and reporting results of the research. Phases and procedures are discussed in detail in the article.

  7. A departmental initiative for clinical and translational research.

    PubMed

    Colombo, Christopher J; Baer, Stephanie; Blake, Lindsay; Bollag, Wendy B; Colombo, Rhonda; Diamond, Matthew; George, Varghese; Huber, Lu; Merchen, Lee; Miles, Kathy; Yang, Frances; Nahman, N Stanley

    2016-06-01

    To encourage departmental research activities, the Department of Medicine of the Medical College of Georgia (MCG) introduced an internally funded Translational Research Program (TRP) in 2014. Patterned after the Vanderbilt Institute for Clinical and Translational Research, the program offers research studios for project guidance, research mentoring and the availability of limited financial support through research vouchers. Additional academic services include abstract reviewing, conducting research conferences, organizing departmental research programs for students, and offering courses in biostatistics. During the first 15 months of its existence, the TRP working group addressed 132 distinct activities. Research mentoring, publications, and the conduct of research studios or voucher approvals encompassed 49% of working group activities. Other academic services constituted the remaining 51%. Twenty-four per cent of TRP committee activities involved research mentoring of 32 investigators (25% faculty and 75% trainees). Mentored projects generated 17 abstracts, 2 manuscripts and $87,000 in funds. The TRP conducted 13 research studios; trainees presented 54%. The TRP reviewed 36 abstracts for local and state organizations. Monthly research conferences and statistical courses were conducted and well attended. Our experience thus far indicates that a departmental TRP may serve to facilitate the growth of patient-oriented research with minimal financial support. It requires active engagement of volunteer faculty and departmental leadership willing to balance research with the other demands of the academic mission. PMID:27073213

  8. Education of research ethics for clinical investigators with Moodle tool

    PubMed Central

    2013-01-01

    Background In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess knowledge in bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research. Methods 57 PhD-students (medical, nursing and dental sciences) enrolled and 46 completed the course. Course evaluation was done using a questionnaire. The response rate was 78%. Data were analyzed using quantitative methods and qualitative content analysis. Results The course was viewed as useful and technically easy to perform. Students were pleased with the guidance offered. Personal feedback from teachers about students’ own performance was seen advantageous and helped them to appreciate how these aspects could be applied their own studies. The course was also considered valuable for future research projects. Conclusions Ethical issues and legislation of clinical research can be understood more easily when students can reflect the principles upon their own research project. Web based teaching environment is a feasible learning method for clinical investigators. PMID:24330709

  9. Toward an Ontology-Based Framework for Clinical Research Databases

    PubMed Central

    Kong, Y. Megan; Dahlke, Carl; Xiang, Qun; Qian, Yu; Karp, David; Scheuermann, Richard H.

    2010-01-01

    Clinical research includes a wide range of study designs from focused observational studies to complex interventional studies with multiple study arms, treatment and assessment events, and specimen procurement procedures. Participant characteristics from case report forms need to be integrated with molecular characteristics from mechanistic experiments on procured specimens. In order to capture and manage this diverse array of data, we have developed the Ontology-Based eXtensible conceptual model (OBX) to serve as a framework for clinical research data in the Immunology Database and Analysis Portal (ImmPort). By designing OBX around the logical structure of the Basic Formal Ontology (BFO) and the Ontology for Biomedical Investigations (OBI), we have found that a relatively simple conceptual model can represent the relatively complex domain of clinical research. In addition, the common framework provided by BFO makes it straightforward to develop data dictionaries based on reference and application ontologies from the OBO Foundry. PMID:20460173

  10. Ethics: the risk management tool in clinical research.

    PubMed

    Wadlund, Jill; Platt, Leslie A

    2002-01-01

    Scientific discovery and knowledge expansion in the post genome era holds great promise for new medical technologies and cellular-based therapies with multiple applications that will save and enhance lives. While human beings long have hoped to unlock the mysteries of the molecular basis of life; our society is now on the verge of doing so. But new scientific and technological breakthroughs often come with some risks attached. Research--especially clinical trials and research involving human participants--must be conducted in accordance with the highest ethical and scientific principles. Yet, as the number and complexity of clinical trials increase, so do pressures for new revenue sources and shorter product development cycles, which could have an adverse impact on patient safety. This article explores the use of risk management tools in clinical research.

  11. 75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...

  12. 76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...

  13. 77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... the Clinical Science Research and Development Service on the relevance and feasibility of...

  14. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Committee advises the Chief Research and Development Officer through the Director of the Clinical...

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

    PubMed Central

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

    2013-01-01

    Clinical data has 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 of 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

  16. India's growing clinical research sector: opportunity for global companies.

    PubMed

    Varawalla, Nermeen

    2007-06-01

    Backed by a compelling foundation of essential requirements necessary for effective clinical trial conduct, and aided by initiatives that address concerns of data quality, regulatory timelines and IP protection, the clinical development sector in India has experienced annual revenue growth rates of 25% in the past two to three years, and is poised to participate substantially in global drug development. As both clinical trial sponsors and CROs increase their research capabilities in India, the clinical development sector is facing challenges with staff resourcing and facilities. Existing initiatives in the clinical sector must continue, and further investment must be made by stakeholders to overcome the current limitations in sector growth. Furthermore, global organizations seeking to derive long-term sustainable revenue growth and competitive advantage in the global marketplace from their business units in India must establish an appropriate organizational culture and an effective intra-organizational and industry interface for their operations.

  17. Discovering system requirements

    SciTech Connect

    Bahill, A.T.; Bentz, B.; Dean, F.F.

    1996-07-01

    Cost and schedule overruns are often caused by poor requirements that are produced by people who do not understand the requirements process. This report provides a high-level overview of the system requirements process, explaining types, sources, and characteristics of good requirements. System requirements, however, are seldom stated by the customer. Therefore, this report shows ways to help you work with your customer to discover the system requirements. It also explains terminology commonly used in the requirements development field, such as verification, validation, technical performance measures, and the various design reviews.

  18. [National Strategic Promotion for Large-Scale Clinical Cancer Research].

    PubMed

    Toyama, Senya

    2016-04-01

    The number of clinical research by clinical cancer study groups has been decreasing this year in Japan. They say the reason is the abolition of donations to the groups from the pharmaceutical companies after the Diovan scandal. But I suppose fundamental problem is that government-supported large-scale clinical cancer study system for evidence based medicine (EBM) has not been fully established. An urgent establishment of the system based on the national strategy is needed for the cancer patients and the public health promotion.

  19. Adaptive Semantic Tag Mining from Heterogeneous Clinical Research Texts

    PubMed Central

    Hao, Tianyong; Weng, Chunhua

    2015-01-01

    Summary Objectives To develop an adaptive approach to mine frequent semantic tags (FSTs) from heterogeneous clinical research texts. Methods We develop a “plug-n-play” framework that integrates replaceable unsupervised kernel algorithms with formatting, functional, and utility wrappers for FST mining. Temporal information identification and semantic equivalence detection were two example functional wrappers. We first compared this approach's recall and efficiency for mining FSTs from ClinicalTrials.gov to that of a recently published tag-mining algorithm. Then we assessed this approach's adaptability to two other types of clinical research texts: clinical data requests and clinical trial protocols, by comparing the prevalence trends of FSTs across three texts. Results Our approach increased the average recall and speed by 12.8% and 47.02% respectively upon the baseline when mining FSTs from ClinicalTrials.gov, and maintained an overlap in relevant FSTs with the baseline ranging between 76.9% and 100% for varying FST frequency thresholds. The FSTs saturated when the data size reached 200 documents. Consistent trends in the prevalence of FST were observed across the three texts as the data size or frequency threshold changed. Conclusions This paper contributes an adaptive tag-mining framework that is scalable and adaptable without sacrificing its recall. This component-based architectural design can be potentially generalizable to improve the adaptability of other clinical text mining methods. PMID:25327613

  20. Semantic processing of EHR data for clinical research.

    PubMed

    Sun, Hong; Depraetere, Kristof; De Roo, Jos; Mels, Giovanni; De Vloed, Boris; Twagirumukiza, Marc; Colaert, Dirk

    2015-12-01

    There is a growing need to semantically process and integrate clinical data from different sources for clinical research. This paper presents an approach to integrate EHRs from heterogeneous resources and generate integrated data in different data formats or semantics to support various clinical research applications. The proposed approach builds semantic data virtualization layers on top of data sources, which generate data in the requested semantics or formats on demand. This approach avoids upfront dumping to and synchronizing of the data with various representations. Data from different EHR systems are first mapped to RDF data with source semantics, and then converted to representations with harmonized domain semantics where domain ontologies and terminologies are used to improve reusability. It is also possible to further convert data to application semantics and store the converted results in clinical research databases, e.g. i2b2, OMOP, to support different clinical research settings. Semantic conversions between different representations are explicitly expressed using N3 rules and executed by an N3 Reasoner (EYE), which can also generate proofs of the conversion processes. The solution presented in this paper has been applied to real-world applications that process large scale EHR data.

  1. Semantic processing of EHR data for clinical research.

    PubMed

    Sun, Hong; Depraetere, Kristof; De Roo, Jos; Mels, Giovanni; De Vloed, Boris; Twagirumukiza, Marc; Colaert, Dirk

    2015-12-01

    There is a growing need to semantically process and integrate clinical data from different sources for clinical research. This paper presents an approach to integrate EHRs from heterogeneous resources and generate integrated data in different data formats or semantics to support various clinical research applications. The proposed approach builds semantic data virtualization layers on top of data sources, which generate data in the requested semantics or formats on demand. This approach avoids upfront dumping to and synchronizing of the data with various representations. Data from different EHR systems are first mapped to RDF data with source semantics, and then converted to representations with harmonized domain semantics where domain ontologies and terminologies are used to improve reusability. It is also possible to further convert data to application semantics and store the converted results in clinical research databases, e.g. i2b2, OMOP, to support different clinical research settings. Semantic conversions between different representations are explicitly expressed using N3 rules and executed by an N3 Reasoner (EYE), which can also generate proofs of the conversion processes. The solution presented in this paper has been applied to real-world applications that process large scale EHR data. PMID:26515501

  2. Ethics and epistemology of accurate prediction in clinical research.

    PubMed

    Hey, Spencer Phillips

    2015-07-01

    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research.

  3. Global and cultural perinatal nursing research: improving clinical practice.

    PubMed

    Callister, Lynn Clark

    2011-01-01

    High-quality perinatal nursing care should be based on the best evidence including research findings, clinical expertise, and the preferences of women and their families. Principles of perinatal research initiatives are defined, with suggested research priorities designed to close current gaps in the micro and macro environments of perinatal nursing throughout the world. Nearly a decade ago, the following question was asked, "Where is the 'E' (evidence) in maternal child health?" Improving the quality and safety of perinatal nursing care for culturally diverse women globally is the primary goal of nurse researchers leading the future of perinatal healthcare.

  4. Ethics and epistemology of accurate prediction in clinical research.

    PubMed

    Hey, Spencer Phillips

    2015-07-01

    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. PMID:25249375

  5. Teaching clinical reasoning by making thinking visible: an action research project with allied health clinical educators

    PubMed Central

    2014-01-01

    Background Clinical reasoning is fundamental to all forms of professional health practice, however it is also difficult to teach and learn because it is complex, tacit, and effectively invisible for students. In this paper we present an approach for teaching clinical reasoning based on making expert thinking visible and accessible to students. Methods Twenty-one experienced allied health clinical educators from three tertiary Australian hospitals attended up to seven action research discussion sessions, where they developed a tentative heuristic of their own clinical reasoning, trialled it with students, evaluated if it helped their students to reason clinically, and then refined it so the heuristic was targeted to developing each student’s reasoning skills. Data included participants’ written descriptions of the thinking routines they developed and trialed with their students and the transcribed action research discussion sessions. Content analysis was used to summarise this data and categorise themes about teaching and learning clinical reasoning. Results Two overriding themes emerged from participants’ reports about using the ‘making thinking visible approach’. The first was a specific focus by participating educators on students’ understanding of the reasoning process and the second was heightened awareness of personal teaching styles and approaches to teaching clinical reasoning. Conclusions We suggest that the making thinking visible approach has potential to assist educators to become more reflective about their clinical reasoning teaching and acts as a scaffold to assist them to articulate their own expert reasoning and for students to access and use. PMID:24479414

  6. Biobanking informatics infrastructure to support clinical and translational research.

    PubMed

    Lasalle, Bernie; Varner, Michael; Botkin, Jeff; Jackson, Marc; Stark, Louisa; Cessna, Melissa; Orthner, Carolyn; Hulse, Nathan; Bernasconi, Aldo; Madsen, Randy; Schultz, Dustin; Bradshaw, Richard; Mitchell, Joyce

    2013-01-01

    The University of Utah Health Sciences (UUHSC) and Intermountain Healthcare (IH) support high value clinical and translational research programs. The Utah Biohealth Initiative will facilitate next generation research by leveraging the combined resources of both institutions through an infrastructure which links biospecimens and electronic health records (EHR). During phase I of the Utah BioHealth Initiative (UBI) the participating institutions developed a legal, regulatory and information technology infrastructure that supports clinical and translational research, and advances our understanding of health and disease, improves healthcare value and health for current and future generations of Utahns. We used the Federated Utah Research and Translational Health electronic Repository (FURTHeR) 1 to combine EHR and biospecimen data from an actual study populated by both institutions to demonstrate the robustness of the infrastructure. PMID:24303252

  7. Clinical and outcome research in oncology. The need for integration.

    PubMed

    Apolone, Giovanni

    2003-01-01

    Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR), defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care) that matter to decision makers (from patients to society at large), with special emphasis on the use of patient-reported outcomes (PRO). Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon the availability of

  8. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

    PubMed

    Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy

    2014-07-01

    The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs.

  9. Research Ethics Committees: can they contribute to the improvement of clinical research in Europe?

    PubMed

    Liberati, Alessandro

    2004-01-01

    There is an increasing crisis of credibility in the world of clinical and epidemiological research because of lack of transparency in the identification of research priorities, increasing dominance of commercial interests over patients' problems, limited funds for independent research, and lack of awareness that clinical research is integral to the duties of clinicians as patients' agents. Research Ethics Committees (RECs) are an important component of the research world and since their institution there are expectations at their ability to protect patients and improve clinico-epidemiological research. To many people, however, the task of RECs is still essentially that of safeguarding the ethical/informed consent issues related to research protocols without a role in the core content (scientific and clinical) of the research projects themselves. Others argue that the duties of RECs should be broader because scientifically invalid research is in itself unethical. The remits of RECs, therefore, should embrace a full range of issues, from assessment of the core content of research (objectives, nonredundancy, clinical relevance, and likelihood of reaching the stated goals) to the protection of publication and dissemination rights of researchers from the intrusiveness of commercial sponsors. This debate is further complicated by current arrangements in countries where RECs' decentralization has made their operation less homogeneous and reproducible, with a diffuse discontent about the end results of their activities. In the first part of the article I discuss the evolution of the concept of the ethics of clinical research and the main differences in the arrangements of RECs across Europe. In the second part, after a brief discussion of the new European Directive on Clinical Trials and its potential problematic impact on publicly-funded trials, I propose a series of actions that should be taken to improve the functioning of RECs and outline the cultural changes needed

  10. Closing the Gap between Research Evidence and Clinical Practice: Jordanian Nurses' Perceived Barriers to Research Utilisation

    ERIC Educational Resources Information Center

    Al Khalaileh, Murad; Al Qadire, Mohammad; Musa, Ahmad S.; Al-Khawaldeh, Omar A.; Al Qudah, Hani; Alhabahbeh, Atalla

    2016-01-01

    Background: The nursing profession is a combination of theory and practical skill, and nurses are required to generate and develop knowledge through implementing research into clinical practice. Considerable number of barriers could hind implementing research findings into practice. Barriers to research utilisation are not identified in the…

  11. An attachment primer for couple therapists: research and clinical implications.

    PubMed

    Seedall, Ryan B; Wampler, Karen S

    2013-10-01

    According to attachment theory, humans are relational beings and even a child's earliest experiences with caregivers have a profound effect on emotional development and an overall approach to relationships. With increasing regularity, couple therapy has utilized attachment language as a conceptual tool, but more work is needed to understand the full clinical implications of attachment theory. These include understanding the intergenerational nature of attachment and adapting the delivery, timing, and pace of interventions to client attachment strategies. In this article, we summarize the origins of attachment theory, its measurement, the role of attachment in couple relationships, attachment stability and change, and ways that attachment informs therapy process and intervention. We hope that this article will provide an impetus for couple therapists to expand their conceptualization and use of attachment in their clinical work and for couple researchers to conduct more clinically relevant, attachment-oriented process research. PMID:25800420

  12. Trace Elements in Nails as Biomarkers in Clinical Research

    PubMed Central

    He, Ka

    2010-01-01

    Background The importance of trace elements in relation to human health has been increasingly recognized. Accurate and adequate quantification of trace elements are crucial in clinical research. Design This review was to discuss the rationale of using nail trace elements as biomarkers in clinical studies. Results For most trace elements, dietary instruments can not appropriately capture the intakes because of the minimal amounts and wide variations in the same foods grown in different area as well as the non-dietary exposures. Therefore, biomarkers may be essential in studying trace elements. Although there are notable differences among trace elements in the availability of biomarkers, increasing evidence supports that nail particularly toenail concentrations of most trace elements are useful biomarkers of exposure in which a single sample is assumed to represent long-term exposure. Conclusions As compared to other potential biomarkers of trace elements, nail measurement has certain advantages in clinical research. PMID:20813017

  13. Clinical proteomics and OMICS clues useful in translational medicine research

    PubMed Central

    2012-01-01

    Since the advent of the new proteomics era more than a decade ago, large-scale studies of protein profiling have been used to identify distinctive molecular signatures in a wide array of biological systems, spanning areas of basic biological research, clinical diagnostics, and biomarker discovery directed toward therapeutic applications. Recent advances in protein separation and identification techniques have significantly improved proteomic approaches, leading to enhancement of the depth and breadth of proteome coverage. Proteomic signatures, specific for multiple diseases, including cancer and pre-invasive lesions, are emerging. This article combines, in a simple manner, relevant proteomic and OMICS clues used in the discovery and development of diagnostic and prognostic biomarkers that are applicable to all clinical fields, thus helping to improve applications of clinical proteomic strategies for translational medicine research. PMID:22642823

  14. Building Networks for Global Clinical Research: The Basics.

    PubMed

    Shearer, David W; Volberding, Paul A; Schemitsch, Emil H; Cook, Gillian E; Slobogean, Gerard P; Morshed, Saam

    2015-12-01

    Over the last several decades, interest in global health across all fields of medicine, including orthopaedic surgery, has grown markedly. Cross-national collaborations are an effective means of conducting high-quality clinical research and offer many advantages over single-center investigations. Successful collaboration requires a well-designed research protocol, development of an effective team structure, and the funding to ensure the project is sustained to completion. Equally important, investigators must consider the social, linguistic, and cultural context in which the study is being undertaken. Although randomized clinical trials are the highest level of evidence, study designs may have to be adapted to accommodate available resources, expertise, and local contextual factors. With appropriate planning, these collaborative endeavors can generate changes in clinical practice and positively impact health policy. PMID:26584260

  15. Biospecimen Solicitation - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    A new funding opportunity in support of the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) seeks to prospectively procure tumor samples, collected for proteomics investigation. This procurement is being solicited for award by SAIC-F under its contract #HHSN261200800001E for Operations and Technical support at the Frederick National Laboratory for Cancer Research.

  16. Biospecimen Core Resource - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The purpose of this notice is to notify the community that the National Cancer Institute's (NCI’s) Office of Cancer Clinical Proteomics Research (OCCPR) is seeking sources to establish a Biospecimen Core Resource (BCR), capable of receiving, qualifying, processing, and distributing annotated biospecimens.

  17. Tumor Cold Ischemia - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    In a recently published manuscript in the journal of Molecular and Cellular Proteomics, researchers from the National Cancer Institutes (NCI) Clinical Proteomic Tumor Analysis Consortium (CPTAC) investigated the effect of cold ischemia on the proteome of fresh frozen tumors.

  18. My Librarian: Personalized Research Clinics and the Academic Library.

    ERIC Educational Resources Information Center

    Cardwell, Catherine; Furlong, Katherine; O'Keeffe, Julie

    2002-01-01

    Describes personalized research clinics (PRC) programs at three diverse institutions: Gettysburg College (Pennsylvania), Marquette University (Wisconsin), and Bowling Green State University (Ohio). Addresses logistics, publicity methods, program analysis, and assessment issues, and weighs the benefits of the labor-intensive service against other…

  19. Clinical Application and Research Advances of CT Myocardial Perfusion Imaging.

    PubMed

    2016-06-10

    Computed tomography (CT)-based myocardial perfusion imaging (CTP)has been widely recognized as a one-station solution for the imaging of myocardial ischemia-related diseases. This article reviews the clinical scanning protocols,analytical methods,and research advances of CTP in recent years and briefly discusses its limitations and future development. PMID:27469926

  20. Discovering the Expanding Universe

    NASA Astrophysics Data System (ADS)

    Nussbaumer, Harry; Bieri, Lydia; Sandage, Foreword by Allan

    2009-03-01

    Acknowledgments; Foreword; 1. Introduction; 2. Cosmological concepts at the end of the Middle Ages; 3. Nebulae as a new astronomical phenomenon; 4. On the construction of the Heavens; 5. Island universes turn into astronomical facts: a universe of galaxies; 6. The early cosmology of Einstein and de Sitter; 7. The dynamical universe of Friedmann; 8. Redshifts: how to reconcile Slipher and de Sitter?; 9. Lemaître discovers the expanding universe; 10. Hubble's contribution of 1929; 11. The breakthrough for the expanding universe; 12. Hubble's anger about de Sitter; 13. Robertson and Tolman join the game; 14. The Einstein-de Sitter universe; 15. Are Sun and Earth older than the universe?; 16. In search of alternative tracks; 17. The seed for the Big Bang; 18. Summary and Postscript; Appendix; References; Index.

  1. Student Discovers New Pulsar

    NASA Astrophysics Data System (ADS)

    2010-01-01

    A West Virginia high-school student has discovered a new pulsar, using data from the giant Robert C. Byrd Green Bank Telescope (GBT). Shay Bloxton, 15, a participant in a project in which students analyze data from the radio telescope, spotted evidence of the pulsar on October 15. Bloxton, along with NRAO astronomers observed the object again one month later. The new observation confirmed that the object is a pulsar, a rotating, superdense neutron star. Bloxton is a sophomore at Nicholas County High School in Summersville, West Virginia. "I was very excited when I found out I had actually made a discovery," Bloxton said. She went to Green Bank in November to participate in the follow-up observation. She termed that visit "a great experience." "It also helped me learn a lot about how observations with the GBT are actually done," she added. The project in which she participated, called the Pulsar Search Collaboratory (PSC), is a joint project of the National Radio Astronomy Observatory (NRAO) and West Virginia University, funded by a grant from the National Science Foundation. Pulsars are known for their lighthouse-like beams of radio waves that sweep through space as the neutron star rotates, creating a pulse as the beam sweeps by the Earth. First discovered in 1967, pulsars serve as valuable natural "laboratories" for physicists studying exotic states of matter, quantum mechanics and General Relativity. The GBT, dedicated in 2000, has become one of the world's leading tools for discovering and studying pulsars. The PSC, led by NRAO Education Officer Sue Ann Heatherly and Project Director Rachel Rosen, includes training for teachers and student leaders, and provides parcels of data from the GBT to student teams. The project involves teachers and students in helping astronomers analyze data from 1500 hours of observing with the GBT. The 120 terabytes of data were produced by 70,000 individual pointings of the giant, 17-million-pound telescope. Some 300 hours of the

  2. Regulatory aspects for translating gene therapy research into the clinic.

    PubMed

    Laurencot, Carolyn M; Ruppel, Sheryl

    2009-01-01

    Gene therapy products are highly regulated, therefore moving a promising candidate from the laboratory into the clinic can present unique challenges. Success can only be achieved by proper planning and communication within the clinical development team, as well as consultation with the regulatory scientists who will eventually review the clinical plan. Regulators should not be considered as obstacles but rather as collaborators whose advice can significantly expedite the product development. Sound scientific data is required and reviewed by the regulatory agencies to determine whether the potential benefit to the patient population outweighs the risk. Therefore, compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) principles to ensure quality, safety, purity, and potency of the product, and to establish "proof of concept" for efficacy, and for safety information, respectively, is essential. The design and conduct of the clinical trial must adhere to Good Clinical Practice (GCP) principals. The clinical protocol should contain adequate rationale, supported by nonclinical data, to justify the starting dose and regimen, and adequate safety monitoring based on the patient population and the anticipated toxicities. Proper review and approval of gene therapy clinical studies by numerous committees, and regulatory agencies before and throughout the study allows for ongoing risk assessment of these novel and innovative products. The ethical conduct of clinical trials must be a priority for all clinical investigators and sponsors. As history has shown us, only a few fatal mistakes can dramatically alter the regulation of investigational products for all individuals involved in gene therapy clinical research, and further delay the advancement of gene therapy to licensed medicinal products.

  3. Confounding Effect in Clinical Research of Otolaryngology and Its Control.

    PubMed

    Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming

    2015-06-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect. PMID:26149004

  4. Confounding Effect in Clinical Research of Otolaryngology and Its Control.

    PubMed

    Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming

    2015-06-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect.

  5. [The Research Domain Criteria (Rdoc), reductionism and clinical psychiatry].

    PubMed

    Faucher, Luc; Goyer, Simon

    2016-12-01

    The focus of the advocates of the Research Domain Critria (RDoC) on faulty brain circuits has led some to suspect it of being a reductionist enterprise. And because RDoC will eventually impact clinical psychiatry, some have feared that it will transform clinical psychiatry in a mindless and applied neurobehavioral science. We argue that if RDoC is officially endorsing a kind of reductionism, the particular kind of reductionism it endorses is not suffering from the shortcomings of more classical forms of reductionism. Because of that, at least in principle, RDoC could enrich rather than impoverish clinical psychiatry. This paper raises few potential problems of the RDoC for clinical psychiatry caused by its implicit epistemological reductionism. PMID:27550461

  6. Research Participant-Centered Outcomes at NIH-Supported Clinical Research Centers

    PubMed Central

    Kost, Rhonda G.; Lee, Laura N.; Yessis, Jennifer M.; Wesley, Robert; Alfano, Sandra; Alexander, Steven R.; Kassis, Sylvia Baedorf; Cola, Phil; Dozier, Ann; Ford, Dan E.; Harris, Paul; Kim, Emmelyn; Lee, Simon Craddock; O’Riordan, Gerri; Roth, Mary-Tara; Schuff, Kathryn; Wasser, June; Henderson, David K.; Coller, Barry S.

    2014-01-01

    Background Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants’ experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. Methods Survey questions addressed core aspects of the research participants’ experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. Results Respondents broadly represented the research population in sex, race, and ethnicity. Seventy-three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R2=0.80 - 0.96). White participants trusted researchers (88%) than did non-white participants collectively (80%) (p<0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). Conclusions Our survey demonstrates that a majority of participants at NIH-supported clinical research centers rate their research experience very positively and that participant-centered outcome measures identify actionable items for improvement of participant’s experiences, research protections, and the conduct of clinical investigation. PMID:24842076

  7. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis.

    PubMed

    Ross, Joseph S

    2016-09-20

    The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process.

  8. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis.

    PubMed

    Ross, Joseph S

    2016-01-01

    The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process. PMID:27649796

  9. US Government mandates for clinical and translational research.

    PubMed

    Shuster, Jonathan J

    2012-02-01

    This commentary is germane for clinical and translational researchers. Basic scientists may face different obstacles to developing their research careers. Over the past several years, the federal government has seen reductions in funding for extramural research. It seems that under the adverse economic forecasts, things are going to get worse. It might seem logical for the federal government to stretch whatever limited resources exist, by asking the institutions to cost-share greater fractions of the actual research costs, and as an incentive, avoid the imposition of unfunded mandates. But alas, although well intended, there have been expensive requirements imposed by the government, making it difficult for investigators and institutions to adequately fund and conduct their research and for scientific journals to maintain paying subscribers. Five prominent and costly changes, which are the focus of this commentary are (1) HIPAA, (2) http://ClinicalTrials.Gov, (3) Clinical and Translational Science Awards, (4) Upcoming rule changes for IRBs, and (5) PubMedCentral, each of which will be discussed in the ensuing paragraphs.

  10. Bibliography of clinical research in malaysia: methods and brief results.

    PubMed

    Teng, C L; Zuhanariah, M N; Ng, C S; Goh, C C

    2014-08-01

    This article describes the methodology of this bibliography. A search was conducted on the following: (1) bibliographic databases (PubMed, Scopus, and other databases) using search terms that maximize the retrieval of Malaysian publications; (2) Individual journal search of Malaysian healthrelated journals; (3) A targeted search of Google and Google Scholar; (4) Searching of Malaysian institutional repositories; (5) Searching of Ministry of Health and Clinical Research Centre website. The publication years were limited to 2000- 2013. The citations were imported or manually entered into bibliographic software Refworks. After removing duplicates, and correcting data entry errors, PubMed's Medical Subject Headings (MeSH terms) were added. Clinical research is coded using the definition "patient-oriented-research or research conducted with human subjects (or on material of human origin) for which the investigator directly interacts with the human subjects at some point during the study." A bibliography of citations [n=2056] that fit the criteria of clinical research in Malaysia in selected topics within five domains was generated: Cancers [589], Cardiovascular diseases [432], Infections [795], Injuries [142], and Mental Health [582]. This is done by retrieving citations with the appropriate MESH terms, as follow: For cancers (Breast Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms), for cardiovascular diseases (Coronary Disease; Hypertension; Stroke), for infections (Dengue; Enterovirus Infections, HIV Infections; Malaria; Nipah Virus; Tuberculosis), for injuries (Accidents, Occupational; Accidents, Traffic; Child Abuse; Occupational Injuries), for mental health (Depression; Depressive Disorder; Depressive Disorder, Major; Drug Users; Psychotic Disorders; Suicide; Suicide, Attempted; Suicidal Ideation; Substance- Related Disorders). PMID:25417946

  11. Bibliography of clinical research in malaysia: methods and brief results.

    PubMed

    Teng, C L; Zuhanariah, M N; Ng, C S; Goh, C C

    2014-08-01

    This article describes the methodology of this bibliography. A search was conducted on the following: (1) bibliographic databases (PubMed, Scopus, and other databases) using search terms that maximize the retrieval of Malaysian publications; (2) Individual journal search of Malaysian healthrelated journals; (3) A targeted search of Google and Google Scholar; (4) Searching of Malaysian institutional repositories; (5) Searching of Ministry of Health and Clinical Research Centre website. The publication years were limited to 2000- 2013. The citations were imported or manually entered into bibliographic software Refworks. After removing duplicates, and correcting data entry errors, PubMed's Medical Subject Headings (MeSH terms) were added. Clinical research is coded using the definition "patient-oriented-research or research conducted with human subjects (or on material of human origin) for which the investigator directly interacts with the human subjects at some point during the study." A bibliography of citations [n=2056] that fit the criteria of clinical research in Malaysia in selected topics within five domains was generated: Cancers [589], Cardiovascular diseases [432], Infections [795], Injuries [142], and Mental Health [582]. This is done by retrieving citations with the appropriate MESH terms, as follow: For cancers (Breast Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms), for cardiovascular diseases (Coronary Disease; Hypertension; Stroke), for infections (Dengue; Enterovirus Infections, HIV Infections; Malaria; Nipah Virus; Tuberculosis), for injuries (Accidents, Occupational; Accidents, Traffic; Child Abuse; Occupational Injuries), for mental health (Depression; Depressive Disorder; Depressive Disorder, Major; Drug Users; Psychotic Disorders; Suicide; Suicide, Attempted; Suicidal Ideation; Substance- Related Disorders).

  12. Governance Strategies for Conducting Text Messaging Interventions in Clinical Research

    PubMed Central

    Anderson, Nicholas; Morrison, Caitlin; Griffin, Jonathan; Reiter, William; Baldwin, Laura-Mae; Edwards, Kelly

    2015-01-01

    There is increasing interest in medical text messaging interventions being used to achieve positive patient outcomes across a range of clinical research and health practice environments. Short messaging service (SMS) is a low-cost tool that provides an easy communication route to engage potentially broad populations through text messaging, and is part of the growing social trend toward increased adoption of personal communication technologies by patient populations. Testing the effectiveness and impact of various communication strategies requires navigation of a complex web of clinical and research regulations and oversight mechanisms. We describe a case study of the implementation of SMS to provide bidirectional communications between physicians and patients involved in routine care reminders to illustrate the review processes and governance structures needed. By mapping the regulatory and approval processes required to manage and steward a research study across clinical and community boundaries, we provide a guide for other translational health researchers who may utilize similar kinds of personally owned technology interventions as research tools. PMID:24774328

  13. Recommendations for planning pilot studies in clinical and translational research.

    PubMed

    Moore, Charity G; Carter, Rickey E; Nietert, Paul J; Stewart, Paul W

    2011-10-01

    Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase "pilot study" is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well-designed pilot studies play in the advancement of science and scientific careers. PMID:22029804

  14. Use of altered informed consent in pragmatic clinical research

    PubMed Central

    McKinney, Ross E.; Beskow, Laura M.; Ford, Daniel E.; Lantos, John D.; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J.; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-01-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to IRBs as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients’ rights and interests. PMID:26374677

  15. Psychobiology and psychopharmacology: issues in clinical research training.

    PubMed

    Janowsky, D S; Glick, I D; Lash, L; Mitnick, L; Klein, D F; Goodwin, F K; Hanin, I; Nemeroff, C; Robins, L

    1986-02-01

    Although the scope of basic studies in psychopharmacology and psychobiology has been expanding steadily for about 30 years, relatively few clinical psychiatrists, psychologists, and psychopharmacologists now choose to become researchers or teachers in these disciplines. Such training is crucial to the future vitality of both academic and private-practice psychiatry, and in view of increasing constraints on training funds, student researchers may well be an endangered species. With these concerns in mind, at its 1984 meeting, the American College of Neuropsychopharmacology's Education and Training Committee organized a symposium of investigators, administrators, and former trainees to explore aspects of effective clinical research training in psychobiology and psychopharmacology. Aspects discussed included mentoring, settings and content of training, depth versus breadth of curriculum, and the effect of a critical mass of colleagues at various stages of professional development. Following a brief overview, selected panelists addressed the issues from their individual perspectives.

  16. Valuing research in clinical practice: a basis for developing a strategic plan for nursing research.

    PubMed

    Butler, L

    1995-01-01

    With a view to developing a strategic plan for nursing research in a clinical practice setting, a survey was conducted to examine nurses' attitudes towards research as a part of their work. The 348 nurse respondents represented various nursing roles: staff nurses, head nurses, clinical nurse specialists, nurse educators, hospice nurses, expanded-role nurses, and an enterostomal therapist. They were classified into two groups, staff nurses and leadership nurses. The subjects reported that they valued research highly and that they believed the nursing division was supportive of research activities. Few were actually involved in conducting research; the nurses reported a lack of confidence in their ability to participate in designing and conducting studies. Most staff nurses were not using research in their work, while the majority of leadership nurses were. Factors that explain both research use by nurses and their participation in designing and conducting research differed for the two groups.

  17. Encouraging primary care research: evaluation of a one-year, doctoral clinical epidemiology research course

    PubMed Central

    Liira, Helena; Koskela, Tuomas; Thulesius, Hans; Pitkälä, Kaisu

    2016-01-01

    Objective Research and PhDs are relatively rare in family medicine and primary care. To promote research, regular one-year research courses for primary care professionals with a focus on clinical epidemiology were started. This study explores the academic outcomes of the first four cohorts of research courses and surveys the participants’ perspectives on the research course. Design An electronic survey was sent to the research course participants. All peer-reviewed scientific papers published by these students were retrieved by literature searches in PubMed. Setting Primary care in Finland. Subjects A total of 46 research course participants who had finished the research courses between 2007 and 2012. Results Of the 46 participants 29 were physicians, eight nurses, three dentists, four physiotherapists, and two nutritionists. By the end of 2014, 28 of the 46 participants (61%) had published 79 papers indexed in PubMed and seven students (15%) had completed a PhD. The participants stated that the course taught them critical thinking, and provided basic research knowledge, inspiration, and fruitful networks for research. Conclusion A one-year, multi-professional, clinical epidemiology based research course appeared to be successful in encouraging primary care research as measured by research publications and networking. Activating teaching methods, encouraging focus on own research planning, and support from peers and tutors helped the participants to embark on research projects that resulted in PhDs for 15% of the participants. Key PointsClinical research and PhDs are rare in primary care in Finland, which has consequences for the development of the discipline and for the availability of clinical lecturers at the universities.A clinical epidemiology oriented, one-year research course increased the activity in primary care research. Focus on own research planning and learning the challenges of research with peers appeared to enhance the success of a doctoral

  18. Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

    PubMed

    Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

    2016-01-01

    Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts. PMID:27252559

  19. Clinical research of traditional Chinese medicine in big data era.

    PubMed

    Zhang, Junhua; Zhang, Boli

    2014-09-01

    With the advent of big data era, our thinking, technology and methodology are being transformed. Data-intensive scientific discovery based on big data, named "The Fourth Paradigm," has become a new paradigm of scientific research. Along with the development and application of the Internet information technology in the field of healthcare, individual health records, clinical data of diagnosis and treatment, and genomic data have been accumulated dramatically, which generates big data in medical field for clinical research and assessment. With the support of big data, the defects and weakness may be overcome in the methodology of the conventional clinical evaluation based on sampling. Our research target shifts from the "causality inference" to "correlativity analysis." This not only facilitates the evaluation of individualized treatment, disease prediction, prevention and prognosis, but also is suitable for the practice of preventive healthcare and symptom pattern differentiation for treatment in terms of traditional Chinese medicine (TCM), and for the post-marketing evaluation of Chinese patent medicines. To conduct clinical studies involved in big data in TCM domain, top level design is needed and should be performed orderly. The fundamental construction and innovation studies should be strengthened in the sections of data platform creation, data analysis technology and big-data professionals fostering and training.

  20. [Clinical research on malaria: what for the future?].

    PubMed

    Cot, M

    2005-06-01

    Malaria still remains one of the main public health problems in the world. In spite of early and numerous clinical trials, the situation seems to have been worsening in the last ten years. Malaria clinical research involves several levels: Several meta-analyses have been performed on this topic (in particular, the Cochrane Database Library has published studies on malaria prevention during pregnancy, management of clinical malaria attacks, vaccine trials or impregnated bed net trials). All these studies show the uneven quality of trials (only 10% to 50% can be kept in the analysis for methodological reasons), which seldom lead to similar conclusions. Besides, as resistances of both parasites and vectors to drugs or insecticides are regularly increasing, trials have to be repeated and new molecules have to be found and evaluated. Finally, practical application of such interventions may be difficult, due to the heterogeneity of epidemiological situations and the poverty of target populations. Various initiatives aiming to develop malaria clinical research have recently been launched. Donators are public or international (Global Fund, Roll Back Malaria Initiative, NIH, EDCTP programme), as well as private (Bill & Melinda Gates Foundation). These substantial funds should enhance the research of new antimalarial drugs and large-scale, adequately designed trials. However, to make sure these trials really benefit to populations exposed to the disease, ethical principles should be co-elaborated with developing countries, within collaborative networks between laboratories from industrialized and developing countries.

  1. The Mid-South clinical Data Research Network.

    PubMed

    Rosenbloom, S Trent; Harris, Paul; Pulley, Jill; Basford, Melissa; Grant, Jason; DuBuisson, Allison; Rothman, Russell L

    2014-01-01

    The Mid-South Clinical Data Research Network (CDRN) encompasses three large health systems: (1) Vanderbilt Health System (VU) with electronic medical records for over 2 million patients, (2) the Vanderbilt Healthcare Affiliated Network (VHAN) which currently includes over 40 hospitals, hundreds of ambulatory practices, and over 3 million patients in the Mid-South, and (3) Greenway Medical Technologies, with access to 24 million patients nationally. Initial goals of the Mid-South CDRN include: (1) expansion of our VU data network to include the VHAN and Greenway systems, (2) developing data integration/interoperability across the three systems, (3) improving our current tools for extracting clinical data, (4) optimization of tools for collection of patient-reported data, and (5) expansion of clinical decision support. By 18 months, we anticipate our CDRN will robustly support projects in comparative effectiveness research, pragmatic clinical trials, and other key research areas and have the capacity to share data and health information technology tools nationally. PMID:24821742

  2. Clinical research of traditional Chinese medicine in big data era.

    PubMed

    Zhang, Junhua; Zhang, Boli

    2014-09-01

    With the advent of big data era, our thinking, technology and methodology are being transformed. Data-intensive scientific discovery based on big data, named "The Fourth Paradigm," has become a new paradigm of scientific research. Along with the development and application of the Internet information technology in the field of healthcare, individual health records, clinical data of diagnosis and treatment, and genomic data have been accumulated dramatically, which generates big data in medical field for clinical research and assessment. With the support of big data, the defects and weakness may be overcome in the methodology of the conventional clinical evaluation based on sampling. Our research target shifts from the "causality inference" to "correlativity analysis." This not only facilitates the evaluation of individualized treatment, disease prediction, prevention and prognosis, but also is suitable for the practice of preventive healthcare and symptom pattern differentiation for treatment in terms of traditional Chinese medicine (TCM), and for the post-marketing evaluation of Chinese patent medicines. To conduct clinical studies involved in big data in TCM domain, top level design is needed and should be performed orderly. The fundamental construction and innovation studies should be strengthened in the sections of data platform creation, data analysis technology and big-data professionals fostering and training. PMID:25217972

  3. Foresight scanning: future directions of clinical and pharmaceutical research.

    PubMed

    Foster, Brian C

    2008-01-01

    Foresight Scanning: Future Directions of Clinical and Pharmaceutical Research. Brian C. Foster, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada ABSTRACT The Canadian Society for Pharmaceutical Sciences Satellite Symposium on Foresight Scanning, May 26 and 27, 2008, Nordegg, Alberta, Canada, focussed on the future directions of clinical and pharmaceutical research. The symposium brought together a group of clinicians, regulatory scientists, researchers and students to examine where clinical, pharmaceutical, and regulatory science might be in 10 to 15 years. Industry, regulatory, analytical, and clinical perspectives were presented and discussed, as well as the impact of exogenous (indirect) and endogenous (direct) change drivers. Unconditional funding was provided by Bayer HealthCare; they had no input on the direction of the meeting or selection of speakers. It was envisioned that the more important endogenous drivers may not be new information or changes in technology, policy, regulation, or health care delivery, but amplification of long-term underlying trends by emergence of new technologies, convergence of existing technologies or new communication and collaboration vehicles such as Web 2.0.

  4. Patient Confidentiality in the Research Use of Clinical Medical Databases

    PubMed Central

    Krishna, Rajeev; Kelleher, Kelly; Stahlberg, Eric

    2007-01-01

    Electronic medical record keeping has led to increased interest in analyzing historical patient data to improve care delivery. Such research use of patient data, however, raises concerns about confidentiality and institutional liability. Institutional review boards must balance patient data security with a researcher’s ability to explore potentially important clinical relationships. We considered the issues involved when patient records from health care institutions are used in medical research. We also explored current regulations on patient confidentiality, the need for identifying information in research, and the effectiveness of deidentification and data security. We will present an algorithm for researchers to use to think about the data security needs of their research, and we will introduce a vocabulary for documenting these techniques in proposals and publications. PMID:17329644

  5. Ancillary Care: From Theory to Practice in International Clinical Research.

    PubMed

    Pratt, Bridget; Zion, Deborah; Lwin, Khin Maung; Cheah, Phaik Yeong; Nosten, Francois; Loff, Bebe

    2013-07-01

    How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger's health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU's dual role as a research unit and medical non-governmental organization. PMID:23864908

  6. Ancillary Care: From Theory to Practice in International Clinical Research.

    PubMed

    Pratt, Bridget; Zion, Deborah; Lwin, Khin Maung; Cheah, Phaik Yeong; Nosten, Francois; Loff, Bebe

    2013-07-01

    How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger's health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU's dual role as a research unit and medical non-governmental organization.

  7. Ancillary Care: From Theory to Practice in International Clinical Research

    PubMed Central

    Pratt, Bridget; Zion, Deborah; Lwin, Khin Maung; Cheah, Phaik Yeong; Nosten, Francois; Loff, Bebe

    2013-01-01

    How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger’s health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit’s (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU’s dual role as a research unit and medical non-governmental organization. PMID:23864908

  8. Clinical pharmacology of analgesics assessed with human experimental pain models: bridging basic and clinical research

    PubMed Central

    Oertel, Bruno Georg; Lötsch, Jörn

    2013-01-01

    The medical impact of pain is such that much effort is being applied to develop novel analgesic drugs directed towards new targets and to investigate the analgesic efficacy of known drugs. Ongoing research requires cost-saving tools to translate basic science knowledge into clinically effective analgesic compounds. In this review we have re-examined the prediction of clinical analgesia by human experimental pain models as a basis for model selection in phase I studies. The overall prediction of analgesic efficacy or failure of a drug correlated well between experimental and clinical settings. However, correct model selection requires more detailed information about which model predicts a particular clinical pain condition. We hypothesized that if an analgesic drug was effective in an experimental pain model and also a specific clinical pain condition, then that model might be predictive for that particular condition and should be selected for development as an analgesic for that condition. The validity of the prediction increases with an increase in the numbers of analgesic drug classes for which this agreement was shown. From available evidence, only five clinical pain conditions were correctly predicted by seven different pain models for at least three different drugs. Most of these models combine a sensitization method. The analysis also identified several models with low impact with respect to their clinical translation. Thus, the presently identified agreements and non-agreements between analgesic effects on experimental and on clinical pain may serve as a solid basis to identify complex sets of human pain models that bridge basic science with clinical pain research. PMID:23082949

  9. Tissue fluid pressures - From basic research tools to clinical applications

    NASA Technical Reports Server (NTRS)

    Hargens, Alan R.; Akeson, Wayne H.; Mubarak, Scott J.; Owen, Charles A.; Gershuni, David H.

    1989-01-01

    This paper describes clinical applications of two basic research tools developed and refined in the past 20 years: the wick catheter (for measuring tissue fluid pressure) and the colloid osmometer (for measuring osmotic pressure). Applications of the osmometer include estimations of the reduced osmotic pressure of sickle-cell hemoglobin with deoxygenation, and of reduced swelling pressure of human nucleus pulposus with hydration or upon action of certain enzymes. Clinical uses of the wick-catheter technique include an improvement of diagnosis and treatment of acute and chronic compartment syndromes, the elucidation of the tissue pressure thresholds for neuromuscular dysfunction, and the development of a better tourniquet for orthopedics.

  10. Auditing clinical research data: objectives, applications and results.

    PubMed

    Justice, R L

    1983-01-01

    Formal auditing of clinical research data has become a standard contemporary practice within the pharmaceutical industry. Its basic purpose is to provide documentation relevant to an assessment of the quality and integrity of data collected in the course of a clinical trial. This paper outlines the audit procedures developed within one major pharmaceutical firm. These procedures require an intensive investigation of internal and external aspects of study management, records management, data entry, data analysis and statistical report preparation. A qualitative evaluation of the results achieved by this auditing procedure are presented.

  11. Measurement of social capital among clinical research trainees.

    PubMed

    Primack, Brian A; Colditz, Jason B; Cohen, Elan; Switzer, Galen E; Robinson, Georgeanna F W B; Seltzer, Deborah L; Rubio, Doris M; Kapoor, Wishwa N

    2014-02-01

    While physical and human capital are established as important predictors of success among early-career clinical investigators, less is known about the role of social capital. The authors aimed to develop a brief scale to assess social capital in this population and test its reliability and validity. A three-item assessment was developed based on a conceptual framework and measures of social capital from other fields and was administered to 414 clinical research trainees at the University of Pittsburgh in 2007-2012. The measure exhibited good internal consistency reliability (α = 0.71) and a normal distribution. On a 10-point scale, mean social capital was 6.4 (SD = 1.7). Social capital was significantly associated with 7 of the 9 expected constructs: sex, age, confidence in research skills, work-related motivation, burnout, and social support. Exploratory multivariable regression analysis demonstrated that social capital was most strongly associated with higher research confidence (β = 0.35, p < 0.001), higher extrinsic motivation (β = 0.50, p = 0.003), and lower burnout (ptrend = 0.02). This three-item scale measures social capital in this population with adequate internal consistency reliability, face validity, and construct validity. This brief assessment provides a tool that may be valuable to benchmark social capital of clinical research trainees and to better contextualize programmatic and trainee outcomes. PMID:24118964

  12. Measurement of Social Capital among Clinical Research Trainees

    PubMed Central

    Primack, Brian A.; Colditz, Jason B.; Cohen, Elan; Switzer, Galen E.; Robinson, Georgeanna; Seltzer, Deborah L.; Rubio, Doris M.; Kapoor, Wishwa N.

    2013-01-01

    While physical- and human capital are established as important predictors of success among early-career clinical investigators, less is known about the role of social capital. The authors aimed to develop a brief scale to assess social capital in this population and test its reliability and validity. A three-item assessment was developed based on a conceptual framework and measures of social capital from other fields and was administered to 414 clinical research trainees at the University of Pittsburgh in 2007–2012. The measure exhibited good internal consistency reliability (α=0.71) and a normal distribution. On a 10-point scale, mean social capital was 6.4 (SD=1.7). Social capital was significantly associated with 7 of the 9 expected constructs: sex, age, confidence in research skills, work-related motivation, burnout, and social support. Exploratory multivariable regression analysis demonstrated that social capital was most strongly associated with higher research confidence (β=0.35, P<.001), higher extrinsic motivation (β=0.50, P=.003), and lower burnout (Ptrend=.02). This 3-item scale measures social capital in this population with adequate internal consistency reliability, face validity, and construct validity. This brief assessment provides a tool which may be valuable to benchmark social capital of clinical research trainees and to better contextualize programmatic and trainee outcomes. PMID:24118964

  13. Measurement of social capital among clinical research trainees.

    PubMed

    Primack, Brian A; Colditz, Jason B; Cohen, Elan; Switzer, Galen E; Robinson, Georgeanna F W B; Seltzer, Deborah L; Rubio, Doris M; Kapoor, Wishwa N

    2014-02-01

    While physical and human capital are established as important predictors of success among early-career clinical investigators, less is known about the role of social capital. The authors aimed to develop a brief scale to assess social capital in this population and test its reliability and validity. A three-item assessment was developed based on a conceptual framework and measures of social capital from other fields and was administered to 414 clinical research trainees at the University of Pittsburgh in 2007-2012. The measure exhibited good internal consistency reliability (α = 0.71) and a normal distribution. On a 10-point scale, mean social capital was 6.4 (SD = 1.7). Social capital was significantly associated with 7 of the 9 expected constructs: sex, age, confidence in research skills, work-related motivation, burnout, and social support. Exploratory multivariable regression analysis demonstrated that social capital was most strongly associated with higher research confidence (β = 0.35, p < 0.001), higher extrinsic motivation (β = 0.50, p = 0.003), and lower burnout (ptrend = 0.02). This three-item scale measures social capital in this population with adequate internal consistency reliability, face validity, and construct validity. This brief assessment provides a tool that may be valuable to benchmark social capital of clinical research trainees and to better contextualize programmatic and trainee outcomes.

  14. Perceptions Community Residents Have about Partner Institutions and Clinical Research

    PubMed Central

    Kennedy, Betty M.; Katzmarzyk, Peter T.; Johnson, William D.; Griffin, Willene P.; Kennedy, Kathleen B.; Cefalu, William T.; Ryan, Donna H.

    2014-01-01

    Introduction Engaging community residents to obtain their feedback in conducting clinical research, and including them as leaders in implementing applicable health advances is crucial for success and sustaining large center awards. Methods Forty-four adult men and women participated in one of four focus groups. Two groups each (one African American and one Caucasian) were conducted in Baton Rouge and in New Orleans. Results In an effort to determine the knowledge, attitudes, and beliefs Louisiana residents have about the Louisiana Clinical and Translational Science (LA CaTS) Center concept, four main themes emerged from focus group participants concerning the state’s research institutions, and what it means to have these institutions operating under one umbrella to improve the quality of health of its people: 1) academic/research institutions of the State are uniformly widely recognized and held in high regard; 2) increasing awareness of clinical research is a necessity; 3) establishing the LA CaTS Center is an excellent idea; and 4) effective communication including delivery style is crucial to partnerships and especially to the community. Conclusion Focus group discussions can provide insight into community residents’ perceptions, beliefs, motivations and patterns of behavior for strategically planning for large center awards. PMID:24138681

  15. [Assessment of innovations in clinical research: strengths and potentials for improvement of research in Germany].

    PubMed

    Vollmar, Horst Christian; Georgieff, Peter; Bührlen, Bernhard

    2010-01-01

    Clinical research is a central link in the development chain of new treatment methods; scientifically, it belongs between basic science and health services research. It spans from the first application of a new substance or device in humans to the main proofs of its efficacy and safety. Economically speaking, it absorbs almost half of the total expenditures for the research and development of a new drug and represents a significant factor in the labour market for researchers and study personnel. Also, through participation in clinical trials, patients gain early access to new treatment methods, while on the other hand they are placed at higher risk for undesired side effects. Politics have taken significant steps to strengthen clinical research, but the pharmaceutical industry continues to complain about competitive disadvantages. Despite internationally recognised and, to a large extent, legally codified guidelines there are still significant national differences in implementation. In addition, traditional practices in clinical research are challenged by novel, mainly biotechnological therapeutic methods for which our current knowledge base is rather limited and which therefore entail a higher risk for patients or trial participants. The following paper summarises a report for the Office of Technology Assessment at the German Federal Parliament (TAB). Based on current regulations, scientific literature and expert interviews, current challenges and solution strategies for clinical research will be analysed in terms of an international comparison.

  16. On the Relation of Clinical Research to Clinical Practice: Current Issues, New Directions.

    ERIC Educational Resources Information Center

    Barlow, David H.

    1981-01-01

    In seven articles methods of enhancing clinical practice through empirical approaches and realistic approaches and realistic research are discussed including: (1) Cronbach's method of intensive observation; (2) intensive monitoring of treatment strength, integrity, and effectiveness; (3) the use of dependent measures; (4) drawing valid conclusions…

  17. The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet)

    PubMed Central

    de Andrade, Joao; Schwarz, Marvin; Collard, Harold R.; Gentry-Bumpass, Tedryl; Colby, Thomas; Lynch, David; Schwarz, M.; Zisman, D. A.; Hunninghake, G.; Chapman, J.; Olman, M.; Lubell, S.; Morrison, L. D.; Steele, M. P.; Haram, T.; Roman, J.; Perez, R.; Perez, T.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Brown, K. K.; Schwarz, M.; Bair, C.; Kervitsky, D.; Lasky, J. A.; Ditta, S.; deAndrade, J.; Thannickal, V. J.; Stewart, M.; Zisman, D. A.; Lynch, J.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J. A.; Wolters, P. J.; Jeffrey, R.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; White, S. R.; Brown, C.; Garic, I.; Maleckar, S.; Martinez, F. J.; Flaherty, K. R.; Han, M.; Moore, B.; Toews, G. B.; Dahlgren, D.; Raghu, G.; Hayes, J.; Snyder, M.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Monroy, V.; Wang, M.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Becker, R. C.; Eisenstein, E. L.; MacIntyre, N. R.; Morrison, L. D; Rochon, J.; Steele, M. P.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Anderson, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Ingham, M.; Kagan, E.; Kaur, J.; Matti, C.; McClelland, J.; Meredith, A.; Nguyen, T.; Pesarchick, J.; Roberts, R. S.; Tate, W.; Thomas, T.; Walker, J.; Whelan, D.; Winsor, J.; Yang, Q.; Yow, E.; Reynolds, H. Y.; Tian, X.; Kiley, J.; Noth, I.; Olman, M.; Schwarz, M.; Toews, G. B.; Hunninghake, G.; Culver, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Wehrmann, R.; Morrison, L. D.; Steele, M. P.; Haram, T.; Kidd, R.; Kallay, M.; Lyda, E.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Sahn, S.; O’Banner, N.; Stokes, F.; Brown, K. K.; Bair, C.; Kervitsky, D.; Ettinger, N. A.; Merli, S.; de Andrade, J.; Thannickal, V. J.; Stewart, M.; Belperio, J.; Lynch, J. P.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J.; Wolters, P.; Eller, A.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; Maleckar, S.; Rahimova, G.; Sardin, L.; Roman, J.; Perez, R.; Perez, T.; Glassberg, M.; Simonet, E.; Martinez, F. J.; Baumann, K.; Chan, K.; Chughtai, A.; Gross, B.; Flaherty, K. R.; Han, M. L.; Hyzy, R.; Kazerooni, E.; Moore, B.; Myers, J.; Toews, G. B.; White, E.; Dahlgren, D.; Rossman, M.; Kreider, M.; Le, K.; Fitzgerald, J.; Glazer, C.; Scholand, M. B.; Brewster, L.; Johnson, A.; Raghu, G.; Berry-Bell, P.; Snydsman, A.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Kinser, K.; Richardson, R.; Mason, W.; Kaner, R. J.; Bandong, K.; Antin-Ozerkis, D.; Holm, C.; Estrom, J.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Eisenstein, E. L.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Beci, R.; Calvert, S.; Gentry-Bumpass, T.; Hill, D.; Hofmann, P. V.; Hwang, K.; Kaur, J.; Matti, C.; Meredith, A.; Pesarchick, J.; Ramey, S.; Roberts, R. S.; Sharlow, A.; Winsor, J.; Yang, Q.; Yow, E.; Weinmann, G. G.; Reynolds, H.; Schmetter, B.; Tian, X.; Kiley, J.; Martinez, F. J.; Raghu, G.; Schwarz, M.; Toews, G. B.; Zibrak, J.; Demersky, A.; Vey, M.; Rosas, I. O.; Debrosse, P.; Culver, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Wehrmann, R.; Morrison, L. D.; Steele, M. P.; Haram, T.; Kidd, R.; Kallay, M.; Lyda, E.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Sahn, S.; O’Banner, N.; Stokes, F.; Padilla, M.; Berhanu, G.; Brown, K. K.; Bair, C.; Kervitsky, D.; Ettinger, N. A.; Merli, S.; Criner, G. J.; Swift, I. Q.; Satti, A.; Cordova, F.; Patel, N.; West, K.; Jones, G.; Lasky, J. A.; Ditta, S.; de Andrade, J.; Thannickal, V. J.; Stewart, M.; Belperio, J.; Lynch, J. P.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J.; Wolters, P.; Eller, A.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; Maleckar, S.; Rahimova, G.; Sardin, L.; Roman, J.; Perez, R.; Perez, T.; Glassberg, M.; Simonet, E.; Martinez, F. J.; Baumann, K.; Chan, K.; Chughtai, A.; Gross, B.; Flaherty, K. R.; Han, M. L.; Hyzy, R.; Kazerooni, E.; Moore, B.; Myers, J.; Toews, G. B.; White, E.; Dahlgren, D.; Rossman, M.; Kreider, M.; Le, K.; Fitzgerald, J.; Glazer, C.; Scholand, M. B.; Brewster, L.; Johnson, A.; Raghu, G.; Berry-Bell, P.; Snydsman, A.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Bandong, K.; Antin-Ozerkis, D.; Holm, C.; Estrom, J.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Becker, R. C.; Eisenstein, E. L.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Huang, K.; Kaur, J.; Matti, C.; Meredith, A.; Pesarchick, J.; Ramey, S.; Roberts, R. S.; Sharlow, A.; Winsor, J.; Yow, E.; Weinmann, G. G.; Reynolds, H.; Schmetter, B.; Tian, X.; Kiley, J.

    2015-01-01

    BACKGROUND: The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes. METHODS: The diagnostic process was based on review of clinical data and high-resolution CT scans with central review of lung biopsies when available. The AC worked closely with the data coordinating center to obtain clinical, radiologic, and histologic data and to communicate with the clinical centers. The AC used a multidisciplinary discussion model with four clinicians, one radiologist, and one pathologist to adjudicate diagnosis and outcome measures. RESULTS: The IPFnet trials screened 1,015 subjects; of these, 23 cases required review by the AC to establish eligibility. The most common diagnosis for exclusion was suspected chronic hypersensitivity pneumonitis. The AC reviewed 88 suspected acute exacerbations (AExs), 93 nonelective hospitalizations, and 16 cases of bleeding. Determination of AEx presented practical challenges to adjudicators, as necessary clinical data were often not collected, particularly when subjects were evaluated outside of the primary study site. CONCLUSIONS: The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as they incorporate AExs and hospitalizations as outcome measures. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00517933, NCT00650091, NCT00957242; URL: www.clinicaltrials.gov PMID

  18. Animal research as a basis for clinical trials.

    PubMed

    Faggion, Clovis M

    2015-04-01

    Animal experiments are critical for the development of new human therapeutics because they provide mechanistic information, as well as important information on efficacy and safety. Some evidence suggests that authors of animal research in dentistry do not observe important methodological issues when planning animal experiments, for example sample-size calculation. Low-quality animal research directly interferes with development of the research process in which multiple levels of research are interconnected. For example, high-quality animal experiments generate sound information for the further planning and development of randomized controlled trials in humans. These randomized controlled trials are the main source for the development of systematic reviews and meta-analyses, which will generate the best evidence for the development of clinical guidelines. Therefore, adequate planning of animal research is a sine qua non condition for increasing efficacy and efficiency in research. Ethical concerns arise when animal research is not performed with high standards. This Focus article presents the latest information on the standards of animal research in dentistry, more precisely in the field of implant dentistry. Issues on precision and risk of bias are discussed, and strategies to reduce risk of bias in animal research are reported.

  19. Big Data Clinical Research: Validity, Ethics, and Regulation.

    PubMed

    Balas, E Andrew; Vernon, Marlo; Magrabi, Farah; Gordon, Lynne Thomas; Sexton, Joanne

    2015-01-01

    Electronic Health Records (EHR) promise improvement for patient care and also offer great value for biomedical research including clinical, public health, and health services research. Unfortunately, the full potential of EHR big data research has remained largely unrealized. The purpose of this study was to identify rate limiting factors, and develop recommendations to better balance unrestricted extramural EHR access with legitimate safeguarding of EHR data in retrospective research. By exploring primary, secondary, and tertiary sources, this review identifies external constraints and provides a comparative analysis of social influencers in retrospective EHR-based research. Results indicate that EHRs have the advantage of reflecting the reality of patient care but also show a frequency of between 4.3-86% of incomplete and inaccurate data in various fields. The rapid spread of alternative analytics for health data challenges traditional interpretations of confidentiality protections. A confusing multiplicity of controls creates barriers to big data EHR research. More research on the use of EHR big data is likely to improve accuracy and validity. Information governance and research approval processes should be simplified. Comprehensive regulatory policies that do not exclusively cover health care entities, are needed. Finally, new computing safeguards are needed to address public concerns, like research access only to aggregate data and not to individually identifiable information.

  20. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good... Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is... relationships among FDA and clinical trial staff, investigators, and institutional review boards...

  1. Clinical Trial Results Vary Widely, But Always Advance Research | NIH MedlinePlus the Magazine

    MedlinePlus

    ... of this page please turn Javascript on. Feature: Clinical Trials Clinical Trial Results Vary Widely, But Always Advance Research Past ... very emotional." Should You Be Interested in a Clinical Trial People volunteer to take part in clinical trials ...

  2. Standardization of clinical decision making for the conduct of credible clinical research in complicated medical environments.

    PubMed Central

    Morris, A. H.; East, T. D.; Wallace, C. J.; Franklin, M.; Heerman, L.; Kinder, T.; Sailor, M.; Carlson, D.; Bradshaw, R.

    1996-01-01

    The likelihood that past experience will produce correct guides to current practice depends on the signal-to-noise ratio for the clinical problem of interest. If the signal-to-noise ratio is high, the decision will be sound and patient benefit likely to occur. If the signal-to-noise ratio is low, as is commonly the case with difficult clinical decisions, then personal experience and the best intentions will not assure sound clinical decisions. When the probability of benefit cannot be quantified, clinicians in complex settings are in danger of being misled by data and experience. Quantifiable probabilities established by group experiment or observation will be necessary for clinical decisions that can be expected to confer benefit on the patient. Explicit methods are necessary for interventions that can be replicated in experiments or in practice. Computerized protocols force the articulation of explicit clinical care methods and standardize clinical decision making. We have developed explicit, rule-based protocols, implemented them in our hospital, exported them to other hospitals, and successfully achieved a rigorous experimental environment in the clinical ICU. Exportation of such explicit methods may narrow the gap between efficacy (university hospital) and effectiveness (community hospital) research results. PMID:8947700

  3. Cardiomyopathy in Friedreich ataxia: clinical findings and research.

    PubMed

    Payne, R Mark; Wagner, Gregory R

    2012-09-01

    Friedreich ataxia is the most common human ataxia and results from inadequate production of the frataxin protein, most often the result of a triplet expansion in the nuclear FXN gene. The gene cannot be transcribed to generate the messenger ribonucleic acid for frataxin. Frataxin is an iron-binding protein targeted to the mitochondrial matrix. In its absence, multiple iron-sulfur-dependent proteins in mitochondria and the cytosol lack proper assembly, destroying mitochondrial and nuclear function. Mitochondrial oxidant stress may also participate in ongoing cellular injury. Although progressive and debilitative ataxia is the most prominent clinical finding, hypertrophic cardiomyopathy with heart failure is the most common cause of early death in this disease. There is no cure. In this review the authors cover recent basic and clinical findings regarding the heart in Friedreich ataxia, offer recommendations for clinical management of the cardiomyopathy in this disease, and point out new research directions to advance the field.

  4. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

    PubMed

    Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

    2016-05-01

    Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. PMID:27002223

  5. Highlights of the 2012 research workshop: Using nutrigenomics and metabolomics in clinical nutrition research

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Research Workshop, "Using Nutrigenomics and Metabolomics in Clinical Nutrition Research," was held on January 21, 2012, in Orlando, Florida. The conference brought together experts in human nutrition who use nutrigenomic and meta...

  6. A Feminine Care Clinical Research Program Transforms Women's Lives.

    PubMed

    Tzeghai, Ghebre E; Ajayi, Funmilayo O; Miller, Kenneth W; Imbescheid, Frank; Sobel, Jack D; Farage, Miranda A

    2015-01-01

    Feminine hygiene products and menstruation education have transformed the lives of women throughout the world. The P&G Feminine Care Clinical Innovation Research Program has played a key role by expanding scientific knowledge as well as developing technical insights and tools for the development of feminine hygiene products. The aim has been to meet the needs of women throughout their life stages, advancing their urogenital health beyond just menstruation, as well as helping to understand the role of sex hormones in various important health issues that women face. This review article highlights key contributions and research findings in female hygiene products, urogenital health research, and method development. The clinical research team focused on utilizing the results of clinical safety studies to advance the acceptance of feminine hygiene products world-wide. Key findings include that perception of skin sensitivity is not limited to the facial area, but is also relevant to the body and the genital area. Also, they shed light on the role of estrogen in autoimmune diseases as well as premenstrual syndrome. Efforts in the method development area focused on innovative tools that are reliable, predictive of clinical trial results and capable of measuring wear comfort, genital skin health, and the impact of product use on the consumer's quality of life. A novel method, behind-the-knee (BTK) test, developed to model irritation under normal wear conditions, was the first to account for both chemical and mechanical sources of irritation. The method has been accepted by the FDA as a substitute in clinical trials in some cases, and by American Society for Testing and Materials as a global standard test method. Additional proprietary methods were developed to enhance visual grading of irritation using cross-polarized light, to measure the amount of lotion transferred from sanitary pads, and to evaluate the skin mildness. Finally, the Farage Quality of Life tool was created

  7. A Feminine Care Clinical Research Program Transforms Women's Lives.

    PubMed

    Tzeghai, Ghebre E; Ajayi, Funmilayo O; Miller, Kenneth W; Imbescheid, Frank; Sobel, Jack D; Farage, Miranda A

    2015-01-01

    Feminine hygiene products and menstruation education have transformed the lives of women throughout the world. The P&G Feminine Care Clinical Innovation Research Program has played a key role by expanding scientific knowledge as well as developing technical insights and tools for the development of feminine hygiene products. The aim has been to meet the needs of women throughout their life stages, advancing their urogenital health beyond just menstruation, as well as helping to understand the role of sex hormones in various important health issues that women face. This review article highlights key contributions and research findings in female hygiene products, urogenital health research, and method development. The clinical research team focused on utilizing the results of clinical safety studies to advance the acceptance of feminine hygiene products world-wide. Key findings include that perception of skin sensitivity is not limited to the facial area, but is also relevant to the body and the genital area. Also, they shed light on the role of estrogen in autoimmune diseases as well as premenstrual syndrome. Efforts in the method development area focused on innovative tools that are reliable, predictive of clinical trial results and capable of measuring wear comfort, genital skin health, and the impact of product use on the consumer's quality of life. A novel method, behind-the-knee (BTK) test, developed to model irritation under normal wear conditions, was the first to account for both chemical and mechanical sources of irritation. The method has been accepted by the FDA as a substitute in clinical trials in some cases, and by American Society for Testing and Materials as a global standard test method. Additional proprietary methods were developed to enhance visual grading of irritation using cross-polarized light, to measure the amount of lotion transferred from sanitary pads, and to evaluate the skin mildness. Finally, the Farage Quality of Life tool was created

  8. Computational Approaches for Translational Clinical Research in Disease Progression

    PubMed Central

    McGuire, Mary F.; Iyengar, M. Sriram; Mercer, David W.

    2011-01-01

    Today, there is an ever-increasing amount of biological and clinical data available that could be used to enhance a systems-based understanding of disease progression through innovative computational analysis. In this paper we review a selection of published research regarding computational methodologies, primarily from systems biology, that support translational research from the molecular level to the bedside, with a focus on applications in trauma and critical care. Trauma is the leading cause of mortality in Americans under 45 years of age, and its rapid progression offers both opportunities and challenges for computational analysis of trends in molecular patterns associated with outcomes and therapeutic interventions. This review presents methods and domain-specific examples that may inspire the development of new algorithms and computational methods that utilize both molecular and clinical data for diagnosis, prognosis and therapy in disease progression. PMID:21712727

  9. The DSM and Professional Practice: Research, Clinical, and Institutional Perspectives.

    PubMed

    Halpin, Michael

    2016-06-01

    How mental illnesses are defined has significant ramifications, given the substantial social and individual repercussions of these conditions. Using actor-network theory, I analyze how mental health professionals use the Diagnostic and Statistical Manual of Mental Disorders (DSM) in their work. Drawing on observations of a neuropsychological laboratory and interviews with 27 professionals (i.e., psychiatrists, psychologists), I investigate how the DSM is used in research, clinical, and institutional work. In research, the DSM influences study design and exclusion/inclusion criteria. In the clinic, the DSM influences how disorders are conceptualized and diagnosed. Institutionally, the DSM aligns the patient-professional encounter to insurance and pharmaceutical interests. I conclude that the DSM operates as multiple, context-specific taxonomies that pervasively influence professional practices, such that all possible actions must orient to DSM criteria, with professionals both a source and an object of institutionalized gaze. PMID:27284075

  10. Multisystemic Therapy(®) : Clinical Overview, Outcomes, and Implementation Research.

    PubMed

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

    Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes. PMID:27370172

  11. Integrated and Gender-Affirming Transgender Clinical Care and Research

    PubMed Central

    Radix, Asa; Deutsch, Madeline B.

    2016-01-01

    Abstract: Transgender (trans) communities worldwide, particularly those on the trans feminine spectrum, are disproportionately burdened by HIV infection and at risk for HIV acquisition/transmission. Trans individuals represent an underserved, highly stigmatized, and under-resourced population not only in HIV prevention efforts but also in delivery of general primary medical and clinical care that is gender affirming. We offer a model of gender-affirmative integrated clinical care and community research to address and intervene on disparities in HIV infection for transgender people. We define trans terminology, briefly review the social epidemiology of HIV infection among trans individuals, highlight gender affirmation as a key social determinant of health, describe exemplar models of gender-affirmative clinical care in Boston MA, New York, NY, and San Francisco, CA, and offer suggested “best practices” for how to integrate clinical care and research for the field of HIV prevention. Holistic and culturally responsive HIV prevention interventions must be grounded in the lived realities the trans community faces to reduce disparities in HIV infection. HIV prevention interventions will be most effective if they use a structural approach and integrate primary concerns of transgender people (eg, gender-affirmative care and management of gender transition) alongside delivery of HIV-related services (eg, biobehavioral prevention, HIV testing, linkage to care, and treatment). PMID:27429189

  12. Integrated and Gender-Affirming Transgender Clinical Care and Research.

    PubMed

    Reisner, Sari L; Radix, Asa; Deutsch, Madeline B

    2016-08-15

    Transgender (trans) communities worldwide, particularly those on the trans feminine spectrum, are disproportionately burdened by HIV infection and at risk for HIV acquisition/transmission. Trans individuals represent an underserved, highly stigmatized, and under-resourced population not only in HIV prevention efforts but also in delivery of general primary medical and clinical care that is gender affirming. We offer a model of gender-affirmative integrated clinical care and community research to address and intervene on disparities in HIV infection for transgender people. We define trans terminology, briefly review the social epidemiology of HIV infection among trans individuals, highlight gender affirmation as a key social determinant of health, describe exemplar models of gender-affirmative clinical care in Boston MA, New York, NY, and San Francisco, CA, and offer suggested "best practices" for how to integrate clinical care and research for the field of HIV prevention. Holistic and culturally responsive HIV prevention interventions must be grounded in the lived realities the trans community faces to reduce disparities in HIV infection. HIV prevention interventions will be most effective if they use a structural approach and integrate primary concerns of transgender people (eg, gender-affirmative care and management of gender transition) alongside delivery of HIV-related services (eg, biobehavioral prevention, HIV testing, linkage to care, and treatment). PMID:27429189

  13. A clinical research analytics toolkit for cohort study.

    PubMed

    Yu, Yiqin; Zhu, Yu; Sun, Xingzhi; Tao, Ying; Zhang, Shuo; Xu, Linhao; Pan, Yue

    2012-01-01

    This paper presents a clinical informatics toolkit that can assist physicians to conduct cohort studies effectively and efficiently. The toolkit has three key features: 1) support of procedures defined in epidemiology, 2) recommendation of statistical methods in data analysis, and 3) automatic generation of research reports. On one hand, our system can help physicians control research quality by leveraging the integrated knowledge of epidemiology and medical statistics; on the other hand, it can improve productivity by reducing the complexities for physicians during their cohort studies.

  14. Research and clinical findings--a wholistic view.

    PubMed

    Hanson, Marvin L

    2012-11-01

    Valuable information is available to clinicians both from research articles, and reports from clinicians. Both sources have limitations. Research, with the exception of longitudinal studies, tends to isolate a variable or two from the whole, limiting its usefulness. Clinical techniques reported are sometimes biased, and perform well for certain therapists in certain settings, and not so well for others. Interrelationships are important among variables such as dentition, anatomy, physiology, oral muscle functions, oral rest postures, eating, and speech. Each affects the others. Equally important are interrelationships among all the specialists who treat patients with orofacial myofunctional disorders. A wholistic approach to the evaluation and treatment of orofacial disorders is advocated.

  15. Evidence based dental care: integrating clinical expertise with systematic research.

    PubMed

    Kishore, Mallika; Panat, Sunil R; Aggarwal, Ashish; Agarwal, Nupur; Upadhyay, Nitin; Alok, Abhijeet

    2014-02-01

    Clinical dentistry is becoming increasingly complex and our patients more knowledgeable. Evidence-based care is now regarded as the "gold standard" in health care delivery worldwide. The basis of evidence based dentistry is the published reports of research projects. They are, brought together and analyzed systematically in meta analysis, the source for evidence based decisions. Activities in the field of evidence-based dentistry has increased tremendously in the 21(st) century, more and more practitioners are joining the train, more education on the subject is being provided to elucidate the knotty areas and there is increasing advocacy for the emergence of the field into a specialty discipline. Evidence-Based Dentistry (EBD), if endorsed by the dental profession, including the research community, may well- influence the extent to which society values dental research. Hence, dental researchers should understand the precepts of EBD, and should also recognize the challenges it presents to the research community to strengthen the available evidence and improve the processes of summarizing the evidence and translating it into practice This paper examines the concept of evidence-based dentistry (EBD), including some of the barriers and will discuss about clinical practice guidelines. PMID:24701551

  16. Patient involvement in clinical research: why, when, and how

    PubMed Central

    Sacristán, José A; Aguarón, Alfonso; Avendaño-Solá, Cristina; Garrido, Pilar; Carrión, Juan; Gutiérrez, Alipio; Kroes, Robert; Flores, Angeles

    2016-01-01

    The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient. PMID:27175063

  17. ASBMB Journal Club - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    On Wednesday, November 12, 2014 from 2:00 PM to 3:00 PM EST, Daniel Liebler, PhD (Vanderbilt University) and Karin Rodland, PhD (Pacific Northwestern National Laboratory) and Ruedi Aebersold, PhD (Swiss Federal Institute of Technology) will share their research insight as part of the ASBMB Journal Club.  Both Doctors Liebler and Rodland are Principal Investigators in the NCI’s Clinical Proteomic Tumor Analysis Consortium.

  18. TMS-EEG: From basic research to clinical applications

    NASA Astrophysics Data System (ADS)

    Hernandez-Pavon, Julio C.; Sarvas, Jukka; Ilmoniemi, Risto J.

    2014-11-01

    Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a powerful technique for non-invasively studying cortical excitability and connectivity. The combination of TMS and EEG has widely been used to perform basic research and recently has gained importance in different clinical applications. In this paper, we will describe the physical and biological principles of TMS-EEG and different applications in basic research and clinical applications. We will present methods based on independent component analysis (ICA) for studying the TMS-evoked EEG responses. These methods have the capability to remove and suppress large artifacts, making it feasible, for instance, to study language areas with TMS-EEG. We will discuss the different applications and limitations of TMS and TMS-EEG in clinical applications. Potential applications of TMS are presented, for instance in neurosurgical planning, depression and other neurological disorders. Advantages and disadvantages of TMS-EEG and its variants such as repetitive TMS (rTMS) are discussed in comparison to other brain stimulation and neuroimaging techniques. Finally, challenges that researchers face when using this technique will be summarized.

  19. Special population considerations and regulatory affairs for clinical research

    PubMed Central

    Grimsrud, Kristin N.; Sherwin, Catherine M. T.; Constance, Jonathan E.; Tak, Casey; Zuppa, Athena F.; Spigarelli, Michael G.; Mihalopoulos, Nicole L.

    2015-01-01

    Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of “special population” exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld. PMID:26401094

  20. How to Develop an Electronic Clinical Endometriosis Research File Integrated in Clinical Practice.

    PubMed

    Vanhie, A; Fassbender, A; O, D; Tomassetti, C; Meuleman, C; Peeraer, K; Debrock, S; D'Hooghe, Th

    2015-01-01

    Endometriosis is associated with a range of pelvic-abdominal pain symptoms and infertility. It is a chronic disease that can have a significant impact on various aspects of women's lives, including their social and sexual relationships, work, and study. Despite several international guidelines on the management of endometriosis, there is a wide variety of clinical practice in the management of endometriosis, resulting in many women receiving delayed or suboptimal care. In this paper we discuss the possibilities and benefits of using electronic health records for clinical research in the field of endometriosis. The development of a wide range of clinical software for electronic patient records has made the registration of large datasets feasible and the integration of research files and clinical files possible. Integration of global standards on registration of endometriosis care in electronic health records could improve reporting of research data and facilitate the execution of large, multicentre randomized trials on the management of endometriosis. These highly needed trials could bring us the evidence needed for the optimisation of management of women with endometriosis.

  1. Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research.

    PubMed

    Glickman, Seth W; Ndubuizu, Adanma; Weinfurt, Kevin P; Hamilton, Carol D; Glickman, Lawrence T; Schulman, Kevin A; Cairns, Charles B

    2011-03-01

    Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical research. This inherently limits the societal benefits of the research and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical research, the authors critically evaluated LEP consent requirements posted on the Web sites of 134 academic health centers in March 2008. They found wide variability with regard to consent policies and striking interinstitutional differences in posted IRB policies and attitudes toward consent of LEP patients in research. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the research, yet the consent process is often resource-intensive and complex. The authors suggest that more uniform and specific guidance from federal agencies for enrollment of LEP patients in clinical research be established and that this guidance explicitly recalibrate the current balance between autonomy and justice. Investigators and institutional review boards should also develop streamlined best practices to reduce unnecessary effort and expense associated with recruitment of LEP individuals. LEP individuals should have fair access to clinical research in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

  2. 76 FR 19189 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Science Research and Development Service on the relevance and feasibility of proposed projects and...

  3. Writing a research proposal: the critical first step for successful clinical research.

    PubMed

    Saunderlin, G

    1994-01-01

    The proposal is a key element in the thesis or clinical research project. It identifies what is to be studied, why the topic is relevant, and how the research will be conducted. The proposal is a detailed plan or "blueprint" for the intended study, and once it is completed, the research project should flow smoothly. Writing a proposal may seem like a daunting undertaking, but a little thought and preparation will make it easier. In this article, the author provides a sample research proposal and a set of instructions that the beginning researcher should find helpful.

  4. Tasks of research in forensic medicine - different study types in clinical research and forensic medicine.

    PubMed

    Madea, Burkhard; Saukko, Pekka; Musshoff, Frank

    2007-01-17

    In the last years the research output of forensic medicine has sometimes been regarded as insufficient and as of poor quality, especially when parameters as impact factors and external funding were taken into account. However, forensic medicine has different tasks compared to clinical medicine. The main difference between basic subjects, clinical and forensic medicine is not a lack of scientific efficiency in forensic medicine but is a result of the questions asked, the available methods and specific aims. In contrast to natural-scientific research, forensic science has furthermore important intersections with arts and socio-scientific disciplines. Etiologic and pathogenetic research is of only limited relevance in forensic medicine. Thus, forensic medicine is excluded from these research fields, which are mainly supported by external funding. In forensic medicine research mainly means applied research regarding findings, the probative value and reconstruction as well as examination at different points of intersection between medicine and law. Clinical types of research such as controlled randomised, prospective cross-sectional, cohort or case-control studies can only rarely be applied in forensic medicine due to the area specific research fields (e.g. thantatology, violent death, vitality, traffic medicine, analytical toxicology, hemogenetics and stain analysis). The types of studies which are successfully established in forensic medicine are comparison of methods, sensitivity studies, validation of methods, kinetic examinations etc. Tasks of research in forensic medicine and study types, which may be applied will be addressed.

  5. Data Resource Profile: Clinical Practice Research Datalink (CPRD)

    PubMed Central

    Herrett, Emily; Gallagher, Arlene M; Bhaskaran, Krishnan; Forbes, Harriet; Mathur, Rohini; van Staa, Tjeerd; Smeeth, Liam

    2015-01-01

    The Clinical Practice Research Datalink (CPRD) is an ongoing primary care database of anonymised medical records from general practitioners, with coverage of over 11.3 million patients from 674 practices in the UK. With 4.4 million active (alive, currently registered) patients meeting quality criteria, approximately 6.9% of the UK population are included and patients are broadly representative of the UK general population in terms of age, sex and ethnicity. General practitioners are the gatekeepers of primary care and specialist referrals in the UK. The CPRD primary care database is therefore a rich source of health data for research, including data on demographics, symptoms, tests, diagnoses, therapies, health-related behaviours and referrals to secondary care. For over half of patients, linkage with datasets from secondary care, disease-specific cohorts and mortality records enhance the range of data available for research. The CPRD is very widely used internationally for epidemiological research and has been used to produce over 1000 research studies, published in peer-reviewed journals across a broad range of health outcomes. However, researchers must be aware of the complexity of routinely collected electronic health records, including ways to manage variable completeness, misclassification and development of disease definitions for research. PMID:26050254

  6. Off-shoring clinical research: exploitation and the reciprocity constraint.

    PubMed

    Mitra, Agomoni Ganguli

    2013-12-01

    The last 20 years have seen a staggering growth in the practice of off-shoring clinical research to low-and middle-income countries (LICs and MICs), a growth that has been matched by the neoliberal policies adopted by host countries towards attracting trials to their shores. A recurring concern in this context is the charge of exploitation, linked to various aspects of off-shoring. In this paper, I examine Alan Wertheimer's approach and offer an alternative view of understanding exploitation in this context. I will suggest that the justification for the enterprise of research is largely dependent on its integration within a health system from which participants regularly benefit and I argue that an attention to a principle of reciprocity will enable us to better recognize and address exploitation in international research.

  7. Coordinating ‘Ethical’ Clinical Trials: The Role of Research Coordinators in the Contract Research Industry

    PubMed Central

    Fisher, Jill A.

    2010-01-01

    Change in the way new drugs are developed, including the privatization of clinical trials, has altered the arrangement and roles of health care professions. In this article I examine one aspect of this change: the role of research coordinators in the conduct of contract research in the United States. My focus on coordinators highlights the ethical conflicts embedded in clinical trials. I describe the ways in which coordinators experience and contend with the conflict between research and care and show how their construction of ethics is distinct from institutional conceptions formally associated with human subjects research. My analysis demonstrates how the coordinators' focus on ethics is a response to their role conflict and an attempt to reinsert individualized care into the context of research. PMID:17184412

  8. Citation Analysis May Severely Underestimate the Impact of Clinical Research as Compared to Basic Research

    PubMed Central

    van Eck, Nees Jan; Waltman, Ludo; van Raan, Anthony F. J.; Klautz, Robert J. M.; Peul, Wilco C.

    2013-01-01

    Background Citation analysis has become an important tool for research performance assessment in the medical sciences. However, different areas of medical research may have considerably different citation practices, even within the same medical field. Because of this, it is unclear to what extent citation-based bibliometric indicators allow for valid comparisons between research units active in different areas of medical research. Methodology A visualization methodology is introduced that reveals differences in citation practices between medical research areas. The methodology extracts terms from the titles and abstracts of a large collection of publications and uses these terms to visualize the structure of a medical field and to indicate how research areas within this field differ from each other in their average citation impact. Results Visualizations are provided for 32 medical fields, defined based on journal subject categories in the Web of Science database. The analysis focuses on three fields: Cardiac & cardiovascular systems, Clinical neurology, and Surgery. In each of these fields, there turn out to be large differences in citation practices between research areas. Low-impact research areas tend to focus on clinical intervention research, while high-impact research areas are often more oriented on basic and diagnostic research. Conclusions Popular bibliometric indicators, such as the h-index and the impact factor, do not correct for differences in citation practices between medical fields. These indicators therefore cannot be used to make accurate between-field comparisons. More sophisticated bibliometric indicators do correct for field differences but still fail to take into account within-field heterogeneity in citation practices. As a consequence, the citation impact of clinical intervention research may be substantially underestimated in comparison with basic and diagnostic research. PMID:23638064

  9. Discovering the Sky.

    ERIC Educational Resources Information Center

    Weedman, Daniel W.

    1997-01-01

    An astronomer gives teachers tips on learning how to look at the night sky then on passing along personal instruction to students. Presents ideas for finding information through astronomers at colleges, science museums, planetariums, research observatories, and on the World Wide Web. Contains a resource list and foldout poster of galaxies with…

  10. Emerging uses of patient generated health data in clinical research.

    PubMed

    Wood, William A; Bennett, Antonia V; Basch, Ethan

    2015-05-01

    Recent advancements in consumer directed personal computing technology have led to the generation of biomedically-relevant data streams with potential health applications. This has catalyzed international interest in Patient Generated Health Data (PGHD), defined as "health-related data - including health history, symptoms, biometric data, treatment history, lifestyle choices, and other information-created, recorded, gathered, or inferred by or from patients or their designees (i.e. care partners or those who assist them) to help address a health concern."(Shapiro et al., 2012) PGHD offers several opportunities to improve the efficiency and output of clinical trials, particularly within oncology. These range from using PGHD to understand mechanisms of action of therapeutic strategies, to understanding and predicting treatment-related toxicity, to designing interventions to improve adherence and clinical outcomes. To facilitate the optimal use of PGHD, methodological research around considerations related to feasibility, validation, measure selection, and modeling of PGHD streams is needed. With successful integration, PGHD can catalyze the application of "big data" to cancer clinical research, creating both "n of 1" and population-level observations, and generating new insights into the nature of health and disease. PMID:25248998

  11. Standardization of clinical protocols in oral malodor research.

    PubMed

    Yaegaki, Ken; Brunette, Donald M; Tangerman, Albert; Choe, Yong-Sahm; Winkel, Edwin G; Ito, Sayaka; Kitano, Tomohiro; Ii, Hisataka; Calenic, Bogdan; Ishkitiev, Nikolay; Imai, Toshio

    2012-03-01

    The objective of this study is to standardize protocols for clinical research into oral malodor caused by volatile sulfur compounds (VSCs). To detect VSCs, a gas chromatograph (GC) using a flame photometric detector equipped with a bandpass filter (at 393 nm) is the gold standard (sensitivity: 5 × 10(-11) gS s(-1)). The baselines of VSC concentrations in mouth air varied considerably over a week. When the subjects refrained from eating, drinking and oral hygiene including mouth rinsing, the VSC concentrations remained constant until eating. Over a 6 h period after a meal, VSC concentrations decreased dramatically (p < 0.01). These results point to optimal times and conditions for sampling subjects. Several portable devices were compared with the measurements by the GCs. Portable GCs demonstrated capabilities similar to those of the GCs. We also applied the recommended protocols described below to clinical research testing the efficacy of ZnCl(2) products, and confirmed that using the recommended protocols in a randomized crossover design would provide very clear results. Proposed protocols include: (a) a short-term study rather than a long-term study is strongly recommended, since the VSC concentrations are constant in the short term; (b) a crossover study would be the best design to avoid the effects of individual specificities on each clinical intervention; (c) measurements of VSCs should preferably be carried out using either a GC or portable GCs. PMID:22368249

  12. The perils of protection: vulnerability and women in clinical research.

    PubMed

    Schonfeld, Toby

    2013-06-01

    Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring "additional protections," often referred to as "vulnerable populations." The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I assess critically the role of this categorization of pregnant women involved in research as "vulnerable," both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not "vulnerable" according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as "vulnerable" and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research.

  13. Barriers to Effective Deliberation in Clinical Research Oversight.

    PubMed

    Wenner, Danielle M

    2016-09-01

    Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call "deliberative pathologies," or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research.

  14. Barriers to Effective Deliberation in Clinical Research Oversight.

    PubMed

    Wenner, Danielle M

    2016-09-01

    Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call "deliberative pathologies," or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. PMID:26613717

  15. A guide to clinical trials. Part II: interpreting medical research.

    PubMed

    Highleyman, Liz

    2006-01-01

    Part I of this two-part article, which appeared in the Summer 2005 issue of BETA, provided an overview of the clinical trial process. Part II covers features of clinical trials and interpretation of study results. Clinical trials provide the foundation for evidence-based medicine, or medical decision-making guided by data from formal research. Medical professionals keep up with the latest information by reading peer-reviewed medical journals and attending conferences. Likewise, HIV positive people can keep abreast of the state of the art by following the medical literature and community publications like BETA. Trials offer important information about a therapy's benefits and risks in a population, but they cannot predict how well a given treatment will work for a specific person. Healthcare providers, therefore, must still rely heavily on clinical experience, intuition, and a careful evaluation of the various factors unique to each individual case--the practice of medicine remains an art as well as a science. PMID:16610119

  16. [Ten challenging issues in the clinical research of Chinese medicine].

    PubMed

    Li, Yong-Ming

    2009-05-01

    While continuing its journey to the West, traditional Chinese medicine (TCM) encounters various barriers. The ten most challenging issues in TCM clinical research are: (1) the justification of the specificity of acupuncture points; (2) the evidence of the effectiveness of manual needle manipulation; (3) the role of placebo in TCM practice; (4) the advantage of TCM pattern differentiation in clinical management; (5) quality control of Chinese herbs and optional formulation for current practice; (6) the classification of herbal medicine based on safety and toxicity; (7) the efficacy of herbal medicine for specific diseases or symptoms proven by randomized double blinded controlled clinical trial; (8) interactions between Western drugs and herbal medicine; (9) the application of Western medical diagnosis, pathology, imaging data, and test results in TCM pattern differentiation; (10) the best clinical set-up and model for TCM practice in modern society. There is no doubt that the understanding and resolving of these issues will significantly accelarate the acceptance of TCM by the scientific community and the Western society.

  17. Design and implementation of clinical trials in rehabilitation research.

    PubMed

    Hart, Tessa; Bagiella, Emilia

    2012-08-01

    The growth of evidence-based medicine means that both researchers and clinicians must grasp the complex issues involved in implementing clinical trials, which are especially challenging for the behavioral (experience-based) treatments that predominate in rehabilitation. In this article we discuss selected issues germane to the design, implementation, and analysis of group-level clinical trials in rehabilitation. We review strengths, weaknesses, and best applications of 1-sample, between-subjects, and within-subjects study designs, including newer models such as practical clinical trials and point-of-care trials. We also discuss the selection of appropriate control conditions against which to test rehabilitation treatments, as well as issues related to trial blinding. In a section on treatment definition, we discuss the challenges of specifying the active ingredients in the complex interventions that are widely used in rehabilitation, and present an illustration of 1 approach to defining treatments via the learning mechanisms that underlie them. Issues related to treatment implementation are also discussed, including therapist allocation and training, and assessment of treatment fidelity. Finally we consider 2 statistical topics of particular importance to many rehabilitation trials: the use of multiple or composite outcomes, and factors that must be weighed in estimating sample size for clinical trials.

  18. Reports from research centres--20. Alcohol research at the Hjellestad Clinic.

    PubMed

    Laberg, J C; Fauske, S; Løberg, T

    1989-09-01

    Treatment and research efforts at the Hjellestad Clinic are based on a biobehavioural model of the addictions. The treatment program encompasses life-style changes and relapse prevention, and extensive assessment for the purpose of the treatment choices. The clinic is treating nearly 1500 patients a year. Psychological and medical research projects have included experimental drinking studies, psychopharmacological and biomedical studies, treatment evaluations, studies of neuropsychological assessment, studies of personality subtypes, studies of violence related to alcohol and drugs, and investigations of women alcoholics. A new research laboratory houses an experimental bar, and state-of-the-art facilities for psychophysiological and neuropsychological testing. The Hjellestad Clinic is the only Norwegian centre for clinical and experimental research on the addictions from a psycho-physiological as well as behavioral and cognitive perspective. In addition, a national educational program offers theoretical and practical training for professionals and paraprofessionals in the addictions in co-operation with the University of Bergen. Training in the addictions and internships for psychology students at the University of Bergen is provided at the Clinic. The centre has established connections with centres in Scandinavia, England, Canada and the U.S., through visiting scholars and study trips. (The centre has an especially strong liaison with the Rutgers Center of Alcohol Studies.)

  19. Litigation seeking access to data from ongoing clinical trials: a threat to clinical research.

    PubMed

    Kernan, Walter N; Viscoli, Catherine M; Varughese, Mathew C

    2014-09-01

    Researchers conducting randomized clinical trials may find themselves subject to legal subpoenas for interim data. When a subpoena demands premature disclosure of unblinded data, there is potential for damage to the scientific integrity and reputation of the on-going trial. We describe herein general issues raised by subpoenas for trial data and the particular case of a 2012 subpoena served on investigators from Yale University who were successful in winning reprieve from Connecticut Superior Court.

  20. [Analysis and discussion on current condition of acupuncture clinical research registration].

    PubMed

    Xu, Ying; Chen, Bo; Guo, Yi

    2015-06-01

    To introduce the international registration condition of acupuncture clinical research. With the examples of World Health Organization International Clinical Trials Registry Platform and the U. S. National Institutes of Health Clinical Registration Platform, the registration method and current condition of acupuncture clinical trials in international clinical trials registration platform were analyzed. The results indicate that the number of acupuncture clinical trials registration is gradually increased and the registration number from China is on the rise as well. But most domestic acupuncture clinical researches haven't been registered arid the researchers' valuing degree for clinical trials registration and methodology research needs to be improved. PMID:26480568

  1. 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

  2. Discover the U.S.A.!

    ERIC Educational Resources Information Center

    Popovich, Michele

    2000-01-01

    Describes Discover the USA, an interdisciplinary unit for middle school students that uses trip-planning software and World Wide Web-based resources to teach organizational, research, writing, computer, and practical math and geography skills. Students plan a 1-month road trip in the United States, then take the trip, keeping records of routes,…

  3. Television: A Medium for Discovering Diversity?

    ERIC Educational Resources Information Center

    Selva, Marta; Sola, Anna

    1995-01-01

    Examines television news programs as media for discovering diversity. Discusses television as a means of information and communication, its role in the creation of public opinion, its inability to permit understanding, and the need for empirical research to assess its influence on cognitive processes. (AEF)

  4. The Greater Plains Collaborative: a PCORnet Clinical Research Data Network.

    PubMed

    Waitman, Lemuel R; Aaronson, Lauren S; Nadkarni, Prakash M; Connolly, Daniel W; Campbell, James R

    2014-01-01

    The Greater Plains Collaborative (GPC) is composed of 10 leading medical centers repurposing the research programs and informatics infrastructures developed through Clinical and Translational Science Award initiatives. Partners are the University of Kansas Medical Center, Children's Mercy Hospital, University of Iowa Healthcare, the University of Wisconsin-Madison, the Medical College of Wisconsin and Marshfield Clinic, the University of Minnesota Academic Health Center, the University of Nebraska Medical Center, the University of Texas Health Sciences Center at San Antonio, and the University of Texas Southwestern Medical Center. The GPC network brings together a diverse population of 10 million people across 1300 miles covering seven states with a combined area of 679 159 square miles. Using input from community members, breast cancer was selected as a focus for cohort building activities. In addition to a high-prevalence disorder, we also selected a rare disease, amyotrophic lateral sclerosis.

  5. 78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Research and Development Officer through the Director of the Clinical Science Research and...

  6. 78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Chief Research and Development Officer through the Director of the Clinical Science Research...

  7. Ethical challenges in conducting clinical research in lung cancer

    PubMed Central

    Tod, Angela M.

    2016-01-01

    The article examines ethical challenges that arise with clinical lung cancer research focusing on design, recruitment, conduct and dissemination. Design: problems related to equipoise can arise in lung cancer studies. Equipoise is an ethics precondition for RCTs and exists where there is insufficient evidence to decide which of two or more treatments is best. Difficulties arise in deciding what level of uncertainty constitutes equipoise and who should be in equipoise, for example, patients might not be even where clinicians are. Patient and public involvement (PPI) can reduce but not remove the problems. Recruitment: (I) lung cancer studies can be complex, making it difficult to obtain good quality consent. Some techniques can help, such as continuous consent. But researchers should not expect consent to be the sole protection for participants’ welfare. This protection is primarily done elsewhere in the research process, for example, in ethics review; (II) the problem of desperate volunteers: some patients only consent to a trial because it gives them a 50/50 option of the treatment they want and can be disappointed or upset if randomised to the other arm. This is not necessarily unfair, given clinical equipoise. However, it should be avoided where possible, for example, by using alternative trial designs; (III) the so-called problem of therapeutic misconception: this is the idea that patients are mistaken if they enter trials believing this to be in their clinical best interest. We argue the problem is misconceived and relates only to certain health systems. Conduct: lung cancer trials face standard ethical challenges with regard to trial conduct. PPI could be used in decisions about criteria for stopping rules. Dissemination: as in other trial areas, it is important that all results, including negative ones, are reported. We argue also that the role of PPI with regard to dissemination is currently under-developed. PMID:27413698

  8. Discovering electrophysiology in photobiology

    PubMed Central

    Volkov, Vadim

    2014-01-01

    The mini-review gives special attention to holistic approach and mechanisms of processes. The physical and chemical frames and background for visual perception and signaling are discussed. Perception of photons by retinal rod cells is described in more detail starting from photon absorption and culminating in ion currents. Dark noise and temperature-dependence of photocurrents in photoreceptor cells are analyzed. Perception of polarized light, its effects and informational importance are discussed based on underlying mechanisms and specialized morphological structures of biological organisms. Role of statistics of photons in photoreception is questioned. The review also pinpoints new and developing directions and raises questions for future research. PMID:25328636

  9. Henry Beecher's Contributions to the Ethics of Clinical Research.

    PubMed

    Veatch, Robert M

    2016-01-01

    In the 1950s and '60s, Henry Beecher pioneered the discussion of the ethics of clinical research, leading eventually to the publication of the famous New England Journal of Medicine article summarizing 22 research studies that Beecher suggests were unethical. Those studies generally showed a pattern of posing serious risks to subjects without anticipated proportional benefit. Beecher famously claimed that the problem was not that researchers were malicious or evil; rather, he claimed the problem was they manifested thoughtlessness or carelessness. He called for more rigorous self-scrutiny rather than public review.This article argues that Beecher's reliance on conscientious investigators is problematic. In particular, it focuses on benefits and harms to the exclusion of other moral criteria. However, both research subjects and public regulators are also concerned about autonomy and the consent requirement, confidentiality, and fairness in subject selection and research design. The movement in the 1970s toward more public scrutiny was critical, even though Beecher was right in holding that it was not "vicious disregard for subject welfare" that explained unethical protocols. PMID:27499481

  10. DISCOVERING PATIENT PHENOTYPES USING GENERALIZED LOW RANK MODELS

    PubMed Central

    SCHULER, ALEJANDRO; LIU, VINCENT; WAN, JOE; CALLAHAN, ALISON; UDELL, MADELEINE; STARK, DAVID E.; SHAH, NIGAM H.

    2016-01-01

    The practice of medicine is predicated on discovering commonalities or distinguishing characteristics among patients to inform corresponding treatment. Given a patient grouping (hereafter referred to as a phenotype), clinicians can implement a treatment pathway accounting for the underlying cause of disease in that phenotype. Traditionally, phenotypes have been discovered by intuition, experience in practice, and advancements in basic science, but these approaches are often heuristic, labor intensive, and can take decades to produce actionable knowledge. Although our understanding of disease has progressed substantially in the past century, there are still important domains in which our phenotypes are murky, such as in behavioral health or in hospital settings. To accelerate phenotype discovery, researchers have used machine learning to find patterns in electronic health records, but have often been thwarted by missing data, sparsity, and data heterogeneity. In this study, we use a flexible framework called Generalized Low Rank Modeling (GLRM) to overcome these barriers and discover phenotypes in two sources of patient data. First, we analyze data from the 2010 Healthcare Cost and Utilization Project National Inpatient Sample (NIS), which contains upwards of 8 million hospitalization records consisting of administrative codes and demographic information. Second, we analyze a small (N=1746), local dataset documenting the clinical progression of autism spectrum disorder patients using granular features from the electronic health record, including text from physician notes. We demonstrate that low rank modeling successfully captures known and putative phenotypes in these vastly different datasets. PMID:26776181

  11. Bright Transients discovered by PSST

    NASA Astrophysics Data System (ADS)

    Smith, K. W.; Wright, D.; Smartt, S. J.; Huber, M.; Chambers, K. C.; Flewelling, H.; Willman, M.; Primak, N.; Schultz, A.; Gibson, B.; Magnier, E.; Waters, C.; Tonry, J.; Wainscoat, R. J.; Denneau, L.; Stalder, B.; Heinze, A.; Sherstyuk, A.; Foley, R. J.; Jha, S. W.; Rest, A.; Scolnic, D.

    2016-04-01

    Seven bright transients have been discovered as part of the Pan-STARRS Survey for Transients (PSST). Information on all objects discovered by the Pan-STARRS Survey for Transients is available at http://star.pst.qub.ac.uk/ps1threepi/ (see Huber et al. ATel #7153).

  12. Bright Transients discovered by PSST

    NASA Astrophysics Data System (ADS)

    Smith, K. W.; Wright, D.; Smartt, S. J.; Huber, M.; Chambers, K. C.; Flewelling, H.; Willman, M.; Primak, N.; Schultz, A.; Gibson, B.; Magnier, E.; Waters, C.; Tonry, J.; Wainscoat, R. J.; Foley, R. J.; Jha, S. W.; Rest, A.; Scolnic, D.

    2016-03-01

    Seven bright transients have been discovered as part of the Pan-STARRS Survey for Transients (PSST). Information on all objects discovered by the Pan-STARRS Survey for Transients is available at http://star.pst.qub.ac.uk/ps1threepi/ (see Huber et al. ATel #7153).

  13. Bright Transients discovered by PSST

    NASA Astrophysics Data System (ADS)

    Smith, K. W.; Wright, D.; Smartt, S. J.; Young, D. R.; Huber, M.; Chambers, K. C.; Flewelling, H.; Willman, M.; Primak, N.; Schultz, A.; Gibson, B.; Magnier, E.; Waters, C.; Tonry, J.; Wainscoat, R. J.; Foley, R. J.; Jha, S. W.; Rest, A.; Scolnic, D.

    2016-08-01

    Six bright transients have been discovered as part of the Pan-STARRS Survey for Transients (PSST). Information on all objects discovered by the Pan-STARRS Survey for Transients is available at http://star.pst.qub.ac.uk/ps1threepi/ (see Huber et al. ATel #7153).

  14. Two Transients discovered by PSST

    NASA Astrophysics Data System (ADS)

    Smith, K. W.; Wright, D.; Smartt, S. J.; Young, D. R.; Huber, M.; Chambers, K. C.; Flewelling, H.; Willman, M.; Primak, N.; Schultz, A.; Gibson, B.; Magnier, E.; Waters, C.; Tonry, J.; Wainscoat, R. J.; Foley, R. J.; Jha, S. W.; Rest, A.; Scolnic, D.

    2016-08-01

    Two transients have been discovered as part of the Pan-STARRS Survey for Transients (PSST). Information on all objects discovered by the Pan-STARRS Survey for Transients is available at http://star.pst.qub.ac.uk/ps1threepi/ (see Huber et al. ATel #7153).

  15. Bibliomining for Automated Collection Development in a Digital Library Setting: Using Data Mining To Discover Web-Based Scholarly Research Works.

    ERIC Educational Resources Information Center

    Nicholson, Scott

    2003-01-01

    Discusses quality issues regarding Web sites and describes research that created an intelligent agent for automated collection development in a digital academic library setting, which uses a predictive model based on facets of each Web page to select scholarly works. Describes the use of bibliomining, or data mining for libraries. (Author/LRW)

  16. Interactive Voice/Web Response System in clinical research

    PubMed Central

    Ruikar, Vrishabhsagar

    2016-01-01

    Emerging technologies in computer and telecommunication industry has eased the access to computer through telephone. An Interactive Voice/Web Response System (IxRS) is one of the user friendly systems for end users, with complex and tailored programs at its backend. The backend programs are specially tailored for easy understanding of users. Clinical research industry has experienced revolution in methodologies of data capture with time. Different systems have evolved toward emerging modern technologies and tools in couple of decades from past, for example, Electronic Data Capture, IxRS, electronic patient reported outcomes, etc. PMID:26952178

  17. CPTAC Scientific Symposium - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    On behalf of the National Cancer Institute and the Office of Cancer Clinical Proteomics Research, you are invited to the First Annual CPTAC Scientific Symposium on Wednesday, November 13, 2013. The purpose of this symposium, which consists of plenary and poster sessions, is for investigators from CPTAC community and beyond to share and discuss novel biological discoveries, analytical methods, and translational approaches using CPTAC data. All scientists who use, or wish to use CPTAC data are welcome to participate at this free event. The symposium will be held at the Natcher Conference Facility on the main campus of the National Institutes of Health in Bethesda, Maryland.

  18. [Informed consent in clinical practice and medical research].

    PubMed

    Santillan-Doherty, Patricio; Cabral-Castañeda, Antonio; Soto-Ramírez, Luis

    2003-01-01

    The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats

  19. Interactive Voice/Web Response System in clinical research.

    PubMed

    Ruikar, Vrishabhsagar

    2016-01-01

    Emerging technologies in computer and telecommunication industry has eased the access to computer through telephone. An Interactive Voice/Web Response System (IxRS) is one of the user friendly systems for end users, with complex and tailored programs at its backend. The backend programs are specially tailored for easy understanding of users. Clinical research industry has experienced revolution in methodologies of data capture with time. Different systems have evolved toward emerging modern technologies and tools in couple of decades from past, for example, Electronic Data Capture, IxRS, electronic patient reported outcomes, etc. PMID:26952178

  20. Nurturing the global workforce in clinical research: the National Institutes of Health Fogarty International Clinical Scholars and Fellows Program.

    PubMed

    Heimburger, Douglas C; Carothers, Catherine Lem; Gardner, Pierce; Primack, Aron; Warner, Tokesha L; Vermund, Sten H

    2011-12-01

    The Fogarty International Clinical Research Scholars and Fellows Program's goal is to foster the next generation of clinical investigators and to help build international health research partnerships between American and international investigators and institutions. Through June 2012, 61 sites in 27 countries have hosted 436 Scholars (American students or junior trainees from the host countries) and/or 122 Fellows (American and host country postdoctoral fellows) for year-long experiences in global health research. Initially, the program was oriented toward infectious diseases, but recently emphasis on chronic disease research has increased. At least 521 manuscripts have been published, many in high-impact journals. Projects have included clinical trials, observational studies, translational research, clinical-laboratory interface initiatives, and behavioral research. Strengths of the program include training opportunities for American and developing country scientists in well-established international clinical research settings, and mentorship from experienced global health experts.

  1. Assessing research impact in academic clinical medicine: a study using Research Excellence Framework pilot impact indicators

    PubMed Central

    2012-01-01

    Background Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE) developed proposals for the Research Excellence Framework (REF) to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. Methods The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford’s REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university’s Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate). Results The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. Conclusions While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing and describing impact

  2. Potential of adaptive clinical trial designs in pharmacogenetic research.

    PubMed

    van der Baan, Frederieke H; Knol, Mirjam J; Klungel, Olaf H; Egberts, Antoine Cg; Grobbee, Diederick E; Roes, Kit C B

    2012-04-01

    Adaptive trial designs can be beneficial in pharmacogenetic research when prior uncertainty exists regarding the exact role and clinical relevance of genetic variability in drug response. This type of design enables us to learn about the effect of the genetic variability on drug response and to immediately use this information for the remainder of the study. For different types of adaptive trial designs, we discuss when and how the designs are suitable for pharmacogenetic research: adaptation of randomization, adaptation of patient enrollment and adaptive enrichment. To illustrate the potential benefits of an adaptive design over a fixed design, we simulated an adaptive trial based on the results of the IPASS trial. With a simple model we show that for this example an adaptive enrichment design would have led to a smaller trial, with less EGF receptor mutation-negative patients unnecessarily exposed to the drug, without compromising the α level or reducing power. PMID:22462749

  3. Medical research in clinical emergency settings in Europe.

    PubMed

    Lötjönen, S

    2002-06-01

    Clinical emergencies necessitate immediate action to avert the danger to the patient's life or health. Emergency patients might be in greatest need of novel therapies, and even presumed willing to assume some risk, but research into emergency conditions should be conducted under commonly accepted principles that fulfil the scientific, ethical, and legal criteria. Such criteria already exist in the US, but are still under development in Europe. This article introduces criteria upon which trials in emergency settings may be ethically and legally justified in Europe. Based on both legal texts and professional guidelines, the author has established seven conditions for emergency research, of which informed consent and its substitutes, as well as the conditions of direct benefit requirement and necessity, are considered most problematic and therefore analysed more closely. Other conditions include absence of alternative methods, scientific validity, and approval by an ethics committee.

  4. Recent Topics in Chemical and Clinical Research on Glycated Albumin

    PubMed Central

    Ueda, Yuki; Matsumoto, Hideyuki

    2015-01-01

    The measuring method for glycated albumin (GA) has been developed as a new glycemic control marker since the beginning of the 21st century. Since GA has an advantage in reflecting glycemic status over a shorter period than hemoglobin A1c (HbA1c), much research and many reviews have been reported. However, so far there have been few reports on glycation sites based on the tertiary structure of human serum albumin (HSA) and the comparison of glycation rates between GA and HbA1c in detail. The present review discusses how the glycation sites of lysine residues in HSA are modified with glucose, whereas the glycation sites of lysine residues are located inside of HSA as well as the direct comparison of glycation rates between GA and HbA1c using human blood. Moreover, the most recent clinical researches on GA are described. PMID:25614014

  5. Clinical genetic research 3: Genetics ELSI (Ethical, Legal, and Social Issues) research.

    PubMed

    Pullman, Daryl; Etchegary, Holly

    2015-01-01

    ELSI (Ethical, Legal, and Social Issues) is a widely used acronym in the bioethics literature that encompasses a broad range of research areas involved in examining the various impacts of science and technology on society. In Canada, GE3LS (Genetics, Ethical, Economic, Environmental, Legal, Social issues) is the term used to describe ELSI studies. It is intentionally more expansive in that GE3LS explicitly brings economic and environmental issues under its purview. ELSI/GE3LS research has become increasingly important in recent years as there has been a greater emphasis on "translational research" that moves genomics from the bench to the clinic. The purpose of this chapter is to outline a range of ELSI-related work that might be conducted as part of a large scale genetics or genomics research project, and to provide some practical insights on how a scientific research team might incorporate a strong and effective ELSI program within its broader research mandate. We begin by describing the historical context of ELSI research and the development of GE3LS research in the Canadian context. We then illustrate how some ELSI research might unfold by outlining a variety of research questions and the various methodologies that might be employed in addressing them in an area of ELSI research that is encompassed under the term "public engagement." We conclude with some practical pointers about how to build an effective ELSI/GE3LS team and focus within a broader scientific research program.

  6. Dynamic Categorization of Clinical Research Eligibility Criteria by Hierarchical Clustering

    PubMed Central

    Luo, Zhihui; Yetisgen-Yildiz, Meliha; Weng, Chunhua

    2011-01-01

    Objective To semi-automatically induce semantic categories of eligibility criteria from text and to automatically classify eligibility criteria based on their semantic similarity. Design The UMLS semantic types and a set of previously developed semantic preference rules were utilized to create an unambiguous semantic feature representation to induce eligibility criteria categories through hierarchical clustering and to train supervised classifiers. Measurements We induced 27 categories and measured the prevalence of the categories in 27,278 eligibility criteria from 1,578 clinical trials and compared the classification performance (i.e., precision, recall, and F1-score) between the UMLS-based feature representation and the “bag of words” feature representation among five common classifiers in Weka, including J48, Bayesian Network, Naïve Bayesian, Nearest Neighbor, and Instance-based Learning Classifier. Results The UMLS semantic feature representation outperforms the “bag of words” feature representation in 89% of the criteria categories. Using the semantically induced categories, machine-learning classifiers required only 2,000 instances to stabilize classification performance. The J48 classifier yielded the best F1-score and the Bayesian Network classifier achieved the best learning efficiency. Conclusion The UMLS is an effective knowledge source and can enable an efficient feature representation for semi-automated semantic category induction and automatic categorization for clinical research eligibility criteria and possibly other clinical text. PMID:21689783

  7. Clinical Cancer Registries - Are They Up for Health Services Research?

    PubMed

    Pobiruchin, Monika; Bochum, Sylvia; Martens, Uwe M; Schramm, Wendelin

    2016-01-01

    Clinical cancer registries are a valuable data source for health services research (HSR). HSR is in need of high quality routine care data for its evaluations. However, the secondary use of routine data - such as documented cancer cases in a disease registry - poses new challenges in terms of data quality, IT-management, documentation processes and data privacy. In the clinical cancer registry Heilbronn-Franken, real-world data from the Giessen Tumor Documentation System (GTDS) was utilized for analyses of patients' disease processes and guideline adherence in follow-up care. A process was developed to map disease state definitions to fields of the GTDS database and extract patients' disease progress information. Thus, the disease process of sub-cohorts could be compared to each other, e.g., comparison of disease free survival of HER2 (human epidermal growth factor receptor 2)-positive and -negative women who were treated with Trastuzumab, a targeted therapy applied in breast cancer. In principle, such comparisons are feasible and of great value for HSR as they depict a routine care setting of a diverse patient cohort. Yet, local documentation practice, missing flow of information from external health care providers or small sub-cohorts impede the analyses of clinical cancer registries data bases and usage for HSR. PMID:27577380

  8. Repeating tests: different roles in research studies and clinical medicine.

    PubMed

    Monach, Paul A

    2012-10-01

    Researchers often decide whether to average multiple results in order to produce more precise data, and clinicians often decide whether to repeat a laboratory test in order to confirm its validity or to follow a trend. Some of the major sources of variation in laboratory tests (analytical imprecision, within-subject biological variation and between-subject variation) and the effects of averaging multiple results from the same sample or from the same person over time are discussed quantitatively in this article. This analysis leads to the surprising conclusion that the strategy of averaging multiple results is only necessary and effective in a limited range of research studies. In clinical practice, it may be important to repeat a test in order to eliminate the possibility of a rare type of error that has nothing to do analytical imprecision or within-subject variation, and for this reason, paradoxically, it may be most important to repeat tests with the highest sensitivity and/or specificity (i.e., ones that are critical for clinical decision-making).

  9. [Transcranial direct current stimulation: new clinical roadmaps for psychiatric research].

    PubMed

    Heeren, Alexandre; Coussement, Charlotte; Colon, Élisabeth

    Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that has undergone intensive research over the past decade with promising results. tDCS is based on the application of weak, direct current over the scalp, leading to cortical hypo- or hyperpolarization according to the specified parameters. Recent studies have shown that tDCS is able to induce potent changes in cortical excitability as well as to elicit long-lasting modifications in brain activity. Over the last decade, tDCS physiological mechanisms of action have been intensively investigated. This research has given support for the investigation of tDCS applications in a wide range of clinical populations, including patients with post-stroke motor and language deficits, chronic pain, and tinnitus. Recently, its efficacy to treat psychiatric conditions has been explored increasingly. In this review, we will gather clinical studies involving tDCS to ameliorate psychiatric symptoms and discuss reasonable next steps in this direction. PMID:27615184

  10. Basics of case report form designing in clinical research

    PubMed Central

    Bellary, Shantala; Krishnankutty, Binny; Latha, M. S.

    2014-01-01

    Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process. PMID:25276625

  11. A Clinical Librarian-Nursing Partnership to Bridge Clinical Practice and Research in an Oncology Setting.

    PubMed

    Ginex, Pamela K; Hernandez, Marisol; Vrabel, Mark

    2016-09-01

    Nurses today work in practice settings where the expectation is to "draw upon the best evidence to provide the care most appropriate to each patient" (Olsen, Goolsby, & McGinnis, 2009, p. 10) while caring for patients with high acuity in highly specialized settings. Within the nursing profession, the Magnet Recognition Program® advocates for exemplary professional practice and the generation of new knowledge through research and clinical innovation. Nurses working in a clinical setting are often the best resource to identify important clinical questions and gaps in practice, but a lack of resources presents challenges to nurses in fully developing their questions and identifying the most appropriate methods to answer them. These challenges often fall into three broad categories: individual nurse characteristics, organizational characteristics, and environmental characteristics (Dobbins, Ciliska, Cockerill, Barnsley, & DiCenso, 2002). Creating a dedicated partnership between nurses and library staff is one method that can overcome these challenges to use existing resources and support nurses who are asking and answering important clinical questions (DePalma, 2005; Vrabel, 2005). 
. PMID:27541547

  12. Translation of clinical problems in osteoarthritis into pathophysiological research goals

    PubMed Central

    Berenbaum, Francis; Blanco, Francisco J; Cosimo, de Bari; Lafeber, Floris; Hauge, Ellen; Higginbottom, Adele; Ioan-Facsinay, Andreea; Loughlin, John; Meulenbelt, Ingrid; Moilanen, Eeva; Pitsillidou, Irene; Tsezou, Aspasia; van Meurs, Joyce; Vincent, Tonia; Wittoek, Ruth; Lories, Rik

    2016-01-01

    Osteoarthritis (OA) accounts for more disability among the elderly than any other disease and is associated with an increased mortality rate. The prevalence in Europe will rise in the future since this continent has a strongly ageing population and an obesity epidemic; obesity and age both being major risk factors for OA. No adequate therapeutic options, besides joint replacement, are available, although they are greatly needed and should be acquired by adequate research investments. However, the perspective on OA from a researcher's point of view is not always aligned with the perspective of a patient with OA. Researchers base their views on OA mainly on abnormalities in structure and function while patients consider OA as a collection of symptoms. In this viewpoint paper, we discuss the possibility of translating the most important clinical problems into pathophysiological research goals to facilitate the translation from bench to bedside and vice versa. This viewpoint is the outcome of a dialogue within the ‘European League Against Rheumatism study group on OA’ and People with Arthritis/Rheumatism across Europe (PARE) representatives. PMID:27252894

  13. A critique of statistical hypothesis testing in clinical research

    PubMed Central

    Raha, Somik

    2011-01-01

    Many have documented the difficulty of using the current paradigm of Randomized Controlled Trials (RCTs) to test and validate the effectiveness of alternative medical systems such as Ayurveda. This paper critiques the applicability of RCTs for all clinical knowledge-seeking endeavors, of which Ayurveda research is a part. This is done by examining statistical hypothesis testing, the underlying foundation of RCTs, from a practical and philosophical perspective. In the philosophical critique, the two main worldviews of probability are that of the Bayesian and the frequentist. The frequentist worldview is a special case of the Bayesian worldview requiring the unrealistic assumptions of knowing nothing about the universe and believing that all observations are unrelated to each other. Many have claimed that the first belief is necessary for science, and this claim is debunked by comparing variations in learning with different prior beliefs. Moving beyond the Bayesian and frequentist worldviews, the notion of hypothesis testing itself is challenged on the grounds that a hypothesis is an unclear distinction, and assigning a probability on an unclear distinction is an exercise that does not lead to clarity of action. This critique is of the theory itself and not any particular application of statistical hypothesis testing. A decision-making frame is proposed as a way of both addressing this critique and transcending ideological debates on probability. An example of a Bayesian decision-making approach is shown as an alternative to statistical hypothesis testing, utilizing data from a past clinical trial that studied the effect of Aspirin on heart attacks in a sample population of doctors. As a big reason for the prevalence of RCTs in academia is legislation requiring it, the ethics of legislating the use of statistical methods for clinical research is also examined. PMID:22022152

  14. A critique of statistical hypothesis testing in clinical research.

    PubMed

    Raha, Somik

    2011-07-01

    Many have documented the difficulty of using the current paradigm of Randomized Controlled Trials (RCTs) to test and validate the effectiveness of alternative medical systems such as Ayurveda. This paper critiques the applicability of RCTs for all clinical knowledge-seeking endeavors, of which Ayurveda research is a part. This is done by examining statistical hypothesis testing, the underlying foundation of RCTs, from a practical and philosophical perspective. In the philosophical critique, the two main worldviews of probability are that of the Bayesian and the frequentist. The frequentist worldview is a special case of the Bayesian worldview requiring the unrealistic assumptions of knowing nothing about the universe and believing that all observations are unrelated to each other. Many have claimed that the first belief is necessary for science, and this claim is debunked by comparing variations in learning with different prior beliefs. Moving beyond the Bayesian and frequentist worldviews, the notion of hypothesis testing itself is challenged on the grounds that a hypothesis is an unclear distinction, and assigning a probability on an unclear distinction is an exercise that does not lead to clarity of action. This critique is of the theory itself and not any particular application of statistical hypothesis testing. A decision-making frame is proposed as a way of both addressing this critique and transcending ideological debates on probability. An example of a Bayesian decision-making approach is shown as an alternative to statistical hypothesis testing, utilizing data from a past clinical trial that studied the effect of Aspirin on heart attacks in a sample population of doctors. As a big reason for the prevalence of RCTs in academia is legislation requiring it, the ethics of legislating the use of statistical methods for clinical research is also examined.

  15. [Guiding principles of clinical research on mild cognitive impairment (protocol)].

    PubMed

    Tian, Jin-Zhou; Shi, Jing; Zhang, Xin-Qing; Bi, Qi; Ma, Xin; Wang, Zhi-Liang; Li, Xiao-Bin; Sheng, Shu-Li; Li, Lin; Wu, Zhen-Yun; Fang, Li-Yan; Zhao, Xiao-Dong; Miao, Ying-Chun; Wang, Peng-Wen; Ren, Ying; Yin, Jun-Xiang; Wang, Yong-Yan

    2008-01-01

    Mild cognitive impairment (MCI), as a nosological entity referring to elderly people with MCI but without dementia, was proposed as a warning signal of dementia occurrence and a novel therapeutic target. MCI clinical criteria and diagnostic procedure from the MCI Working Group of the European Alzheimer's Disease Consortium (EADC) may better reflect the heterogeneity of MCI syndrome. Beijing United Study Group on MCI funded by the Capital Foundation of Medical Developments (CFMD) proposed the guiding principles of clinical research on MCI. The diagnostic methods include clinical, neuropsychological, functional, neuroimaging and genetic measures. The diagnostic procedure includes three stages. Firstly, MCI syndrome must be defined, which should correspond to: (1) cognitive complaints coming from the patients or their families; (2) reporting of a relative decline in cognitive functioning during the past year by the patient or informant; (3) cognitive disorders evidenced by clinical evaluation; (4) activities of daily living preserved and complex instrumental functions either intact or minimally impaired; and (5) absence of dementia. Secondly, subtypes of MCI have to be recognized as amnestic MCI (aMCI), single non-memory MCI (snmMCI) and multiple-domains MCI (mdMCI). Finally, the subtype causes could be identified commonly as Alzheimer disease (AD), vascular dementia (VaD), and other degenerative diseases such as frontal-temporal dementia (FTD), Lewy body disease (LBD), semantic dementia (SM), as well as trauma, infection, toxicity and nutrition deficiency. The recommended special tests include serum vitamin B12 and folic acid, plasma insulin, insulin-degrading enzyme, Abeta40, Abeta42, inflammatory factors. Computed tomography (or preferentially magnetic resonance imaging, when available) is mandatory. As measurable therapeutic outcomes, the primary outcome should be the probability of progression to dementia, the secondary outcomes should be cognition and function

  16. Digimarc Discover on Google Glass

    NASA Astrophysics Data System (ADS)

    Rogers, Eliot; Rodriguez, Tony; Lord, John; Alattar, Adnan

    2015-03-01

    This paper reports on the implementation of the Digimarc® Discover platform on Google Glass, enabling the reading of a watermark embedded in a printed material or audio. The embedded watermark typically contains a unique code that identifies the containing media or object and a synchronization signal that allows the watermark to be read robustly. The Digimarc Discover smartphone application can read the watermark from a small portion of printed image presented at any orientation or reasonable distance. Likewise, Discover can read the recently introduced Digimarc Barcode to identify and manage consumer packaged goods in the retail channel. The Digimarc Barcode has several advantages over the traditional barcode and is expected to save the retail industry millions of dollars when deployed at scale. Discover can also read an audio watermark from ambient audio captured using a microphone. The Digimarc Discover platform has been widely deployed on the iPad, iPhone and many Android-based devices, but it has not yet been implemented on a head-worn wearable device, such as Google Glass. Implementing Discover on Google Glass is a challenging task due to the current hardware and software limitations of the device. This paper identifies the challenges encountered in porting Discover to the Google Glass and reports on the solutions created to deliver a prototype implementation.

  17. Discovering Teenage Galaxies

    NASA Astrophysics Data System (ADS)

    2007-11-01

    Staring for the equivalent of every night for two weeks at the same little patch of sky with ESO's Very Large Telescope, an international team of astronomers has found the extremely faint light from teenage galaxies billions of light years away. These galaxies, which the research team believes are the building blocks of normal galaxies like our Milky Way, had eluded detection for three decades, despite intensive searches. ESO PR Photo 52/07 ESO PR Photo 52/07 A 92-hour long spectrum Two-dimensional spectrum obtained in 92 hours of exposure time, showing the line emitter candidates. The quasar absorption lines are visible close to the centre of the image. The team, led by Martin Haehnelt of the University of Cambridge, UK, Michael Rauch and George Becker of the Observatories of the Carnegie Institution, USA, and Andy Bunker of the Anglo-Australian Observatory, reports their results in the 1 March 2008 issue of the Astrophysical Journal. "This is the first time that the sky has been searched to this depth and the unrivalled sensitivity of the picture taken with the VLT was key to succeeding," says Haehnelt. Experts have long speculated that galaxies like ours were created by the amalgamation of proto-galaxies early in the history of the Universe, but the light from these fragments was so faint that astronomers had struggled to prove they were there at all. Astronomers thought that the teenage galaxies must be out there because they were blocking part of the light from objects even further away in space. "Previous attempts have usually been frustrated by the difficulty of detecting extremely faint objects: the amount of time required even with an 8-metre class telescope like the VLT considerably exceeds typical observing time awards. We have thus exploited the periods of less good weather with the FORS2 spectrograph at the VLT, taking advantage of the service observing mode," says Becker. In service mode, ESO staff astronomers at Paranal are responsible for carrying

  18. Clinical Pharmacokinetic Service and Research--Present Status and Future Goals at SUNY-Buffalo

    ERIC Educational Resources Information Center

    Koup, Jeffrey R.

    1976-01-01

    Two Clinical Pharmacokinetics Laboratories at Buffalo are described: one at the Millard Fillmore Hospital and the other at the Buffalo Children's Hospital. Their research efforts are reviewed and their scientific contributions to clinical therapeutics and pharmaceutical research are noted. (LBH)

  19. Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

    PubMed

    Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D

    2016-02-01

    There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. PMID:26856217

  20. ClinicalCodes: an online clinical codes repository to improve the validity and reproducibility of research using electronic medical records.

    PubMed

    Springate, David A; Kontopantelis, Evangelos; Ashcroft, Darren M; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

    2014-01-01

    Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects. PMID:24941260

  1. Implementing a pragmatic framework for authentic patient-researcher partnerships in clinical research.

    PubMed

    Fagan, Maureen B; Morrison, Constance Rc; Wong, Celene; Carnie, Martha B; Gabbai-Saldate, Paulette

    2016-05-01

    In response to the creation of the Patient-Centered Outcomes Research Institute in 2010, researchers have begun to incorporate patient and family stakeholders into the research process as equal partners, bringing their unique perspectives and experiences to the table. Nonetheless, there is a dearth of literature around how best to engage patients and families and many barriers to doing so effectively. This paper outlines a pragmatic framework of collaborative engagement and partnership between research investigators and patient and family advisors from existing patient and family advisory councils (PFACs) at an academic medical center. This framework includes the role for each party throughout the clinical research process (launch, hypothesis, specific aims, measures/methods, results, interpretations/recommendation and dissemination).

  2. Protecting clinical data in PACS, teleradiology systems, and research environments

    NASA Astrophysics Data System (ADS)

    Meissner, Marion C.; Collmann, Jeff R.; Tohme, Walid G.; Mun, Seong K.

    1997-05-01

    As clinical data is more widely stored in electronic patient record management systems and transmitted over the Internet and telephone lines, it becomes more accessible and therefore more useful, but also more vulnerable. Computer systems such as PACS, telemedicine applications, and medical research networks must protect against accidental or deliberate modification, disclosure, and violation of patient confidentiality in order to be viable. Conventional wisdom in the medical field and among lawmakers legislating the use of electronic medical records suggests that, although it may improve access to information, an electronic medical record cannot be as secure as a traditional paper record. This is not the case. Information security is a well-developed field in the computer and communications industry. If medical information systems, such as PACS, telemedicine applications, and research networks, properly apply information security techniques, they can ensure the accuracy and confidentiality of their patient information and even improve the security of their data over a traditional paper record. This paper will elaborate on some of these techniques and discuss how they can be applied to medical information systems. The following systems will be used as examples for the analysis: a research laboratory at Georgetown University Medical Center, the Deployable Radiology system installed to support the US Army's peace- keeping operation in Bosnia, a kidney dialysis telemedicine system in Washington, D.C., and various experiences with implementing and integrating PACS.

  3. Strategies to improve clinical research in surgery through international collaboration.

    PubMed

    Søreide, Kjetil; Alderson, Derek; Bergenfelz, Anders; Beynon, John; Connor, Saxon; Deckelbaum, Dan L; Dejong, Cornelis H; Earnshaw, Jonathan J; Kyamanywa, Patrick; Perez, Rodrigo O; Sakai, Yoshiharu; Winter, Desmond C

    2013-09-28

    More than 235 million patients undergo surgery every year worldwide, but less than 1% are enrolled in surgical clinical trials--few of which are international collaborations. Several levels of action are needed to improve this situation. International research collaborations in surgery between developed and developing countries could encourage capacity building and quality improvement, and mutually enhance care for patients with surgical disorders. Low-income and middle-income countries increasingly report much the same range of surgical diseases as do high-income countries (eg, cancer, cardiovascular disease, and the surgical sequelae of metabolic syndrome); collaboration is therefore of mutual interest. Large multinational trials that cross cultures and levels of socioeconomic development might have faster results and wider applicability than do single-country trials. Surgeons educated in research methods, and aided by research networks and trial centres, are needed to foster these international collaborations. Barriers to collaboration could be overcome by adoption of global strategies for regulation, health insurance, ethical approval, and indemnity coverage for doctors.

  4. 78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... the Director of the Clinical Science Research and Development Service on the relevance and...

  5. 77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...

  6. Recruiting Post-Doctoral Fellows into Global Health Research: Selecting NIH Fogarty International Clinical Research Fellows

    PubMed Central

    Heimburger, Douglas C.; Warner, Tokesha L.; Carothers, Catherine Lem; Blevins, Meridith; Thomas, Yolanda; Gardner, Pierce; Primack, Aron; Vermund, Sten H.

    2014-01-01

    From 2008 to 2012, the National Institutes of Health (NIH) Fogarty International Clinical Research Fellows Program (FICRF) provided 1-year mentored research training at low- and middle-income country sites for American and international post-doctoral health professionals. We examined the FICRF applicant pool, proposed research topics, selection process, and characteristics of enrollees to assess trends in global health research interest and factors associated with applicant competitiveness. The majority (58%) of 67 US and 57 international Fellows were women, and 83% of Fellows had medical degrees. Most applicants were in clinical fellowships (41%) or residencies (24%). More applicants proposing infectious disease projects were supported (59%) than applicants proposing non-communicable disease (NCD) projects (41%), although projects that combined both topic areas were most successful (69%). The numbers of applicants proposing research on NCDs and the numbers of these applicants awarded fellowships rose dramatically over time. Funding provided to the FICRF varied significantly among NIH Institutes and Centers and was strongly associated with the research topics awarded. PMID:24865678

  7. Recruiting post-doctoral fellows into global health research: selecting NIH Fogarty International Clinical Research Fellows.

    PubMed

    Heimburger, Douglas C; Warner, Tokesha L; Carothers, Catherine Lem; Blevins, Meridith; Thomas, Yolanda; Gardner, Pierce; Primack, Aron; Vermund, Sten H

    2014-08-01

    From 2008 to 2012, the National Institutes of Health (NIH) Fogarty International Clinical Research Fellows Program (FICRF) provided 1-year mentored research training at low- and middle-income country sites for American and international post-doctoral health professionals. We examined the FICRF applicant pool, proposed research topics, selection process, and characteristics of enrollees to assess trends in global health research interest and factors associated with applicant competitiveness. The majority (58%) of 67 US and 57 international Fellows were women, and 83% of Fellows had medical degrees. Most applicants were in clinical fellowships (41%) or residencies (24%). More applicants proposing infectious disease projects were supported (59%) than applicants proposing non-communicable disease (NCD) projects (41%), although projects that combined both topic areas were most successful (69%). The numbers of applicants proposing research on NCDs and the numbers of these applicants awarded fellowships rose dramatically over time. Funding provided to the FICRF varied significantly among NIH Institutes and Centers and was strongly associated with the research topics awarded.

  8. [Clinical research XX. From clinical judgment to multiple logistic regression model].

    PubMed

    Berea-Baltierra, Ricardo; Rivas-Ruiz, Rodolfo; Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Moreno, Jorge; Talavera, Juan O

    2014-01-01

    The complexity of the causality phenomenon in clinical practice implies that the result of a maneuver is not solely caused by the maneuver, but by the interaction among the maneuver and other baseline factors or variables occurring during the maneuver. This requires methodological designs that allow the evaluation of these variables. When the outcome is a binary variable, we use the multiple logistic regression model (MLRM). This multivariate model is useful when we want to predict or explain, adjusting due to the effect of several risk factors, the effect of a maneuver or exposition over the outcome. In order to perform an MLRM, the outcome or dependent variable must be a binary variable and both categories must mutually exclude each other (i.e. live/death, healthy/ill); on the other hand, independent variables or risk factors may be either qualitative or quantitative. The effect measure obtained from this model is the odds ratio (OR) with 95 % confidence intervals (CI), from which we can estimate the proportion of the outcome's variability explained through the risk factors. For these reasons, the MLRM is used in clinical research, since one of the main objectives in clinical practice comprises the ability to predict or explain an event where different risk or prognostic factors are taken into account.

  9. Molecular Subgrouping of Medulloblastoma: Impact Upon Research and Clinical Practice.

    PubMed

    Gupta, Tejpal; Shirsat, Neelam; Jalali, Rakesh

    2015-01-01

    Medulloblastoma, the most common primary pediatric malignant brain tumor is a molecularly heterogeneous disease with different developmental origins, distinct phenotypes, diverse biological behaviour, and contrasting clinical outcomes. The current clinico-radiological risk-classification fails to take account of this heterogeneity and existent prognostic variability. It is widely accepted that dysregulation of normal developmental processes constitute a key mechanism of tumorigenesis in at least a subset of medulloblastomas. Several attempts at biological classification have successfully identified distinct subgroups with subgroup-specific gene signatures, demographics, histologic subtypes, and rates of metastases. Several research groups have classified medulloblastoma into molecular subgroups using a variety of different genomic approaches and platforms such as gene expression profiling, microRNA profiling and methylation arrays. Recently, a consensus has emerged that classifies medulloblastoma into four distinct molecular subgroups named as wingless (WNT), sonic hedgehog (SHH), Group 3 and Group 4 respectively. However, such integrative approaches have limited applicability in the clinic due to the need of fresh-frozen tissues and elaborate molecular biology tools. In parallel, some groups have proposed and validated traditional antibody-based approaches using immunohistochemistry on archival specimen for rapid and reliable molecular subgrouping to be applied in any basic neuropathology laboratory. Heterogeneity within each of these four consensus subgroups has also been demonstrated that needs to be considered in the design of future clinical trials. There is a compelling need to integrate molecular biomarkers with clinico-pathologic outcome indicators to refine risk-stratification as well as develop novel molecularly targeted agents for optimizing therapeutic index and personalizing therapy.

  10. Weaning from mechanical ventilation: the evidence from clinical research.

    PubMed

    Meade, M O; Guyatt, G H; Cook, D J

    2001-12-01

    Mechanical ventilation incurs substantial morbidity, mortality, and costs. Both premature extubation and delayed extubation can cause harm. Therefore, weaning that is both expeditious and safe is highly desirable. The purpose of this review is to summarize the literature related to weaning modes, spontaneous breathing trials, weaning predictors, weaning with noninvasive positive pressure ventilation, and weaning protocols. We used 5 computerized databases and a duplicate independent review process to select articles for this review. We included randomized clinical trials evaluating any weaning interventions and nonrandomized trials of weaning predictors, with a focus on studies reporting clinically important outcomes. We abstracted quantitative data using several metrics and pooled results across studies only when our assessment of the patients, interventions, and outcomes indicated that pooling was legitimate. The available clinical research evidence suggests that, for progressive weaning of the level of mechanical support, it may be best to choose modes other than synchronized intermittent mandatory ventilation and it is unreasonable to be dogmatic about the use of other modes. There may also be substantial benefits to early extubation with back-up institution of noninvasive positive pressure ventilation, as needed, though this remains an experimental approach. For trials of spontaneous breathing, low levels of pressure support may hasten extubation. We did not uncover any consistently powerful weaning predictors, suggesting that formal use of predictors in patients being considered for reduction or discontinuation of mechanical support is unlikely to improve patient care. The likely explanation is that clinicians already fully consider information from weaning predictors in choosing patients for trials of reduction or discontinuation of mechanical ventilation. Finally, implementation of respiratory therapist- or nurse-driven protocols may be useful for all

  11. Hepcidin modulation in human diseases: From research to clinic

    PubMed Central

    Piperno, Alberto; Mariani, Raffaella; Trombini, Paola; Girelli, Domenico

    2009-01-01

    By modulating hepcidin production, an organism controls intestinal iron absorption, iron uptake and mobilization from stores to meet body iron need. In recent years there has been important advancement in our knowledge of hepcidin regulation that also has implications for understanding the physiopathology of some human disorders. Since the discovery of hepcidin and the demonstration of its pivotal role in iron homeostasis, there has been a substantial interest in developing a reliable assay of the hormone in biological fluids. Measurement of hepcidin in biological fluids can improve our understanding of iron diseases and be a useful tool for diagnosis and clinical management of these disorders. We reviewed the literature and our own research on hepcidin to give an updated status of the situation in this rapidly evolving field. PMID:19195055

  12. [Diagnosing Alzheimer's disease: from research to clinical practice and ethics].

    PubMed

    Tarquini, Daniela; Pucci, Eugenio; Gasparini, Maddalena; Zullo, Silvia; Tiraboschi, Pietro; Bonito, Virginio; Defanti, Carlo Alberto

    2014-01-01

    In 2011, the so-called Dubois criteria introduced the use of biomarkers in research (in particular, brain amyloid positron emission tomography imaging and the cerebrospinal fluid levels of tau/fosfo-tau and beta-amyloid 1-42) for the early or preclinical diagnosis of Alzheimer's disease. Even so, we are looking at an increased use of these markers in clinical practice. In the 1960s, Alzheimer's disease was considered a rare form of presenile dementia, but gradually it has been recognized as the prevalent form of old-age dementia. As a consequence, what was once regarded as an inevitable outcome of old age is now recognized as a true disease. Several factors contributed to this paradigm shift, in particular a longer lifespan, new techniques of in vivo study of the central nervous system, and the pressure exerted by the pharmaceutical industry and patient groups. The current lack of disease-modifying therapies and the high incidence of mild cognitive impairment, which is a risk factor for dementia, raise a series of clinical ethical problems ranging from how diagnosis is communicated to how resources are used. This article offers a conceptual scheme through which these issues can be addressed.

  13. The biology of infertility: research advances and clinical challenges

    PubMed Central

    Matzuk, Martin M; Lamb, Dolores J

    2013-01-01

    Reproduction is required for the survival of all mammalian species, and thousands of essential ‘sex’ genes are conserved through evolution. Basic research helps to define these genes and the mechanisms responsible for the development, function and regulation of the male and female reproductive systems. However, many infertile couples continue to be labeled with the diagnosis of idiopathic infertility or given descriptive diagnoses that do not provide a cause for their defect. For other individuals with a known etiology, effective cures are lacking, although their infertility is often bypassed with assisted reproductive technologies (ART), some accompanied by safety or ethical concerns. Certainly, progress in the field of reproduction has been realized in the twenty-first century with advances in the understanding of the regulation of fertility, with the production of over 400 mutant mouse models with a reproductive phenotype and with the promise of regenerative gonadal stem cells. Indeed, the past six years have witnessed a virtual explosion in the identification of gene mutations or polymorphisms that cause or are linked to human infertility. Translation of these findings to the clinic remains slow, however, as do new methods to diagnose and treat infertile couples. Additionally, new approaches to contraception remain elusive. Nevertheless, the basic and clinical advances in the understanding of the molecular controls of reproduction are impressive and will ultimately improve patient care. PMID:18989307

  14. Major clinical research advances in gynecologic cancer in 2012.

    PubMed

    Suh, Dong Hoon; Kim, Jae-Weon; Kim, Kidong; Kim, Hak Jae; Lee, Kyung-Hun

    2013-01-01

    Ten topics were chosen among major clinical research achievements in gynecologic oncology in 2012. For ovarian cancer, comprehensive review of the history of bevacizumab studies was followed by poly adenosine diphosphate [ADP]-ribose polymerase (PARP) inhibitors and other molecular targeted agents such as epidermal growth factor receptor tyrosine kinase inhibitor and AMG 386. For the development of genomic study in gynecologic cancers, BRCA and DICER1 mutations were covered in epithelial and nonepithelial ovarian cancer, respectively. For endometrial cancer, targeted agents including mammalian target of rapamycin (mTOR) inhibitors and bevacizumab were discussed. Radiation therapy "sandwiched" between combination chemotherapy schedules for the treatment of uterine papillary serous carcinoma was also reviewed. Preoperative prediction of lymph node metastasis, definition of low-risk group, and recurrence and survival outcomes of laparoscopic approaches were addressed. For cervical cancer, we reviewed long-term benefit of human papillomavirus test and efficacy of paclitaxel/carboplatin versus paclitaxel/cisplatin in stage IVB, persistent or recurrent disease. In addition, the effect of three dimensional image-based high-dose rate brachytherapy was also reviewed. For vulvar cancer, the diagnostic value of sentinel lymph node biopsy was discussed. For breast cancer, positive results of three outstanding phase III randomized clinical trials, CLEOPATRA, EMILIA, and BOLERO-2 were introduced. Lastly, updates of major practice guidelines were summarized.

  15. Major clinical research advances in gynecologic cancer in 2014.

    PubMed

    Suh, Dong Hoon; Lee, Kyung Hun; Kim, Kidong; Kang, Sokbom; Kim, Jae Weon

    2015-04-01

    In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of cervical cancer in women aged 25 and older, based on the results of the ATHENA trial, which suggested that the HPV test was a more sensitive and efficient strategy for cervical cancer screening than methods based solely on cytology. For corpus cancers, results of a phase III Gynecologic Oncology Group (GOG) 249 study of early-stage endometrial cancer with high-intermediate risk factors are followed by the controversial topic of uterine power morcellation in minimally invasive gynecologic surgery. Promising results of phase II studies regarding the effectiveness of olaparib in various ovarian cancer settings are summarized. After a brief review of results from a phase III study on pazopanib maintenance therapy in advanced ovarian cancer, 2 outstanding 2014 ASCO presentations cover the topic of using molecular subtypes in predicting response to bevacizumab. A review of the use of opportunistic bilateral salpingectomy as an ovarian cancer preventive strategy in the general population is presented. Two remarkable studies that discussed the effectiveness of adjuvant ovarian suppression in premenopausal early breast cancer have been selected as the last topics covered in this review.

  16. Deep sequencing of HIV: clinical and research applications.

    PubMed

    Chabria, Shiven B; Gupta, Shaili; Kozal, Michael J

    2014-01-01

    Human immunodeficiency virus (HIV) exhibits remarkable diversity in its genomic makeup and exists in any given individual as a complex distribution of closely related but nonidentical genomes called a viral quasispecies, which is subject to genetic variation, competition, and selection. This viral diversity clinically manifests as a selection of mutant variants based on viral fitness in treatment-naive individuals and based on drug-selective pressure in those on antiretroviral therapy (ART). The current standard-of-care ART consists of a combination of antiretroviral agents, which ensures maximal viral suppression while preventing the emergence of drug-resistant HIV variants. Unfortunately, transmission of drug-resistant HIV does occur, affecting 5% to >20% of newly infected individuals. To optimize therapy, clinicians rely on viral genotypic information obtained from conventional population sequencing-based assays, which cannot reliably detect viral variants that constitute <20% of the circulating viral quasispecies. These low-frequency variants can be detected by highly sensitive genotyping methods collectively grouped under the moniker of deep sequencing. Low-frequency variants have been correlated to treatment failures and HIV transmission, and detection of these variants is helping to inform strategies for vaccine development. Here, we discuss the molecular virology of HIV, viral heterogeneity, drug-resistance mutations, and the application of deep sequencing technologies in research and the clinical care of HIV-infected individuals. PMID:24821496

  17. Revisioning Clinical Psychology: Integrating Cultural Psychology into Clinical Research and Practice with Portuguese Immigrants

    PubMed Central

    James, Susan; Harris, Sara; Foster, Gary; Clarke, Juanne; Gadermann, Anne; Morrison, Marie; Bezanson, Birdie Jane

    2013-01-01

    This article outlines a model for conducting psychotherapy with people of diverse cultural backgrounds. The theoretical foundation for the model is based on clinical and cultural psychology. Cultural psychology integrates psychology and anthropology in order to provide a complex understanding of both culture and the individual within his or her cultural context. The model proposed in this article is also based on our clinical experience and mixed-method research with the Portuguese community. The model demonstrates its value with ethnic minority clients by situating the clients within the context of their multi-layered social reality. The individual, familial, socio-cultural, and religio-moral domains are explored in two research projects, revealing the interrelation of these levels/contexts. The article is structured according to these domains. Study 1 is a quantitative study that validates the Agonias Questionnaire in Ontario. The results of this study are used to illustrate the individual domain of our proposed model. Study 2 is an ethnography conducted in the Azorean Islands, and the results of this study are integrated to illustrate the other three levels of the model, namely family, socio-cultural, and the religio-moral levels. PMID:23720642

  18. Highlights of the 2012 Research Workshop: Using nutrigenomics and metabolomics in clinical nutrition research.

    PubMed

    Zeisel, Steven H; Waterland, Robert A; Ordovás, José M; Muoio, Deborah M; Jia, Wei; Fodor, Anthony

    2013-03-01

    The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Research Workshop, "Using Nutrigenomics and Metabolomics in Clinical Nutrition Research," was held on January 21, 2012, in Orlando, Florida. The conference brought together experts in human nutrition who use nutrigenomic and metabolomic methods to better understand metabolic individuality and nutrition effects on health. We are beginning to understand how genetic variation and epigenetic events alter requirements for and responses to foods in our diet (the field of nutrigenetics/nutrigenomics and epigenetics). At the same time, methods for profiling almost all of the products of metabolism in plasma, urine, and tissues (metabolomics) are being refined. The relationships between diet and nutrigenomic-metabolomic profiles, as well as between these profiles and health, are being elucidated, and this will dramatically alter clinical practice in nutrition.

  19. [Advances in cancer research. Cancer research and clinical oncology in the 21st century].

    PubMed

    Kanamaru, R

    1999-06-01

    It is my great pleasure to congradulate the Japanese Journal of Cancer and Chemotherapy on its 25 th anniversary. During this period, great progress has been made in cancer research, mainly owing to the advances in technology in molecular biology. Recently, not only researchers, but lay people as well have come to understand that cancer is mainly a genetic disease. Advances in the human genome project, DNA chip technology and gene technology; including gene targeting and cloning techniques, will enable us to accelerate progress forward the final goal of cancer research in the coming century. Major changes are coming in both cancer research and clinical oncology, which will completely transform the human social environment.

  20. Research Priorities, Measures, and Recommendations for Assessment of Tobacco Use in Clinical Cancer Research.

    PubMed

    Land, Stephanie R; Toll, Benjamin A; Moinpour, Carol M; Mitchell, Sandra A; Ostroff, Jamie S; Hatsukami, Dorothy K; Duffy, Sonia A; Gritz, Ellen R; Rigotti, Nancy A; Brandon, Thomas H; Prindiville, Sheila A; Sarna, Linda P; Schnoll, Robert A; Herbst, Roy S; Cinciripini, Paul M; Leischow, Scott J; Dresler, Carolyn M; Fiore, Michael C; Warren, Graham W

    2016-04-15

    There is strong evidence that cigarette smoking causes adverse outcomes in people with cancer. However, more research is needed regarding those effects and the effects of alternative tobacco products and of secondhand smoke, the effects of cessation (before diagnosis, during treatment, or during survivorship), the biologic mechanisms, and optimal strategies for tobacco dependence treatment in oncology. Fundamentally, tobacco is an important source of variation in clinical treatment trials. Nevertheless, tobacco use assessment has not been uniform in clinical trials. Progress has been impeded by a lack of consensus regarding tobacco use assessment suitable for cancer patients. The NCI-AACR Cancer Patient Tobacco Use Assessment Task Force identified priority research areas and developed recommendations for assessment items and timing of assessment in cancer research. A cognitive interview study was conducted with 30 cancer patients at the NIH Clinical Center to evaluate and improve the measurement items. The resulting Cancer Patient Tobacco Use Questionnaire (C-TUQ) includes "Core" items for minimal assessment of tobacco use at initial and follow-up time points, and an "Extension" set. Domains include the following: cigarette and other tobacco use status, intensity, and past use; use relative to cancer diagnosis and treatment; cessation approaches and history; and secondhand smoke exposure. The Task Force recommends that assessment occur at study entry and, at a minimum, at the end of protocol therapy in clinical trials. Broad adoption of the recommended measures and timing protocol, and pursuit of the recommended research priorities, will help us to achieve a clearer understanding of the significance of tobacco use and cessation for cancer patients. PMID:26888828

  1. After the clinic? Researching sexual health technology in context.

    PubMed

    Davis, Mark

    2015-01-01

    There is great interest in what testing, pharmaceutical, information and social media technology can do for sexual health. Much programmatic and research activity is focused on assessing how these technologies can be used to best effect. Less obvious are analyses that place technology into historical, political and real-world settings. Developing an 'in-context' analysis of sexual health technology, this paper draws on interviews with leading community advocates, researchers and clinicians in Australia, Canada and the UK and looks across examples, including social media, rapid HIV testing, pre-Exposure Prophylaxis for HIV and polymerase chain reaction Chlamydia testing. The analysis is framed by studies of techno-society and the dialectics of sex-affirmative advocacy with biomedical authority and attends to: the rationalistic and affective dimensions of the imaginary associated with technology; the role of technology in the re-spatialisation and re-temporalisation of the sexual health clinic; and the re-invention of technology in its real-world contexts. This in-context approach is important for: the effective implementation of new technology; strengthening the social science contribution to the field; and enriching social theory in general on life in techno-societies. PMID:24955722

  2. After the clinic? Researching sexual health technology in context.

    PubMed

    Davis, Mark

    2015-01-01

    There is great interest in what testing, pharmaceutical, information and social media technology can do for sexual health. Much programmatic and research activity is focused on assessing how these technologies can be used to best effect. Less obvious are analyses that place technology into historical, political and real-world settings. Developing an 'in-context' analysis of sexual health technology, this paper draws on interviews with leading community advocates, researchers and clinicians in Australia, Canada and the UK and looks across examples, including social media, rapid HIV testing, pre-Exposure Prophylaxis for HIV and polymerase chain reaction Chlamydia testing. The analysis is framed by studies of techno-society and the dialectics of sex-affirmative advocacy with biomedical authority and attends to: the rationalistic and affective dimensions of the imaginary associated with technology; the role of technology in the re-spatialisation and re-temporalisation of the sexual health clinic; and the re-invention of technology in its real-world contexts. This in-context approach is important for: the effective implementation of new technology; strengthening the social science contribution to the field; and enriching social theory in general on life in techno-societies.

  3. Model for a university-based clinical research development infrastructure.

    PubMed

    Havermahl, Tamara; LaPensee, Elizabeth; Williams, David; Clauw, Daniel; Parker, Robert A; Downey, Brad; Liu, Jing; Myles, James

    2015-01-01

    The Research Development Core (RDC) is housed within the Michigan Institute for Clinical & Health Research (MICHR) at the University of Michigan (U-M). Established in 2006, RDC provides no-cost, in-person consultations to help U-M investigators strengthen their grant proposals. RDC offers investigators feedback and critique on all aspects of their study design, plus partnerships, funding mechanisms, and future directions. This article describes RDC's model and provides data describing the success of its services.RDC is composed of a multidisciplinary team of professionals in grant development. It comprises two senior faculty codirectors from the U-M Medical School, two senior biostatisticians, outside faculty content experts, and RDC administrative staff. Investigators contact RDC to request a consultation and submit advance grant materials for review by the RDC team. During the consultation, investigators explain their project and identify challenges. The RDC team and additional experts offer feedback that is captured in meeting notes and provided to investigators. RDC commitments beyond the meetings are implemented and carefully tracked. Investigators may also request grant editing, budgeting, or proposal submission assistance. Investigators using RDC have been awarded $44.5 million since 2011.The demand for RDC consultations doubled from 2010 to 2011 and reached a high of 131 consultations in 2012. Investigator feedback has been positive: 80% reported that RDC had a strong impact on their proposal, and over 90% indicated that they would recommend RDC to colleagues. MICHR is committed to providing investigators with RDC services to better ensure strong grant applications and successful research careers. PMID:25340362

  4. Model for a University-Based Clinical Research Development Infrastructure

    PubMed Central

    Havermahl, Tamara; LaPensee, Elizabeth; Williams, David; Clauw, Daniel; Parker, Robert A.; Downey, Brad; Liu, Jing; Myles, James

    2014-01-01

    The Research Development Core (RDC) is housed within the Michigan Institute for Clinical & Health Research (MICHR) at the University of Michigan (U-M). Established in 2006, RDC provides no-cost, in-person consultations to help U-M investigators strengthen their grant proposals. RDC offers investigators feedback and critique on all aspects of their study design, plus partnerships, funding mechanisms and future directions. This article describes RDC’s model and provides data describing the success of its services. The RDC is composed of a multidisciplinary team of professionals in grant development. It is comprised of two senior faculty co-directors from the U-M Medical School, two senior biostatisticians, outside faculty content experts, and RDC administrative staff. Investigators contact RDC to request a consultation and submit advance grant materials for review by the RDC team. During the consultation, investigators explain their project and identify challenges. The RDC team and additional experts offer feedback that is captured in meeting notes and provided to investigators. RDC commitments beyond the meetings are implemented and carefully tracked. Investigators may also request grant editing, budgeting, or proposal submission assistance. Investigators utilizing RDC have been awarded $44.5 million since 2011. The demand for RDC consultations doubled from 2010 to 2011, and reached a high of 131 consultations in 2012. Investigator feedback has been positive: 80% reported RDC had a strong impact on their proposal, and over 90% indicated they would recommend RDC to colleagues. MICHR is committed to providing investigators with RDC services to better ensure strong grant applications and successful research careers. PMID:25340362

  5. Research priorities in bronchiectasis: a consensus statement from the EMBARC Clinical Research Collaboration.

    PubMed

    Aliberti, Stefano; Masefield, Sarah; Polverino, Eva; De Soyza, Anthony; Loebinger, Michael R; Menendez, Rosario; Ringshausen, Felix C; Vendrell, Montserrat; Powell, Pippa; Chalmers, James D

    2016-09-01

    Bronchiectasis is a disease of renewed interest in light of an increase in prevalence and increasing burden on international healthcare systems. There are no licensed therapies, and large gaps in knowledge in terms of epidemiology, pathophysiology and therapy. The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration, funded by ERS to promote high-quality research in bronchiectasis. The objective of this consensus statement was to define research priorities in bronchiectasis. From 2014 to 2015, EMBARC used a modified Delphi process among European bronchiectasis experts to reach a consensus on 55 key research priorities in this field. During the same period, the European Lung Foundation collected 711 questionnaires from adult patients with bronchiectasis and their carers from 22 European countries reporting important research priorities from their perspective. This consensus statement reports recommendations for bronchiectasis research after integrating both physicians and patients priorities, as well as those uniquely identified by the two groups. Priorities identified in this consensus statement provide the clearest possible roadmap towards improving our understanding of the disease and the quality of care for patients with bronchiectasis. PMID:27288031

  6. Researchers discover genetic link to mesothelioma

    Cancer.gov

    Scientists have found that individuals who carry a mutation in a gene called BAP1 are susceptible to developing two forms of cancer – mesothelioma, and melanoma of the eye. Additionally, when these individuals are exposed to asbestos or similar mineral f

  7. Major clinical research advances in gynecologic cancer in 2014.

    PubMed

    Suh, Dong Hoon; Lee, Kyung Hun; Kim, Kidong; Kang, Sokbom; Kim, Jae Weon

    2015-04-01

    In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of cervical cancer in women aged 25 and older, based on the results of the ATHENA trial, which suggested that the HPV test was a more sensitive and efficient strategy for cervical cancer screening than methods based solely on cytology. For corpus cancers, results of a phase III Gynecologic Oncology Group (GOG) 249 study of early-stage endometrial cancer with high-intermediate risk factors are followed by the controversial topic of uterine power morcellation in minimally invasive gynecologic surgery. Promising results of phase II studies regarding the effectiveness of olaparib in various ovarian cancer settings are summarized. After a brief review of results from a phase III study on pazopanib maintenance therapy in advanced ovarian cancer, 2 outstanding 2014 ASCO presentations cover the topic of using molecular subtypes in predicting response to bevacizumab. A review of the use of opportunistic bilateral salpingectomy as an ovarian cancer preventive strategy in the general population is presented. Two remarkable studies that discussed the effectiveness of adjuvant ovarian suppression in premenopausal early breast cancer have been selected as the last topics covered in this review. PMID:25872896

  8. Clinical-histological associations in gastroparesis: Results from the Gastroparesis Clinical Research Consortium

    PubMed Central

    2012-01-01

    Background Cellular changes associated with diabetic (DG) and idiopathic gastroparesis (IG) have recently been described from patients enrolled in the Gastroparesis Clinical Research Consortium. The association of these cellular changes with gastroparesis symptoms and gastric emptying is unknown. Aim Relate cellular changes to symptoms and gastric emptying in patients with gastroparesis. Methods Earlier, using full thickness gastric body biopsies from 20 DG, 20 IG and 20 matched controls, we found decreased interstitial cells of Cajal (ICC) and enteric nerves and an increase in immune cells in both DG and IG. Here, demographic, symptoms (gastroparesis cardinal symptom index score), and gastric emptying were related to cellular alterations using Pearson’s correlation coefficients. Results ICC counts inversely correlated with 4 hours gastric retention in DG but not in IG (r=−0.6, p=0.008, DG, r=0.2, p=0.4, IG). There was also a significant correlation between loss of ICC and enteric nerves in DG but not in IG (r=0.5, p=0.03 for DG, r=0.3, p=0.16, IG). IG with a myenteric immune infiltrate scored higher on the average GCSI (3.6±0.7 vs 2.7±0.9, p=0.05) and nausea score (3.8±0.9 vs 2.6±1.0, p=0.02) as compared to those without an infiltrate. Conclusions In DG, loss of ICC is associated with delayed gastric emptying. ICC or enteric nerve loss did not correlate with symptom severity. Overall clinical severity and nausea in IG is associated with a myenteric immune infiltrate. Thus, full thickness gastric biopsies can help define specific cellular abnormalities in gastroparesis, some of which are associated with physiological and clinical characteristics of gastroparesis. PMID:22339929

  9. Attachment and family therapy: clinical utility of adolescent-family attachment research.

    PubMed

    Liddle, Howard A; Schwartz, Seth J

    2002-01-01

    The divide separating research and clinical work is narrowing. New therapies have been informed by research from specialties such as developmental psychology and developmental psychopathology. In this article, we attempt to illustrate the usefulness of research on attachment relations for family-based therapy with adolescents. We examine the clinical utility of adolescent attachment research within the context of multidimensional family therapy, an empirically supported treatment model that has incorporated developmental research, including basic research on attachment, in its assessment and intervention framework.

  10. Using Software to Elicit User Needs for Clinical Research Visit Scheduling

    PubMed Central

    Weng, Chunhua; Boland, Mary Regina; So, Yat; Rusanov, Alexander; Lopez, Carlos; Steinman, Richard; Busacca, Linda; Bakken, Suzanne; Bigger, J Thomas

    2014-01-01

    User needs understanding is critical for developing useful and usable clinical research decision support. Existing methods largely depend on self-reporting and often fail to elicit implicit or fine-grained user needs. We hypothesized that functional software would address this problem by presenting to users existing technology while simultaneously encouraging users to optimize workflow. Using clinical research visit scheduling as an example, we used a piece of software under development that was called IMPACT to reveal user needs iteratively. The identified user needs explained why most clinical research coordinators still rely on paper to schedule clinical research visits. The common user needs themes such as information completeness for software to be useful may generalize to other clinical decision support. This paper contributes valuable firsthand knowledge about user needs for decision support for clinical research visit scheduling among clinical research coordinators and a generalizable methodology for collecting and analyzing software usage data to inform user needs elicitation. PMID:25954586

  11. From free to free market: cost recovery in federally funded clinical research.

    PubMed

    McCammon, Margaret G; Fogg, Thomas T; Jacobsen, Lynda; Roache, John; Sampson, Royce; Bower, Cynthia L

    2012-07-01

    In a climate of increased expectation for the translation of research, academic clinical research units are looking at new ways to streamline their operation and maintain effective translational support services. Clinical research, although undeniably expensive, is an essential step in the translation of any medical breakthrough, and as a result, many academic clinical research units are actively looking to expand their clinical services despite financial pressures. We examine some of the hybrid academic-business models in 19 clinical research centers within the Clinical and Translational Science Award consortium that are emerging to address the issue of cost recovery of clinical research that is supported by the United States federal government. We identify initiatives that have succeeded or failed, essential supporting and regulatory components, and lessons learned from experience to design an optimal cost recovery model and a timeline for its implementation. PMID:22764204

  12. From Free to Free Market: Cost Recovery in Federally Funded Clinical Research

    PubMed Central

    McCammon, Margaret G.; Fogg, Thomas T.; Jacobsen, Lynda; Roache, John; Sampson, Royce; Bower, Cynthia L.

    2012-01-01

    In a climate of increased expectation for the translation of research, academic clinical research units are looking at new ways to streamline their operation and maintain effective translational support services. Clinical research, although undeniably expensive, is an essential step in the translation of any medical breakthrough, and as a result, many academic clinical research units are actively looking to expand their clinical services despite financial pressures. We examine some of the hybrid academic-business models in 19 clinical research centers within the Clinical and Translational Science Award consortium that are emerging to address the issue of cost recovery of clinical research that is supported by the United States federal government. We identify initiatives that have succeeded or failed, essential supporting and regulatory components, and lessons learned from experience to design an optimal cost recovery model and a timeline for its implementation. PMID:22764204

  13. Nurses’ Clinical Judgment Development: A Qualitative Research in Iran

    PubMed Central

    Seidi, Jamal; Alhani, Fatemeh; Salsali, Mahvash

    2015-01-01

    Background: Clinical judgment development is necessary because it leads to appropriate nursing diagnoses, clinical decision-making and health promotion. Objectives: In this study we explored the process of Iranian nurses’ development in clinical judgment. Patients and Methods: This qualitative study was conducted in 2013 at hospitals of Kurdistan University of Medical Sciences, located in the Sanandaj city of Iran. The data were collected based on semi-structured interviews and the study included 24 participants. Data analysis was carried out concurrently with data collection using the grounded theory method. Results: The study participants’ main concern was ‘being non-professional in clinical judgment’. In response to this concern, they were struggling for gaining professional autonomy, striving for integrating clinical judgment skills, scrambling to make effective educational interventions and striving for professional and inter professional collaboration in clinical judgment. The core category was ‘struggling for becoming professional in clinical judgment development’. When nurses were supported professionally, they were able to develop their professional clinical judgment. Conclusions: The findings of this study provided critical information about nurses’ professionalization in clinical judgment. Accordingly, the participants adopted different strategies to develop their clinical judgment ability. Integrating these strategies into nursing theory and clinical education can improve nurses’ clinical judgment ability. PMID:26473075

  14. RETURN OF RESULTS: ETHICAL AND LEGAL DISTINCTIONS BETWEEN RESEARCH AND CLINICAL CARE

    PubMed Central

    Burke, Wylie; Evans, Barbara J; Jarvik, Gail P

    2014-01-01

    The return of individual results to research participants has been vigorously debated. Consensus statements indicate that researchers and bioethicists consider the return of research results most appropriate when the findings are clinically relevant. Even when clinical utility is the motivator, however, the return of individual research results is not equivalent to clinical care. There are important differences in the domains of research and medical care, both from a legal standpoint and in terms of the ethical responsibilities of clinicians and researchers. As a corollary, researchers risk promoting a therapeutic misconception if they create quasi-clinical settings for return of clinically relevant research results. Rather, efforts should be focused on clarity in the provision of research results, appropriate caveats and, most important, appropriate referrals when the results may be helpful to consider in medical care. PMID:24616381

  15. 78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good... workshop regarding FDA's clinical trial requirements is designed to aid the clinical research professional... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  16. Research fellowship programs as a pathway for training independent clinical pharmacy scientists.

    PubMed

    Mueller, Eric W; Bishop, Jeffrey R; Kanaan, Abir O; Kiser, Tyree H; Phan, Hanna; Yang, Katherine Y

    2015-03-01

    The American College of Clinical Pharmacy (ACCP) Research Affairs Committee published a commentary in 2013 on training clinical pharmacy scientists in the context of changes in economic, professional, political, and research environments. The commentary centered on the opportunities for pharmacists in clinical/translational research including strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. A postdoctoral fellowship is cited as a current training pathway, capable of producing independent and productive pharmacy researchers. However, a decline in the number of programs, decreased funding availability, and variability in fellowship program activities and research focus have brought into question the relevance of this research training pathway to meet demand and opportunities. In response to these points, this commentary examines the state of research fellowship training including the current ACCP research fellowship review process, the need for standardization of research fellowship programs, and strategies to strengthen and promote research fellowships as relevant researcher training pathways.

  17. Glowing Hot Transiting Exoplanet Discovered

    NASA Astrophysics Data System (ADS)

    2003-04-01

    for exoplanets More than 100 planets in orbit around stars other than the Sun have been found so far. These "exoplanets" come in many different sizes and they move in a great variety of orbits at different distances from their central star, some nearly round and others quite elongated. Some planets are five to ten times more massive than the largest one in the solar system, Jupiter - the lightest exoplanets known at this moment are about half as massive as Saturn, i.e. about 50 times more massive than the Earth. Astronomers are hunting exoplanets not just to discover more such objects, but also to learn more about the apparent diversity of planetary systems. The current main research goal is to eventually discover an Earth-like exoplanet, but the available telescopes and instrumentation are still not "sensitive" enough for this daunting task. However, also in this context, it is highly desirable to know not only the orbits of the observable exoplanets, but also their true masses . But this is not an easy task. Masses of exoplanets Virtually all exoplanets detected so far have been found by an indirect method - the measurement of stellar velocity variations . It is based on the gravitational pull of the orbiting planet that causes the central star to move a little back and forth; the heavier the planet, the greater is the associated change in the star's velocity. This technique is rapidly improving: the new HARPS spectrograph (High Accuracy Radial Velocity Planet Searcher) , now being tested on the 3.6-m telescope at the ESO La Silla Observatory , can measure such stellar motions with an unrivalled accuracy of about 1 metre per second (m/s), cf. ESO PR 06/03 . It will shortly be able to search for exoplanets only a few times more massive than the Earth. However, velocity measurements alone do not allow to determine the true mass of the orbiting planet. Because of the unknown inclination of the planetary orbit (to the line-of-sight), they only provide a lower limit to

  18. Applications of Functional Protein Microarrays in Basic and Clinical Research

    PubMed Central

    Zhu, Heng; Qian, Jiang

    2013-01-01

    The protein microarray technology provides a versatile platform for characterization of hundreds of thousands of proteins in a highly parallel and high-throughput manner. It is viewed as a new tool that overcomes the limitation of DNA microarrays. On the basis of its application, protein microarrays fall into two major classes: analytical and functional protein microarrays. In addition, tissue or cell lysates can also be directly spotted on a slide to form the so-called “reverse-phase” protein microarray. In the last decade, applications of functional protein microarrays in particular have flourished in studying protein function and construction of networks and pathways. In this chapter, we will review the recent advancements in the protein microarray technology, followed by presenting a series of examples to illustrate the power and versatility of protein microarrays in both basic and clinical research. As a powerful technology platform, it would not be surprising if protein microarrays will become one of the leading technologies in proteomic and diagnostic fields in the next decade. PMID:22989767

  19. Neurostimulation in Alzheimer's disease: from basic research to clinical applications.

    PubMed

    Nardone, Raffaele; Höller, Yvonne; Tezzon, Frediano; Christova, Monica; Schwenker, Kerstin; Golaszewski, Stefan; Trinka, Eugen; Brigo, Francesco

    2015-05-01

    The development of different methods of brain stimulation provides a promising therapeutic tool with potentially beneficial effects on subjects with impaired cognitive functions. We performed a systematic review of the studies published in the field of neurostimulation in Alzheimer's disease (AD), from basic research to clinical applications. The main methods of non-invasive brain stimulation are repetitive transcranial magnetic stimulation and transcranial direct current stimulation. Preliminary findings have suggested that both techniques can enhance performances on several cognitive functions impaired in AD. Another non-invasive emerging neuromodulatory approach, the transcranial electromagnetic treatment, was found to reverse cognitive impairment in AD transgenic mice and even improves cognitive performance in normal mice. Experimental studies suggest that high-frequency electromagnetic fields may be critically important in AD prevention and treatment through their action at mitochondrial level. Finally, the application of a widely known invasive technique, the deep brain stimulation (DBS), has increasingly been considered as a therapeutic option also for patients with AD; it has been demonstrated that DBS of fornix/hypothalamus and nucleus basalis of Meynert might improve or at least stabilize cognitive functioning in AD. Initial encouraging results provide support for continuing to investigate non-invasive and invasive brain stimulation approaches as an adjuvant treatment for AD patients. PMID:25721941

  20. Compliance in early-phase cancer clinical trials research.

    PubMed

    Kurzrock, Razelle; Stewart, David J

    2013-01-01

    Regulations and ethical principles require that investigators seek consent and that patients participate in experimental studies only under circumstances that minimize the possibility of undue pressure and/or enticements. In recent years, there has been a rapid rise in the monitoring requirements of early-phase trials accompanied by an increasing emphasis on assuring "investigator" compliance with the protocol. It is actually, however, the patient who must comply with the requirements of the study. If there is divergence from the protocol, investigators may be reported to regulatory bodies or agencies. Whereas the investigative community is expected to be vigilant about ensuring that patients participate in studies voluntarily and that their consent is procured without duress, it is also required to guarantee that complex protocols, which entail multiple procedures, be followed exactly by participants who suffer from the complications of advanced cancer. We explore the issue of compliance in a research environment in which investigators are subject to disciplinary action if they fail to ensure that patients adhere precisely to the intense monitoring mandates of a clinical trial.

  1. Ontology-based data integration between clinical and research systems.

    PubMed

    Mate, Sebastian; Köpcke, Felix; Toddenroth, Dennis; Martin, Marcus; Prokosch, Hans-Ulrich; Bürkle, Thomas; Ganslandt, Thomas

    2015-01-01

    Data from the electronic medical record comprise numerous structured but uncoded elements, which are not linked to standard terminologies. Reuse of such data for secondary research purposes has gained in importance recently. However, the identification of relevant data elements and the creation of database jobs for extraction, transformation and loading (ETL) are challenging: With current methods such as data warehousing, it is not feasible to efficiently maintain and reuse semantically complex data extraction and trans-formation routines. We present an ontology-supported approach to overcome this challenge by making use of abstraction: Instead of defining ETL procedures at the database level, we use ontologies to organize and describe the medical concepts of both the source system and the target system. Instead of using unique, specifically developed SQL statements or ETL jobs, we define declarative transformation rules within ontologies and illustrate how these constructs can then be used to automatically generate SQL code to perform the desired ETL procedures. This demonstrates how a suitable level of abstraction may not only aid the interpretation of clinical data, but can also foster the reutilization of methods for un-locking it. PMID:25588043

  2. Ontology-based data integration between clinical and research systems.

    PubMed

    Mate, Sebastian; Köpcke, Felix; Toddenroth, Dennis; Martin, Marcus; Prokosch, Hans-Ulrich; Bürkle, Thomas; Ganslandt, Thomas

    2015-01-01

    Data from the electronic medical record comprise numerous structured but uncoded elements, which are not linked to standard terminologies. Reuse of such data for secondary research purposes has gained in importance recently. However, the identification of relevant data elements and the creation of database jobs for extraction, transformation and loading (ETL) are challenging: With current methods such as data warehousing, it is not feasible to efficiently maintain and reuse semantically complex data extraction and trans-formation routines. We present an ontology-supported approach to overcome this challenge by making use of abstraction: Instead of defining ETL procedures at the database level, we use ontologies to organize and describe the medical concepts of both the source system and the target system. Instead of using unique, specifically developed SQL statements or ETL jobs, we define declarative transformation rules within ontologies and illustrate how these constructs can then be used to automatically generate SQL code to perform the desired ETL procedures. This demonstrates how a suitable level of abstraction may not only aid the interpretation of clinical data, but can also foster the reutilization of methods for un-locking it.

  3. Best clinical and research practice in pediatric neurology.

    PubMed

    Martland, Timothy; Helen Cross, J

    2009-06-01

    Many children with epilepsy experience it as part of a broader disability. The cause is often a developmental, genetic, or early acquired abnormality associated with learning difficulties and impairments in other systems. In addition, it has become increasingly recognized in recent years that even children with so-called idiopathic generalized epilepsies may have specific language or cognitive impairments. The combination of seizures and these factors can form a significant barrier to the child and family in social and emotional terms as well. A child's brain must mature and learn new skills; and a large proportion of childhood epilepsies directly impact on this. The degree of control of the epilepsy can affect cognitive progress; but for many children the underlying cause of the impairment is the significant factor. For all children, access to appropriate clinical, educational, and social services for assessment and therapy is paramount. Specific initiatives in the North West of the United Kingdom are attempting to address service and organizational issues. Current research projects are investigating the impairments children with epilepsy have in addition to having seizures. PMID:19303946

  4. Ontology-Based Data Integration between Clinical and Research Systems

    PubMed Central

    Mate, Sebastian; Köpcke, Felix; Toddenroth, Dennis; Martin, Marcus; Prokosch, Hans-Ulrich

    2015-01-01

    Data from the electronic medical record comprise numerous structured but uncoded ele-ments, which are not linked to standard terminologies. Reuse of such data for secondary research purposes has gained in importance recently. However, the identification of rele-vant data elements and the creation of database jobs for extraction, transformation and loading (ETL) are challenging: With current methods such as data warehousing, it is not feasible to efficiently maintain and reuse semantically complex data extraction and trans-formation routines. We present an ontology-supported approach to overcome this challenge by making use of abstraction: Instead of defining ETL procedures at the database level, we use ontologies to organize and describe the medical concepts of both the source system and the target system. Instead of using unique, specifically developed SQL statements or ETL jobs, we define declarative transformation rules within ontologies and illustrate how these constructs can then be used to automatically generate SQL code to perform the desired ETL procedures. This demonstrates how a suitable level of abstraction may not only aid the interpretation of clinical data, but can also foster the reutilization of methods for un-locking it. PMID:25588043

  5. Schistosome Vaccine Adjuvants in Preclinical and Clinical Research

    PubMed Central

    Stephenson, Rachel; You, Hong; McManus, Donald; Toth, Istvan

    2014-01-01

    There is currently no vaccine available for human use for any parasitic infections, including the helminth disease, schistosomiasis. Despite many researchers working towards this goal, one of the focuses has been on identifying new antigenic targets. The bar to achieve protective efficacy in humans was set at a consistent induction of 40% protection or better by the World Health Organisation (WHO), and although this is a modest goal, it is yet to be reached with the six most promising schistosomiasis vaccine candidates (Sm28GST, IrV5, Sm14, paramyosin, TPI, and Sm23). Adjuvant selection has a large impact on the effectiveness of the vaccine, and the use of adjuvants to aid in the stimulation of the immune system is a critical step and a major variable affecting vaccine development. In addition to a comprehensive understanding of the immune system, level of protection and the desired immune response required, there is also a need for a standardised and effective adjuvant formulation. This review summarises the status of adjuvants that have been or are being employed in schistosomiasis vaccine development focusing on immunisation outcomes at preclinical and clinical stages. PMID:26344751

  6. [Clinical researchers and the pharmaceutic industry. The research contract is not an addendum].

    PubMed

    Cohen, A F

    1999-06-26

    The relation between a pharmaceutical company and a clinical investigator combines a certain form of entrepreneurship with scientific endeavour. Both parties are concerned with the content of the clinical study as well as with its business aspects. A good contract is essential for the project to succeed. In three cases based on actual experience the contract failed. In the first case, dosage miscalculation in the hospital pharmacy led to side effects in patients as a consequence of which the study was stopped. The pharmaceutical company sued the investigator. In the second case the investigator published data in a congress abstract, which prevented a patent by the company. In the third case scientific information was published by the company with the principal investigator featuring in the acknowledgement section of the article only. Investigators should have their own standard contract ready, and they should invest time and energy in understanding the contracts of the research they are carrying out. PMID:10416489

  7. Directions for clinical research and genomic research into the next decade: implications for informatics.

    PubMed

    Rindfleisch, T C; Brutlag, D L

    1998-01-01

    Medical informatics is defined largely by its host disciplines in clinical and biological medicine, and to project the agenda for informatics into the next decade, the health community must envision the broad context of biomedical research. This paper is a sketch of this vision, taking into account pressures from changes in the U.S. health care system, the need for more objective information on which to base health care decisions, and the accelerating progress and clinical impact of genomics research. The lessons of modern genomics research demonstrate the power of computing and communication tools to facilitate rapid progress through the adoption of open community standards for information exchange and collaboration. While aspects of this vision are speculative, it seems clear that the core agenda for informatics must be the development of interoperating systems that can facilitate the secure gathering, interchange, and analysis of high-quality information and can gain leverage from worldwide collaboration in advancing and applying new medical knowledge. PMID:9760387

  8. Families Discover the Outdoors Together.

    ERIC Educational Resources Information Center

    Parent, Polly

    1980-01-01

    An idea for hands-on activities for families to use in discovering the outdoors together when visiting parks is described. Family packs contain discovery and natural history cards, thermometers, magnifiers, insect boxes, photographs of animals and plants, a pencil, and a feedback form. (SA)

  9. Discovering Your Place in History

    ERIC Educational Resources Information Center

    White, Carol

    2006-01-01

    The Historica Foundation of Canada has a mandate to provide or support programs and resources for the teaching of Canadian history in Canadian schools. This paper outlines how Historica discovered what was needed and the programs and resources they developed to fulfill their mandate.

  10. Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research

    PubMed Central

    Burt, Tal; Gupta, Yogendra K; Mehta, Nalin; Swamy, Nagendra; Sovani, Vishwas; Speers, Marjorie A

    2014-01-01

    Like other emerging economies, India’s quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR −16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world’s population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)—aimed at establishing responsible and ethical clinical research standards—and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)—aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors. PMID:25558428

  11. 77 FR 41431 - Proposed Collection; Comment Request: Impact of Clinical Research Training and Medical Education...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and... Physician Careers in Academia and Clinical Research. Type of Information Collection Request: Extension; 0925... safety; (b) research productivity and independence; and (c) future career development within...

  12. HIV research in Australia: linking basic research findings with clinical and public health outcomes

    PubMed Central

    Lewin, Sharon R; Kaldor, John M; Cooper, David A

    2006-01-01

    Despite a population of only 20 million and sustained low prevalence of HIV infection in Australia, Australian researchers have provided many substantial original findings to the fields of HIV pathogenesis, treatment and prevention. More recently, Australian clinicians and scientists have turned their attention to assisting other countries in developing effective responses, particularly within the Asia-Pacific region. It is therefore fitting that the 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention will be held in Sydney in July 2007. The meeting is expected to attract over 5000 participants and will have a dynamic and innovative programme within the three major themes of HIV basic science, clinical research and biomedical prevention. PMID:17140433

  13. Translating research and into everyday clinical practice: Lessons learned from a USA national dental practice-based research network

    PubMed Central

    Gordan, Valeria V.

    2012-01-01

    Clinical studies are of paramount importance for testing and translation of the research findings to the community. Despite the existence of clinical studies, a significant delay exists between the generation of new knowledge and its application into the medical/dental community and their patients. One example is the repair of defective dental restorations. About 75% of practitioners in general dental practices do not consider the repair of dental restorations as a viable alternative to the replacement of defective restorations. Engaging and partnering with health practitioners in the field on studies addressing everyday clinical research questions may offer a solution to speed up the translation of the research findings. Practice-based research (PBR) offers a unique opportunity for practitioners to be involved in the research process, formulating clinical research questions. Additionally, PBR generates evidence-based knowledge with a broader spectrum that can be more readily generalized to the public. With PBR, clinicians are involved in the entire research process from its inception to its dissemination. Early practitioner interaction in the research process may result in ideas being more readily incorporated into practice. This paper discusses PBR as a mean to speed up the translation of research findings to clinical practice. It also reviews repair versus replacement of defective restorations as one example of the delay in the application of research findings to clinical practice. PMID:22889478

  14. Biospecimen Solicitation - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    A funding opportunity in support of the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) seeks to prospectively procure tumor samples, collected for proteomics investigation.

  15. Continuing Education in Research Ethics for the Clinical Nurse.

    ERIC Educational Resources Information Center

    Jeffers, Brenda Recchia

    2002-01-01

    Review of professional nursing statements, federal policy, and recommendations for protection of human research subjects resulted in a topic and content outline for research ethics training for nurses. Suggestions for continuing education programs on research ethics were formulated. (SK)

  16. Merging genomic and phenomic data for research and clinical impact.

    PubMed

    Shublaq, Nour W; Coveney, Peter V

    2012-01-01

    Driven primarily by advances in genomics, pharmacogenomics and systems biology technologies, large amounts of genomic and phenomic data are today being collected on individuals worldwide. Integrative analysis, mining, and computer modeling of these data, facilitated by information technology, have led to the development of predictive, preventive, and personalized medicine. This transformative approach holds the potential inter alia to enable future general practitioners and physicians to prescribe the right drug to the right patient at the right dosage. For such patient-specific medicine to be adopted as standard clinical practice, publicly accumulated knowledge of genes, proteins, molecular functional annotations, and interactions need to be unified and with electronic health records including phenotypic information, most of which still reside as paper-based records in hospitals. We review the state-of-the-art in terms of electronic data capture and medical data standards. Some of these activities are drawn from research projects currently being performed within the European Virtual Physiological Human (VPH) initiative; all are being monitored by the VPH INBIOMEDvision Consortium. Various ethical, legal and societal issues linked with privacy will increasingly arise in the post-genomic era. This will require a closer interaction between the bioinformatics/systems biology and medical informatics/healthcare communities. Planning for how individuals will own their personal health records is urgently needed, as the cost of sequencing a whole human genome will soon be less than U.S. $100. We discuss some of the issues that will need to be addressed by society as a result of this revolution in healthcare. PMID:22491122

  17. Merging genomic and phenomic data for research and clinical impact.

    PubMed

    Shublaq, Nour W; Coveney, Peter V

    2012-01-01

    Driven primarily by advances in genomics, pharmacogenomics and systems biology technologies, large amounts of genomic and phenomic data are today being collected on individuals worldwide. Integrative analysis, mining, and computer modeling of these data, facilitated by information technology, have led to the development of predictive, preventive, and personalized medicine. This transformative approach holds the potential inter alia to enable future general practitioners and physicians to prescribe the right drug to the right patient at the right dosage. For such patient-specific medicine to be adopted as standard clinical practice, publicly accumulated knowledge of genes, proteins, molecular functional annotations, and interactions need to be unified and with electronic health records including phenotypic information, most of which still reside as paper-based records in hospitals. We review the state-of-the-art in terms of electronic data capture and medical data standards. Some of these activities are drawn from research projects currently being performed within the European Virtual Physiological Human (VPH) initiative; all are being monitored by the VPH INBIOMEDvision Consortium. Various ethical, legal and societal issues linked with privacy will increasingly arise in the post-genomic era. This will require a closer interaction between the bioinformatics/systems biology and medical informatics/healthcare communities. Planning for how individuals will own their personal health records is urgently needed, as the cost of sequencing a whole human genome will soon be less than U.S. $100. We discuss some of the issues that will need to be addressed by society as a result of this revolution in healthcare.

  18. Proton beam scattering system optimization for clinical and research applications

    SciTech Connect

    Wroe, A. J.; Schulte, R. W.; Slater, J. D.; Barnes, S.; McAuley, G.; Slater, J. M.

    2013-04-15

    Purpose: To develop and test a method for optimizing and constructing a dual scattering system in passively scattered proton therapy. Methods: A beam optics optimization algorithm was developed to optimize the thickness of the first scatterer (S1) and the profile (of both the high-Z material and Lexan) of the second scatterer (S2) to deliver a proton beam matching a given set of parameters, including field diameter, fluence, flatness, and symmetry. A new manufacturing process was also tested that allows the contoured second scattering foil to be created much more economically and quickly using Cerrobend casting. Two application-specific scattering systems were developed and tested using both experimental and Monte Carlo techniques to validate the optimization process described. Results: A scattering system was optimized and constructed to deliver large uniform irradiations of radiobiology samples at low dose rates. This system was successfully built and tested using film and ionization chambers. The system delivered a uniform radiation field of 50 cm diameter (to a dose of {+-}7% of the central axis) while the depth dose profile could be tuned to match the specifications of the particular investigator using modulator wheels and range shifters. A second scattering system for intermediate field size (4 cm < diameter < 10 cm) stereotactic radiosurgery and radiation therapy (SRS and SRT) treatments was also developed and tested using GEANT4. This system improved beam efficiency by over 70% compared with existing scattering systems while maintaining field flatness and depth dose profile. In both cases the proton range uniformity across the radiation field was maintained, further indicating the accuracy of the energy loss formalism in the optimization algorithm. Conclusions: The methods described allow for rapid prototyping of scattering foils to meet the demands of both research and clinical beam delivery applications in proton therapy.

  19. Pressure ulcer prevention and treatment: transforming research findings into consensus based clinical guidelines.

    PubMed

    Lewis, Matthew; Pearson, Alan; Ward, Cathy

    2003-04-01

    The translation of research findings into practice guidelines is an important aspect in maintaining the currency of practice and adding value to research. While there has been a large amount of published literature regarding the treatment and prevention of pressure ulcers, very few studies have attempted to provide clear clinical guidelines. The present study proposes a model to transform research into clinical guidelines whilst developing a series of guidelines that can be applied to a variety of clinical settings. PMID:12694478

  20. ClinData Express--a metadata driven clinical research data management system for secondary use of clinical data.

    PubMed

    Li, Zuofeng; Wen, Jingran; Zhang, Xiaoyan; Wu, Chunxiao; Li, Zuogao; Liu, Lei

    2012-01-01

    Aim to ease the secondary use of clinical data in clinical research, we introduce a metadata driven web-based clinical data management system named ClinData Express. ClinData Express is made up of two parts: 1) m-designer, a standalone software for metadata definition; 2) a web based data warehouse system for data management. With ClinData Express, what the researchers need to do is to define the metadata and data model in the m-designer. The web interface for data collection and specific database for data storage will be automatically generated. The standards used in the system and the data export modular make sure of the data reuse. The system has been tested on seven disease-data collection in Chinese and one form from dbGap. The flexibility of system makes its great potential usage in clinical research. The system is available at http://code.google.com/p/clindataexpress. PMID:23304327

  1. Establishing research in a palliative care clinical setting: perceived barriers and implemented strategies.

    PubMed

    Bullen, Tracey; Maher, Kate; Rosenberg, John P; Smith, Bradley

    2014-02-01

    There are many challenges in developing research projects in research-naïve clinical settings, especially palliative care where resistance to participate in research has been identified. These challenges to the implementation of research are common in nursing practice and are associated with attitudes towards research participation, and some lack of understanding of research as a process to improve clinical practice. This is despite the professional nursing requirement to conduct research into issues that influence palliative care practice. The purpose of this paper is to describe the process of implementing a clinical research project in collaboration with the clinicians of a palliative care community team and to reflect on the strategies implemented to overcome the challenges involved. The challenges presented here demonstrate the importance of proactively implementing engagement strategies from the inception of a research project in a clinical setting.

  2. Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

    PubMed

    Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

    2016-07-01

    A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information.

  3. Advances take stage - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    Regulatory advances in proteomics will be taking center stage at a Symposia scheduled to occur at the 2011 American Association for Clinical Chemistry (AACC) Annual Meeting. The symposium entitled "Enabling Translational Proteomics with NCI's Clinical Proteomic Technologies for Cancer" is scheduled for July 25, 2011 at AACC's annual Meeting.

  4. Clinical review: Sleep measurement in critical care patients: research and clinical implications

    PubMed Central

    Bourne, Richard S; Minelli, Cosetta; Mills, Gary H; Kandler, Rosalind

    2007-01-01

    Sleep disturbances are common in critically ill patients and have been characterised by numerous studies using polysomnography. Issues regarding patient populations, monitoring duration and timing (nocturnal versus continuous), as well as practical problems encountered in critical care studies using polysomnography are considered with regard to future interventional studies on sleep. Polysomnography is the gold standard in objectively measuring the quality and quantity of sleep. However, it is difficult to undertake, particularly in patients recovering from critical illness in an acute-care area. Therefore, other objective (actigraphy and bispectral index) and subjective (nurse or patient assessment) methods have been used in other critical care studies. Each of these techniques has its own particular advantages and disadvantages. We use data from an interventional study to compare agreement between four of these alternative techniques in the measurement of nocturnal sleep quantity. Recommendations for further developments in sleep monitoring techniques for research and clinical application are made. Also, methodological problems in studies validating various sleep measurement techniques are explored. Current Controlled Trials ISRCTN47578325. PMID:17764582

  5. Clinical Research of Traditional Chinese Medicine Needs to Develop Its Own System of Core Outcome Sets

    PubMed Central

    Zhang, Li; Zhang, Junhua; Chen, Jing; Xing, Dongmei; Wang, Jiaying

    2013-01-01

    Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards. PMID:24312133

  6. Promoting the place of the allied health professions in clinical research.

    PubMed

    Rothan-Tondeur, Monique; Courcier, Soizic; Béhier, Jehan-Michel; Leblanc, Judith; Peoch, Nadia; Lefort, Marie-Claude; Barthélémy, Philippe; Bassompierre, François; Bilbault, Pascal; Déal, Cécile; Diebolt, Vincent; Fraleux, Michèle; François, Bruno; Gambotti, Laetitia; Lévy-Marchal, Claire; Misse, Christophe; Roussel, Christophe; Sibenaler, Claire; Simon, Tabassome; Tavernier, Blanche; Thoby, Frédérique

    2014-01-01

    Clinical research is of major importance to today's society, as scientific evidence is increasingly demanded as a basis for progress, whether this involves developing new healthcare products, improving clinical practice and care protocols or progress in prevention. Clinical research therefore requires professionals who are both experienced and increasingly well trained. Against this background, allied health professionals are becoming involved more and more, both as team members supporting clinical research projects and as managers or coordinators of projects in their own field. Clinical research activities provide an ideal opportunity for continuing professional development. All of this means that the professional skills of the allied health professions and clinical research support professions must be enhanced, their role promoted in the context of lecturer status and in the longer term, their status recognised by the supervisory authorities. PMID:25099668

  7. Discovering novel neuroactive drugs through high-throughput behavior-based chemical screening in the zebrafish

    PubMed Central

    Bruni, Giancarlo; Lakhani, Parth; Kokel, David

    2014-01-01

    Most neuroactive drugs were discovered through unexpected behavioral observations. Systematic behavioral screening is inefficient in most model organisms. But, automated technologies are enabling a new phase of discovery-based research in central nervous system (CNS) pharmacology. Researchers are using large-scale behavior-based chemical screens in zebrafish to discover compounds with new structures, targets, and functions. These compounds are powerful tools for understanding CNS signaling pathways. Substantial differences between human and zebrafish biology will make it difficult to translate these discoveries to clinical medicine. However, given the molecular genetic similarities between humans and zebrafish, it is likely that some of these compounds will have translational utility. We predict that the greatest new successes in CNS drug discovery will leverage many model systems, including in vitro assays, cells, rodents, and zebrafish. PMID:25104936

  8. Components of the Doctoral Curriculum That Build Success in the Clinical Nurse Researcher Role.

    ERIC Educational Resources Information Center

    Dennis, Karen E.

    1991-01-01

    Increasing numbers of hospitals and medical centers employ clinical nurse researchers. Nursing doctoral programs can prepare graduates for this role with courses in philosophy and ethics; research methods, statistics, and measurement; grantsmanship; and information dissemination. (SK)

  9. [Organization of clinical research: in a large scale department for cardiothoracic surgery].

    PubMed

    Sarikouch, S; Schilling, T; Haverich, A

    2010-04-01

    Translation of basic research results into routine patient care is delayed in parts by lack of institutionalization in clinical research. In this article the research structure and organization of our Department of Cardiac, Thoracic, Transplantation and Vascular Surgery are described.Basic research, separately directed, is accomplished in the Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO) and within the scope of the Excellence cluster "REBIRTH--from Regenerative Biology to Reconstructive Therapy".Clinical research is directed by heads of the subdepartments of our institution (valve and coronary surgery, aortic surgery, surgical electrophysiology, vascular surgery, thoracic surgery, cardiac assist systems, thoracic transplantation, intensive care and pediatric heart surgery).A separate subdepartment for clinical research is responsible for study coordination and accompanies clinical studies from study design and patient screening to publication. This subdepartment also serves as a constant contact to sponsors and superordinated research organizations within the Hannover Medical School.

  10. Hirsch Index and Truth Survival in Clinical Research

    PubMed Central

    Poynard, Thierry; Thabut, Dominique; Munteanu, Mona; Ratziu, Vlad; Benhamou, Yves; Deckmyn, Olivier

    2010-01-01

    Background Factors associated with the survival of truth of clinical conclusions in the medical literature are unknown. We hypothesized that publications with a first author having a higher Hirsch' index value (h-I), which quantifies and predicts an individual's scientific research output, should have a longer half-life. Methods and Results 474 original articles concerning cirrhosis or hepatitis published from 1945 to 1999 were selected. The survivals of the main conclusions were updated in 2009. The truth survival was assessed by time-dependent methods (Kaplan Meier method and Cox). A conclusion was considered to be true, obsolete or false when three or more observers out of the six stated it to be so. 284 out of 474 conclusions (60%) were still considered true, 90 (19%) were considered obsolete and 100 (21%) false. The median of the h-I was = 24 (range 1–85). Authors with true conclusions had significantly higher h-I (median = 28) than those with obsolete (h-I = 19; P = 0.002) or false conclusions (h-I = 19; P = 0.01). The factors associated (P<0.0001) with h-I were: scientific life (h-I = 33 for>30 years vs. 16 for<30 years), -methodological quality score (h-I = 36 for high vs. 20 for low scores), and -positive predictive value combining power, ratio of true to not-true relationships and bias (h-I = 33 for high vs. 20 for low values). In multivariate analysis, the risk ratio of h-I was 1.003 (95%CI, 0.994–1.011), and was not significant (P = 0.56). In a subgroup restricted to 111 articles with a negative conclusion, we observed a significant independent prognostic value of h-I (risk ratio = 1.033; 95%CI, 1.008–1.059; P = 0.009). Using an extrapolation of h-I at the time of article publication there was a significant and independent prognostic value of baseline h-I (risk ratio = 0.027; P = 0.0001). Conclusions The present study failed to clearly demonstrate that the h-index of authors was a prognostic

  11. Clinical research using an information system: the multicenter perioperative outcomes group.

    PubMed

    Kheterpal, Sachin

    2011-09-01

    Clinical research using electronic medical record (EMR) data is an emerging source of scientific progress. Increasingly, researchers are using retrospective observational data acquired from EMRs as the substrate for their clinical research into comorbidities, procedures, situations, and outcomes that have historically presented significant challenges. Although EMR data collection is perceived to require fewer resources than manual chart review, there are many specific regulatory, privacy, data quality, and technique issues unique to clinical research using EMR data. This article discusses the use of EMRs for observational research.

  12. The practice of clinical research in accredited marriage and family therapy programs.

    PubMed

    McWey, Lenore M; West, Stacy Hernandez; Ruble, Nikki M; Handy, Amy K; Handy, David G; Koshy, Mathen; Mills, Kathleen

    2002-01-01

    This study aims to explore the prevalence of clinic-based research among accredited marriage and family therapy (MFT) programs and reveal rationales explaining why academic settings may or may not be conducting clinical research. Findings of this project are the result of electronic-mail surveys completed by 26 accredited MFT programs. Approximately one-half of the respondents reported currently conducting clinic-based research. Open-ended responses reveal factors that lead to research success and failure, as well as reasons research was not being conducted at training programs.

  13. Letter from the Director - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The NCI’s Clinical Proteomic Technologies for Cancer (CPTC) initiative is focused on developing a better understanding of cancer biology through the proteomic interrogation of genomically characterized tumors from sources such as The Cancer Genome Atlas.

  14. Opioid-induced hyperalgesia: clinically relevant or extraneous research phenomenon?

    PubMed

    Tompkins, D Andrew; Campbell, Claudia M

    2011-04-01

    Opioids have become the unequivocal therapy of choice in treating many varieties of chronic pain. With the increased prescription of opioids, some unintended consequences have occurred. After prolonged opioid exposure, opioid-induced hyperalgesia (OIH), the paradoxical effect that opioid therapy may in fact enhance or aggravate preexisting pain, may occur. Over the past several decades, an increasing number of laboratory and clinical reports have suggested lowered pain thresholds and heightened atypical pain unrelated to the original perceived pain sensations as hallmarks of OIH. However, not all evidence supports the clinical importance of OIH, and some question whether the phenomenon exists at all. Here, we present a nonexhaustive, brief review of the recent literature. OIH will be reviewed in terms of preclinical and clinical evidence for and against its existence; recommendations for clinical evaluation and intervention also will be discussed.

  15. Director's Update - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (NCI-CPTAC) has recently begun the proteomic interrogation of genomically-characterized tumors from The Cancer Genome Atlas.

  16. Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research Cavalieri Jennifer and Rupp Mark Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research 336pp US$44.95 Sigma Theta Tau 9781937554637 1937554635 [Formula: see text].

    PubMed

    2014-08-28

    CLINICAL NURSES, alongside other healthcare professionals, are being drawn into clinical research in their day-to-day working in different ways, so an understanding of how clinical trials are managed and what role nurses can play in them is important.

  17. Will the proposed compensation guidelines for research-related injury spell the death knell for clinical research in India?

    PubMed

    Pramesh, C S; Badwe, R A

    2012-01-01

    The Indian Council of Medical Research and the Central Drugs Standards Control Organization of the Directorate General of Health Services of the Ministry of Health and Family Welfare' draft guidelines for compensation of research-related injury have evoked strong responses from the clinical research community. All stakeholders, including academic researchers, teachers in medical colleges, the pharmaceutical industry and even members of Institutional Review Boards and Ethics Committees have expressed grave reservations about several clauses in the guidelines. Moreover, these two guidelines differ from each other in important areas, reiterating that more thought and discussion is necessary to refine the guidelines. We present an academic researcher's perspective of the guidelines and our views on how they will affect clinical research in the country. The paper covers the types of research-related injury that are entitled for compensation, controversies on whether injury resulting from standard care should be entitled for compensation, whether causality needs to be established as a prerequisite for eligibility for compensation and whether all forms of research should have mandatory provision for compensation. We also put forward the potential dangers of such recommendations, which could potentially be inducement for patients to participate in clinical research. Finally, we raise the philosophical issue of infringement of an individual's fundamental rights regarding what research he/she wishes to participate in. While these points are based on several formal and informal discussions with stakeholders from various fields of clinical research, the views expressed are the authors' own personal thoughts.

  18. Five-year review of an international clinical research-training program

    PubMed Central

    Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben MW; Fregni, Felipe

    2015-01-01

    The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008–2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background. PMID:25878518

  19. Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

    PubMed

    Mello, Michelle M; Clarridge, Brian R; Studdert, David M

    2005-01-01

    We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

  20. Five-year review of an international clinical research-training program.

    PubMed

    Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; Dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben Mw; Fregni, Felipe

    2015-01-01

    The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008-2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background. PMID:25878518

  1. Current state of information technologies for the clinical research enterprise across academic medical centers.

    PubMed

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

    2012-06-01

    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. PMID:22686207

  2. [Clinical research. XIII. Research design contribution in the structured revision of an article].

    PubMed

    Talavera, Juan O; Rivas-Ruiz, Rodolfo

    2013-01-01

    The quality of information obtained in accordance to research design is integrated to the revision structured in relation to the causality model, used in the article "Reduction in the Incidence of Nosocomial Pneumonia Poststroke by Using the 'Turn-mob' Program", which corresponds to a clinical trial design. Points to identify and analyze are ethical issues in order to safeguard the security and respect for patients, randomization that seek to create basal homogeneous groups, subjects with the same probability of receiving any of the maneuvers in comparison, with the same pre maneuver probability of adherence, and which facilitate the blinding of outcome measurement and the distribution between groups of subjects with the same probability of leaving the study for reasons beyond the maneuvers. Other aspects are the relativity of comparison, the blinding of the maneuver, the parallel application of comparative maneuver, early stopping, and analysis according to the degree of adherence. The analysis in accordance with the design is complementary, since it is done based on the architectural model of causality, and the statistical and clinical relevance consideration.

  3. Preparing clinical pharmacy scientists for careers in clinical/translational research: can we meet the challenge?: ACCP Research Affairs Committee Commentary.

    PubMed

    Parker, Robert B; Ellingrod, Vicki; DiPiro, Joseph T; Bauman, Jerry L; Blouin, Robert A; Welage, Lynda S

    2013-12-01

    Developing clinical pharmacists' research skills and their ability to compete for extramural funding is an important component of the American College of Clinical Pharmacy's (ACCP) vision for pharmacists to play a prominent role in generating the new knowledge used to guide patient pharmacotherapy. Given the recent emphasis on clinical/translational research at the National Institutes of Health (NIH) and the key role of drug therapy in the management of many diseases, there is an unprecedented opportunity for the profession to contribute to this enterprise. A crucial question facing the profession is whether we can generate enough appropriately trained scientists to take advantage of these opportunities to generate the new knowledge to advance drug therapy. Since the 2009 publication of the ACCP Research Affairs Committee editorial recommending the Ph.D. degree (as opposed to fellowship training) as the optimal method for preparing pharmacists as clinical/translational scientists, significant changes have occurred in the economic, professional, political, and research environments. As a result, the 2012 ACCP Research Affairs Committee was charged with reexamining the college's position on training clinical pharmacy scientists in the context of these substantial environmental changes. In this commentary, the potential impact of these changes on opportunities for pharmacists in clinical/translational research are discussed as are strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. Failure of our profession to take advantage of these opportunities risks our ability to contribute substantively to the biomedical research enterprise and ultimately improve the pharmacotherapy of our patients.

  4. Longitudinal omics modeling and integration in clinical metabonomics research: challenges in childhood metabolic health research

    PubMed Central

    Sperisen, Peter; Cominetti, Ornella; Martin, François-Pierre J.

    2015-01-01

    Systems biology is an important approach for deciphering the complex processes in health maintenance and the etiology of metabolic diseases. Such integrative methodologies will help better understand the molecular mechanisms involved in growth and development throughout childhood, and consequently will result in new insights about metabolic and nutritional requirements of infants, children and adults. To achieve this, a better understanding of the physiological processes at anthropometric, cellular and molecular level for any given individual is needed. In this respect, novel omics technologies in combination with sophisticated data modeling techniques are key. Due to the highly complex network of influential factors determining individual trajectories, it becomes imperative to develop proper tools and solutions that will comprehensively model biological information related to growth and maturation of our body functions. The aim of this review and perspective is to evaluate, succinctly, promising data analysis approaches to enable data integration for clinical research, with an emphasis on the longitudinal component. Approaches based on empirical and mechanistic modeling of omics data are essential to leverage findings from high dimensional omics datasets and enable biological interpretation and clinical translation. On the one hand, empirical methods, which provide quantitative descriptions of patterns in the data, are mostly used for exploring and mining datasets. On the other hand, mechanistic models are based on an understanding of the behavior of a system's components and condense information about the known functions, allowing robust and reliable analyses to be performed by bioinformatics pipelines and similar tools. Herein, we will illustrate current examples, challenges and perspectives in the applications of empirical and mechanistic modeling in the context of childhood metabolic health research. PMID:26301225

  5. Visual Impairment/Intracranial Pressure Research Clinical Advisory Panel (RCAP) Meeting. [Summary Report

    NASA Technical Reports Server (NTRS)

    Villarreal, Jennifer

    2014-01-01

    The Visual Impairment/Intracranial Pressure (VIIP) Research and Clinical Advisory Panel convened on December 1, 2014 at the ISS Conference Facility in Houston. The panel members were provided updates to the current clinical cases and treatment plans along with the latest research activities (http://humanresearchroadmap.nasa.gov/Risks/?i=105) and preliminary study results. The following is a summary of this meeting.

  6. The Impact of VA's Geriatric Research, Education and Clinical Centers on Academic Affiliates

    ERIC Educational Resources Information Center

    Bragg, Elizabeth J.; Meganathan, Karthikeyan; Shay, Kenneth; Gilman, Stuart C.; Zeiss, Robert A.; Hettler, Debbie L.

    2011-01-01

    The education mission of the Department of Veterans Affairs (VA) is to train health professionals to benefit VA and the United States. One approach for achieving that mission, along with VA's research and clinical missions, was the establishment of Geriatric Research, Education and Clinical Centers (GRECCs) in 1975. These were developed at VA…

  7. Offering African Americans Opportunities to Participate in Clinical Trials Research: How Social Workers Can Help

    ERIC Educational Resources Information Center

    Mason, Susan E.

    2005-01-01

    Historically, African Americans have resisted participation in clinical trials and other research projects because of distrust of the mostly white research establishment. Although there are legitimate reasons for refusing to join clinical trials, most notably the abuses of the Tuskegee Syphilis Study, African Americans may be passing up…

  8. Client Similarities and Differences in Two Childhood Anxiety Disorders Research Clinics

    ERIC Educational Resources Information Center

    Southam-Gerow, Michael A.; Silverman, Wendy K.; Kendall, Philip C.

    2006-01-01

    Some evidence suggests that research and service clinics differ on treatment-relevant dimensions, but no study has examined whether research clinics (RCs) themselves differ. We compared 2 samples of children and adolescents (ages 7 to 17 years) with anxiety disorders treated in 2 different university-based child anxiety RCs, one in Philadelphia (n…

  9. Cellular Therapies Clinical Research Roadmap: Lessons learned on how to move a cellular therapy into a clinical trial

    PubMed Central

    Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M.

    2014-01-01

    A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, via and Investigational New Drug (IND) application, into early phase clinical trials. The roadmap describes four key areas; basic and preclinical research, resource development, translational research and good manufacturing practice (GMP), and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value using a model of the relevant disease. During resource development the appropriate specialists and the required expertise to bring this product into the clinic are identified (e.g., researchers, regulatory specialists, GMP manufacturing staff, clinicians, and clinical trials staff, etc.). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase the plan to translate the research product into a clinical grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States this is done by filing an IND application with the Food and Drug Administration. The NHLBI-funded Production Assistance for Cellular Therapies (PACT) program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five PACT facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly, and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. PMID:25484311

  10. Ontology driven integration platform for clinical and translational research.

    PubMed

    Mirhaji, Parsa; Zhu, Min; Vagnoni, Mattew; Bernstam, Elmer V; Zhang, Jiajie; Smith, Jack W

    2009-01-01

    Semantic Web technologies offer a promising framework for integration of disparate biomedical data. In this paper we present the semantic information integration platform under development at the Center for Clinical and Translational Sciences (CCTS) at the University of Texas Health Science Center at Houston (UTHSC-H) as part of our Clinical and Translational Science Award (CTSA) program. We utilize the Semantic Web technologies not only for integrating, repurposing and classification of multi-source clinical data, but also to construct a distributed environment for information sharing, and collaboration online. Service Oriented Architecture (SOA) is used to modularize and distribute reusable services in a dynamic and distributed environment. Components of the semantic solution and its overall architecture are described.

  11. Ontology driven integration platform for clinical and translational research

    PubMed Central

    Mirhaji, Parsa; Zhu, Min; Vagnoni, Mattew; Bernstam, Elmer V; Zhang, Jiajie; Smith, Jack W

    2009-01-01

    Semantic Web technologies offer a promising framework for integration of disparate biomedical data. In this paper we present the semantic information integration platform under development at the Center for Clinical and Translational Sciences (CCTS) at the University of Texas Health Science Center at Houston (UTHSC-H) as part of our Clinical and Translational Science Award (CTSA) program. We utilize the Semantic Web technologies not only for integrating, repurposing and classification of multi-source clinical data, but also to construct a distributed environment for information sharing, and collaboration online. Service Oriented Architecture (SOA) is used to modularize and distribute reusable services in a dynamic and distributed environment. Components of the semantic solution and its overall architecture are described. PMID:19208190

  12. Parenteral trace element provision: recent clinical research and practical conclusions.

    PubMed

    Stehle, P; Stoffel-Wagner, B; Kuhn, K S

    2016-08-01

    The aim of this systematic review (PubMed, www.ncbi.nlm.nih.gov/pubmed and Cochrane, www.cochrane.org; last entry 31 December 2014) was to present data from recent clinical studies investigating parenteral trace element provision in adult patients and to draw conclusions for clinical practice. Important physiological functions in human metabolism are known for nine trace elements: selenium, zinc, copper, manganese, chromium, iron, molybdenum, iodine and fluoride. Lack of, or an insufficient supply of, these trace elements in nutrition therapy over a prolonged period is associated with trace element deprivation, which may lead to a deterioration of existing clinical symptoms and/or the development of characteristic malnutrition syndromes. Therefore, all parenteral nutrition prescriptions should include a daily dose of trace elements. To avoid trace element deprivation or imbalances, physiological doses are recommended. PMID:27049031

  13. [Medical practice and clinical research: keys to generate knowledge and improve care].

    PubMed

    Martínez Castuera-Gómez, Carla; Talavera, Juan O

    2013-01-01

    The increased quality in medical care may be immediately accomplished if clinical research is integrated into daily clinical practice. In the generation of medical knowledge are four steps: an unanswered question awakened from clinical practice, the critical analysis of specialized literature, the development of a research protocol, and, finally, the publication of outcomes. Decision making and continuous training are becoming part of an effective strategy of medical attention improvement.

  14. [Genomic Tests: From Basic Research to Clinical Practice].

    PubMed

    Nakatani, Kaname; Mochiki, Ikuyo

    2015-03-01

    Advanced genomic analytical technologies are developing and challenging the current framework of clinical laboratory testing. However, most genomic tests have been devised as laboratory-developed tests (LDTs) without sufficient validation of their analytical validity. Quality assurance (QA) of tests is mandatory for routine clinical practice. External quality management systems such as ISO add QA. Other than QAs of pre-analysis, analytical procedures, reports, and laboratory personnel should be regularly assessed using appropriate best practices and guidelines for analytical validity. Moreover, ethical, legal, and social issues concerning genomic information should be resolved in genomic tests. Taken together, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient's clinical status and the risks and benefits resulting from test use. Genomic tests in current use vary in terms of their accuracy and potential to improve health outcomes. Recently, high-throughput analysis using next-generation sequencing and microarrays is being developed and introduced into clinical practice. As analysis of these data sets is a huge challenge, it requires novel analytical processes that include data quality assessment, comprehensive analysis, interpretation of the results, and presenting the results to users. Especially, human resources are required to develop genome informatics to interpret large amounts of data. Another issue is to regulate Direct To Consumers (DTC) genetic tests by medical institutions as a salutary health service. Although advanced genomic analytical technologies present some issues, they are useful and powerful tools in clinical practice. Thus, they will be properly introduced into clinical practices in a step by step manner. PMID:26524861

  15. [Genomic Tests: From Basic Research to Clinical Practice].

    PubMed

    Nakatani, Kaname; Mochiki, Ikuyo

    2015-03-01

    Advanced genomic analytical technologies are developing and challenging the current framework of clinical laboratory testing. However, most genomic tests have been devised as laboratory-developed tests (LDTs) without sufficient validation of their analytical validity. Quality assurance (QA) of tests is mandatory for routine clinical practice. External quality management systems such as ISO add QA. Other than QAs of pre-analysis, analytical procedures, reports, and laboratory personnel should be regularly assessed using appropriate best practices and guidelines for analytical validity. Moreover, ethical, legal, and social issues concerning genomic information should be resolved in genomic tests. Taken together, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient's clinical status and the risks and benefits resulting from test use. Genomic tests in current use vary in terms of their accuracy and potential to improve health outcomes. Recently, high-throughput analysis using next-generation sequencing and microarrays is being developed and introduced into clinical practice. As analysis of these data sets is a huge challenge, it requires novel analytical processes that include data quality assessment, comprehensive analysis, interpretation of the results, and presenting the results to users. Especially, human resources are required to develop genome informatics to interpret large amounts of data. Another issue is to regulate Direct To Consumers (DTC) genetic tests by medical institutions as a salutary health service. Although advanced genomic analytical technologies present some issues, they are useful and powerful tools in clinical practice. Thus, they will be properly introduced into clinical practices in a step by step manner.

  16. Computer AIDS for Clinical Research Management and Control: General Analysis and Design

    PubMed Central

    Willard, Christopher G.; Gatewood, Laël C.; Ellis, Lynda B. M.

    1979-01-01

    Clinical research projects involve concurrent management of subjects, protocol, analysis and study. This complicated management problem could be aided by the use of computerized data systems. For most effective aid, such a system should consider all aspects of clinical research. We have analyzed clinical research tasks involving data collection, communication, and management and have used this task analysis to develop a system model for clinical research data management and control. The model deals with data control, study monitoring, user interfaces, report and analysis libraries, and study subject and support data bases. It may be used as a basis for computerized data system study and development. The model also indicates that the role of computerized systems in clinical research could be expanded into such areas as automatic report generation and control, process control aids, quality assurance monitoring, and study documentation.

  17. Why might people donate tissue for cancer research? Insights from organ/tissue/blood donation and clinical research.

    PubMed

    Axler, Renata E; Irvine, Rob; Lipworth, Wendy; Morrell, Bronwen; Kerridge, Ian H

    2008-01-01

    Little is known about why patients with cancer do or do not donate their biopsied/cancerous tissue to research. A review of the literature on motivations to participate in clinical research and to donate tissues/organs for therapeutic use may provide some insights relevant to tumour banking research. While more research is necessary, a better understanding of the factors that motivate patients to give or refuse consent to tumour banking may ultimately improve consent practices, public trust and donation rates.

  18. [Enlightenment of big-data era on clinical research of TCM and acupuncture].

    PubMed

    Zhao, Tianyi; Chen, Bo; Pan, Xingfang; Guo, Yongming; Guo, Yi

    2015-09-01

    The big-data era has arrived, which involves all professions and trades. Its impact on the medical field has gradually revealed. With the characteristics of big data "4V" (volume, velocity, variety, value) and its theory generality with TCM (holistic thinking, correlativity) as well as regularity of disease development, combined with present status of acupuncture clinical research, the influences of big-data era on trial design, data collection, analysis and sharing of acupuncture clinical research are discussed in this paper, aiming to provide references for solving the difficulties of study design and determining the future research direction of acupuncture clinical research.

  19. A Systematic Review on the Designs of Clinical Technology: Findings and Recommendations for Future Research

    PubMed Central

    PhD, Greg Alexander; Staggers, Nancy

    2010-01-01

    Human factors (HF) studies are increasingly important as technology infuses into clinical settings. No nursing research reviews exist in this area. The authors conducted a systematic review on designs of clinical technology, 34 articles with 50 studies met inclusion criteria. Findings were classified into three categories based on HF research goals. The majority of studies evaluated effectiveness of clinical design; efficiency was fewest. Current research ranges across many interface types examined with no apparent pattern or obvious rationale. Future research should expand types, settings, participants; integrate displays; and expand outcome variables. PMID:19707093

  20. [Enlightenment of big-data era on clinical research of TCM and acupuncture].

    PubMed

    Zhao, Tianyi; Chen, Bo; Pan, Xingfang; Guo, Yongming; Guo, Yi

    2015-09-01

    The big-data era has arrived, which involves all professions and trades. Its impact on the medical field has gradually revealed. With the characteristics of big data "4V" (volume, velocity, variety, value) and its theory generality with TCM (holistic thinking, correlativity) as well as regularity of disease development, combined with present status of acupuncture clinical research, the influences of big-data era on trial design, data collection, analysis and sharing of acupuncture clinical research are discussed in this paper, aiming to provide references for solving the difficulties of study design and determining the future research direction of acupuncture clinical research. PMID:26721155