Science.gov

Sample records for clinic researchers discover

  1. 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.

  2. 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 ...

  3. 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

  4. Governance of clinical research.

    PubMed

    Camilleri, Michael; Tremaine, William J

    2012-03-01

    We review the principal methods and issues in the governance of clinical research: oversight of human research by federal offices, certification of clinical trial centers, management of conflict of interest in clinical research, and trial registration and reporting. PMID:22388015

  5. A Systematic Approach for Discovering Novel, Clinically Relevant Bacteria

    PubMed Central

    Simmon, Keith E.; Fisher, Mark A.

    2012-01-01

    Sequencing of the 16S rRNA gene (16S) is a reference method for bacterial identification. Its expanded use has led to increased recognition of novel bacterial species. In most clinical laboratories, novel species are infrequently encountered, and their pathogenic potential is often difficult to assess. We reviewed partial 16S sequences from >26,000 clinical isolates, analyzed during February 2006–June 2010, and identified 673 that have <99% sequence identity with valid reference sequences and are thus possibly novel species. Of these 673 isolates, 111 may represent novel genera (<95% identity). Isolates from 95 novel taxa were recovered from multiple patients, indicating possible clinical relevance. Most repeatedly encountered novel taxa belonged to the genera Nocardia (14 novel taxa, 42 isolates) and Actinomyces (12 novel taxa, 52 isolates). This systematic approach for recognition of novel species with potential diagnostic or therapeutic relevance provides a basis for epidemiologic surveys and improvement of sequence databases and may lead to identification of new clinical entities. PMID:22377371

  6. 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.

  7. 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.

  8. Clinical Trials in Vision Research

    MedlinePlus

    ... Clinical Trials in Vision Research Clinical Trials in Vision Research Clinical studies depend on people who volunteer. ... about the treatment. How are clinical trials in vision different from other clinical trials? Eyes are one ...

  9. Listening for Listeners: Two Educational Radio Stations Discover Audience Research.

    ERIC Educational Resources Information Center

    Stavitsky, Alan G.

    Two pioneering public radio stations--WOSU-AM, licensed to the Ohio State University in Columbus, and WHA-AM, licensed to the University of Wisconsin in Madison--conducted audience research as early as the 1920s. The challenge for early education broadcasters became to adapt the existing audience research paradigm to their purposes, or to develop…

  10. 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)

  11. Research to Discover Strategies for Spray Delivery Success

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Efficacious application of crop production materials to an ornamental canopy remains a challenge on many fronts. Limitations by crop, formulation, and production environment require producers to understand how to use each device to achieve their production goals. Research conducted by USDA-ARS sci...

  12. 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

  13. 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 ...

  14. 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

  15. 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…

  16. A method for discovering and inferring appropriate eligibility criteria in clinical trial protocols without labeled data

    PubMed Central

    2013-01-01

    Background We consider the user task of designing clinical trial protocols and propose a method that discovers and outputs the most appropriate eligibility criteria from a potentially huge set of candidates. Each document d in our collection D is a clinical trial protocol which itself contains a set of eligibility criteria. Given a small set of sample documentsD′,|D′|≪|D|, a user has initially identified as relevant e.g., via a user query interface, our scoring method automatically suggests eligibility criteria from D, D ⊃ D', by ranking them according to how appropriate they are to the clinical trial protocol currently being designed. The appropriateness is measured by the degree to which they are consistent with the user-supplied sample documents D'. Method We propose a novel three-step method called LDALR which views documents as a mixture of latent topics. First, we infer the latent topics in the sample documents using Latent Dirichlet Allocation (LDA). Next, we use logistic regression models to compute the probability that a given candidate criterion belongs to a particular topic. Lastly, we score each criterion by computing its expected value, the probability-weighted sum of the topic proportions inferred from the set of sample documents. Intuitively, the greater the probability that a candidate criterion belongs to the topics that are dominant in the samples, the higher its expected value or score. Results Our experiments have shown that LDALR is 8 and 9 times better (resp., for inclusion and exclusion criteria) than randomly choosing from a set of candidates obtained from relevant documents. In user simulation experiments using LDALR, we were able to automatically construct eligibility criteria that are on the average 75% and 70% (resp., for inclusion and exclusion criteria) similar to the correct eligibility criteria. Conclusions We have proposed LDALR, a practical method for discovering and inferring appropriate eligibility criteria in clinical

  17. 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

  18. Discovering Disease Associations by Integrating Electronic Clinical Data and Medical Literature

    PubMed Central

    Holmes, Antony B.; Hawson, Alexander; Liu, Feng; Friedman, Carol; Khiabanian, Hossein; Rabadan, Raul

    2011-01-01

    Electronic health record (EHR) systems offer an exceptional opportunity for studying many diseases and their associated medical conditions within a population. The increasing number of clinical record entries that have become available electronically provides access to rich, large sets of patients' longitudinal medical information. By integrating and comparing relations found in the EHRs with those already reported in the literature, we are able to verify existing and to identify rare or novel associations. Of particular interest is the identification of rare disease co-morbidities, where the small numbers of diagnosed patients make robust statistical analysis difficult. Here, we introduce ADAMS, an Application for Discovering Disease Associations using Multiple Sources, which contains various statistical and language processing operations. We apply ADAMS to the New York-Presbyterian Hospital's EHR to combine the information from the relational diagnosis tables and textual discharge summaries with those from PubMed and Wikipedia in order to investigate the co-morbidities of the rare diseases Kaposi sarcoma, toxoplasmosis, and Kawasaki disease. In addition to finding well-known characteristics of diseases, ADAMS can identify rare or previously unreported associations. In particular, we report a statistically significant association between Kawasaki disease and diagnosis of autistic disorder. PMID:21731656

  19. Clinical research nurse or nurse researcher?

    PubMed

    Jones, Helen Claire

    This article gives an overview of two research-related roles that can form part of a nurse's career path: clinical research nurse and nurse researcher. It highlights the influences on both roles, and the skills and differences within them, as well as offering advice on how nurses can access either role. PMID:26182597

  20. PROFESSIONAL INTEGRATION AND CLINICAL RESEARCH.

    ERIC Educational Resources Information Center

    WARD, TED W.

    THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…

  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. Discovering Our Delta: A Learning Guide for Community Research. Teacher Guide [and] Student Community Research Guide.

    ERIC Educational Resources Information Center

    Smithsonian Institution, Washington, DC. Center for Folklife Programs and Cultural Studies.

    This teacher guide and student community research guide unit are intended to help students learn to conduct research in their community and to communicate the results of that research to classmates and others. The unit, which can be used in conjunction with a video, helps students learn about community research, oral history, and folklore…

  3. 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

  4. Ethics in clinical research.

    PubMed

    Garattini, Silvio; Bertele', Vittorio

    2009-10-01

    R&D of new drugs is driven by pharmaceutical companies that invest considerable amounts of money for this purpose. This may introduce bias, to emphasize the clinical value of drugs to be allowed onto the market. Bias is caused by methodological flaws including the population under study, the choice of inadequate comparators or of their dosage, the adoption of surrogate or composite endpoints, the decision to publish mainly positive findings or to overlook some safety concerns, etc. All this happens in a legal context that requires no added value for new drugs to be approved for the market. This encourages the use of placebo even when active comparators are available, or the search for non-inferiority of new products in comparison with active comparators. Superiority over placebo and non-inferiority to active comparators may allow drugs onto the market that are in fact less active (or safe, tolerable, convenient, etc.) than those already available, usually with consolidated properties and lower costs. In addition, they do not meet patients' or physicians' needs of defining the place in therapy and respective roles of new and available treatments. The current legislative and regulatory setting seems designed to meet commercial interests rather than public health needs. PMID:19664839

  5. 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. PMID:26202196

  6. What do educated Americans believe? Alternative geoscience conceptions discovered through research using the Geoscience Concept Inventory

    NASA Astrophysics Data System (ADS)

    Anderson, S. W.; Libarkin, J. C.

    2006-12-01

    One of the key challenges geoscientists face as they disseminate scientific results to the general public is understanding the background level of their audience and delivering the information in a form that is easily understood. This is particularly difficult when dealing with people who have little background in geosciences. However, our research on learning in college-level courses suggests that reaching college-educated Americans who have some background in the geosciences is problematic as well. We have discovered a plethora of geoscience misconceptions that are not only common in the general public, but persist despite college-level geoscience instruction. These trends were discovered through delivery of the Geoscience Concept Inventory (GCI). The GCI is a valid and reliable multiple-choice assessment test that we developed and is now being used in over 100 colleges and high schools nationwide. One unique aspect of the GCI is that we use common misconceptions, gleaned from hundreds of interviews with students, as distractors (incorrect answers). In 2002 and 2003 we pre-tested nearly 4000 students nationwide at the beginning of college-level geoscience courses, and then post-tested these same students at the end of the semester, and found that a number of incorrect conceptions persisted despite instruction. Prior research has shown that these persistent misconceptions, or entrenched ideas, can greatly affect learning and may require prolonged exposure to the topic before improvement in conceptual understanding can occur. We have identified some of the most entrenched ideas in the geosciences, and find that many stem from basic physics and chemistry principles, such as gravity, magnetism, and time scale. Several are also related to misunderstandings of the relationships between tectonic plates, volcanoes and earthquakes. Scientists who understand which of these alternative conceptions are entrenched may be better able to prepare information for public

  7. Managing clinical research permissions electronically

    PubMed Central

    Sanderson, Iain C; Obeid, Jihad S; Madathil, Kapil Chalil; Gerken, Katherine; Fryar, Katrina; Rugg, Daniel; Alstad, Colin E; Alexander, Randall; Brady, Kathleen T; Gramopadhye, Anand K; Moskowitz, Jay

    2014-01-01

    Background One mechanism to increase participation in research is to solicit potential research participants’ general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. Purpose The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants’ interest in current and future research involvement and to provide a foundation for facilitating the research workflow. Methods The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users. Results An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions. Limitations There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials. Conclusions We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents. PMID:23785065

  8. 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

  9. [Regulatory burden of clinical research].

    PubMed

    Smeets, Edgar

    2015-01-01

    A few recent reports in both daily newspapers and interviews indicate that investigators working on trials in the Netherlands are experiencing too much red-tape, that regulations are getting too strict, and that they are being asked to do things which, in their view, are not really important. This impairs their efforts in delivering good research. Analysis shows that no new legislation has been introduced since the implementation of the EU Clinical Trial Directive in 2004. Over this 8-year period, the number of clinical research projects submitted nationwide has remained almost steady at approximately 1,800 per year. Of these a steady 42% are investigator-initiated studies. Recent new guidance from the FDA and MHRA indicates that over-interpretation of rules has indeed occurred. The newly promoted risk-based methodologies allow things to change. A potentially 'leaner' way forward has also been discussed. PMID:25761295

  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. 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 ...

  12. 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

  13. 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

  14. 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

  15. Why Most Clinical Research Is Not Useful.

    PubMed

    Ioannidis, John P A

    2016-06-01

    John Ioannidis argues that problem base, context placement, information gain, pragmatism, patient centeredness, value for money, feasibility, and transparency define useful clinical research. He suggests most clinical research is not useful and reform is overdue. PMID:27328301

  16. 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

  17. 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

  18. Clinical research informatics: a conceptual perspective

    PubMed Central

    Weng, Chunhua

    2012-01-01

    Clinical research informatics is the rapidly evolving sub-discipline within biomedical informatics that focuses on developing new informatics theories, tools, and solutions to accelerate the full translational continuum: basic research to clinical trials (T1), clinical trials to academic health center practice (T2), diffusion and implementation to community practice (T3), and ‘real world’ outcomes (T4). We present a conceptual model based on an informatics-enabled clinical research workflow, integration across heterogeneous data sources, and core informatics tools and platforms. We use this conceptual model to highlight 18 new articles in the JAMIA special issue on clinical research informatics. PMID:22523344

  19. Weaving Webs: School Leadership Isn't Hierarchical, Researchers Are Discovering

    ERIC Educational Resources Information Center

    Archer, Jeff

    2004-01-01

    This article focuses on James P. Spillane's research on distributed leadership. Spillane is the principal investigator for one of the largest studies ever conducted on distributed leadership in education. With $1 million from the National Science Foundation, he has for the past five years led a team of other researchers at Northwestern in studying…

  20. [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. PMID:15448853

  1. 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.

  2. 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

  3. 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…

  4. 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…

  5. 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…

  6. 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…

  7. Roles and Responsibilities of Clinical Nurse Researchers.

    ERIC Educational Resources Information Center

    Kirchhoff, Karin T.; Mateo, Magdelena A.

    1996-01-01

    A follow-up survey of 142 nurse researchers employed in clinical settings (75% response) found that fewer than half have a budget, 52% have secretarial support, 82% have a research committee, and 71% report to the chief nurse executive. Although their positions were primarily research, the average time spent on research was 50%. (JOW)

  8. Understanding the conditions for improvement: research to discover which context influences affect improvement success.

    PubMed

    Øvretveit, John

    2011-04-01

    Context can be defined as all factors that are not part of a quality improvement intervention itself. More research indicates which aspects are 'conditions for improvement', which influence improvement success. However, little is known about which conditions are most important, whether these are different for different quality interventions or whether some become less or more important at different times in carrying out an improvement. Knowing more about these conditions could help speed up and spread improvements and develop the science. This paper proposes ways to build knowledge about the conditions needed for different changes, and to create conditional-attribution explanations to provide qualified generalisations. It describes theory-based, non-experimental research designs. It also suggests that 'practical improvers' can make their changes more effective by reflecting on and revising their own 'assumption-theories' about the conditions which will help and hinder the improvements they aim to implement. PMID:21450764

  9. Understanding the conditions for improvement: research to discover which context influences affect improvement success

    PubMed Central

    2011-01-01

    Context can be defined as all factors that are not part of a quality improvement intervention itself. More research indicates which aspects are ‘conditions for improvement’, which influence improvement success. However, little is known about which conditions are most important, whether these are different for different quality interventions or whether some become less or more important at different times in carrying out an improvement. Knowing more about these conditions could help speed up and spread improvements and develop the science. This paper proposes ways to build knowledge about the conditions needed for different changes, and to create conditional-attribution explanations to provide qualified generalisations. It describes theory-based, non-experimental research designs. It also suggests that ‘practical improvers’ can make their changes more effective by reflecting on and revising their own ‘assumption-theories’ about the conditions which will help and hinder the improvements they aim to implement. PMID:21450764

  10. Doing clinical research: the challenges and benefits.

    PubMed

    Higgins, Isabel; Parker, Vicki; Keatinge, Diana; Giles, Michelle; Winskill, Rhonda; Guest, Eileen; Kepreotes, Elizabeth; Phelan, Caroline

    2010-06-01

    The need for research in practice is well documented within nursing and other health care disciplines. This acceptance is predicated on the belief that clinically applied research will inform and improve practice and health service delivery resulting in better outcomes for consumers and their families. Nurses, however, find doing clinical research challenging. This paper describes nurses' experiences of doing clinical research. The main challenges of doing clinical research arise from a culture that prioritises practice where nursing work is core business and there is the need to address immediate and short term goals. There are also problems associated with the use of research language amongst clinical nurses and ambiguity in relation to research role expectations. Lack of support and resources for doing research along with keeping up the momentum for a research project also pose significant challenges. The benefits of doing clinical nursing research include experiential learning that has the potential to lead to practice change and improved patient outcomes that are evidence based. PMID:20950198

  11. Relating clinical study design to basic research.

    PubMed

    Choh, V; Priolo, S

    1999-07-01

    Devising any research study involves careful attention to its design, as well as the development of an appropriate research question and hypothesis. Together, these attributes ensure the validity of the study in question. In most clinical or epidemiological studies, the types of research designs are often explicitly noted, whereas in papers describing basic or biological research, they are couched in different terms or, more often, are ignored, thus potentially hindering communication between basic and clinical researchers. However, given that the framework for all valid scientific research is based on sound logic, it is proposed that for each study design, a direct homology exists between clinical and basic research paradigms, despite the problem of relating epidemiological vernacular to basic research. By applying examples of basic research protocols to traditional clinical study designs, this paper shows that parallels can be drawn between the two strategies, suggesting that in the absence of a conventional nomenclature to describe basic research study designs, the use of traditional clinical design jargon is valid in describing basic research protocols. PMID:10445637

  12. 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

  13. 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

  14. 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)…

  15. 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

  16. Optimizing Clinical Research Participant Selection with Informatics

    PubMed Central

    Weng, Chunhua

    2015-01-01

    Clinical research participants are often not reflective of the real-world patients due to overly restrictive eligibility criteria. Meanwhile, unselected participants introduce confounding factors and reduce research efficiency. Biomedical Informatics, especially Big Data increasingly made available from electronic health records, offers promising aids to optimize research participant selection through data-driven transparency. PMID:26549161

  17. Discovering research value in the Campo del Cielo, Argentina, meteorite craters

    NASA Astrophysics Data System (ADS)

    Cassidy, William A.; Renard, Marc L.

    1996-07-01

    The Campo del Cielo meteorite crater field in Argentina contains at least 20 small meteorite craters, but a recent review of the field data and a remote sensing study suggest that there may be more. The fall occurred ˜4000 years ago into a uniform loessy soil, and the craters are well enough preserved so that some of their parameters of impact can be determined after excavation. The craters were formed by multi-ton fragments of a type IA meteoroid with abundant silicate inclusions. Relative to the horizontal, the angle of infall was ˜9°. Reflecting the low angle of infall, the crater field is elongated with apparent dimensions of 3 × 18.5 km. The largest craters are near the center of this ellipse. This suggests that when the parent meteoroid broke apart, the resulting fragments diverged from the original trajectory in inverse relation to their masses and did not undergo size sorting due to atmospheric deceleration. The major axis of the crater field as we know it extends along N63°E, but the azimuths of infall determined by excavation of Craters 9 and 10 are N83.5°E and N75.5°E, respectively. This suggests that the major axis of the crater field is not yet well determined. The three or four largest craters appear to have been formed by impacts that disrupted the projectiles, scattering fragments around the outsides of the craters and leaving no large masses within them; these are relatively symmetrical in shape. Other craters are elongated features with multi-ton masses preserved within them and no fragmentation products outside. There are two ways in which field research on the Campo del Cielo crater field is found to be useful. (1) Studies exist that have been used to interpret impact craters on planetary surfaces other than the Earth. This occurrence of a swarm of projectiles impacting at known angles and similar velocities into a uniform target material provides an excellent field site at which to test the applicability of those studies. (2) Individual

  18. 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

  19. 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. PMID:24778201

  20. Research without borders: fostering innovative clinical research and implementation.

    PubMed

    Xian, Ying; Peterson, Eric D

    2015-09-01

    Stroke remains one of the major killers worldwide. Addressing this epidemic will require combined efforts of researchers (bench, translational, clinical, epidemiologists, outcomes, and implementation scientists) as well as all forms of health care workers and policy experts. However, the translation of bench findings into bedside has been a challenge. Improved strategies for clinical research are needed to shorten the time required to translate bench findings into patient care. Large national or even globe stroke registries are uniquely positioned to advance the science by providing a rich data source for disease and post marketing surveillance, comparative effectiveness and safety research, and ultimately dissemination of clinical trials findings to routine clinical practice. Fostering innovative clinical research and implementation through international collaborations provides an unprecedented opportunity to tackle the globe of stroke. PMID:25973646

  1. Medical Schools, Clinical Research, and Ethical Leadership

    ERIC Educational Resources Information Center

    Makarushka, Julia L.; Lally, John J.

    1974-01-01

    Recent discussion of the ethical problems of biomedical human experimentation has drawn attention to the responsibility of the medical schools for training new clinical investigators and for safeguarding the rights and welfare of the subjects of clinical research conducted in the medical schools and their affiliated hospitals. (Author)

  2. Qualitative Clinical Research with Children and Adolescents

    ERIC Educational Resources Information Center

    Nelson, Mary Lee; Quintana, Stephen M.

    2005-01-01

    This article provides an overview of how qualitative research methods (QRMs) can augment the literature in child and adolescent clinical psychology by contributing to theory and hypothesis building. We discuss the utility of qualitative methods in examining the nature of clinical processes and obtaining deeper understandings about quantitative…

  3. Software Systems for Clinical Research

    PubMed Central

    Olson, N.E.; Smith, D.; Mason, C.; Smith, T.

    2011-01-01

    By the end of 2011 we will likely know the DNA sequences for 30,000 human genomes. However, to truly understand how the variation between these genomes affect phenotype at a molecular level, future research projects need to analyze these genomes in conjunction with data from multiple ultra-high throughput assays obtained from large sample populations. In cancer research, for example, studies that examine 1000s of specific tumors in 1000s of patients are needed to fully characterize the more than 10,000 types and subtypes of cancer and develop diagnostic biomarkers. These studies will use high throughput DNA sequencing to characterize tumor genomes and their transcriptomes. Sequencing results will be validated with nonsequencing technologies and putative biomarkers will be examined in large populations using rapid targeted assay approaches. Geospiza is transforming the above scenario from vision into reality in several ways. The Company's GeneSifter platform utilizes scalable data management technologies based on open-source HDF5 and BioHDF technologies to capture, integrate, and mine raw data and analysis results from DNA, RNA, and other high-throughput assays. Analysis results are integrated and linked to multiple repositories of information that include variation, expression, pathway, and ontology databases to enable discovery process and support verification assays. Using this platform and RNA-Sequencing and Genomic DNA sequencing from matched tumor/normal samples, we were able to characterize differential gene expression, differential splicing, allele specific expression, RNA editing, somatic mutations and genomic rearrangements as well as validate these observations in a set of patients with oral and other cancers.

  4. 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.

  5. 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.

  6. Conducting Clinical Research Using Crowdsourced Convenience Samples.

    PubMed

    Chandler, Jesse; Shapiro, Danielle

    2016-03-28

    Crowdsourcing has had a dramatic impact on the speed and scale at which scientific research can be conducted. Clinical scientists have particularly benefited from readily available research study participants and streamlined recruiting and payment systems afforded by Amazon Mechanical Turk (MTurk), a popular labor market for crowdsourcing workers. MTurk has been used in this capacity for more than five years. The popularity and novelty of the platform have spurred numerous methodological investigations, making it the most studied nonprobability sample available to researchers. This article summarizes what is known about MTurk sample composition and data quality with an emphasis on findings relevant to clinical psychological research. It then addresses methodological issues with using MTurk-many of which are common to other nonprobability samples but unfamiliar to clinical science researchers-and suggests concrete steps to avoid these issues or minimize their impact. PMID:26772208

  7. 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

  8. 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

  9. 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

  10. Pharmacy Administration and Clinical Practice Research Agenda.

    ERIC Educational Resources Information Center

    Hepler, Charles D.

    1987-01-01

    Research needs for pharmacy administration and clinical pharmacy include study of the relationship of pharmacists and society, management methods for providing health care services, pharmacist training and socialization, competence evaluation, formative and summative research on drug use control, and organizational decision making. (MSE)

  11. Brief Psychotherapy Methods in Clinical Research.

    ERIC Educational Resources Information Center

    Koss, Mary P.; And Others

    1986-01-01

    After a concise overview of the technical characteristics that define brief psychotherapy, the current use and misuse of these methods in clinical research on the outcome and process of treatment is examined. Suggests that brief psychotherapy methods possess unique technical advantages to the researcher. (Author/BL)

  12. [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. PMID:18432135

  13. Clinical acupuncture research in the West.

    PubMed

    Meng, Xianze; Xu, Shifen; Lao, Lixing

    2011-06-01

    In recent years, acupuncture has rapidly become part of mainstream medicine in the West, where new developments in acupuncture clinical research show extensive progress in evaluating the efficacy and safety of the modality in many categories of disease, especially in pain conditions. Although challenges and difficulties remain, the acupuncture research community has matured and its past experience may lead to even better methods and more innovative research. PMID:21695617

  14. Keeping Clinicians in Clinical Research: The Clinical Research/Reproductive Scientist Training Program

    PubMed Central

    Armstrong, Alicia Y.; DeCherney, Alan; Leppert, Phyllis; Rebar, Robert; Maddox, Yvonne T.

    2009-01-01

    In recent years the need for translational and clinical research has increased while the number of physicians involved in clinical research has diminished. There is clearly a need for formalized academic training in the quantitative and methodological principles of clinical research in reproductive medicine. The Clinical Research/Reproductive Scientist Training Program (CREST), a program supported by the National Institute of Child Health and Human Development, the Clinical Research Training Program (CRTP) at Duke University, and the American Society for Reproductive Medicine,(ASRM) meets this existing need. In addition, this program is specifically designed for physicians in private or academic clinical practice in reproductive medicine. Innovative programs such as CREST encourage the practicing physician to engage in clinical research while maintaining an active role in clinical practice. Participants in the program receive didactic on-line training from the CRTP, attend intensive weekend seminars at the National Institutes of Health (NIH) and CREST seminars at the annual meeting of ASRM. Successful participants in the program receive a Certificate in Clinical Research from the CRTP. The program’s goal is to provide practicing physicians with the tools and research credentials that will facilitate collaborations with investigators involved in large clinical trials. PMID:19144332

  15. An Opportunity to Bridge the Gap Between Clinical Research and Clinical Practice: Implications for Clinical Training

    PubMed Central

    Hershenberg, Rachel; Drabick, Deborah A. G.; Vivian, Dina

    2013-01-01

    Clinical researchers and clinical practitioners share a goal of increasing the integration of research and clinical practice, which is reflected in an evidence-based practice (EBP) approach to psychology. The EBP framework involves the integration of research findings with clinical expertise and client characteristics, values, and preferences, and consequently provides an important foundation for conducting clinically relevant research, as well as empirically based and clinically sensitive practice. Given the critical role that early training can play in the integration of science and practice and in promoting the future of the field, the present article addresses predoctoral training programs as a context for adopting an EBP approach to clinical work. We address training in the three components of EBP and provide suggestions for curriculum development and practicum training that we hope will contribute to bridging the gap between research and practice. PMID:22642520

  16. Ethics in Clinical Research: The Indian Perspective

    PubMed Central

    Sanmukhani, J.; Tripathi, C. B.

    2011-01-01

    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

  17. 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

  18. 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

  19. [Clinical research progress in infantile nystagmus syndrome].

    PubMed

    Zong, Yao; Wang, Li-hua

    2013-07-01

    Infantile nystagmus syndrome (INS) is an ocular motor disorder that presents at birth or early infancy. It is clinically characterized by involuntary and conjugated oscillation of the eyes, which often causes several complications such as amblyopia, lateral view, strabismus and torticollis. The etiology of INS is not fully understood, and this disease cannot be cured completely. This paper reviews the progress of research on the concept, etiology and pathogenesis, clinical manifestations, common examination methods, diagnosis and treatment of INS. PMID:24257363

  20. "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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. PMID:26306244

  6. 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

  7. 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…

  8. 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],…

  9. 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 ...

  10. 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.

  11. [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. PMID:9380169

  12. The social value of clinical research

    PubMed Central

    2014-01-01

    Background International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic. Discussion Our analysis and interpretation of the concept social value has led to three proposals. First, as no direct benefits are expected for the research participants in first-in-human trials, we believe it is better to discuss a risk- value assessment instead of a risk - benefit assessment. This will also make explicit the necessity to have a clear and common use for the concept social value. Second, to avoid confusion we propose to limit the concept social value to the intervention tested. It is the expected improvement the intervention can bring to the wellbeing of (future) patients or society that is referred to when we speak about social value. For the sole purpose of gaining knowledge, we should not expose humans to potential harm; the ultimate justification of involving humans in research lies in the anticipated social value of the intervention. Third, at the moment only the validity of the clinical research proposal is a prerequisite for research to take place. We recommend making the anticipated social value a prerequisite as well. Summary In this paper we analyze the use of the concept social value in research ethics. Despite its unavoidable ambiguity, we aim to find a best use of the concept, subject to its role in

  13. 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

  14. 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

  15. 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…

  16. 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

  17. Clinical Research Trials | NIH MedlinePlus the Magazine

    MedlinePlus

    ... version 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? ...

  18. Neuroethical issues in clinical neuroscience research.

    PubMed

    Anderson, James A; Eijkholt, Marleen; Illes, Judy

    2013-01-01

    In this chapter, we use the special features of neuroimaging to illustrate research ethics issues for the clinical neurologic sciences, and focus on one particularly compelling case: studies involving first-episode schizophrenic treatment-naïve individuals (FESTNIs) (Eijkholt et al., 2012). FESTNIs are scanned prior to the administration of medication in order to control for the confounding effects of treatment. By concentrating on this program of research, we capture the distinctive ethical challenges associated with neuroimaging research overall, and foreground the issues particular to neuroimaging research involving FESTNIs that have yet to receive sufficient attention in the literature. We highlight assessment of risks and burdens, including risks associated with treatment delays and incidental findings; assessment of benefit, including direct benefit, social value, and scientific quality; subject selection; justice questions related to responsiveness and poststudy access; and, finally, issues related to consent and capacity. PMID:24182390

  19. Periprosthetic Joint Infections: Clinical and Bench Research

    PubMed Central

    Legout, Laurence; Senneville, Eric

    2013-01-01

    Prosthetic joint infection is a devastating complication with high morbidity and substantial cost. The incidence is low but probably underestimated. Despite a significant basic and clinical research in this field, many questions concerning the definition of prosthetic infection as well the diagnosis and the management of these infections remained unanswered. We review the current literature about the new diagnostic methods, the management and the prevention of prosthetic joint infections. PMID:24288493

  20. Periprosthetic joint infections: clinical and bench research.

    PubMed

    Legout, Laurence; Senneville, Eric

    2013-01-01

    Prosthetic joint infection is a devastating complication with high morbidity and substantial cost. The incidence is low but probably underestimated. Despite a significant basic and clinical research in this field, many questions concerning the definition of prosthetic infection as well the diagnosis and the management of these infections remained unanswered. We review the current literature about the new diagnostic methods, the management and the prevention of prosthetic joint infections. PMID:24288493

  1. 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. PMID:17087398

  2. Roles and responsibilities of clinical nurse researchers.

    PubMed

    Kirchhoff, K T; Mateo, M A

    1996-01-01

    A follow-up survey of 142 nurse researchers employed in clinical settings (NRECS) was conducted 10 years after the first one conducted by Knafl, Bevis, and Kirchhoff in which only 34 individuals qualified for inclusion. An 80-item questionnaire included items about the structure of the position, processes used, variables that may influence outcomes, and outside activities. When ineligible persons were excluded, the response rate was 75 per cent. Most commonly NRECS had positions in clinical settings only (55.7 per cent), offices (75.5 per cent), some staff (72.6 per cent), and secretarial support (52.8 per cent), and they usually reported to the chief nurse executives (71.7 per cent). Although the majority of NRECS reported responsibility for research activities, the average time spent on research is only 50 per cent. Most (82 per cent) have a nursing research committee, but NRECS also sit on other research-related committees in the department or hospital. Details about salary, responsibilities, and processes will be helpful to those preparing themselves or others for this role, for those who wish to start such a position for themselves or another, or for those in the role wanting to know how other NRECS perform. PMID:8632106

  3. [International clinical trials: perspectives of clinical research coordinators].

    PubMed

    Aotani, Eriko

    2007-02-01

    There are several different task roles among the co-medicals who are involved in international clinical trials (ICTs). In this review article, several issues related with ICTs from the view point of clinical research coordinators (CRCs) will be discussed. The discussions include interview results from eight CRCs of four institutions who have been involved in ICTs, current status of education for co-medicals in the field of ICTs, and future perspectives of ICTs from the CRC's view point. The following topics are especially focused in the discussion. 1) It is necessary to establish the infra-structure for free discussion among the ICT team so that opinions of co-medicals as the operation managers of the participating institutions can be openly shared and importantly taken into account. 2) It is also important for co-medicals to conduct research studies to clarify the problems in the current ICT support systems. 3) Lastly, the significance of early involvement of CRCs into the ICT protocol development must be emphasized, because the quality of protocols will be better improved by the practical insight of CRCs, and consequently, the accomplishment of the ICT, such as the speed and the data quality, may be accelerated. PMID:17301551

  4. Contract research organizations in oncology clinical research: Challenges and opportunities.

    PubMed

    Roberts, Daniel A; Kantarjian, Hagop M; Steensma, David P

    2016-05-15

    Contract research organizations (CROs) represent a multibillion dollar industry that is firmly embedded in the contemporary clinical trial process. Over the past 30 years, and especially within the last decade, the reach of CROs has extended to service all phases of drug trials in an increasingly global research environment. The presence of CROs is particularly noticeable in medical oncology because of the large number of investigational compounds developed to treat cancer that are currently undergoing testing in human subjects. Although limited data are available with which to objectively define the effects that CROs have had on the clinical trial process, with the expansion of these organizations, several reports have called into question whether ethical and professional standards in research conduct are at times secondary to economic considerations. CROs can add considerable value to the clinical trial process, but difficulty communicating with CRO representatives and time spent answering trivial data queries generated by CROs are current obstacles for study site personnel interacting with CROs. Further study of the effect of the CRO industry on the clinical trial process is needed to ensure efficient data collection and patient safety while collaboratively developing novel therapies in an expedited fashion. Cancer 2016;122:1476-82. © 2016 American Cancer Society. PMID:27018651

  5. 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

  6. A Research Mentor Training Curriculum for Clinical and Translational Researchers

    PubMed Central

    Pfund, Christine; House, Stephanie; Spencer, Kimberly; Asquith, Pamela; Carney, Paula; Masters, Kristyn S.; McGee, Richard; Shanedling, Janet; Vecchiarelli, Stephanie; Fleming, Michael

    2012-01-01

    Purpose To design and evaluate a research mentor training curriculum for clinical and translational researchers. The resulting eight hour curriculum was implemented as part of a national mentor training trial. Method The mentor training curriculum was implemented with 144 mentors at 16 academic institutions. Facilitators of the curriculum participated in a train-the-trainer workshop to ensure uniform delivery. The data used for this report were collected from participants during the training sessions through reflective writing, and following the last training session via confidential survey with a 94% response rate. Results 88% of respondents reported high levels of satisfaction with the training experience, and 90% noted they would recommend the training to a colleague. Participants also reported significant learning gains across six mentoring competencies as well as specific impacts of the training on their mentoring practice. Conclusions The data suggest the described research mentor training curriculum is an effective means of engaging research mentors to reflect upon and improve their research mentoring practices. The training resulted in high satisfaction, self-reported skill gains as well as behavioral changes of clinical and translation research mentors. Given success across 16 diverse sites, this training may serve as a national model. PMID:23399086

  7. The Problem of Competing Clinical and Research Goals in the Conduct of Clinical Nursing Research.

    ERIC Educational Resources Information Center

    Van Dover, Leslie J.

    Because the science of nursing is still at an early stage of development, nurses involved in clinical research often find that no appropriate measures are available to sample the theoretical construct of interest. Researchers often must design and test new instruments before proceeding to test theory. A study of the effect of nurse-client…

  8. International regulatory aspects of clinical periodontal research.

    PubMed

    Cooley, W E; Castellion, A W

    1997-03-01

    The Food and Drug Administration (FDA) was the pioneer regulatory agency to set standards for clinical studies aimed at approval of new drugs. For years the FDA's rules represented the most thorough, stringent, and consistent policy. Now most other developed countries have comparable requirements for the conduct of clinical trials. The European Community (EC). Canadian, and Japanese regulations are most important for United States (US) scientists attempting to globalize their research. Regulations in Eastern Europe, some Asian countries, and Latin America are of growing importance. The Pacific-Rim appears to be the fastest growing pharmaceutical market in the next decade. Currently, the EC and Japan's Good Clinical Practice (GCP) regulations are more detailed than those of the US. Moreover, the World Health Organization recently published GCP recommendations similar to the EC requirements. Well-designed and well-controlled studies done in the EC, US, and other developed countries are generally accepted throughout the world. Japan and some other countries require studies in local patients. American scientists cannot expect to conduct studies in other countries as principal investigators, but many are associated with national clinicians. Mutual recognition of marketing approvals is the ultimate goal for the globalization of drug research. While it is the objective of the Scheme for the Mutual Recognition of Evaluation Reports on Pharmaceutical Products and the EC Decentralized Procedure, it is not apparent when the FDA will totally accept another regulatory body's approval decision. The International Conference on Harmonization involves the EC, Japan, and the US. This most important series of meetings will finally align the major countries more closely in regulating clinical studies and the production of safe, effective, and quality products, especially in these times of worldwide economic considerations and health care reform. It is imperative that US dental

  9. 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

  10. VISAGE: A Query Interface for Clinical Research.

    PubMed

    Zhang, Guo-Qiang; Siegler, Trish; Saxman, Paul; Sandberg, Neil; Mueller, Remo; Johnson, Nathan; Hunscher, Dale; Arabandi, Sivaram

    2010-01-01

    We present the design and implementation of VISAGE (VISual AGgregator and Explorer), a query interface for clinical research. We follow a user-centered development approach and incorporate visual, ontological, searchable and explorative features in three interrelated components: Query Builder, Query Manager and Query Explorer. The Query Explorer provides novel on-line data mining capabilities for purposes such as hypothesis generation or cohort identification. The VISAGE query interface has been implemented as a significant component of Physio-MIMI, an NCRR-funded, multi-CTSA-site pilot project. Preliminary evaluation results show that VISAGE is more efficient for query construction than the i2b2 web-client. PMID:21347154

  11. Parental consent in paediatric clinical research

    PubMed Central

    Chappuy, H; Doz, F; Blanche, S; Gentet, J‐C; Pons, G; Tréluyer, J‐M

    2006-01-01

    Aims To assess parental understanding and memorisation of the information given when seeking for consent to their child's participation to clinical research, and to identify the factors of significant influence on parents' decision making process. Methods Sixty eight parents who had been approached for enrolling their child in a clinical oncology or HIV study were asked to complete an interview. Their understanding was measured by a score which included items required to obtain a valid consent according to French legislation. Results Items that were best understood by parents were the aims of the study (75%), the risks (70%), the potential benefits to their child (83%), the potential benefits to other children (70%), the right to withdraw (73%), and voluntariness (84%). Items that were least understood were the procedures (44%), the possibility of alternative treatments (53%), and the duration of participation (39%). Less than 10% of the parents had understood all these points. Ten parents (15%) did not remember that they had signed up for a research protocol. Thirty three parents (48%) reported no difficulty in making their decision. Twenty four parents (38%) declared that they made their decision together with the investigator; 26 (41%) let the physician decide. Fifty four parents (78%) felt that the level of information given was satisfactory. Conclusion There was an apparent discrepancy between parents' evaluation of the adequacy of the information delivered and evaluation of their understanding and memorisation. The majority of parents preferred that the physician take as much responsibility as possible in the decision making process. PMID:16246853

  12. Louisiana Clinical Data Research Network: establishing an infrastructure for efficient conduct of clinical research

    PubMed Central

    Khurshid, Anjum; Nauman, Elizabeth; Carton, Tom; Horswell, Ron

    2014-01-01

    The state of Louisiana, like the nation as a whole, is facing the salient challenge of improving population health and efficiency of healthcare delivery. Research to inform innovations in healthcare will best enhance this effort if it is timely, efficient, and patient-centered. The Louisiana Clinical Data Research Network (LACDRN) will increase the capacity to conduct robust comparative effectiveness research by building a health information technology infrastructure that provides access to comprehensive clinical data for more than 1 million patients statewide. To ensure that network-based research best serves its end-users, the project will actively engage patients and providers as key informants and decision-makers in the implementation of LACDRN. The network's patient-centered research agenda will prioritize patients’ and clinicians’ needs and aim to support evidence-based decisions on the healthcare they receive and provide, to optimize patient outcomes and quality of life. PMID:24821735

  13. Louisiana Clinical Data Research Network: establishing an infrastructure for efficient conduct of clinical research.

    PubMed

    Khurshid, Anjum; Nauman, Elizabeth; Carton, Tom; Horswell, Ron

    2014-01-01

    The state of Louisiana, like the nation as a whole, is facing the salient challenge of improving population health and efficiency of healthcare delivery. Research to inform innovations in healthcare will best enhance this effort if it is timely, efficient, and patient-centered. The Louisiana Clinical Data Research Network (LACDRN) will increase the capacity to conduct robust comparative effectiveness research by building a health information technology infrastructure that provides access to comprehensive clinical data for more than 1 million patients statewide. To ensure that network-based research best serves its end-users, the project will actively engage patients and providers as key informants and decision-makers in the implementation of LACDRN. The network's patient-centered research agenda will prioritize patients' and clinicians' needs and aim to support evidence-based decisions on the healthcare they receive and provide, to optimize patient outcomes and quality of life. PMID:24821735

  14. 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.

  15. 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..., 2010......... Crowne Plaza Neurobiology-D November 19, 2010......... Crowne Plaza Pulmonary...

  16. 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... Medicine. City. Surgery November 22, 2011... The Sheraton Crystal City. Endocrinology-A November...

  17. 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..., 2012...... *VA Central Office. Cellular and Molecular Medicine...... November 19, 2012.........

  18. 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... & Molecular Medicine........ June 7, 2010 Hotel Palomar. Surgery June 7, 2010 Crowne Plaza....

  19. Integrating wound care research into clinical practice.

    PubMed

    Ho, Chester H; Bogie, Kath M

    2007-10-01

    The process of integrating wound care research into clinical practice incorporates research methodology--i.e., the standardized practices, procedures, and rules by which research is performed--and an evidence-based approach. Using examples from the literature and clinician experience treating pressure ulcers in a 32-bed regional spinal cord injury unit in a tertiary referral center in Cleveland, Ohio, the authors describe this process and review the challenges faced by an interdisciplinary skin care team tasked with implementing evidence-based care. Additional considerations include determining the amount of current wound care that is evidence-based and whether wound prevention and care outcomes are improved through the use of evidence-based medicine. Five years after establishing the skin care team and implementing evidence-based care, improvements in care processes and short-term outcomes--specifically, pressure ulcer prevention and treatment protocols including documentation--have been realized. Studies to ascertain the effects of these changes on long-term outcomes are planned. PMID:17978411

  20. [ECRIN (European clinical research infrastructures network), a pan-European infrastructure for clinical research].

    PubMed

    Demotes-Mainard, Jacques

    2010-12-01

    Clinical research plays a key role both in the development of innovative health products and in the optimisation of medical strategies, leading to evidence-based practice and healthcare cost containment. ECRIN is a distributed ESFRI-roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific providing services to multinational. Servicing of multinational trials started during the preparatory phase, and ECRIN has applied for ERIC status in 2011. In parallel, ECRIN has also proposed an FP7 integrating activity project to further develop, upgrade and expand the ECRIN infrastructure built up during the past FP6 and FP7 projects, facilitating an efficient organization of clinical research in Europe, with ECRIN developing generic tools and providing generic services for multinational studies, and supporting the construction of pan-European disease-oriented networks that will in turn act as ECRIN users. This organization will improve Europe's attractiveness for industry trials, boost its scientific competitiveness, and result in better healthcare for European citizens. The three medical areas supported in this project (rare diseases, medical devices, and nutrition) will serve as pilots for other biomedical research fields. By creating a single area for clinical research in Europe, this structure will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of research and educational capacities, tackling the major societal challenges (starting with healthy aging), and removing barriers to bringing ideas to the market. PMID:22043593

  1. 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

  2. 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

  3. Clinical Research, Dental Education, and the NIH Clinical Research Training Program.

    ERIC Educational Resources Information Center

    Baum, Bruce J.; Davis, Clifford

    1998-01-01

    An expert panel, convened by the National Institutes of Health to address concerns about the future of clinical research, describes a training program at the National Institutes of Health that also included dental students. Possible reasons for low application rates among dental students are ascribed to inadequate dissemination of information,…

  4. Alcoholic liver disease: Clinical and translational research.

    PubMed

    Neuman, Manuela G; Malnick, Stephen; Maor, Yaakov; Nanau, Radu M; Melzer, Ehud; Ferenci, Peter; Seitz, Helmut K; Mueller, Sebastian; Mell, Haim; Samuel, Didier; Cohen, Lawrence B; Kharbanda, Kusum K; Osna, Natalia A; Ganesan, Murali; Thompson, Kyle J; McKillop, Iain H; Bautista, Abraham; Bataller, Ramon; French, Samuel W

    2015-12-01

    The present review spans a broad spectrum of topics dealing with alcoholic liver disease (ALD), including clinical research, translational research, pathogenesis and therapies. A special accent is placed on alcohol misuse, as alcohol is a legally commercialized and taxable product. Drinking alcohol, particularly from a young age, is a major health problem. Alcoholism is known to contribute to morbidity and mortality. A systematic literature search was performed in order to obtain updated data (2008-2015). The review is focused on genetic polymorphisms of alcohol metabolizing enzymes and the role of cytochrome p450 2E1 and iron in ALD. Alcohol-mediated hepatocarcinogenesis is also discussed in the presence or absence of co-morbidities such as viral hepatitis C as well as therapeutic the role of innate immunity in ALD-HCV. Moreover, emphasis was placed on alcohol and drug interactions, as well as liver transplantation for end-stage ALD. Finally, the time came to eradicate alcohol-induced liver and intestinal damage by using betaine. PMID:26342547

  5. 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. PMID:25885928

  6. 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

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

    PubMed

    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

  8. Cultural psychiatry. Theoretical, clinical, and research issues.

    PubMed

    Lewis-Fernández, R; Kleinman, A

    1995-09-01

    As a discipline, cultural psychiatry has matured considerably in recent years and the ongoing quality of its theoretical, clinical, and research development holds great promise. The contemporary emphasis on culture as process permits a deeper analysis of the complexities of sociosomatics--the translation of meanings and social relations into bodily experience--and, thus, of the social course of illness. We also are learning a great deal more about cultural processes that affect therapy, including ethnopharmacologic and culturally valid family interventions that are directly relevant to patient care and mental health policy. And an important set of studies is examining the trauma experienced by refugees and immigrants. But at the same time many disquieting findings still point to the limited impact of cultural psychiatry on knowledge creation and clinical application in psychiatry. The failure of the cultural validation of DSM-IV is only the most dismaying. The persistent misdiagnosis of minority patients and the continued presence of racial bias in some treatment recommendations are also disheartening, as is the seeming contempt of many mainstream psychiatrists for culturally defined syndromes and folk healing systems. Widespread inattention to ethnic issues in medical ethics is another source of dismay. It is for these reasons that the culture of psychiatry itself becomes as important as the culture of patients as a topic for research and intervention. Most of the world still suffers from a terrible lack of basic mental health services, including life-saving medications and hospital beds. In the face of these limitations, and because of the increasing multicultural and pluralistic reality of contemporary life, the growing interpretive bridges linking indigenous systems of illness classification and healing to Western nosologies and therapeutic modalities become even more essential and the reluctance of mainstream clinicians to explore folk healing methods more

  9. 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

  10. Obstetrics and gynecology between clinics and research.

    PubMed

    Eskes, T

    2003-01-01

    An evaluation of a 25-year chairmanship at the University of Nijmegen is given. The main tasks were patient care, teaching and research. Patient care was influenced by new techniques later introduced into the various subdisciplines of Obstetrics and Gynecology. Evaluation of patient care was guaranteed by annual reports focussing on avoidable factors for morbidity or mortality. Furthermore the department was visited every five years by a hospital recognition committee for specialist training. There were just two juridical complaints that finally were denied. Clinical teaching involved medical students, interns and residents. The changes in teaching followed an international change from one-person lectures to student study groups. Efficacy of teaching was evaluated by an inter-university comparison of study duration. Nijmegen scored high. The evaluation of teaching for residents was done by the yearly one-day participation in the American CREOG (Council Resident Examination Obstetrics and Gynecology) multiple choice examination. The level of final positions of trained residents can also be seen as a partial result of the quality of training. Twenty out of 128 (15.6%) were nominated as professors. The Ph.D. residents were all working in major teaching hospitals. Research efforts were evaluated by the number of Ph.D.'s acquired by residents. Fifty-three percent of the residents accomplished a Ph.D. thesis. This was ten times the mean of the country. Several new techniques were introduced by the department in the Netherlands: amniotic fluid analysis, chromosomal investigations, fetal monitoring, animal studies, laparoscopy, ultrasound, radio-immuno-assay, gasanalysis of cord blood, genetic counseling, monoclonal antibodies and prolactin-agonists. Four research lines could be considered as an international breakthrough: the silent fetal heart rate pattern, dopamine-agonists, fetal behavioural states and homocysteine metabolism associated with neural tube defects. The

  11. 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

  12. Considerations for using research data to verify clinical data accuracy.

    PubMed

    Fort, Daniel; Weng, Chunhua; Bakken, Suzanne; Wilcox, Adam B

    2014-01-01

    Collected to support clinical decisions and processes, clinical data may be subject to validity issues when used for research. The objective of this study is to examine methods and issues in summarizing and evaluating the accuracy of clinical data as compared to primary research data. We hypothesized that research survey data on a patient cohort could serve as a reference standard for uncovering potential biases in clinical data. We compared the summary statistics between clinical and research datasets. Seven clinical variables, i.e., height, weight, gender, ethnicity, systolic and diastolic blood pressure, and diabetes status, were included in the study. Our results show that the clinical data and research data had similar summary statistical profiles, but there are detectable differences in definitions and measurements for individual variables such as height, diastolic blood pressure, and diabetes status. We discuss the implications of these results and confirm the important considerations for using research data to verify clinical data accuracy. PMID:25717415

  13. 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…

  14. 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. PMID:25629882

  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. 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...

  17. [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

  18. 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…

  19. 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

  20. 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 ...

  1. 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)

  2. 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.

  3. 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

  4. 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

  5. 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. PMID:18576248

  6. International market research at the Mayo Clinic.

    PubMed

    Hathaway, M; Seltman, K

    2001-01-01

    Mayo Clinic has a long international history and has been providing care to international patients since its inception. Despite its history and reputation, however, the marketing staff continues to monitor the international market to gauge the level of awareness, reputation, and attractiveness of Mayo Clinic around the world. Here's a look at how one institution has used word-of-mouth marketing to maintain its global reputation. PMID:11763648

  7. 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.

  8. 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.

  9. Towards a European Clinical Research Infrastructures Network: the ECRIN programme.

    PubMed

    Demotes-Mainard, Jacques

    2004-01-01

    On the basis of the interconnection of national networks of clinical research centres (CRCs) and clinical trials units (CTUs), the European Clinical Research Infrastructures Network (ECRIN) programme aims to develop an infrastructure allowing for bottom-up harmonisation of the support and training for, and practice of, clinical research, and to provide public sponsors for biotechnology small and medium-sized companies (SMEs) with support for translational research and multicentre clinical studies in Europe. This will be achieved through an application to the next FP6 'Integrated Infrastructure Initiatives' call. However, prior work is required to improve the reciprocal knowledge of partners in the ECRIN consortium and, as a first step, country-specific workshops will be organised by national networks in order to address the organisation of CRC/CTUs and national networks, and their interaction with the national environment of clinical research; this will enable in-depth discussion addressing the bottlenecks hampering transnational studies. PMID:15199684

  10. 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

  11. Students Discover Unique Planet

    NASA Astrophysics Data System (ADS)

    2008-12-01

    Three undergraduate students, from Leiden University in the Netherlands, have discovered an extrasolar planet. The extraordinary find, which turned up during their research project, is about five times as massive as Jupiter. This is also the first planet discovered orbiting a fast-rotating hot star. Omega Centauri ESO PR Photo 45a/08 A planet around a hot star The students were testing a method of investigating the light fluctuations of thousands of stars in the OGLE database in an automated way. The brightness of one of the stars was found to decrease for two hours every 2.5 days by about one percent. Follow-up observations, taken with ESO's Very Large Telescope in Chile, confirmed that this phenomenon is caused by a planet passing in front of the star, blocking part of the starlight at regular intervals. According to Ignas Snellen, supervisor of the research project, the discovery was a complete surprise. "The project was actually meant to teach the students how to develop search algorithms. But they did so well that there was time to test their algorithm on a so far unexplored database. At some point they came into my office and showed me this light curve. I was completely taken aback!" The students, Meta de Hoon, Remco van der Burg, and Francis Vuijsje, are very enthusiastic. "It is exciting not just to find a planet, but to find one as unusual as this one; it turns out to be the first planet discovered around a fast rotating star, and it's also the hottest star found with a planet," says Meta. "The computer needed more than a thousand hours to do all the calculations," continues Remco. The planet is given the prosaic name OGLE2-TR-L9b. "But amongst ourselves we call it ReMeFra-1, after Remco, Meta, and myself," says Francis. The planet was discovered by looking at the brightness variations of about 15 700 stars, which had been observed by the OGLE survey once or twice per night for about four years between 1997 and 2000. Because the data had been made public

  12. Enhancing electronic health records to support clinical research.

    PubMed

    Vawdrey, David K; Weng, Chunhua; Herion, David; Cimino, James J

    2014-01-01

    The "Learning Health System" has been described as an environment that drives research and innovation as a natural outgrowth of patient care. Electronic health records (EHRs) are necessary to enable the Learning Health System; however, a source of frustration is that current systems fail to adequately support research needs. We propose a model for enhancing EHRs to collect structured and standards-based clinical research data during clinical encounters that promotes efficiency and computational reuse of quality data for both care and research. The model integrates Common Data Elements (CDEs) for clinical research into existing clinical documentation workflows, leveraging executable documentation guidance within the EHR to support coordinated, standardized data collection for both patient care and clinical research. PMID:25954585

  13. The origins of modern clinical research.

    PubMed

    Green, Stuart A

    2002-12-01

    The single-blind or double-blind, placebo-controlled randomized clinical trial is considered the gold standard for evaluating the potential efficacy of pharmaceuticals, medical devices, and treatment protocols. The characteristic features of placebo-controlled clinical evaluations include two essential elements: a sham intervention and subject ignorance about the bogus nature of that intervention. Although it commonly is assumed that such clinical trials were developed in the 1930s, the first published report that used intentional subject ignorance and sham intervention was the result of a 1784 French royal commission investigation into mesmerism, headed by Benjamin Franklin. The strategy the Franklin commission used to debunk Franz Mesmer's assertions about health and illness served as a model for subsequent inquiries that use placebo controls and blinded assessment to arrive at their conclusions. PMID:12461388

  14. 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 ...

  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. [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

  17. Cultural humility: Essential foundation for clinical researchers

    PubMed Central

    Yeager, Katherine A.; Bauer-Wu, Susan

    2013-01-01

    Cultural humility is a process of self-reflection and discovery in order to build honest and trustworthy relationships. It offers promise for researchers to understand and eliminate health disparities, a continual and disturbing problem necessitating attention and action on many levels. This paper presents a discussion of the process of cultural humility and its important role in research to better understand the perspectives and context of the researcher and the research participant. We discern cultural humility from similar concepts, specifically cultural competence and reflexivity. We will also explore ways to cultivate cultural humility in the context of human subjects research. Mindfulness is one approach that can be helpful in enhancing awareness of self and others in this process. With a foundation in cultural humility, nurse researchers and other investigators can implement meaningful and ethical projects to better address health disparities. PMID:23938129

  18. The distribution of outcomes research papers across clinical journals.

    PubMed

    Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

    2011-06-01

    This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies. PMID:21411472

  19. 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

  20. 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…

  1. Center for Clinical Services Research, California.

    ERIC Educational Resources Information Center

    Findley, Foster

    2001-01-01

    Highlights Stanford University's 220,000 square-foot Center for Clinical Sciences, the design of which represents a high-quality architectural departure from the old building styles and creates an elegant, solar-protected gathering place for scientists. Includes photographs, sectional drawing, and site plan. (GR)

  2. Legitimating Clinical Research in the Study of Organizational Culture.

    ERIC Educational Resources Information Center

    Schein, Edgar H.

    1993-01-01

    Argues that traditional research model used in industrial-organizational psychology is not useful in understanding deeper dynamics of organizations, especially those phenomena labeled as "cultural." Contends that use of data obtained during clinical and consulting work should be legitimated as valid research data. Spells out clinical model and…

  3. The physician scientist: balancing clinical and research duties.

    PubMed

    Morel, Penelope A; Ross, Gillian

    2014-12-01

    Physician scientists bridge the gap between biomedical research and clinical practice. However, the continuing decrease in number of people who choose this career path poses a threat to the advancement of biomedical science and the translation of research findings to clinical practice. PMID:25396341

  4. 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)

  5. Inservice Education in a Clinical Research Hospital

    ERIC Educational Resources Information Center

    Ellis, Geraldine

    1971-01-01

    Orientation, training, and in-service programs are designed to provide assurance that nursing care standards will be met. Describes how to familiarize staff with the meaning of research, with its demand for repetition and precision, and the many ways in which nursing personnel actually provide support to the research physician. (RB)

  6. 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

  7. [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

  8. Fortuitously discovered liver lesions

    PubMed Central

    Dietrich, Christoph F; Sharma, Malay; Gibson, Robert N; Schreiber-Dietrich, Dagmar; Jenssen, Christian

    2013-01-01

    The fortuitously discovered liver lesion is a common problem. Consensus might be expected in terms of its work-up, and yet there is none. This stems in part from the fact that there is no preventive campaign involving the early detection of liver tumors other than for patients with known liver cirrhosis and oncological patients. The work-up (detection and differential diagnosis) of liver tumors comprises theoretical considerations, history, physical examination, laboratory tests, standard ultrasound, Doppler ultrasound techniques, contrast-enhanced ultrasound (CEUS), computed tomography and magnetic resonance imaging, as well as image-guided biopsy. CEUS techniques have proved to be the most pertinent method; these techniques became part of the clinical routine about 10 years ago in Europe and Asia and are used for a variety of indications in daily clinical practice. CEUS is in many cases the first and also decisive technical intervention for detecting and characterizing liver tumors. This development is reflected in many CEUS guidelines, e.g., in the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) guidelines 2004, 2008 and 2012 as well as the recently published World Federation for Ultrasound in Medicine and Biology-EFSUMB guidelines 2012. This article sets out considerations for making a structured work-up of incidental liver tumors feasible. PMID:23745019

  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. Clinical research in primary dental care.

    PubMed

    Heasman, P A; Macpherson, L E; Haining, S A; Breckons, M

    2015-08-28

    Many commissioning bodies for research expect that researchers will actively involve the public and patients in their projects. The National Institute for Health Research (NIHR), for example, involves members of the public in reviewing funding applications and making recommendations about research funding. The NIHR's portfolio is currently operating in 97% of NHS Trusts and this now includes research sited in primary dental care. This paper presents some case studies of these and other projects which are designed specifically for patient benefit in dental services in the community. This means there is no necessity to translate the outcomes of such research from a university or hospital base to the general population as the projects are undertaken in dental practices that provide primary dental care to (predominantly) NHS patients. The relevance of the outcomes to dental care is, therefore, likely to be of direct interest and importance to commissioners of healthcare funding in the UK who have a duty to use evidence bases for commissioning decisions. PMID:26315174

  11. CLINICAL RESEARCH--A TWO-WAY STREET BETWEEN RESEARCH AND PRACTICE.

    ERIC Educational Resources Information Center

    COOKINGHAM, FRANK; WARD, TED W.

    A CASE IS MADE FOR CLINICAL RESEARCH AS A 2-WAY STREET BETWEEN EDUCATIONAL RESEARCH AND PRACTICE. EDUCATIONAL RESEARCH IS DEFINED AS "THE DEVELOPMENT OF APPROPRIATE TECHNIQUES FOR THE MANAGEMENT OF THE LEARNING PROCESS IN AN EDUCATIONAL SETTING," THUS QUESTIONING THE RELEVANCY OF "BASIC" VS. "APPLIED" THEORIES. CLINICAL RESEARCH STUDIES CONSIST OF…

  12. 77 FR 20489 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-04

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    Federal Register 2010, 2011, 2012, 2013, 2014

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    Federal Register 2010, 2011, 2012, 2013, 2014

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    Federal Register 2010, 2011, 2012, 2013, 2014

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    Federal Register 2010, 2011, 2012, 2013, 2014

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    Federal Register 2010, 2011, 2012, 2013, 2014

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  18. 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

  19. Assessing Research Participants’ Perceptions of their Clinical Research Experiences

    PubMed Central

    Kost, Rhonda G.; Lee, Laura M.; Yessis, Jennifer; Coller, Barry S.; Henderson, David K.

    2013-01-01

    Introduction Participants’ perceptions of their research experiences provide valuable measures of ethical treatment, yet no validated instruments exist to measure these experiences. We conducted focus groups of research participants and professionals as the initial step in developing a validated instrument. Methods Research participants enrolled in twelve focus groups, consisting of: 1) individuals with disorders undergoing interventions or 2) in natural history studies; or 3) healthy volunteers. Research professionals participated in six separate groups of 1) IRB members, ethicists, Research Subject Advocates, 2) research nurses/coordinators, or 3) investigators. Focus groups used standard methodologies. Results 85 participants and 29 professionals enrolled at 8 academic centers. Altruism and personal relevance of the research were commonly identified motivators; financial compensation was less commonly mentioned. Participants were satisfied with informed consent processes but disappointed if not provided test results, or study outcomes. Positive relationships with research teams were valued highly. Research professionals were concerned about risks, undue influence, and informed consent. Conclusions Participants join studies for varied, complex reasons, notably altruism and personal relevance. They value staff relationships, health gains, new knowledge, and compensation, and expect professionalism and good organization. Based on these insights, we propose specific actions to enhance participant recruitment, retention and satisfaction. PMID:22212221

  20. Integration of clinical research documentation in electronic health records.

    PubMed

    Broach, Debra

    2015-04-01

    Clinical trials of investigational drugs and devices are often conducted within healthcare facilities concurrently with clinical care. With implementation of electronic health records, new communication methods are required to notify nonresearch clinicians of research participation. This article reviews clinical research source documentation, the electronic health record and the medical record, areas in which the research record and electronic health record overlap, and implications for the research nurse coordinator in documentation of the care of the patient/subject. Incorporation of clinical research documentation in the electronic health record will lead to a more complete patient/subject medical record in compliance with both research and medical records regulations. A literature search provided little information about the inclusion of clinical research documentation within the electronic health record. Although regulations and guidelines define both source documentation and the medical record, integration of research documentation in the electronic health record is not clearly defined. At minimum, the signed informed consent(s), investigational drug or device usage, and research team contact information should be documented within the electronic health record. Institutional policies should define a standardized process for this integration in the absence federal guidance. Nurses coordinating clinical trials are in an ideal position to define this integration. PMID:25636041

  1. 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

  2. [Organization of clinical research: in general and visceral surgery].

    PubMed

    Schneider, M; Werner, J; Weitz, J; Büchler, M W

    2010-04-01

    The structural organization of research facilities within a surgical university center should aim at strengthening the department's research output and likewise provide opportunities for the scientific education of academic surgeons. We suggest a model in which several independent research groups within a surgical department engage in research projects covering various aspects of surgically relevant basic, translational or clinical research. In order to enhance the translational aspects of surgical research, a permanent link needs to be established between the department's scientific research projects and its chief interests in clinical patient care. Importantly, a focus needs to be placed on obtaining evidence-based data to judge the efficacy of novel diagnostic and treatment concepts. Integration of modern technologies from the fields of physics, computer science and molecular medicine into surgical research necessitates cooperation with external research facilities, which can be strengthened by coordinated support programs offered by research funding institutions. PMID:20237748

  3. 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…

  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. 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 ...

  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. Information Technology for Clinical, Translational and Comparative Effectiveness Research

    PubMed Central

    Choquet, R.

    2015-01-01

    Summary Objectives To select and summarize key constributions to current research and to select best papers published in 2014 in the field of Clinical Research Informatics (CRI). Method A bibliographic search using a combination of MeSH and free terms search over PubMed on Clinical Research Informatics (CRI) was performed followed by a double-blind literature review. Results The review process yielded four papers, illustrating various aspects of current research efforts done in the area of CRI. The first paper exemplifies the process of developping a domain ontology for integrating structured, unstructured, and signal data into a coherent structure for patient care as well as clinical research. In the second paper, the authors analysed in five sites’ hospital information system environments in Germany the possibility of implementing a patient recruitment process and provided recommendations for the development of dedicated patient recruitment modules. The third paper describes the IMI EHR4CR project which developed an instance of a platform, providing communication, security and semantic interoperability services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. The last paper describes the relation between health status severity and the availability of data in EHR systems. They demonstrate that it introduces a biasis in patient selection for clinical research. Conclusions Distributed research networks are growing in importance for clinical research and population health surveillance and current research demonstartes that different projects and initiatives could be well placed to deliver international scale solutions to enable the reuse of hospital EHR data to support clinical research studies. Selected articles demonstrate the potential of formal representation of multimodal and multi-level data in supporting data interoperability across clinical research and care domains. With the development of

  8. [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. PMID:24055589

  9. 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

  10. The Distinction between Clinical and Research Interviews in Psychiatry

    PubMed Central

    2011-01-01

    Research interviews require a fact-based, neutral inquiry style that contrasts markedly from the empathic style of clinical interviews in psychiatric practice. In fact, the research interview generally seeks to gather information and specifically avoid any therapeutic benefit. This article describes the purpose of these opposing interview styles and provides some guidelines for beginning clinicians conducting research. PMID:21487545

  11. 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

  12. 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.

  13. [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

  14. 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

  15. 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... Medicine will meet on June 4, 2012, at the ] Sheraton Suites Old Town Alexandria and not at VA...

  16. 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... 5, 2011..... 6 p.m.-10 p.m.... Crowne Plaza DC/Silver Spring. Medicine. June 6, 2011..... 8 a.m.-5...

  17. 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

  18. 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.

  19. 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 ...

  20. 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.

  1. 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.

  2. 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…

  3. The National Institute of Dental Research Clinical Dental Staff Fellowship.

    ERIC Educational Resources Information Center

    Baum, Bruce J.; And Others

    1988-01-01

    A program in one of the National Institutes of Health offers clinical training fellowships as a means of training potential dental school faculty by providing both unique clinical skills and high-quality research experience. The program was developed in response to a perceived need for change in academic dentistry. (MSE)

  4. The Importance of Early Experiences: Clinical, Research, and Policy Perspectives

    ERIC Educational Resources Information Center

    Zeanah, Charles H.

    2009-01-01

    The degree to which early adverse experiences exert long term effects on development and how much early adversity may be overcome through subsequent experiences are important mental health questions. The clinical, research and policy perspectives on these questions lead to different answers. From a clinical perspective, change is always possible,…

  5. The Challenges of Clinical Researches in Iranian Traditional Medicine (ITM)

    PubMed Central

    Tabarrai, Malihe; Qaraaty, Marzie; Aliasl, Jale

    2016-01-01

    Background: Traditional medicine is one of the medical schools, which has been considered in recent years. Achieving reliable and valid research in ITM is very important to introduce this line of medicine into the healthcare organizations. The aim of this study was to investigate clinical research issues in ITM. Methods: This study is a qualitative research. We formed an expert panel and, after identifying the content, the study findings were divided into two main categories. Results: Challenges of clinical research studies are divided into two major categories in ITM, the problems of clinical trial processes and the difficulties in publishing research results. Lack of standard data collection instruments and questionnaires, limited sample size, lack of study models designed for distemperament treatment, unawareness, and non-compliance of ethics committees in facilities approved by WHO for clinical research of TM, and even rigidity beyond conventional medicine studies are some of the previously mentioned issues. Some difficulties in the publication of research results include lack of specialized journals especially at high academic levels, lack of familiarity with editorial board and difficulty in publishing the results of studies that are designed with combined products. A few proposals for these problems include: Conducting codification questionnaire workshops (approved by a thesis assistant with a subject of research tools)Introducing appropriate methods of multi-intervention research in ITMCreating the database of similarly performed research available for researchersDesigning multicenter researchCollaborations between academic centersLinking two or more thesis assistants or research projects in the form of a joint proposal with larger sample sizesEstablishing joint meeting between researchers, the heads of TM research centers and ethics committeesDedicated TM journal Conclusion: Considering a history of several thousand years, the Iranian traditional medicine

  6. 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

  7. Good clinical practice is now obligatory in academic clinical drug research in the European Union.

    PubMed

    Jørgensen, Annette; Bach, Karin Friis; Friis, Karen

    2004-02-01

    By May 2004, all clinical trials in the European Union (EU) on medicinal products have to be initiated and conducted in compliance with the principles in the new directive on Good Clinical Practice (GCP). This requirement will also apply to non-commercial trials involving registered drugs and may therefore restrain the academic clinical drug research. In Denmark, three public GCP units connected in a national network and associated with the university hospitals in Copenhagen, Odense and Aarhus have been established. The GCP units offer academic researchers the necessary quality assurance and quality control systems to ensure that clinical drug research can be performed according to GCP. The Danish initiative is presented here as a contribution to the future work with implementation of the principles of GCP in academic clinical drug research in the European Union. PMID:14748847

  8. Conflict of interest in clinical research

    PubMed Central

    Ghooi, Ravindra B.

    2015-01-01

    Increased focus on ethical review of research demands a number of improvements in the existing system. Although these are being implemented, some factors that have received less attention in the past could be examined. One of these is conflict of interest. Such conflicts could exist for investigators, ethics committee (EC) members, and even the regulators. Guidance for identification and management of conflicts has been issued by many countries and Indian rules also speak about these conflicts. Greater clarity would help investigators and ECs manage conflicts more effectively. It is admitted that conflicts cannot be done away with, but their timely identification, disclosure, and management can reduce their impact and bring more transparency and accountability to trials in this country. PMID:25657897

  9. 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

  10. Clinical Effectiveness: Leadership in Comparative Effectiveness and Translational Research.

    PubMed Central

    Shah, Nirav R.; Stewart, Walter F.

    2010-01-01

    The Health Maintenance Organization Research Network (HMORN), a consortium of 16 health care delivery systems with integrated research divisions, held its annual meeting in Danville, Pennsylvania in April of 2009 and was attended by more than 260 researchers and operational leaders from HMORN organizations, pharmaceutical companies, the National Cancer Institute, and the Agency for Healthcare Research and Quality. The 2009 meeting was held from April 26th to April 29th at the Henry Hood Center for Health Research, and was hosted by Geisinger Health System. The conference theme was “Clinical Effectiveness: Leadership in Comparative Effectiveness and Translational Research.” This article provides some background on the network, its research activities, and the annual conference. This issue of Clinical Medicine & Research also includes selected scientific abstracts presented at the meeting. PMID:20305148

  11. Launching PCORnet, a national patient-centered clinical research network

    PubMed Central

    Fleurence, Rachael L; Curtis, Lesley H; Califf, Robert M; Platt, Richard; Selby, Joe V; Brown, Jeffrey S

    2014-01-01

    The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research. In December 2013, PCORI's board of governors funded 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs) for a period of 18 months. CDRNs are based on the electronic health records and other electronic sources of very large populations receiving healthcare within integrated or networked delivery systems. PPRNs are built primarily by communities of motivated patients, forming partnerships with researchers. These patients intend to participate in clinical research, by generating questions, sharing data, volunteering for interventional trials, and interpreting and disseminating results. Rapidly building a new national resource to facilitate a large-scale, patient-centered CER is associated with a number of technical, regulatory, and organizational challenges, which are described here. PMID:24821743

  12. Epidemiology and Clinical Research Design, Part 2: Principles

    PubMed Central

    Manja, Veena; Lakshminrusimha, Satyan

    2015-01-01

    This is the third article covering core knowledge in scholarly activities for neonatal physicians. In this article, we discuss various principles of epidemiology and clinical research design. A basic knowledge of these principles is necessary for conducting clinical research and for proper interpretation of studies. This article reviews bias and confounding, causation, incidence and prevalence, decision analysis, cost-effectiveness, sensitivity analysis, and measurement. PMID:26236171

  13. 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

  14. 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. PMID:26004906

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

    PubMed

    Kim, Won Oak

    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

  16. Charting the Course for a New Cancer Clinical Research Culture.

    PubMed

    Tejpar, Sabine; Salgado, Roberto

    2015-01-01

    The convergence of new biological insights from sequencing, digital technologies and advanced bioinformatics tools are creating new opportunities to advance cancer care for individual patients. Fully realising this potential will require the integration and alignment of multiple stakeholders across the healthcare system. To increase the speed in which personalised medicine discoveries are translated into clinical practice and accessible to patients requires appropriately conducted clinical research with input and usage by patients, healthcare providers, regulatory authorities and policy makers. These stakeholders need to align in establishing the right evidence to facilitate clinical research and access to personalised treatments addressing the needs of targeted populations. PMID:26584428

  17. Spectral imaging in preclinical research and clinical pathology.

    PubMed

    Levenson, Richard; Beechem, Joseph; McNamara, George

    2012-01-01

    Spectral imaging methods are attracting increased interest from researchers and practitioners in basic science, pre-clinical and clinical arenas. A combination of better labeling reagents and better optics creates opportunities to detect and measure multiple parameters at the molecular and cellular level. These tools can provide valuable insights into the basic mechanisms of life, and yield diagnostic and prognostic information for clinical applications. There are many multispectral technologies available, each with its own advantages and limitations. This chapter will present an overview of the rationale for spectral imaging, and discuss the hardware, software and sample labeling strategies that can optimize its usefulness in clinical settings. PMID:22475632

  18. Capacity for Clinical Research on Herbal Medicines in Africa

    PubMed Central

    Siegfried, Nandi; Johnson, Quinton

    2012-01-01

    Abstract An electronic survey was used to assess the training needs of clinical and public health researchers who have been involved, and/or plan to become involved, in clinical trials of herbal medicines in Africa. Over 90 researchers were contacted through pre-existing networks, of whom 58 (64%) responded, from 35 institutions in 14 African countries. Over half (57%) had already been involved in a clinical trial of an herbal medicine, and gave information about a total of 23 trials that have already been completed. Of these, only five had been published, and only one had resulted in a licensed product. Fifty-four (54) of the researchers were planning to conduct a clinical trial of an herbal medicine in the future, and gave information about 54 possible trials. Respondents outlined the following most commonly encountered difficulties when conducting clinical trials: resource constraints (including lack of funding, equipment, staff, and infrastructure); social acceptance of the clinical trial (including difficulty recruiting enough patients, poor rapport with traditional healers, and willingness of biomedical staff to be involved); herbal medicine supply (including insufficient cultivation, production, and quality control); lack of trained staff; and logistical issues in conducting trials. The topics in which researchers were least confident were Intellectual Property Rights issues, statistical issues, and issues related to Good Clinical Practice guidelines. PMID:22784350

  19. 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

  20. Challenging Assumptions About Minority Participation in US Clinical Research

    PubMed Central

    Kalbaugh, Corey A.

    2011-01-01

    Although extensive research addresses minorities’ low participation in clinical research, most focuses almost exclusively on therapeutic trials. The existing literature might mask important issues concerning minorities’ participation in clinical trials, and minorities might actually be overrepresented in phase I safety studies that require the participation of healthy volunteers. It is critical to consider the entire spectrum of clinical research when discussing the participation of disenfranchised groups; the literature on minorities’ distrust, poor access, and other barriers to trial participation needs reexamination. Minority participation in clinical trials is an important topic in public health discussions because this representation touches on issues of equality and the elimination of disparities, which are core values of the field. PMID:22021285

  1. 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...

  2. Discovering the barriers to spread the usage of peripherally inserted central venous catheters in the neonatal intensive care units: A qualitative research

    PubMed Central

    Zargham-Boroujeni, Ali; Mahdavi-Lenji, Zahra; Hasanpour, Marzieh; Sadeghnia, Alireza

    2013-01-01

    Background: By increasing the survival of immature newborns, intravenous access methods, used to provide intravenous therapy, became more important. More attention has been recently paid on peripherally inserted central venous catheters in newborns, although it is yet unknown in Iran. In this study, we tried to discover the barriers to spread the usage of peripherally inserted central venous catheters (PICC) in the neonatal intensive care units of hospitals affiliated to Isfahan University of Medical Sciences. Materials and Methods: In this descriptive explorative qualitative research, conducted from December 2011 to April 2012 with purposeful sampling and snowball method, participants were selected from nurses and residents of neonatology and neonatal specialists working in Alzahra, Shahid Beheshty, and Amin hospitals, until data saturation occurred. Data were analyzed with thematic analysis proposed by Broun and Clarke in 2006. Results: Data analysis yielded 175 initial codes, 12 sub-themes, and 3 main themes. The main themes included barriers related to procedure and maintenance, barriers related to persons providing care, and barriers related to management and planning. Conclusions: One of the major problems in premature newborns during hospitalization is long-term and safe intravascular access; therefore, more use of PICC is needed. A complete planning is also needed to eliminate barriers and to provide required catheters. Educating the personnel is also necessary. PMID:24403919

  3. Clinical Research Environment in India: Challenges and Proposed Solutions

    PubMed Central

    Burt, Tal; Sharma, Pooja; Dhillon, Savita; Manchanda, Mukul; Mittal, Sanjay; Trehan, Naresh

    2015-01-01

    India has compelling need and keen aspirations for indigenous clinical research. Notwithstanding this need and previously reported growth the expected expansion of Indian clinical research has not materialized. We reviewed the scientific literature, lay press reports, and ClinicalTrials.gov data for information and commentary on projections, progress, and impediments associated with clinical trials in India. We also propose targeted solutions to identified challenges. The Indian clinical trial sector grew by (+) 20.3% CAGR (compound annual growth rate) between 2005 and 2010 and contracted by (-) 14.6% CAGR between 2010 and 2013. Phase-1 trials grew by (+) 43.5% CAGR from 2005–2013, phase-2 trials grew by (+) 19.8% CAGR from 2005–2009 and contracted by (-) 12.6% CAGR from 2009–2013, and phase-3 trials grew by (+) 13.0% CAGR from 2005–2010 and contracted by (-) 28.8% CAGR from 2010–2013. This was associated with a slowing of the regulatory approval process, increased media coverage and activist engagement, and accelerated development of regulatory guidelines and recuperative initiatives. We propose the following as potential targets for restorative interventions: Regulatory overhaul (leadership and enforcement of regulations, resolution of ambiguity in regulations, staffing, training, guidelines, and ethical principles [e.g., compensation]).Education and training of research professionals, clinicians, and regulators.Public awareness and empowerment. After a peak in 2009-2010, the clinical research sector in India appears to be experiencing a contraction. There are indications of challenges in regulatory enforcement of guidelines; training of clinical research professionals; and awareness, participation, partnership, and the general image amongst the non-professional media and public. Preventative and corrective principles and interventions are outlined with the goal of realizing the clinical research potential in India. PMID:25590017

  4. 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

  5. Epidemiological and Clinical Services Research on Hispanics' Mental Health Care.

    ERIC Educational Resources Information Center

    Rogler, Lloyd H.

    The quality of mental health research on Hispanic populations has not kept pace with the quantity, resulting in a poorly integrated body of scientific knowledge. A conceptual framework for clinical service research with Hispanic populations highlights specific goals and orientations, following a hypothetical five-step temporal sequence. Research…

  6. [Modern pharmacodynamics research and clinic application of huangqintang].

    PubMed

    Zhang, Bao-guo; Liang, Xiao-xia; Liu, Qing-fang

    2008-11-01

    To collect the researching documents of recent years about the pharmacodynamics research and modem clinic application of Huangqintang and its relative prescription, and to discuss the current general situation of the pharmacodynamics research and clinic application. Huangqintang has the pharmacodynamics effect such as resist bacteria and inflammation, adjust immune system, ease pain, protect the liver, lower the index of aminotransferase, anti-cancer and virus, lower the physical temperature, and calm down the emotion. The original and relative prescription can be commonly used in curing intestines disease such as diarrhea, acute enteritis and gastritis, ameba diarrhea, etc. It can also be used in internal medicine, gynecology, dermatology, etc. PMID:19216147

  7. Managing financial conflicts of interest in clinical research.

    PubMed

    Cohen, Jordan J

    2002-07-01

    Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. On both counts, managing financial conflicts of interest is critically important, especially in the modern era when the opportunities for investigators to benefit personally from the commercialization of their intellectual property are overtly encouraged and rapidly expanding. Efforts are underway in the United States to provide more useful guidance to universities and medical schools for purposes of strengthening the oversight and management of financial conflicts of interest in clinical research. PMID:12353369

  8. 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

  9. Clinical Trial and Research Study Recruiters' Verbal Communication Behaviors.

    PubMed

    Morgan, Susan E; Mouton, Ashton; Occa, Aurora; Potter, Jonell

    2016-07-01

    The lack of accrual to research studies and clinical trials is a persistent problem with serious consequences: Advances in medical science depend on the participation of large numbers of people, including members of minority and underserved populations. The current study examines a critical determinant of accrual: the approach of patients by professional recruiters who request participation in research studies and clinical trials. Findings indicate that recruiters use a number of verbal strategies in the communication process, including translating study information (such as simplifying, using examples, and substituting specific difficult or problematic words), using linguistic reframing or metaphors, balancing discussions of research participation risks with benefits, and encouraging potential participants to ask questions. The identification of these verbal strategies can form the basis of new communication protocols that will help medical and nonmedical professionals communicate more clearly and effectively with patients and other potential participants about research studies and clinical trials, which should lead to increased accrual in the future. PMID:27259754

  10. Clinical research in the private office setting--ethical issues.

    PubMed Central

    Fleischman, Alan R.; Klein, Jason E.

    2002-01-01

    A new model for performing clinical investigations has emerged in the United States which utilizes networks of physicians practicing in private office settings. This arrangement has sparked much controversy because of the potential conflicts of interest inherent in the dual roles of physician as clinician and investigator as well as the significant direct financial gains reported by some physicians which might impact on the interests of research subjects. We describe some of the ethical concerns and propose some procedural guidelines to safeguard the interests of research subjects participating in clinical trials in private physician offices. These safeguards include: requiring education of all investigators in research ethics, limiting financial incentives, disclosure to subjects of potential conflicts and financial arrangements, creation of an independent resource available to subjects to discuss concerns and answer questions, and development of educational materials to inform all potential subjects about important issues related to clinical research. PMID:12053705

  11. Clinical Research After Catastrophic Disasters: Lessons Learned From Hurricane Katrina

    PubMed Central

    Flory, Kate; Kloos, Bret; Hankin, Benjamin L.; Cheely, Catherine A.

    2008-01-01

    When catastrophic disasters such as Hurricane Katrina strike, psychologists and other mental health professionals often wonder how to use resources and fill needed roles. We argue that conducting clinical research in response to disasters is 1 important way that these professionals can contribute. However, we recognize that designing and implementing a clinical research study can be a daunting task, particularly in the context of the personal and system-wide chaos that follows most disasters. Thus, we offer a detailed description of our own experiences with conducting clinical research as part of our response to Hurricane Katrina. We describe our study design, recruitment and data collection efforts, and summarize and synthesize the lessons we have learned from this endeavor. Our hope is that others who may wish to conduct disaster-related research will learn from our mistakes and successes. PMID:19177173

  12. 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. PMID:23239403

  13. Exome Sequencing and Unrelated Findings in the Context of Complex Disease Research: Ethical and Clinical Implications

    PubMed Central

    Lyon, Gholson J.; Jiang, Tao; Van Wijk, Richard; Wang, Wei; Bodily, Paul Mark; Xing, Jinchuan; Tian, Lifeng; Robison, Reid J.; Clement, Mark; Lin, Yang; Zhang, Peng; Liu, Ying; Moore, Barry; Glessner, Joseph T.; Elia, Josephine; Reimherr, Fred; van Solinge, Wouter W.; Yandell, Mark; Hakonarson, Hakon; Wang, Jun; Johnson, William Evan; Wei, Zhi; Wang, Kai

    2012-01-01

    Exome sequencing has identified the causes of several Mendelian diseases, although it has rarely been used in a clinical setting to diagnose the genetic cause of an idiopathic disorder in a single patient. We performed exome sequencing on a pedigree with several members affected with attention deficit/hyperactivity disorder (ADHD), in an effort to identify candidate variants predisposing to this complex disease. While we did identify some rare variants that might predispose to ADHD, we have not yet proven the causality for any of them. However, over the course of the study, one subject was discovered to have idiopathic hemolytic anemia (IHA), which was suspected to be genetic in origin. Analysis of this subject’s exome readily identified two rare non-synonymous mutations in PKLR gene as the most likely cause of the IHA, although these two mutations had not been documented before in a single individual. We further confirmed the deficiency by functional biochemical testing, consistent with a diagnosis of red blood cell pyruvate kinase deficiency. Our study implies that exome and genome sequencing will certainly reveal additional rare variation causative for even well-studied classical Mendelian diseases, while also revealing variants that might play a role in complex diseases. Furthermore, our study has clinical and ethical implications for exome and genome sequencing in a research setting; how to handle unrelated findings of clinical significance, in the context of originally planned complex disease research, remains a largely uncharted area for clinicians and researchers. PMID:21794208

  14. New Brunswick nurses' views on nursing research, and factors influencing their research activities in clinical practice.

    PubMed

    Robichaud-Ekstrand, Sylvie

    2016-06-01

    New Brunswick became the first province in Canada to require a baccalaureate degree in nursing as the entry to practice, yet nursing research in hospital settings remains quite low. This study examined clinical nurses' views on nursing research, and identified some contributing factors to the research-practice gap. This descriptive, cross-sectional multicenter study involved 1081 nurses working in the Francophone Regional Health Authority in New Brunswick, Canada. Nurses were eager to identify nursing-care problems to improve patient care (92.9%), and to be involved in collecting data for nursing research studies (95.2%). However, without research supervision, few had engaged in basic research activities, such as formulating or refining research questions (24.5%), presenting at research conferences (6.9%), or changing their practice based on research findings (27.2%). Younger, more educated nurses, nurse managers, and educators participated more readily in research. Sharing research and clinical expertise, as well as infrastructures between academic and clinical institutions is the key to enduring successful patient-centered nursing research in clinical settings. Concrete actions are proposed to build clinical nursing research. PMID:26822438

  15. How to evaluate study methodology in published clinical research.

    PubMed

    Stoddard, G J; Ring, W H

    1993-01-01

    When reading a clinical research article, the clinician must judge if the reported findings and conclusions are valid before applying them to patient care. This concern is legitimate given the wide range of study validity in the clinical literature. In this article, the authors present many validity markers that signify the quality of the information reported from a study, such as authorship, bias, confounding, statistics, randomization, controls, blinding, and the logical framework of scientific investigations. PMID:8478779

  16. 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

  17. 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. PMID:17642002

  18. Characteristics Desired in Clinical Data Warehouse for Biomedical Research

    PubMed Central

    Shin, Soo-Yong; Kim, Woo Sung

    2014-01-01

    Objectives Due to the unique characteristics of clinical data, clinical data warehouses (CDWs) have not been successful so far. Specifically, the use of CDWs for biomedical research has been relatively unsuccessful thus far. The characteristics necessary for the successful implementation and operation of a CDW for biomedical research have not clearly defined yet. Methods Three examples of CDWs were reviewed: a multipurpose CDW in a hospital, a CDW for independent multi-institutional research, and a CDW for research use in an institution. After reviewing the three CDW examples, we propose some key characteristics needed in a CDW for biomedical research. Results A CDW for research should include an honest broker system and an Institutional Review Board approval interface to comply with governmental regulations. It should also include a simple query interface, an anonymized data review tool, and a data extraction tool. Also, it should be a biomedical research platform for data repository use as well as data analysis. Conclusions The proposed characteristics desired in a CDW may have limited transfer value to organizations in other countries. However, these analysis results are still valid in Korea, and we have developed clinical research data warehouse based on these desiderata. PMID:24872909

  19. Echocardiography as a Research and Clinical Tool in Veterinary Medicine

    PubMed Central

    Allen, D. G.

    1982-01-01

    Echocardiography is the accepted term for the study of cardiac ultrasound. Although a relatively new tool for the study of the heart in man it has already found wide acceptance in the area of cardiac research and in the study of clinical cardiac disease. Animals had often been used in the early experiments with cardiac ultrasound, but only recently has echocardiography been used as a research and clinical tool in veterinary medicine. In this report echocardiography is used in the research of anesthetic effects on ventricular function and clinically in the diagnosis of congestive cardiomyopathy in a cat, ventricular septal defect in a calf, and pericardial effusion in a dog. Echocardiography is now an important adjunct to the field of veterinary cardiology. ImagesFigure 7.Figure 8.Figure 9.Figure 10. PMID:17422196

  20. [Clinical research in Chile: How to improve its worrying evolution?].

    PubMed

    Norero, C; Rosselot, E

    2001-03-01

    There is still great collective paucity in our society in appreciating the importance of scientific work for the development of the nation. In this context, relevant clinical research has ben greatly discouraged. The Ministry of Education and the National Commission for Technical and Scientific research (CONICYT) have been committed, with no outstanding results however, to encourage these activities, specially sustaining individual projects originated in the traditional universities. Precarious conditions persist as manifested by meager budgets for investigation. Public health policies and organization are scarcely endorsed in locally generated clinical or public health knowledge. Postgraduate training programs, specially doctorates, needed to increase the academic human resources with a consistent scientific potential, are very limited. Recent governmental initiatives, altogether with specific proposals waiting for implementation, would certainly contribute to optimize and promote the revival of our impoverished scenarios in clinical research. PMID:11372301

  1. 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

  2. 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. PMID:19324048

  3. [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. PMID:27220800

  4. Spectral imaging in preclinical research and clinical pathology.

    PubMed

    Levenson, Richard; Beechem, Joseph; McNamara, George

    2013-01-01

    Spectral imaging methods are attracting increased interest from researchers and practitioners in basic science, preclinical and clinical arenas. A combination of better labeling reagents and better optics creates opportunities to detect and measure multiple parameters at the molecular and cellular level. These tools can provide valuable insights into the basic mechanisms of life, and yield diagnostic and prognostic information for clinical applications. There are many multispectral technologies available, each with its own advantages and limitations. This chapter will present an overview of the rationale for spectral imaging, and discuss the hardware, software and sample labeling strategies that can optimize its usefulness in clinical settings. PMID:23542931

  5. 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

  6. The secure medical research workspace: an IT infrastructure to enable secure research on clinical data.

    PubMed

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

    2013-06-01

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

  7. 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

  8. 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

  9. Nursing students learning to utilize nursing research in clinical practice.

    PubMed

    Mattila, Lea-Riitta; Eriksson, Elina

    2007-08-01

    The purpose of the study was to examine the significance of a learning assignment in relation to research skills and learning of nursing students in clinical practice. The learning assignment included an oral presentation of a nursing research article, which the students gave to their fellow students and ward nurses. The students also chaired the discussion after the presentation. The target group for the study was nursing students of a Finnish polytechnic who had been studying for 2-2 1/2 years and had accomplished a minimum of 120 ECTS credits of the total of 210 ECTS credits. When participating in the study, the students were completing a six-week clinical practice of optional studies. The data were collected with a questionnaire designed for the study. It consisted of six open-ended questions. Three of the questions were related to learning of research skills. Two questions were concerned with learning during the ongoing clinical practice. The final question inquired the students' views on the development of the learning assignment. The students received the questionnaire before the commencement of their clinical practice, and they returned it to the other researcher after their clinical practice. The questionnaire was given to 80 students, of which 50 returned it; the response rate was 63%. The data were analysed by content analysis question by question. According to the results, the learning assignment advanced the understanding of research concepts for the majority of the students. In particular, the students reported that the oral presentation clarified the research concepts, and the structure of a scientific article was also elucidated. The students stated that the assignment generated ideas concerning the development of nursing care. In relation to the ongoing clinical practice, the assignment advanced patient encounters and interaction, and bearing responsibility the most. Proposals for the further development of the learning assignment were expressed by

  10. 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

  11. Professional issues associated with the clinical research nurse role.

    PubMed

    MacArthur, Juliet; Hill, Gordon; Callister, Deborah

    2014-12-01

    Clinical research nurses (CRNs) have a vital role in the conduct and governance of clinical trials. This article compares findings of an online survey conducted in 2012 by the Scottish Research Nurse and Coordinator's Network with two surveys undertaken ten years previously in a single Scottish Health Board, permitting analysis of the development of the CRN role. The findings show that CRNs are highly qualified and experienced. Many had access to professional development and support, while others continued to feel isolated. There is a need for a clear, flexible career structure for CRNs, with appropriate induction, training and continuous professional development. PMID:25467360

  12. 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

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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

  18. Bridges between health care research evidence and clinical practice.

    PubMed Central

    Haynes, R B; Hayward, R S; Lomas, J

    1995-01-01

    Research is producing increasing amounts of important new evidence for health care, but there is a large gap between what this evidence shows can be done and the care that most patients actually receive. An important reason for this gap is the extensive processing that evidence requires before application. This article discusses a three-step model for bridging research evidence to management of clinical problems: getting the evidence straight, formulating evidence-based clinical policies, and applying evidence-based clinical policies at the right place and time. This model is purposely broad in scope and provides a framework for coordinating efforts to support evidence-based medical care. The authors' purpose is to represent the roles of health informatics in the context of the roles of all the key players, including health care researchers and practitioners, health care organizations, and the public. Health informatics has already made important contributions to bridging evidence to practice, including improving evidence retrieval, evaluation, and synthesis; new evidence-based information products; and computerized aids for facilitating the use of these products during clinical decision making. However, much more innovation and coordination are needed. The authors call for health informaticians to pay balanced attention to 1) the quality of evidence embodied in information innovations, 2) the performance of technologies and systems that retrieve, prepare, disseminate, and apply evidence, and 3) the fit of information tools to the specific clinical circumstances in which evidence is to be applied. Effective interdisciplinary teams that include health services researchers and other evidence experts, clinical practitioners, informaticians, and health care managers are needed to achieve success. Informaticians can make increasingly important contributions to the transfer of health care research by joining such teams. PMID:8581550

  19. Biobanking Informatics Infrastructure to Support Clinical and Translational Research

    PubMed Central

    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

    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

  20. A collaborative model for training clinical research staff.

    PubMed

    Reay, Hannah; Sears, Jackie

    2013-06-01

    The challenges of meeting the learning needs of clinical research staff are shared by managers of many groups of specialist practitioners. Such specialists tend, for example, to be few in number, come from a variety of disciplines, have a diversity of roles and work across several organisations or locations in relative isolation. This article gives an overview of a regional training initiative, the Birmingham region Research Training Collaborative, for clinical research staff, and describes how it provides reciprocal access to research-related training across organisational boundaries as well as being a forum where learning resources and events can be shared. It describes the benefits and challenges of this initiative and highlights the main elements of success. PMID:23841234

  1. Delphi survey of priorities in clinical nursing research.

    PubMed

    Lindeman, C A

    1975-01-01

    Using the Delphi technique, a panel of 433 nurse and nonnurse experts was surveyed regarding priorities for clinical research in nursing. Of these, 341 completed all four Delphi survey rounds. Three questions were studied: 1) Is this an area in which nursing should assume primary research responsibility? 2) How important is research on this topic for the profession of nursing? 3) What is the likelihood of change in patient welfare because of research on the topic? Although the nature and amount of data produced prohibited interpretation of the data or delineation of succinct conclusions about priorities for clinical nursing research, responses to the three questions supported these statements: The majority of research areas identified in the questionnaire are areas in which nursing should take research leadership. Although there is some overlap, priorities for professional significance and social or patient welfare relevance are different. In terms of professional significance, highest priority was given to items regarding measuring the quality of care, role, nursing process, and the research process. In terms of patient welfare, several programs of research are discernible in the items ranked in the top ten percent; these include nursing interventions related to stress, care of the aged, pain, and patient education. The Delphi technique also is described. PMID:1042714

  2. 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…

  3. 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

  4. 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

  5. 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.

  6. 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…

  7. 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.

  8. 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.

  9. Trials and tribulations of clinical research teaching and training

    PubMed Central

    Ghooi, Ravindra B.

    2010-01-01

    Clinical research institutions have mushroomed in the country, though there is a generalized lack of experienced faculty. These institutes mostly confine themselves to theoretical aspects of clinical research, since there is lack of facilities for practical training. Students passing out of these institutes often find it difficult to get decent jobs and salaries at the entry level in the industry are poor. Poor placements of graduating students become major barriers for attracting quality students to the courses. This in turn affects the quality of people that the industry requires, in order to ensure a high growth rate of the industry. The industry, in addition to facing a severe crunch of high quality professionals, is also suffering from attrition that is a common feature. This attrition stems from, inter alia the industry’s demand for experienced people at the entry level. To improve overall standards of professionals entering clinical research, institutes and the industry need to get together and work in close co-operation. The industry and the institutes need to take positive steps if recent trends have to be reversed and clinical research as a whole has to move to a higher level. This article is based on the perceptions of the author, about the problems faced and offers some suggestions. Though these perceptions represent the reality, it is difficult to provide hard evidence that they do so. PMID:21350729

  10. [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

  11. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy.

    PubMed

    Tunis, Sean R; Stryer, Daniel B; Clancy, Carolyn M

    2003-09-24

    Decision makers in health care are increasingly interested in using high-quality scientific evidence to support clinical and health policy choices; however, the quality of available scientific evidence is often found to be inadequate. Reliable evidence is essential to improve health care quality and to support efficient use of limited resources. The widespread gaps in evidence-based knowledge suggest that systematic flaws exist in the production of scientific evidence, in part because there is no consistent effort to conduct clinical trials designed to meet the needs of decision makers. Clinical trials for which the hypothesis and study design are developed specifically to answer the questions faced by decision makers are called pragmatic or practical clinical trials (PCTs). The characteristic features of PCTs are that they (1) select clinically relevant alternative interventions to compare, (2) include a diverse population of study participants, (3) recruit participants from heterogeneous practice settings, and (4) collect data on a broad range of health outcomes. The supply of PCTs is limited primarily because the major funders of clinical research, the National Institutes of Health and the medical products industry, do not focus on supporting such trials. Increasing the supply of PCTs will depend on the development of a mechanism to establish priorities for these studies, significant expansion of an infrastructure to conduct clinical research within the health care delivery system, more reliance on high-quality evidence by health care decision makers, and a substantial increase in public and private funding for these studies. For these changes to occur, clinical and health policy decision makers will need to become more involved in all aspects of clinical research, including priority setting, infrastructure development, and funding. PMID:14506122

  12. 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

  13. 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

  14. Clinical research-the silent partner in dental practice.

    PubMed

    Mandel, I D

    1993-07-01

    For 5,000 years innovative researchers, often anonymously, have been providing dentists and their antecedents with a rich inheritance of information, techniques, and materials. The giants of dental research of the past can still serve as role models today. This paper presents a history of clinical research and relates past work to current and future trends. In the last few decades, both technical innovation and oral biology and prevention have been progressing at an accelerated rate to provide a steady influx of new answers to dental practitioners and to elicit new questions from the next generation of dental investigators. PMID:8210314

  15. Clinical and Research Implications of Gambling Disorder in DSM-5

    PubMed Central

    Weinstock, Jeremiah; Rash, Carla J.

    2014-01-01

    The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders contains significant changes related to the diagnosis of gambling problems. These changes include the renaming of the disorder from pathological gambling to gambling disorder, reclassification of gambling disorder from an impulse control disorder to an addictive disorder, removal of the illegal acts criterion, lowering diagnostic threshold to endorsement of four criteria, and recognizing that the course of the disorder is no longer chronic for all diagnosed. This paper reviews the rationale and research support for these changes. Implications of the new revisions for both research and clinical practice are reviewed, including a discussion about future directions for research efforts. PMID:26885470

  16. Chandra Discovers Cosmic Cannonball

    NASA Astrophysics Data System (ADS)

    2007-11-01

    thought to have been ejected by interactions with the supermassive black hole in the Galaxy's center. CTIO Optical Images of Puppis A CTIO Optical Images of Puppis A This neutron star, by contrast, was flung into motion by the supernova that created Puppis A. The data suggest the explosion was lop-sided, kicking the neutron star in one direction and the debris from the explosion in the other. The supernova was precipitated when the core of a massive star imploded to form a neutron star. Computer simulations show that the infall of the outer layers of the star onto a neutron star releases an enormous amount of energy. As this energy propagates outward, it can reverse the infall and eject the outer layers of the star at speeds of millions of miles per hour. Due to the complexity of the flow, the ejection is not symmetric, leading to a rocket effect that propels the neutron star in the opposite direction. ROSAT X-ray ROSAT X-ray The breakneck speed of the Puppis A neutron star, plus an apparent lack of pulsations from it, is not easily explained by even the most sophisticated supernova explosion models. "The problem with discovering this cosmic cannonball is we aren't sure how to make the cannon powerful enough." said Winkler. "The high speed might be explained by an unusually energetic explosion, but the models are complicated and hard to apply to real explosions." Other recent work on RX J0822-4300 was published by C.Y. Hui and Wolfgang Becker, both from the Max Planck Institute for Extraterrestrial Physics in Munich, in the journal Astronomy and Astrophysics in late 2006. Using two of the three Chandra observations reported in the Winkler paper and a different analysis technique, the Hui group found a speed for RX J0822-4300 that is about two-thirds as fast, but with larger reported margins of error. The research by Winkler and Petre was published in the November 20 issue of The Astrophysical Journal. NASA's Marshall Space Flight Center, Huntsville, Ala., manages the

  17. 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

  18. 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

  19. Governance strategies for conducting text messaging interventions in clinical research.

    PubMed

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

    2014-04-01

    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

  20. 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

  1. 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

  2. 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.

  3. Clinical research at a crossroads: the NIH roadmap.

    PubMed

    Zerhouni, Elias A

    2006-05-01

    As a result of the NIH investment in biomedical research, over the past 30 years we have seen many great advances impacting the health of our nation which have been fostered by the effective translation of scientific advances. However, rising costs for both research and health care mean that the NIH must make strategic decisions that maximize the return on its investment. Because treating end-stage disease is so costly, both personally and financially, learning how to pre-empt illness through molecular knowledge and behavioral interventions is the only viable strategy for maintaining the nation's health in the coming years. In order to speed scientific discovery and its efficient translation to patient care, the NIH developed the Roadmap for Biomedical Research. The Roadmap provides an incubator space for funding innovative programs to address a panoply of scientific challenges and has engendered a new culture of cooperation among researchers seeking new avenues for collaboration. An important feature of the Roadmap is the Clinical and Translational Science Awards (CTSA). The program's goals are to eliminate growing barriers between clinical and basic research, to address the increasing complexities involved in conducting clinical research, and to help institutions nationwide create an academic home for clinical and translational science. By adopting a strong strategic vision now, the NIH will be able to stand at the ready as future challenges and opportunities emerge. In keeping with our mission, the NIH's current and future actions will be defined by the requirements of the scientific community and the public health needs of the nation. PMID:17152855

  4. Clinical Comparative Effectiveness Research Through the Lens of Healthcare Decisionmakers

    PubMed Central

    Price-Haywood, Eboni G.

    2015-01-01

    Background Healthcare expenditures in the United States exceed the healthcare expenditures of other countries, yet relatively unfavorable health outcomes persist. Despite the emergence of numerous evidence-based interventions, wide variations in clinical care have caused disparities in quality of care and cost. Comparative effectiveness and cost effectiveness research may better guide healthcare decisionmakers in determining which interventions work best, for which populations, under which conditions, and at what cost. Methods This article reviews national health policies that promote comparative effectiveness research (CER), healthcare decisionmaker roles in CER, methodological approaches to CER, and future implications of CER. Results This article provides a brief summary of CER health policy up to the Patient Protection and Affordable Care Act and its establishment of the Patient-Centered Outcomes Research Institute (PCORI). Through PCORI, participatory methods for engaging healthcare decisionmakers in the entire CER process have gained momentum as a strategy for improving the relevance of research and expediting the translation of research into practice. Well-designed, methodologically rigorous observational studies and randomized trials conducted in real-world settings have the potential to improve the quality, generalizability, and transferability of study findings. Conclusion Learning health systems and practice-based research networks provide the infrastructure for advancing CER methods, generating local solutions to high-quality cost-effective care, and transitioning research into implementation and dissemination science—all of which will ultimately guide health policy on clinical care, payment for care, and population health. PMID:26130978

  5. 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)

  6. Helping Your Children Discover.

    ERIC Educational Resources Information Center

    Schroepfer, Dorothy; Yeaton, Charles

    Children discover many things about themselves, about the world around them, and about words and language, before they go to school. This booklet was prepared to guide parents in helping their children make such discoveries in preparation for the demands of learning in school. Activities are suggested for developing children's self-confidence,…

  7. Discovering Hidden Voices.

    ERIC Educational Resources Information Center

    Collins, Carol

    1991-01-01

    Working with teachers and artists from Florida to Maine, a drama educator has discovered that creative power and insight can emerge when using drama in the language arts classroom. One seventh-grade class began with simple warm-ups to loosen inhibitions and then moved into a unit that dealt with improvising using movement. A student who had hardly…

  8. 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…

  9. The Mid-South Clinical Data Research Network

    PubMed Central

    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

  10. [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. PMID:16227916

  11. 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

  12. 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

  13. 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. PMID:19183518

  14. 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.

  15. 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

  16. Clinical trials and contract research organizations in India.

    PubMed

    Mukherjee, Shoibal

    2012-06-01

    Economics and demography are driving drug development to the developing world. India needs this opportunity to build research skills required to combat its enormous disease burden. A variety of global and local contract research organizations (CROs) that specialize in the execution of research to develop health care products operate in India today. CROs assure quality and compliance to regulations while coordinating with tertiary providers such as a site management organization and the central laboratory. Back room operations to manage, analyze, and report data form a bulk of the employment generated by clinical research, absorbing programmers, data managers, biostatisticians,and medical writers. Despite rapid growth and strong potential, India remains a minor contributor to global pharmaceutical research because of policy stagnation, regulatory gaps, and misinformed controversies in the media. PMID:22727008

  17. Leaders, leadership and future primary care clinical research

    PubMed Central

    Furler, John; Cleland, Jennifer; Del Mar, Chris; Hanratty, Barbara; Kadam, Umesh; Lasserson, Daniel; McCowan, Colin; Magin, Parker; Mitchell, Caroline; Qureshi, Nadeem; Rait, Greta; Steel, Nick; van Driel, Mieke; Ward, Alison

    2008-01-01

    Background A strong and self confident primary care workforce can deliver the highest quality care and outcomes equitably and cost effectively. To meet the increasing demands being made of it, primary care needs its own thriving research culture and knowledge base. Methods Review of recent developments supporting primary care clinical research. Results Primary care research has benefited from a small group of passionate leaders and significant investment in recent decades in some countries. Emerging from this has been innovation in research design and focus, although less is known of the effect on research output. Conclusion Primary care research is now well placed to lead a broad re-vitalisation of academic medicine, answering questions of relevance to practitioners, patients, communities and Government. Key areas for future primary care research leaders to focus on include exposing undergraduates early to primary care research, integrating this early exposure with doctoral and postdoctoral research career support, further expanding cross disciplinary approaches, and developing useful measures of output for future primary care research investment. PMID:18822178

  18. 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

  19. 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

  20. 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

  1. Clinical and translational research studios: a multidisciplinary internal support program.

    PubMed

    Byrne, Daniel W; Biaggioni, Italo; Bernard, Gordon R; Helmer, Tara T; Boone, Leslie R; Pulley, Jill M; Edwards, Terri; Dittus, Robert S

    2012-08-01

    The Vanderbilt Institute for Clinical and Translational Research implemented the "Studio" Program in 2007 to bring together experts to provide free, structured, project-specific feedback for medical researchers. Studios are a series of integrated, dynamic, and interactive roundtable discussions that bring relevant research experts from diverse academic disciplines together to focus on a specific research project at a specific stage. Vanderbilt's Clinical and Translational Science Award supports the program, which is designed to improve the quality and impact of biomedical research. In this article, the authors describe the program's design, and they provide an evaluation of its first four years.After an investigator completes a brief online Studio application, a Studio "manager" reviews the request, assembles a panel of three to six experts (research faculty from multiple disciplines), and circulates the pre-review materials electronically. Investigators can request one of seven Studio formats: hypothesis generation, study design, grant review, implementation, analysis and interpretation, manuscript review, or translation. A Studio moderator leads each Studio session, managing the time (90 minutes) and discussion to optimize the usefulness of the session for the investigator.Feedback from the 157 Studio sessions in the first four years has been overwhelmingly positive. Investigators have indicated that their Studios have improved the quality of their science (99%; 121/122 responses), and experts have reported that the Studios have been a valuable use of their time (98%; 398/406 responses). PMID:22722360

  2. 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…

  3. 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. PMID:25684017

  4. Computerized clinical guidelines: current status & principles for future research.

    PubMed

    Kondylakis, Haridimos; Tsiknakis, Manolis

    2012-01-01

    Although it is widely accepted that the adoption of computerized clinical guidelines would improve the quality of the provided health care, their influence in the daily practice is limited. In this paper we provide insights on the core topics related to computer interpretable clinical guidelines and we present shortly the main approaches in the area. Then we discuss the current limitations, and we present three simple principles that according to our view should be adopted to enhance the penetration of computerized clinical guidelines in the health care organizations. The overall goal of this paper is not only to give readers a quick overview of the works in the area, but also to provide necessary insights for the practical understanding of the issues involved and draw directions for future research and development activities. PMID:22874227

  5. Teaching statistics to clinical research staff in a pharmaceutical company.

    PubMed

    Dhar, Sunil K; Kianifard, Farid

    2006-01-01

    Education of clinical research staff in understanding statistical concepts is an area of importance for pharmaceutical companies. This understanding is needed to help them communicate with statisticians using a common language, in designing clinical trials and interpretation of clinical trial results. Such staff has little time for a one-semester or even a one-week continuing education course in statistics. Faced with this reality, we developed a 3-module course,for a total of 1.5 days, which was taught over a period of one month that addresses the needs of this audience. We describe the format and content of the course and provide references that can serve as a resource for teaching such a course. PMID:17080755

  6. Boom in clinical research industry: a dangerous trend.

    PubMed

    Bajpai, Vikas; Saraya, Anoop

    2009-01-01

    Over the last decade or so India has witnessed a phenomenal growth in the clinical trial industry. The projections forecast a continuing growth of this trend. It has been predicted that by 2011 India will be in charge of 15% of global clinical trials. The enthusiasm for the growth of this industry in India is shared not just by the major pharmaceutical companies and CROs but also equally so by government agencies. The raison d'être for medical research is that it should lead to maximum possible benefit to the largest number of people. Hence, an examination of the extent to which public good is served can act as a measure for objective analysis of this exponential increase in the clinical trial industry. After all it is the health and lives of the people that are at stake. On the face of it, it would seem that all trials testing the safety and efficacy of various molecules, by their very nature work towards public welfare as they are indispensible to the development of any drug including the life-saving ones. An increasing number of clinical trials at all stages in a product's life cycle are funded by the pharmaceutical industry. It would then seem that the industry-sponsored medical research is necessarily furthering the larger objective of human wellbeing. However, the operations of the pharmaceutical industry, the nature of the processes involved and the operative motives are a bit too complex to facilitate this larger objective so simply, just as yet. This warrants a closer look at the various aspects of industry-sponsored clinical research. PMID:20306757

  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. Clinical research regulation: challenges to the institutional review board system.

    PubMed

    Straight, Timothy M

    2009-01-01

    The system in place to ensure the ethical conduct of human subject research in accordance with federal regulations has drawn great criticism from all sides, to include clinical investigators, administrators, research subjects, and legislators. The administrative requirements associated with clinical trials has changed dramatically in the last several decades, as has the complexity of the science being regulated. The institutional review board (IRB) system, however, appears to be struggling to keep pace, and has even been labeled a "system in jeopardy" by a national committee of experts. This contribution outlines the current obstacles and critique of IRBs, providing a discussion of the structure of the IRB system and strategies to meet these challenges. PMID:19539166

  9. 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

  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. 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...

  12. 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 ...

  13. 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 ... very emotional." Should You Be Interested in a Clinical Trial People volunteer to take part in clinical ...

  14. 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

  15. 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

  16. 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...

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

    PubMed

    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

  20. 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

  1. 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

  2. Computer-Acquired Clinical Laboratory Data Bases in Medical Research

    PubMed Central

    Lewis, John W.

    1979-01-01

    A growing number of clinical laboratories use computerized laboratory information systems for data acquisition, data management, and report generation. Although the research potential of the large machine-readable data bases generated by these systems is often mentioned, there has been comparatively little actual use of data bases for research. This presentation will briefly present four research studies using laboratory data bases and discuss the problems which were encountered in acquiring, characterizing, and maintaining these data bases. The use of medical records, pharmacy, financial, and other machine-readable data bases available in many hospitals will be discussed. The problems encountered with the use of coded diagnosis and operations records in combination with laboratory data are of particular concern. Finally, the use of clinical laboratory systems in conjunction with total hospital information systems for the accumulation of research data bases will be illustrated. It is particularly important that the lessons learned to date be incorporated into planning for the use of hospital information systems in research so that the enormous potential of these systems can be realized.

  3. 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

  4. 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.

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

    PubMed Central

    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. PMID:26240823

  6. 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. PMID:26240823

  7. The Southeast Asian Influenza Clinical Research Network: development and challenges for a new multilateral research endeavor.

    PubMed

    Higgs, Elizabeth S; Hayden, Frederick G; Chotpitayasunondh, Tawee; Whitworth, Jimmy; Farrar, Jeremy

    2008-04-01

    The Southeast Asia Influenza Clinical Research Network (SEA ICRN) (www.seaclinicalresearch.org) is a recently developed multilateral, collaborative partnership that aims to advance scientific knowledge and management of human influenza through integrated clinical investigation. The partnership of hospitals and institutions in Indonesia, Thailand, United Kingdom, United States, and Viet Nam was established in late 2005 after agreement on the general principles and mission of the initiative and after securing initial financial support. The establishment of the SEA ICRN was both a response to the re-emergence of the highly pathogenic avian influenza A(H5N1) virus in Southeast Asia in late 2003 and an acknowledgment that clinical trials on emerging infectious diseases require prepared and coordinated research capacity. The objectives of the Network also include building sustainable research capacity in the region, compliance with international standards, and prompt dissemination of information and sharing of samples. The scope of research includes diagnosis, pathogenesis, treatment and prevention of human influenza due to seasonal or novel viruses. The Network has overcome numerous logistical and scientific challenges but has now successfully initiated several clinical trials. The establishment of a clinical research network is a vital part of preparedness and an important element during an initial response phase to a pandemic. PMID:18295355

  8. 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

  9. [Continuing medical education: a clinical research institutional project].

    PubMed

    Fuentes, Nora A; Giunta, Diego H; Pazo, Valeria; Elizondo, Cristina M; Figar, Silvana; González Bernaldo de Quirós, Fernán

    2010-01-01

    In Argentina, education in clinical investigation is based on courses with theoric content. In developed countries programs with ongoing and practical content exist, generating the proper context to learn. In 2006, the Hospital Italiano de Buenos Aires (HIBA) created an area to train physicians, Research Area in Internal Medicine, and enable them to participate in every step of the clinical investigation process. The objective of this study is to describe this teaching area and its impact on the investigation in Internal Medicine in the HIBA, in the period 2006-2008. This area counts with fellow positions and provides training in Clinical Investigation for rotating residents. It has different activities including lectures, project counseling and 3 ongoing Institutional Registers for prevalent medical problems, 33% (6/18) of Intern staff are currently participating, with 3 fellows and 7 monitors for the Registers; 25 residents rotated in the area and generated their own research projects. 59 posters were presented in local and international congresses. Currently 6 original articles are in process of publication and 2 in peer review evaluation. A survey was carried out to evaluate the area where 76% (35/46) of the participants believed that they have acquired new skills; with 93% (44/47) using these knowledges in their every day practice. A 100% thought that they were adequately oriented in their projects, their ideas being fully respected (97%) (45/46). The inclusion of the Research Area in Internal Medicine improved the knowledge of the process of clinical Investigation and increased independent scientific production. PMID:20529773

  10. Common and Divergent Immune Response Signaling Pathways Discovered in Peripheral Blood Mononuclear Cell Gene Expression Patterns in Presymptomatic and Clinically Apparent Malaria†

    PubMed Central

    Ockenhouse, Christian F.; Hu, Wan-chung; Kester, Kent E.; Cummings, James F.; Stewart, Ann; Heppner, D. Gray; Jedlicka, Anne E.; Scott, Alan L.; Wolfe, Nathan D.; Vahey, Maryanne; Burke, Donald S.

    2006-01-01

    Using genome-wide expression profiles from persons either experimentally challenged with malaria-infected mosquitoes or naturally infected with Plasmodium falciparum malaria, we present details of the transcriptional changes that occur with infection and that either are commonly shared between subjects with presymptomatic and clinically apparent malaria or distinguish these two groups. Toll-like receptor signaling through NF-κB pathways was significantly upregulated in both groups, as were downstream genes that function in phagocytosis and inflammation, including the cytokines tumor necrosis factor alpha, gamma interferon (IFN-γ), and interleukin-1β (IL-1β). The molecular program derived from these signatures illuminates the closely orchestrated interactions that regulate gene expression by transcription factors such as IRF-1 in the IFN-γ signal transduction pathway. Modulation of transcripts in heat shock and glycolytic enzyme genes paralleled the intensity of infection. Major histocompatibility complex class I molecules and genes involved in class II antigen presentation are significantly induced in 90% of malaria-infected persons regardless of group. Differences between early presymptomatic infection and natural infection involved genes that regulate the induction of apoptosis through mitogen-activated protein (MAP) kinases and signaling pathways through the endogenous pyrogen IL-1β, a major inducer of fever. The induction of apoptosis in peripheral blood mononuclear cells from patients with naturally acquired infection impacted the mitochondrial control of apoptosis and the activation of MAP kinase pathways centered around MAPK14 (p38α and p38β). Our findings confirm and extend findings regarding aspects of the earliest responses to malaria infection at the molecular level, which may be informative in elucidating how innate and adaptive immune responses may be modulated in different stages of infection. PMID:16988231

  11. Clinical research centre serves 70,000 patients annually.

    PubMed

    1992-01-01

    The Bangladesh, ICDDR,B's Clinical Research Center (CPR) is described since its inception in 1960 as the former Dhaka Hospital. As 1 of 4 divisions, the CRC has increased admissions for diarrheal diseases, which is associated with the respect earned within the population, and averages 70,000/year. Included in the discussion is consideration of the objectives of the CRC and its predecessor, patient care, research, training, physical facilities, and new and other activities. Early research objectives were to find a better protocol for treatment of diarrheal diseases. Cholera and other diarrheal disease findings contributed to the formulation of an iv fluid for the treatment of severely dehydrated patients. Oral rehydration therapy (ORT) research was also conducted at the center. The cholera death rate with treatment has been reduced to 1%. 70% of patients are children under 15 years old and 65% have some malnutrition. Patients in general come from Dhaka city and suburbs, but they also come from outside the district. Current research focuses on clinical management and basic pathophysiological and nutritional issues; efforts are underway to develop a super oral rehydration solution to improve special diets, and to determine successful implementation strategies. Medical, paramedical, and health workers are trained in establishing diarrheal treatment and training programs in other locations and in research methodologies. The Public Health Institutes has increased capacity to include a 60-bed inpatient ward, an intensive care unit of 12 beds, a 120-bed observation unit, a 30-bed research ward, and a traveler's clinic. The research ward also has an office and laboratory facility and endoscopic facilities with computers, icemakers, centrifuge, deep freezers, and a biological safety hood for sample processing and storage. During epidemics the facilities are still inadequate. Water supply and air cooling and electronic precision weighing scales are available. The Child Health

  12. 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...

  13. Ethical issues in clinical neuroscience research: a patient's perspective.

    PubMed

    Cohen, Perry D; Herman, Linda; Jedlinski, Sheryl; Willocks, Peggy; Wittekind, Paula

    2007-07-01

    A patient-centered paradigm for clinical research and medical care is presented as a solution to the problem of declining innovation and increasing costs and development time in the pipeline for new therapies. Fundamental differences in values and motivations among scientists, clinicians, industry sponsor, and patients in neurotherapeutics provide a framework for analysis of ethical conflicts and the loss of public confidence in medical research. Parkinson advocates' views on clinical trial participation, perceived risks and benefits, placebo controls, and sham surgery are presented. These views reflect the sense of urgency and the unique perspective that comes from living with this progressive, debilitating condition full time. A patient-centered paradigm that includes authentic voices of patients as collaborators at every stage of development will help to resolve conflicts, build trust, recruit trial participants, and accelerate new therapies. Key elements are adaptive clinical trial methods and the development of information technology for the assessment of outcomes and surveillance of safety over the life cycle of a medical product. Supported by the Parkinson's Disease Foundation, the Parkinson Pipeline Project is a grassroots group of Parkinson's patients whose goal is to represent an authentic voice for patients in the treatment development process. This group promotes education and communication between members of the Parkinson's community and active stakeholders in medical research, industry, and regulatory agencies. Its members are an example of a new breed of knowledgeable consumers, armed with first-hand access to research findings and reinforced by on-line connections to like-minded peers throughout the world. PMID:17599719

  14. 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

  15. Priority oral health research identification for clinical decision-making.

    PubMed

    Worthington, Helen; Clarkson, Jan; Weldon, Jo

    2015-09-01

    The Cochrane Library is a core resource for clinical decision-making globally, by clinicians, guideline developers, healthcare providers and patients.The publication of Cochrane Library systematic reviews concerning oral health conditions has grown exponentially to over 215 individual titles (as of 20 June 2015) during the past 20 years.Consequently, maintaining updates of the most clinically important reviews to provide up-to-date and accurate sources of evidence for decision-making has become a pressing concern for the editorial group behind their production, Cochrane Oral Health Group.To identify priority research required by oral health decision-makers, the Cochrane OHG embarked on a consultation process across eight defined areas of dentistry (periodontology, operative (including endodontics) and prosthodontics, paediatric dentistry, dental public health, oral and maxillofacial surgery, oral medicine, orthodontics, cleft lip and/or palate) with existing authors (by email), with members of the public (by online survey), and established internationally clinically expert panels for each area of defined area of dentistry to discuss and ratify (by teleconference) a core portfolio of priority evidence to be produced and maintained on the Cochrane Library.The resulting portfolio of priority research encompasses 81 existing titles to be maintained, and an additional 15 new systematic reviews to be developed by the Cochrane OHG in due course.The Cochrane OHG has actively responded to the outcomes of this prioritisation process by allocating resources to primarily supporting the maintenance of identified priority evidence for the Cochrane Library. PMID:26492797

  16. 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

  17. 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

  18. Myeloperoxidase and coronary arterial disease: from research to clinical practice.

    PubMed

    Roman, Raquel Melchior; Wendland, Andrea Elisabet; Polanczyk, Carisi Anne

    2008-07-01

    Myeloperoxidase (MPO) is an enzyme derived of leukocytes that catalyze formation of numerous reactive oxidant species. Besides members of the innate host defense, evidences have been proving the contribution of these oxidants to tissue injury during inflammation. MPO participates in proatherogenic biological activities related to the evolution of cardiovascular disease, including initiation, propagation and acute complications of atherosclerotic process. Thereby, MPO and its inflammatory cascade represents an attractive target for prognostical investigation and therapeutics in atherosclerotic cardiovascular disease. In this review, we present the state of the art in the understanding of biological actions to clinical evidences of the relationship between MPO and coronary arterial disease. Several studies point to the independent effect of MPO levels in the evolution of disease and incidence of events in patients with acute coronary syndrome. However, the additional predictive value of MPO levels in the cardiovascular risk assessment, to incorporate it to the clinical practice as marker of plaque vulnerability, is still not consistent. Additional studies are necessary to confirm its role in the different forms of presentation of ischemic disease, besides the standardization of the assay, fundamental point for transition of this marker from research atmosphere to use in clinical routine: : from laboratory to clinical practice. PMID:18660935

  19. Changing the research landscape: the New York City Clinical Data Research Network.

    PubMed

    Kaushal, Rainu; Hripcsak, George; Ascheim, Deborah D; Bloom, Toby; Campion, Thomas R; Caplan, Arthur L; Currie, Brian P; Check, Thomas; Deland, Emme Levin; Gourevitch, Marc N; Hart, Raffaella; Horowitz, Carol R; Kastenbaum, Isaac; Levin, Arthur Aaron; Low, Alexander F H; Meissner, Paul; Mirhaji, Parsa; Pincus, Harold A; Scaglione, Charles; Shelley, Donna; Tobin, Jonathan N

    2014-01-01

    The New York City Clinical Data Research Network (NYC-CDRN), funded by the Patient-Centered Outcomes Research Institute (PCORI), brings together 22 organizations including seven independent health systems to enable patient-centered clinical research, support a national network, and facilitate learning healthcare systems. The NYC-CDRN includes a robust, collaborative governance and organizational infrastructure, which takes advantage of its participants' experience, expertise, and history of collaboration. The technical design will employ an information model to document and manage the collection and transformation of clinical data, local institutional staging areas to transform and validate data, a centralized data processing facility to aggregate and share data, and use of common standards and tools. We strive to ensure that our project is patient-centered; nurtures collaboration among all stakeholders; develops scalable solutions facilitating growth and connections; chooses simple, elegant solutions wherever possible; and explores ways to streamline the administrative and regulatory approval process across sites. PMID:24821739

  20. Changing the research landscape: the New York City Clinical Data Research Network

    PubMed Central

    Kaushal, Rainu; Hripcsak, George; Ascheim, Deborah D; Bloom, Toby; Campion, Thomas R; Caplan, Arthur L; Currie, Brian P; Check, Thomas; Deland, Emme Levin; Gourevitch, Marc N; Hart, Raffaella; Horowitz, Carol R; Kastenbaum, Isaac; Levin, Arthur Aaron; Low, Alexander F H; Meissner, Paul; Mirhaji, Parsa; Pincus, Harold A; Scaglione, Charles; Shelley, Donna; Tobin, Jonathan N

    2014-01-01

    The New York City Clinical Data Research Network (NYC-CDRN), funded by the Patient-Centered Outcomes Research Institute (PCORI), brings together 22 organizations including seven independent health systems to enable patient-centered clinical research, support a national network, and facilitate learning healthcare systems. The NYC-CDRN includes a robust, collaborative governance and organizational infrastructure, which takes advantage of its participants’ experience, expertise, and history of collaboration. The technical design will employ an information model to document and manage the collection and transformation of clinical data, local institutional staging areas to transform and validate data, a centralized data processing facility to aggregate and share data, and use of common standards and tools. We strive to ensure that our project is patient-centered; nurtures collaboration among all stakeholders; develops scalable solutions facilitating growth and connections; chooses simple, elegant solutions wherever possible; and explores ways to streamline the administrative and regulatory approval process across sites. PMID:24821739

  1. Patient-powered research networks: building capacity for conducting patient-centered clinical outcomes research

    PubMed Central

    Daugherty, Sarah E; Wahba, Sarita; Fleurence, Rachael

    2014-01-01

    The Patient-Centered Outcomes Research Institute (PCORI) recently launched PCORnet to establish a single inter-operable multicenter data research network that will support observational research and randomized clinical trials. This paper provides an overview of the patient-powered research networks (PPRNs), networks of patient organizations focused on a particular health condition that are interested in sharing health information and engaging in research. PPRNs will build on their foundation of trust within the patient communities and draw on their expertise, working with participants to identify true patient-centered outcomes and direct a patient-centered research agenda. The PPRNs will overcome common challenges including enrolling a diverse and representative patient population; engaging patients in governance; designing the data infrastructure; sharing data securely while protecting privacy; prioritizing research questions; scaling small networks into a larger network; and identifying pathways to sustainability. PCORnet will be the first distributed research network to bring PCOR to national scale. PMID:24821741

  2. Patient-powered research networks: building capacity for conducting patient-centered clinical outcomes research.

    PubMed

    Daugherty, Sarah E; Wahba, Sarita; Fleurence, Rachael

    2014-01-01

    The Patient-Centered Outcomes Research Institute (PCORI) recently launched PCORnet to establish a single inter-operable multicenter data research network that will support observational research and randomized clinical trials. This paper provides an overview of the patient-powered research networks (PPRNs), networks of patient organizations focused on a particular health condition that are interested in sharing health information and engaging in research. PPRNs will build on their foundation of trust within the patient communities and draw on their expertise, working with participants to identify true patient-centered outcomes and direct a patient-centered research agenda. The PPRNs will overcome common challenges including enrolling a diverse and representative patient population; engaging patients in governance; designing the data infrastructure; sharing data securely while protecting privacy; prioritizing research questions; scaling small networks into a larger network; and identifying pathways to sustainability. PCORnet will be the first distributed research network to bring PCOR to national scale. PMID:24821741

  3. Portfolio of Clinical Research in Adult Cardiovascular Disease as Reflected in ClinicalTrials.gov

    PubMed Central

    Alexander, Karen P.; Kong, David F.; Starr, Aijing Z.; Kramer, Judith; Chiswell, Karen; Tasneem, Asba; Califf, Robert M.

    2013-01-01

    Background Cardiovascular medicine is widely regarded as a vanguard for evidence‐based drug and technology development. Our goal was to describe the cardiovascular clinical research portfolio from ClinicalTrials.gov. Methods and Results We identified 40 970 clinical research studies registered between 2007 and 2010 in which patients received diagnostic, therapeutic, or other interventions per protocol. By annotating 18 491 descriptors from the National Library of Medicine's Medical Subject Heading thesaurus and 1220 free‐text terms to select those relevant to cardiovascular disease, we identified studies that related to the diagnosis, treatment, or prevention of diseases of the heart and peripheral arteries in adults (n=2325 [66%] included from review of 3503 potential studies). The study intervention involved a drug in 44.6%, a device or procedure in 39.3%, behavioral intervention in 8.1%, and biological or genetic interventions in 3.0% of the trials. More than half of the trials were postmarket approval (phase 4, 25.6%) or not part of drug development (no phase, 34.5%). Nearly half of all studies (46.3%) anticipated enrolling 100 patients or fewer. The majority of studies assessed biomarkers or surrogate outcomes, with just 31.8% reporting a clinical event as a primary outcome. Conclusions Cardiovascular studies registered on ClinicalTrials.gov span a range of study designs. Data have limited verification or standardization and require manual processes to describe and categorize studies. The preponderance of small and late‐phase studies raises questions regarding the strength of evidence likely to be generated by the current portfolio and the potential efficiency to be gained by more research consolidation. PMID:24072529

  4. 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.

  5. Banking stem cells for research and clinical applications.

    PubMed

    Stacey, Glyn

    2012-01-01

    Standardization in stem cell research is a challenging aspect of the field although progress is being made to improve reliability and reproducibility of culture methods and differentiation protocols. A vital element in enabling valid comparisons of research data based on cell lines is to be able to assure the scientific quality of the cells used. Stem cell resource centers or "stem cell banks" can play an important role in stem cell research by focussing on delivery of pluripotent stem cell (PSC) lines that are fit for researchers needs, have not been switched or cross-contaminated by other cells, and are free of microbial contaminants. These fundamental elements of good scientific practice will help to promote good quality and comparable research publications. Stem cell banks can also provide advice on selection from the PSC lines they hold and best practice in culture, preservation, and quality control of stem cell lines. This chapter explores the value of stem cell banks and the various issues to address in delivering PSC lines for both research and as seed stocks for clinical development. PMID:23195414

  6. 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

  7. Dive and discover: Expeditions to the seafloor

    NASA Astrophysics Data System (ADS)

    Ayers Lawrence, Lisa

    The Dive and Discover Web site is a virtual treasure chest of deep sea science and classroom resources. The goals of Dive and Discover are to engage students, teachers, and the general public in the excitement of ocean disco very through an interactive educational Web site. You can follow scientists on oceanographic research cruises by reading their daily cruise logs, viewing photos and video clips of the discoveries, and even e-mailing questions to the scientists and crew. WHOI has also included an "Educator's Companion" section with teaching strategies, activities, and assessments, making Dive and Discover an excellent resource for the classroom.

  8. Dive and discover: Expeditions to the seafloor

    NASA Astrophysics Data System (ADS)

    Lawrence, Lisa Ayers

    The Dive and Discover Web site is a virtual treasure chest of deep sea science and classroom resources. The goals of Dive and Discover are to engage students, teachers, and the general public in the excitement of ocean disco very through an interactive educational Web site. You can follow scientists on oceanographic research cruises by reading their daily cruise logs, viewing photos and video clips of the discoveries, and even e-mailing questions to the scientists and crew. WHOI has also included an “Educator's Companion” section with teaching strategies, activities, and assessments, making Dive and Discover an excellent resource for the classroom.

  9. The clinical research office of the endourological society audit committee.

    PubMed

    Preminger, Glenn M; Alken, Peter; Habuchi, Tomonori; Wijkstra, Hessel; Skolarikos, Andreas; Yin, Chan-Jun

    2011-11-01

    The Clinical Research Office of the Endourological Society (CROES) conducts large-scale, international, multicenter clinical trials in the field of endourology. One of the major challenges that these trials pose is to ensure that data collected remotely and online within a very short time frame are valid and reliable. This editorial describes a formal process for auditing the data by the CROES Audit Committee. The audit process presented is largely based on an automatic scoring system, which takes into consideration several parameters to determine the quality of the data and of the participating institution. This process is dynamic in nature and offers live monitoring of both patient data and study centers. PMID:22010950

  10. 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. PMID:24778202

  11. Dominantly Inherited Alzheimer Network: facilitating research and clinical trials

    PubMed Central

    2013-01-01

    The Dominantly Inherited Alzheimer Network (DIAN) is an international registry of individuals at risk for developing autosomal dominant Alzheimer’s disease (AD). Its primary aims are to investigate the temporal ordering of AD pathophysiological changes that occur in asymptomatic mutation carriers and to identify those markers that herald the transition from cognitive normality to symptomatic AD. DIAN participants undergo longitudinal evaluations, including clinical and cognitive assessments and measurements of molecular and imaging AD biomarkers. This review details the unique attributes of DIAN as a model AD biomarker study and how it provides the infrastructure for innovative research projects, including clinical trials. The recent design and launch of the first anti-amyloid-beta secondary prevention trial in AD, led by the related DIAN Trials Unit, also are discussed. PMID:24131566

  12. Dominantly Inherited Alzheimer Network: facilitating research and clinical trials.

    PubMed

    Moulder, Krista L; Snider, B Joy; Mills, Susan L; Buckles, Virginia D; Santacruz, Anna M; Bateman, Randall J; Morris, John C

    2013-01-01

    The Dominantly Inherited Alzheimer Network (DIAN) is an international registry of individuals at risk for developing autosomal dominant Alzheimer's disease (AD). Its primary aims are to investigate the temporal ordering of AD pathophysiological changes that occur in asymptomatic mutation carriers and to identify those markers that herald the transition from cognitive normality to symptomatic AD. DIAN participants undergo longitudinal evaluations, including clinical and cognitive assessments and measurements of molecular and imaging AD biomarkers. This review details the unique attributes of DIAN as a model AD biomarker study and how it provides the infrastructure for innovative research projects, including clinical trials. The recent design and launch of the first anti-amyloid-beta secondary prevention trial in AD, led by the related DIAN Trials Unit, also are discussed. PMID:24131566

  13. Conditions for the relevance of infant research to clinical psychoanalysis.

    PubMed

    Fajardo, B

    1993-10-01

    There is increased pluralism within psychoanalysis today, and the practice of psychoanalysis rests on many different theories and distinctly different epistemologic perspectives about the nature of the truth, the position of the observer-analyst in the process, and the phenomena to be observed. The relevance of developmental observation research to clinical psychoanalysis will vary with the epistemological perspective of the practitioner, and to be relevant the perspective of the researcher must 'match' that of the clinician. Additionally, its relevance is conditioned by what is considered 'empirical' data, i.e. whether the data are defined behaviourally or by empathic judgements of an observer. Three broad categories of psychoanalytic perspectives are discussed: empirical-natural science, hermeneutic-empirical, and hermeneutic-constructivist. A patient in analysis is described, with details of two sessions. Three imaginary consultants, each representing one of the major epistemological clinical perspectives, comment on the material to demonstrate the relationship among technique, epistemology, and the ways infants and developmental observation research may be relevant (or not relevant). PMID:8307704

  14. How have the past 5 years of research changed clinical practice in paediatric nephrology?

    PubMed Central

    Marks, Stephen D

    2007-01-01

    Clinical practice in paediatric nephrology is continuously evolving to mirror the research output of the 21st century. The management of antenatally diagnosed renal anomalies, urinary tract infections, nephrotic syndrome and hypertension is becoming more evidence based. Obesity and related hypertension is being targeted at primary and secondary care. The evolving field of molecular and cytogenetics is discovering genes that are facilitating clinicians and families with prenatal diagnoses and understanding of disease processes. The progression of chronic kidney disease in childhood to end‐stage renal failure (ESRF) can be delayed using medical treatment to reduce proteinuria and treat hypertension. Pre‐emptive living‐related renal transplantation has become the treatment of choice for children with ESRF, thereby reducing the morbidity and mortality associated with peritoneal and haemodialysis. Although peritoneal dialysis, which is performed in the patient's home, is the preferred modality for children for whom there is no living or deceased donor for transplantation, home nocturnal haemodialysis is becoming a feasible option. Imaging modalities with the use of magnetic resonance and computerised tomography are continuously improving. As mortality for renal and vasculitic diseases improves, the gauntlet is now thrown down to reduce morbidity with secondary prevention of longer‐term complications such as atherosclerosis and hyperlipidaemia. Clinical and drug trials in the fields of hypertension, nephrotic syndrome, systemic lupus erythematosus, vasculitis and transplantation are producing more effective treatments, thereby reducing the morbidity resulting from the disease processes and the side effects of drugs. PMID:17376945

  15. The prostate-specific membrane antigen: Lessons and current clinical implications from 20 years of research

    PubMed Central

    Ristau, Benjamin T.; O’Keefe, Denise S.; Bacich, Dean J.

    2014-01-01

    Objective Despite a multitude of detection and treatment advances in the past two decades, prostate cancer remains the second leading cause of cancer death among men in the United States. Technological evolution and expanding knowledge of tumor biomarkers have invigorated exploration in prostate cancer therapeutics. Prostate-specific membrane antigen (PSMA) was one of the first prostate cancer biomarkers successfully cloned. Since that time, it has been characterized as the prototypical cell-surface marker for prostate cancer and has been the subject of intense clinical inquiry. We review the relevant research in PSMA on the 20th anniversary of its cloning. Methods and materials A PubMed® search using the keywords “prostate-specific membrane antigen” or “glutamate carboxypeptidase II” provided 1019 results. An additional 3 abstracts were included from scientific meetings. Articles were vetted by title and abstract with emphasis placed on those with clinically relevant findings. Results Sixty articles were selected for inclusion. PSMA was discovered and cloned in 1993. Its structure and function were further delineated in the ensuing decade. Consensus sites of expression in normal physiology are prostate, kidney, nervous system, and small intestine. PSMA has been implicated in the neovasculature of several tumors including urothelial and renal cell carcinomas. In prostate cancer, expression of PSMA is directly related to Gleason grade. PSMA has been tested both in imaging and therapeutics in a number of prostate cancer clinical trials. Several recent approaches to target PSMA include use of small molecule inhibitors, PSMA-based immunotherapy, RNA aptamer conjugates, and PSMA-targeted prodrug therapy. Future study of PSMA in prostate cancer might focus on its intracellular functions and possible role in tumor neurogenesis. Conclusions Twenty years from its discovery, PSMA represents a viable biomarker and treatment target in prostate cancer. Research to

  16. 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

  17. Evaluating the Risks of Clinical Research: Direct Comparative Analysis

    PubMed Central

    Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S.; Wendler, David

    2014-01-01

    Abstract Objectives: Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed “risks of daily life” standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. Methods: This study employed a conceptual and normative analysis, and use of an illustrative example. Results: Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the “risks of daily life” standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Conclusions: Direct comparative analysis is a systematic method for applying the “risks of daily life” standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about

  18. 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

  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. 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.

  1. 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

  2. Practicing Research Ethics: Private-Sector Physicians & Pharmaceutical Clinical Trials

    PubMed Central

    2008-01-01

    This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first upon historical studies of physicians as investigators and then upon 12 months of qualitative fieldwork in the South Western US, this paper analyzes the shifting, contextualized ethics that shape physicians’ relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities. PMID:18353515

  3. Recent topics in chemical and clinical research on glycated albumin.

    PubMed

    Ueda, Yuki; Matsumoto, Hideyuki

    2015-03-01

    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

  4. Geriatric epilepsy: research and clinical directions for the future.

    PubMed

    Roberson, Erik D; Hope, Omotola A; Martin, Roy C; Schmidt, Dieter

    2011-09-01

    There is a growing awareness of the need for improved treatment and care of older adults with epilepsy. The present review article highlights key clinical and research issues in the emerging field of geriatric epilepsy. Drs. Martin and Schmidt explore the scope of the problems in the field, outline topic areas including cognitive health/dementia, and diagnostic challenges, and also present important research questions that should be considered for the future. As part of this presentation, we will highlight the work of two promising young investigators whose work holds great promise for the field of geriatric epilepsy. Dr. Roberson will discuss his work focusing on the relationship of epilepsy and cognitive impairment, particularly as it relates to Alzheimer's disease pathology including tau and its role in epileptiform activity. Dr. Hope will outline key issues, as well as her work, relating to defining and measuring quality care in geriatric epilepsy. PMID:21596624

  5. Alzheimer's Disease Clinical and Research Update for Health Care Practitioners

    PubMed Central

    DeFina, Philip A.; Lichtenstein, Jonathan D.; Fellus, Jonathan

    2013-01-01

    Of the approximately 6.8 million Americans who have been diagnosed with dementia, over 5 million have been diagnosed with Alzheimer's Disease (AD). Due to the rise in the aging population, these figures are expected to double by 2050. The following paper provides an up-to-date review of clinical issues and relevant research. Research related to the methods of the earliest possible detection of AD is ongoing. Health care professionals should play a critical role in differentially diagnosing AD patients, as well as supporting their families. Novel interventions, including medications, natural supplements, and behavioral techniques, are constantly appearing in the literature. It is necessary for the health practitioner to remain current, regarding AD, as such information will facilitate better care for patients and their families. PMID:24083026

  6. Barriers to Clinical Research Participation in a Diabetes Randomized Clinical Trial

    PubMed Central

    Yozwiak, John A; Bearman, Diane L; Strand, Trudy D; Strasburg, Katherine R

    2009-01-01

    Little is known about how barriers to research participation are perceived, affected by or interact with patient characteristics, or how they vary over the course of a clinical trial. Participants (285) in the Renin-Angiotensin System Study (RASS), a randomized clinical primary prevention study of diabetic nephropathy and retinopathy at 2 Canadiana dn 1 US university, rated potential barriers to research participation yearly for 5 years. Baseline barriers rated as most adversely affecting participation were: missing work; frequency of appointments and procedures; study length; number of appointments and procedures; access to study location; and physical discomfort associated with procedures. Inadequate social support, unstable job, and use of alcohol and drugs were cited relatively infrequently, suggesting that although they may be important, candidates for whom these might be issues likely self-selected out of the study. Gender and gender by age interactions were found for specific perceived barriers, such as work and child care, and baseline barriers correlated with adherence. Elucidating the natural history of barriers to research participation is a step toward identifying strategies for helping participants overcome them, and ultimately may enhance the conduct of research. PMID:19167143

  7. Validity of the Research Diagnostic Criteria for Temporomandibular Disorders Axis I in clinical and research settings.

    PubMed

    Steenks, Michel H; de Wijer, Anton

    2009-01-01

    The lack of standardized diagnostic criteria for defining clinical subtypes of temporomandibular disorders (TMD) was the main motive to create the Research Diagnostic Criteria for TMD (RDC/TMD), which were provided to allow standardization and replication of research into the most common forms of muscle- and joint-related TMD. The RDC/TMD offered improvement compared to the older literature: the use of one system classifying TMD subgroups and the introduction of a dual-axis classification. The aim of this Focus Article is to appraise the RDC/TMD Axis I (physical findings). Since the original publication in 1992, no modification of the RDC/TMD has taken place, although research has yielded important new findings. The article outlines several concerns, including diagnostic issues in Axis I, classification criteria, feasibility of palpation sites, the myofascial diagnostic algorithm, the lack of joint tests (compression, traction), and missing subgroups. Using a gold standard examiner may improve calibration and offer better reliability; it does not improve any of the diagnostic validity issues. It is also noted that in the 2004 mission statement of the International Consortium For RDC/TMD-Based Research, the RDC/TMD are also advocated for clinical settings. Clinicians may eagerly embrace the RDC/TMD, believing that the clinical use of the RDC/TMD as a diagnostic procedure is already supported by evidence, but its application is not indicated in clinical settings. The article concludes that given the research developments, there is a need to update the RDC/TMD Axis I in the clinical research setting. PMID:19264032

  8. 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...

  9. 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...

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. US biomedical research: basic, translational, and clinical sciences.

    PubMed

    Zerhouni, Elias A

    2005-09-21

    The National Institutes of Health (NIH) is the world's largest biomedical research agency, with a 75-year record of responding to the nation's key medical challenges. Today, medical science is entering a revolutionary period marked by a shift in focus from acute to chronic diseases, rapidly escalating health care costs, a torrent of biological data generated by the sequencing of the human genome, and the development of advanced high-throughput technologies that allow for the study of vast molecular networks in health and disease. This unique period offers the unprecedented opportunity to identify individuals at risk of disease based on precise molecular knowledge, and the chance to intervene to preempt disease before it strikes. Conceptually, this represents the core scientific challenge of the coming century. The NIH is committed to the discoveries that will change the practice of medicine as we know it in order to meet this challenge. The NIH Roadmap constitutes an important vehicle for generating change-a most critical element of this plan is the reengineering of the national clinical research enterprise. This reinvention will call for the transformation of translational clinical science and for novel interdisciplinary approaches that will advance science and enhance the health of the nation. PMID:16174693

  16. Uterine transplantation research: laboratory protocols for clinical application.

    PubMed

    Díaz-García, C; Johannesson, L; Enskog, A; Tzakis, A; Olausson, M; Brännström, M

    2012-02-01

    The aim of this review is to summarize the state-of the-art methods that are used in clinical organ transplantation today, as well as the major findings of recent experimental uterus transplantation (UTx) research regarding organ donation/retrieval, ischemic preservation, surgical techniques for anastomosis, immunosuppression and pregnancy. Absolute uterine factor infertility lacks treatment despite the major developments in infertility treatment and assisted reproduction. Concerning uterine factor infertile patients, genetic motherhood is only possible through gestational surrogacy. The latter can pose medical, ethical and legal concerns such as lack of control of life habits during surrogate pregnancy, economic motives for women to become surrogate mothers, medical/psychological pregnancy-related risks of the surrogate mother and uncertainties regarding the mother definition. Thus, surrogacy is non-approved in large parts of the world. Recent advances in the field of solid organ transplantation and experimental UTx provide a favourable and safe background in a scenario in which a human clinical UTx trial can take place. Protocols based on animal research over the last decade are described with a view to providing a scientifically guided approach to human UTx as an experimental procedure in the future. PMID:21900333

  17. Transforming ocular surface stem cell research into successful clinical practice

    PubMed Central

    Sangwan, Virender S; Jain, Rajat; Basu, Sayan; Bagadi, Anupam B; Sureka, Shraddha; Mariappan, Indumathi; MacNeil, Sheila

    2014-01-01

    It has only been a quarter of a century since the discovery of adult stem cells at the human corneo-scleral limbus. These limbal stem cells are responsible for generating a constant and unending supply of corneal epithelial cells throughout life, thus maintaining a stable and uniformly refractive corneal surface. Establishing this hitherto unknown association between ocular surface disease and limbal dysfunction helped usher in therapeutic approaches that successfully addressed blinding conditions such as ocular burns, which were previously considered incurable. Subsequent advances in ocular surface biology through basic science research have translated into innovations that have made the surgical technique of limbal stem cell transplantation simpler and more predictable. This review recapitulates the basic biology of the limbus and the rationale and principles of limbal stem cell transplantation in ocular surface disease. An evidence-based algorithm is presented, which is tailored to clinical considerations such as laterality of affliction, severity of limbal damage and concurrent need for other procedures. Additionally, novel findings in the form of factors influencing the survival and function of limbal stem cells after transplantation and the possibility of substituting limbal cells with epithelial stem cells of other lineages is also discussed. Finally this review focuses on the future directions in which both basic science and clinical research in this field is headed. PMID:24492499

  18. [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

  19. 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

  20. 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

  1. Key-linked on-line databases for clinical research.

    PubMed

    Müller, Thomas H

    2012-01-01

    Separating patient identification data from clinical data and/or information about biomaterial samples is an effective data protection measure, especially in clinical research employing "on-line", i.e., web-based, data capture. In this paper, we show that this specialised technique can be generalised into a network architecture of interconnected on-line databases potentially serving a variety of purposes. The basic idea of this approach consists of maintaining logical links, i.e., common record keys, between corresponding data structures in pairs of databases while keeping the actual key values hidden from clients. For client systems, simultaneous access to corresponding records is mediated by temporary access tokens. At the relational level, these links are represented by arbitrary unique record keys common to both databases. This architecture allows for integration of related data in different databases without replicating or permanently sharing this data in one place. Each participating on-line database can determine the degree of integration by specifying linkage keys only for those data structures that may be logically connected to other data. Logical links can de designed for specific use cases. In addition, each database controls user access by enforcing its own authorisation scheme. Another advantage is that individual database owners retain considerable leeway in adapting to changing local requirements without compromising the integration into the network. Beyond protecting individual subject identification data, this architecture permits splitting a cooperatively used data pool to achieve many kinds of objectives. Application examples could be clinical registries needing subject contact information for follow-up, biomaterial banks with or without genetic information, and automatic or assisted integration of data from electronic medical records into research data. PMID:22874246

  2. 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

  3. Global Alzheimer Research Summit: basic and clinical research: present and future Alzheimer research.

    PubMed

    Gonsalves, Danielle; Jovanovic, Katarina; Da Costa Dias, Bianca; Weiss, Stefan F T

    2012-01-01

    We report here on the proceedings of the Global Alzheimer Summit that took place September 22-23, 2011 in Madrid, Spain. As Alzheimer disease (AD) is the leading cause of neurodegeneration in elderly individuals and as yet has no effective therapeutic option, it continues to stimulate global research interests. At the conference, leaders in the field of AD research provided insights into current developments in various areas of research, namely molecular mechanisms, genetics, novel aspects of AD research and translational research. Emphasis was also placed on the importance of biomarkers in the diagnosis of AD and development of current therapeutic strategies. PMID:22453170

  4. Research Ethics Committees and clinical research in Italy: where are we going?

    PubMed

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

    2015-01-01

    Italian Ethics Committees (ECs) have entered a new phase because of the recent Law no. 189 of November 8 2012 and the Ministry of Health Decree of February 8 2013. The new norms have introduced important changes. In fact, ECs are now established not to serve a single hospital or research institution but to serve even Regions. Moreover, they are established on the basis of the number of inhabitants, research sites and expected amount of clinical trials. The implementation of the news norms into practice have produced a drastic reduction in the number of ECs. This fact could raise some issues but it could obtain some benefits. The paper explains the main steps of ECs and clinical research development in Italy. Special attention will be paid to recent trends. Moreover, the new norms will be illustrated, showing possible issues and benefits connected to their implementation. PMID:25720722

  5. Sleep and cognitive (memory) function: research and clinical perspectives.

    PubMed

    Roth, T; Costa e Silva, J A; Chase, M H

    2001-09-01

    The field of memory and sleep is controversial and extremely interesting, and the relationships between thought processes, i.e. cognition and sleep, have recently been examined in a variety of clinical and basic research settings, as well as being the object of intense interest by the general public. For example, there are data which demonstrate that insomnia, as well as specific sleep disorders, can have a negative impact on sleep cognition as well as affect daytime patterns of cognitive functioning. Thus, sleep, disturbed sleep and the lack of sleep appear to affect cognitive and memory functions. An International Workshop dealing with Sleep and Cognitive Function: Research and Clinical Perspectives was convened in Cancún, Mexico, 1-4 March 1999 under the auspices of the World Health Organization Worldwide Project on Sleep and Health and the World Federation of Sleep Research Societies. A great number of areas of intersection between sleep and cognitive function were examined during the course of the Workshop, such as aging, cognition and sleep and the dream process and sleep. The results of these discussions are included in a WHO publication (WHO Doc.: MSD/MBD/00.8). In the present report we concentrate on presenting a summary of a coherent set of data which examine memory consolidation during sleep and the impact of insomnia on cognitive functions. Based upon these data, a review of memory and drug effects that are sleep-related, and an examination of the relationship between hypnotics and cognitive function are included. Finally, a summary of recommendations of the Workshop participants is presented. PMID:14592387

  6. 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

  7. Clinical Research Involving Minors in International and Serbian Regulations

    PubMed Central

    PLANOJEVIĆ, Nina; ŽIVOJINOVIĆ, Dragica

    2013-01-01

    Background: Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be – it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative’s consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors’ position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative’s consent is acceptable only for therapeutic research, because these can bring benefits to everyone’s health, including a minor in which those are conducted – this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other’s behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors’ participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model. PMID:24455493

  8. 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)

  9. 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.

  10. ClinicalCodes: An Online Clinical Codes Repository to Improve the Validity and Reproducibility of Research Using Electronic Medical Records

    PubMed Central

    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

  11. 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. PMID:24865678

  12. 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

  13. Clinical drug research in chronic central neurodegenerative disorders.

    PubMed

    Müller, Thomas; Foley, Paul

    2016-05-01

    Several compounds developed the treatment of Alzheimer's disease and Parkinson's disease have been clinically unsuccessful. Suggested reasons for these failures have included heterogeneous symptom expression, inappropriate assessment of effects, safety and tolerability hurdles, short duration of disease-modifying trials, recruiting pressure on study centers, administrative and bureaucratic overload, and pooling results from trial centers in different health care systems with differing quality and therapeutic concepts. The solution to these problems will include reducing the costs of drug development, with a concomitant reduction of approval hurdles. Trial designs are influenced by ethics committees, health care officials, political administrations, and research scientists. None have direct contact with the treated patients. Approval of novel therapeutic agents lies in the remit of health care officials, whereby price plays a more dominant role than therapeutic efficacy. Patients and prescribing physicians, however, are better placed to act as arbiters of the efficacy, risks, and overall value of a new drug in practice. PMID:26950806

  14. 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

  15. Immunotherapy for hepatocellular carcinoma: From basic research to clinical use

    PubMed Central

    Hong, Yu-Peng; Li, Zi-Duo; Prasoon, Pankaj; Zhang, Qi

    2015-01-01

    Hepatocellular carcinoma (HCC) is a common cancer worldwide with a poor prognosis. Few strategies have been proven efficient in HCC treatment, particularly for those patients not indicated for curative resection or transplantation. Immunotherapy has been developed for decades for cancer control and is attaining more attention as a result of encouraging outcomes of new strategies such as chimeric antigen receptor T cells and immune checkpoint blockade. Right at the front of the new era of immunotherapy, we review the immunotherapy in HCC treatment, from basic research to clinical trials, covering anything from immunomodulators, tumor vaccines and adoptive immunotherapy. The mechanisms, efficacy and safety as well as the approach particulars are unveiled to assist readers to gain a concise but extensive understanding of immunotherapy of HCC. PMID:25954480

  16. Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells

    PubMed Central

    Bieback, Karen; Kinzebach, Sven; Karagianni, Marianna

    2010-01-01

    It sounds simple to obtain sufficient numbers of cells derived from fetal or adult human tissues, isolate and/or expand the stem cells, and then transplant an appropriate number of these cells into the patient at the correct location. However, translating basic research into routine therapies is a complex multistep process which necessitates product regulation. The challenge relates to managing the expected therapeutic benefits with the potential risks and to balance the fast move to clinical trials with time-consuming cautious risk assessment. This paper will focus on the definition of mesenchymal stromal cells (MSCs), and challenges and achievements in the manufacturing process enabling their use in clinical studies. It will allude to different cellular sources, special capacities of MSCs, but also to current regulations, with a special focus on accessory material of human or animal origin, like media supplements. As cellular integrity and purity, formulation and lot release testing of the final product, validation of all procedures, and quality assurance are of utmost necessity, these topics will be addressed. PMID:21318154

  17. 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. PMID:23346316

  18. [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. PMID:25072545

  19. 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

  20. 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

  1. Frailty measurement in research and clinical practice: A review.

    PubMed

    Dent, Elsa; Kowal, Paul; Hoogendijk, Emiel O

    2016-06-01

    One of the leading causes of morbidity and premature mortality in older people is frailty. Frailty occurs when multiple physiological systems decline, to the extent that an individual's cellular repair mechanisms cannot maintain system homeostasis. This review gives an overview of the definitions and measurement of frailty in research and clinical practice, including: Fried's frailty phenotype; Rockwood and Mitnitski's Frailty Index (FI); the Study of Osteoporotic Fractures (SOF) Index; Edmonton Frailty Scale (EFS); the Fatigue, Resistance, Ambulation, Illness and Loss of weight (FRAIL) Index; Clinical Frailty Scale (CFS); the Multidimensional Prognostic Index (MPI); Tilburg Frailty Indicator (TFI); PRISMA-7; Groningen Frailty Indicator (GFI), Sherbrooke Postal Questionnaire (SPQ); the Gérontopôle Frailty Screening Tool (GFST) and the Kihon Checklist (KCL), among others. We summarise the main strengths and limitations of existing frailty measurements, and examine how well these measurements operationalise frailty according to Clegg's guidelines for frailty classification - that is: their accuracy in identifying frailty; their basis on biological causative theory; and their ability to reliably predict patient outcomes and response to potential therapies. PMID:27039014

  2. Major clinical research advances in gynecologic cancer in 2012

    PubMed Central

    Suh, Dong Hoon; 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. PMID:23346316

  3. The next best thing to being there: conducting the clinical research interview by telephone.

    PubMed

    Tausig, J E; Freeman, E W

    1988-07-01

    This methodological commentary explores the utility of the telephone as a medium for collecting sensitive clinical research data. The nature of the clinical interview is discussed, clinical and research literature dealing with use of the telephone is reviewed, and a follow-up study conducted entirely by telephone is described. More rigorous study of this research approach is called for. PMID:3407732

  4. 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...

  5. 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...

  6. 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

  7. Li-Fraumeni syndrome: report of a clinical research workshop and creation of a research consortium.

    PubMed

    Mai, Phuong L; Malkin, David; Garber, Judy E; Schiffman, Joshua D; Weitzel, Jeffrey N; Strong, Louise C; Wyss, Oliver; Locke, Luana; Means, Von; Achatz, Maria Isabel; Hainaut, Pierre; Frebourg, Thierry; Evans, D Gareth; Bleiker, Eveline; Patenaude, Andrea; Schneider, Katherine; Wilfond, Benjamin; Peters, June A; Hwang, Paul M; Ford, James; Tabori, Uri; Ognjanovic, Simona; Dennis, Phillip A; Wentzensen, Ingrid M; Greene, Mark H; Fraumeni, Joseph F; Savage, Sharon A

    2012-10-01

    Li-Fraumeni syndrome (LFS) is a rare dominantly inherited cancer predisposition syndrome that was first described in 1969. In most families, it is caused by germline mutations in the TP53 gene and is characterized by early onset of multiple specific cancers and very high lifetime cumulative cancer risk. Despite significant progress in understanding the molecular biology of TP53, the optimal clinical management of this syndrome is poorly defined. We convened a workshop on November 2, 2010, at the National Institutes of Health in Bethesda, Maryland, bringing together clinicians and scientists, as well as individuals from families with LFS, to review the state of the science, address clinical management issues, stimulate collaborative research, and engage the LFS family community. This workshop also led to the creation of the Li-Fraumeni Exploration (LiFE) Research Consortium. PMID:22939227

  8. Li-Fraumeni syndrome: report of a clinical research workshop and creation of a research consortium

    PubMed Central

    Mai, Phuong L.; Malkin, David; Garber, Judy E.; Schiffman, Joshua D.; Weitzel, Jeffrey N.; Strong, Louise C.; Wyss, Oliver; Locke, Luana; Means, Von; Achatz, Maria Isabel; Hainaut, Pierre; Frebourg, Thierry; Evans, D. Gareth; Bleiker, Eveline; Patenaude, Andrea; Schneider, Katherine; Wilfond, Benjamin; Peters, June A.; Hwang, Paul M.; Ford, James; Tabori, Uri; Ognjanovic, Simona; Dennis, Phillip A.; Wentzensen, Ingrid M.; Greene, Mark H.; Fraumeni, Joseph F.; Savage, Sharon A.

    2013-01-01

    Li-Fraumeni syndrome (LFS) is a rare dominantly inherited cancer predisposition syndrome that was first described in 1969. In most families, it is caused by germline mutations in the TP53 gene and is characterized by early onset of multiple specific cancers and very high lifetime cumulative cancer risk. Despite significant progress in understanding the molecular biology of TP53, the optimal clinical management of this syndrome is poorly defined. We convened a workshop on November 2, 2010, at the National Institutes of Health in Bethesda, Maryland, bringing together clinicians and scientists, as well as individuals from families with LFS, to review the state of the science, address clinical management issues, stimulate collaborative research, and engage the LFS family community. This workshop also led to the creation of the Li-Fraumeni Exploration (LiFE) Research Consortium. PMID:22939227

  9. 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

  10. 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

  11. [Three-dimensional cephalometry: applications in clinical practice and research].

    PubMed

    Faure, Jacques; Oueiss, Arlette; Marchal-Sixou, Christine; Braga, José; Treil, Jacques

    2008-03-01

    A 3D cephalometric analysis method from scanner acquisition has been developed thanks to a long collaboration between Dr Treil and the Department of Orthodontics in Toulouse III University. It allows a perfect knowledge of maxillo-facial architecture using fourteen landmarks related to the neuromatricial axis of facial growth. These landmarks can be identified without ambiguity. The marking of each tooth relative to dental arches (gravity centre coordinates and torque and tipping of each tooth), and the location of arches relative to maxillo-facial frame are given by the analysis. Description and reconstruction of dental and maxillo-facial anatomy are possible with three levels: maxillo-facial frame, maxillar and mandibular bases and dentoalveolar level. The method not only gives more precise information than conventional cephalometrics in anteroposterior and vertical directions, but it allows transversal analysis and asymmetry measurement. Applications are numerous in research as well as in clinical medicine: analyses of cases border line surgery, surgical set-up, facial asymmetry, analysis of dentoalveolar compensations, definition of therapeutic aims, occlusal analysis and set-up, study of evolution in anthropology-primatology, study of growth etc. This method of description using a pattern of landmarks is perfectly adapted to the last developments of modern research techniques: morphometric geometry with Procustes superimpositions, EDMA, TPS, FEM. PMID:18364213

  12. Research misconduct in clinical research--the American experience and response.

    PubMed

    Ryan, K J

    1999-01-01

    Research misconduct in the United States has occurred sporadically since 1961 in the laboratories of some of our most distinguished scientists. In view of the enormous number of research grants funded, cases of this kind are relatively uncommon, but have none the less attracted governmental supervision and calls for reform. The scientific community, universities and government have addressed the issue in various ways and changes have been proposed and some actually instituted. In view of human nature, no one seriously believes that dishonesty in research can be prevented to any greater extent than in any other human activity. However, some practices may discourage and mitigate such occurrences. These include: education in sound laboratory research practices, a fair distribution of authorship assignment, and adequate supervision of research personnel including appropriate reviewing of primary data. Other measures which might be considered include: an adequate check of the credentials of all new personnel, audits for clinical research, especially for those involving significant numbers of patients and multiple institutions, and the introduction of quality control concepts into research procedures. The hope is that the senior individual scientist responsible for the quality and integrity of the research will institute such measures as needed, and that institutional and government supervision will not interfere with the creative process. PMID:10090695

  13. 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

  14. 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

  15. Clinical implications of basic research in hepatocellular carcinoma.

    PubMed

    Dhanasekaran, Renumathy; Venkatesh, Sudhakar K; Torbenson, Michael S; Roberts, Lewis R

    2016-03-01

    A 58-year old Caucasian female has compensated hepatitis C related cirrhosis. Her surveillance ultrasound showed hypodense liver nodules and subsequent triple phase CT scan showed five tumor nodules with diameters ranging from 3-5cms involving both hepatic lobes. The nodules showed characteristic radiologic findings on the CT scan and she was diagnosed with hepatocellular carcinoma (HCC) based on non-invasive criteria. There was also associated right portal vein tumor thrombosis. Her functional capacity at diagnosis was slightly limited, but she was capable of performing all activities of daily living and self-care. Her laboratory tests at diagnosis were as follows: sodium 129mmol/L, potassium 3.6mmol/L, blood urea nitrogen 22mg/dL, creatinine 1.0mg/dL, albumin 2.9g/dl, bilirubin 1.8mg/dl, alanine aminotransferase 87U/L, aspartate aminotransferase 68U/L, alkaline phosphatase 139U/L, white blood cell 3.5x10(9)/L, hemoglobin 10.4, platelet count 73x10(9)/L, international normalized ratio 1.9 and alpha-fetoprotein 5200ng/ml. An upper endoscopy was negative for esophageal or gastric varices. Based on the tumor burden, presence of macrovascular invasion, ECOG performance status of 1 and Child-Pugh class A she was classified to have BCLC stage C HCC. She was started on sorafenib therapy at 400mg oral twice daily but unfortunately this had to be discontinued since she experienced severe diarrhea and skin rash. She now returns for follow-up and requests information on the available therapeutic options. This particular case scenario is not uncommon and does raise several clinically relevant questions: This review provides a comprehensive overview of the current state of HCC management and also examines the clinical implications of recent basic research in HCC. PMID:26450813

  16. Major clinical research advances in gynecologic cancer in 2014

    PubMed Central

    Lee, Kyung-Hun; Kim, Kidong; Kang, Sokbom

    2015-01-01

    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

  17. 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)

  18. 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

  19. Incorporating translational research with clinical research to increase effectiveness in healthcare for better health

    PubMed Central

    2014-01-01

    Background The transfer of new scientific discoveries into healthcare interventions requires that basic and clinical researchers work together with health care providers to generate team science. These innovative models require translational teams, and need to extend beyond the academic environment. The future of translational science requires partnerships with the healthcare community as well as the broader, general community. This new integrated model of effective translational teams holds promise for addressing thorny and persistent health disparities, is consistent with the nation’s strategic priority of eliminating health disparities, and bodes well for increasing healthcare effectiveness aimed at better health for all. Discussion As part of the 13th Research Centers in Minority Institutions (RCMI) International Symposium on Health Disparities, several senior academic leaders joined efforts to hold a workshop to discuss a model that considers the incorporation of two translational research strategies in research career development programs: Comparative effectiveness research (CER) and community-based participatory research (CBPR) for increasing healthcare effectiveness and eliminating healthcare disparities. Discussion included what issues may be most germane to the concept of a unified model for research workforce development through formal training and career development leading to increased effectiveness in healthcare for better health. Summary We believe that there is a gap in knowledge and skills in formal research career development programs that will enable physicians, other clinicians, and basic scientists to actively participate in these two translational research strategies. The purpose of this paper is to share the outcomes of these discussions, and encourage further discussion and possible innovation in the formulation of a new model for translational research workforce development. PMID:25024819

  20. 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

  1. 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…

  2. Payment to healthy volunteers in clinical research: the research subject's perspective.

    PubMed

    Czarny, M J; Kass, N E; Flexner, C; Carson, K A; Myers, R K; Fuchs, E J

    2010-03-01

    Although there is much discussion regarding the ethics of making payments to healthy volunteers for participating in clinical research, little data are available from the point of view of the volunteers as to what they would consider to be fair payment. The objectives of this study were to determine healthy volunteers' estimates of appropriate payments for participation in hypothetical clinical trials in order to explore the reasoning behind these estimates and to examine the association between volunteer demographics and payment expectations. Sixty participants with previous experience as healthy volunteers in research studies were presented with four hypothetical studies and interviewed about their impressions of burden and risks involved in the studies. They were also asked to estimate an appropriate payment to the volunteers for each of the studies. For each of the studies, the payment estimates made by the participants varied over a wide range. However, each individual tended to be consistent in estimate placement within this range. No demographic factor was significantly associated with the estimated study payment. Subjects frequently mentioned risk and logistical burden as factors that should determine payment levels. Healthy volunteer subjects appear to have individualized yet consistent methods of arriving at estimates of payments for participating in clinical studies. These estimates are based on each subject's perception of study burden and associated risk. PMID:20090675

  3. 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

  4. 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

  5. Clinical research on neuroblastoma based on serum lactate dehydrogenase.

    PubMed

    Pang, Q M; Li, K; Ma, L J; Sun, R P

    2015-01-01

    In recent years, more and more scholars tend to study neuroblastoma (NB) since it possesses increasing morbidity, but lack of effective treatment. This paper aims to investigate variation and clinical significance of the neuron-specific enolase (NSE) and lactic dehydrogenase (LDH) level in serum of children with NB before and after Auto Peripheral Blood Stem Cell Transplantation (APBSCT). A total of 90 children with NB from various hospitals were included in this research, and we analyzed the relationship between levels of NSE and LDH and the change of disease by comparing the two levels before and after APBSCT treatment. The results indicated that the positive rate of NSE in serum was high before treatment, and the levels of NSE and LDH were remarkably higher than those when the treatment was valid; after comprehensive treatment of chemotherapy, excision and radiotherapy, there was a significant difference of NSE and LDH levels in serum between children with complete remission (CR) and those with partial remission (PR); however, no significant differences of NSE and LDH levels were found among children in progressive stage compared to before treatment. It is believed that NSE and LDH levels are associated to the recurrence and treatment effect of NB, proving that both can reflect tumor load, therefore they can be taken as the auxiliary indicators for monitoring curative effects of NB treatment. PMID:25864749

  6. A research prototype system for quantum-counting clinical CT

    NASA Astrophysics Data System (ADS)

    Kappler, S.; Glasser, F.; Janssen, S.; Kraft, E.; Reinwand, M.

    2010-04-01

    Recent publications emphasize the benefits of quantum-counting applied to the field of Computed Tomography (CT). We present a research prototype scanner with a CdTe-based quantum-counting detector and 20 cm field-of-view (FOV). As of today there is no direct converter material on the market able to operate reliably in the harsh high-flux regime of clinical CT scanners. Nevertheless, we investigate the CT imaging performance that could be expected with high-flux capable material. Therefore we chose pixel sizes of 0.05 mm2, a good compromise between high-flux counting ability and energy resolution. Every pixel is equipped with two energy threshold counters, enabling contrast-optimization and dual-energy scans. We present a first quantitative analysis of contrast measurements, in which we limit ourselves to a low-flux scenario. Using an Iodine-based contrast agent, we find 17% contrast enhancement at 120 kVp, compared to energy-integrating CT. In addition, the general dual-energy capability was confirmed in first measurements. We conclude our work by demonstrating good agreement of measurement results and detailed CT-system simulations.

  7. 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

  8. 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

  9. DISCOVERING PATIENT PHENOTYPES USING GENERALIZED LOW RANK MODELS.

    PubMed

    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

  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. The Inquiry Theory: An Information-Processing Approach to Clinical Problem-Solving Research and Application. Research Series No. 1.

    ERIC Educational Resources Information Center

    Vinsonhaler, John F.; And Others

    This paper is a distillation of research findings on clinical problem-solving over the past decade. These findings are summarized by means of three basic concepts which describe a rudimentary theory of clinical problem-solving performance and instruction: (1) the principle of case simulation--valid clinical problem-solving behavior can be induced…

  12. Integrating Single-System Design Research into the Clinical Practice Class

    ERIC Educational Resources Information Center

    Cooper, Marlene G.

    2006-01-01

    Clinical practice and research are generally taught separately in Master of Social Work programs by faculty with distinct areas of expertise. This paper discusses the teaching of single-subject design research methodology by clinical faculty, in the clinical practice class. Examples from student papers demonstrate the effectiveness of integrating…

  13. 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

  14. 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

  15. 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

  16. 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...

  17. 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).

  18. 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).

  19. 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).

  20. 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

  1. 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

  2. When research seems like clinical care: a qualitative study of the communication of individual cancer genetic research results

    PubMed Central

    Miller, Fiona A; Giacomini, Mita; Ahern, Catherine; Robert, Jason S; de Laat, Sonya

    2008-01-01

    Background Research ethicists have recently declared a new ethical imperative: that researchers should communicate the results of research to participants. For some analysts, the obligation is restricted to the communication of the general findings or conclusions of the study. However, other analysts extend the obligation to the disclosure of individual research results, especially where these results are perceived to have clinical relevance. Several scholars have advanced cogent critiques of the putative obligation to disclose individual research results. They question whether ethical goals are served by disclosure or violated by non-disclosure, and whether the communication of research results respects ethically salient differences between research practices and clinical care. Empirical data on these questions are limited. Available evidence suggests, on the one hand, growing support for disclosure, and on the other, the potential for significant harm. Methods This paper explores the implications of the disclosure of individual research results for the relationship between research and clinical care through analysis of research-based cancer genetic testing in Ontario, Canada in the late 1990s. We analyze a set of 30 interviews with key informants involved with research-based cancer genetic testing before the publicly funded clinical service became available in 2000. Results We advance three insights: First, the communication of individual research results makes research practices seem like clinical services for our respondents. Second, while valuing the way in which research enables a form of clinical access, our respondents experience these quasi-clinical services as inadequate. Finally, our respondents recognize the ways in which their experience with these quasi-clinical services is influenced by research imperatives, but understand and interpret the significance and appropriateness of these influences in different ways. Conclusion Our findings suggest that

  3. 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.

  4. 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

  5. Handling categories properly: a novel objective of clinical research.

    PubMed

    Cleophas, Ton J; Atiqi, Roya; Zwinderman, Aeilko H

    2012-07-01

    A major objective of clinical research is to study outcome effects in subgroups. Such effects generally have stepping functions that are not strictly linear. Analyzing stepping functions in linear models thus raises the risk of underestimating the effects. In the past few years, recoding subgroup properties from continuous variables into categorical ones has been recommended as a solution to the problem. The objectives of this study were to demonstrate from examples how recoding works and to show that stepping functions, if used as continuous variables, do not produce significant effects, whereas they produce very significant effects after recoding. In the first example, the effects on physical strength were assessed in 60 subjects of different races. A linear regression in SPSS with race as the independent and physical strength score as the dependent variable showed that race was not a significant predictor of physical strength. Using the process of recoding, the variable race into categorical dummy variables showed that compared with the presence of Hispanic race, the black and white races were significant positive predictors (P = 0.0001 and 0.004 respectively) and Asian race is a significant negative predictor (P = 0.050). In the second example, the effects of numbers of comedications on admissions to a hospital resulting from adverse drug effects were assessed. A logistic regression in SPSS with numbers of comedications as the independent variable showed that comedications was not a significant predictor of iatrogenic admission. Using again the process of recoding for categorical dummy variables showed that comedication was a very significant predictor of iatrogenic admission with P = 0.004. Categorical variables are currently rarely analyzed in a proper way. Mostly they are analyzed in the form of continuous variables. This approach does not always fit the data patterns causing negative results as demonstrated in the examples of this article. We recommend that

  6. A retrospective of personal craniofaciodental research and clinical practice.

    PubMed

    Sarnat, B G

    1997-07-01

    Recent reports have emphasized the need for further knowledge about the growth of bone(s). This is particularly true because an understanding of the normal and abnormal growth of bone(s) forms the basis of early recognition and appropriate treatment of many deformities. It is less well appreciated, however, that the findings in the abnormal may be employed to test and extend our knowledge of the normal. Genetic makeup, as well as various types of diseases and injuries such as trauma, inflammation, radiation, and chemicals, may affect skeletal growth sites and centers, thereby causing faulty growth of bone(s). The degree of the subsequent deformity will depend not only on the type, intensity, extent, and chronology of the noxious agent but also on the site and its particular susceptibility and growth activity. The problem of treatment of craniofaciodental deformities is a difficult one. Over the years, I conceived, designed, initiated, and carried out a series of experiments in regard to bone(s), teeth, and cartilage in both young and adult animals (turtles, rats, gophers, lagomorphs, pigs, dogs, and monkeys). Eventually, I directed my efforts principally toward local surgical experimentation as it related to both normal and abnormal gross postnatal craniofaciodental growth. Because of the wide variety of different structures, their interrelated individualities, and the challenges presented in both its richness of sites of growth and complexity, the skull proved to be a most unusual source of study. The purpose of this selective, organized, and limited review, analysis, and summary of personally conducted experiments is to relate certain aspects of differential growth and change and nonchange to age, sites, rates, factors, and mechanisms. In many instances, correlations are made between research findings and clinical practice. No such similar report as this was found in the literature. This retrospective study brings it all together. PMID:9207672

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. Bridging basic science and clinical research: the EASL Monothematic Conference on Translational Research in Viral Hepatitis.

    PubMed

    Boettler, Tobias; Moradpour, Darius; Thimme, Robert; Zoulim, Fabien

    2014-09-01

    The EASL Monothematic Conference on Translational Research in Viral Hepatitis brought together a group of leading scientists and clinicians working on both, basic and clinical aspects of viral hepatitis, thereby building bridges from bench to bedside. This report recapitulates the presentations and discussions at the conference held in Lyon, France on November 29-30, 2013. In recent years, great advances have been made in the field of viral hepatitis, particularly in hepatitis C virus (HCV) infection. The identification of IL28B genetic polymorphisms as a major determinant for spontaneous and treatment-induced HCV clearance was a seminal discovery. Currently, hepatologists are at the doorstep of even greater advances, with the advent of a wealth of directly acting antivirals (DAAs) against HCV. Indeed, promising results have accumulated over the last months and few years, showing sustained virological response (SVR) rates of up to 100% with interferon-free DAA combination therapies. Thus, less than 25 years after its identification, HCV infection may soon be curable in the vast majority of patients, highlighting the great success of HCV research over the last decades. However, viral hepatitis and its clinical complications such as liver cirrhosis and hepatocellular carcinoma (HCC) remain major global challenges. New therapeutic strategies to tackle hepatitis B virus (HBV) and hepatitis D virus (HDV) infection are needed, as current therapies have undeniable limitations. Nucleoside/nucleotide analogues (NUC) can efficiently control HBV replication and reduce or even reverse liver damage. However, these drugs have to be given for indefinite periods in most patients to maintain virological and biochemical responses. Although sustained responses off treatment can be achieved by treatment with (pegylated) interferon-α, only about 10-30% of patients effectively resolve chronic hepatitis B. It was the goal of this conference to review the progress made over the last

  13. 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

  14. A breast cancer clinical registry in an Italian comprehensive cancer center: an instrument for descriptive, clinical, and experimental research.

    PubMed

    Baili, Paolo; Torresani, Michele; Agresti, Roberto; Rosito, Giuseppe; Daidone, Maria Grazia; Veneroni, Silvia; Cavallo, Ilaria; Funaro, Francesco; Giunco, Marco; Turco, Alberto; Amash, Hade; Scavo, Antonio; Minicozzi, Pamela; Bella, Francesca; Meneghini, Elisabetta; Sant, Milena

    2015-01-01

    In clinical research, many potentially useful variables are available via the routine activity of cancer center-based clinical registries (CCCR). We present the experience of the breast cancer clinical registry at Fondazione IRCCS "Istituto Nazionale dei Tumori" to give an example of how a CCCR can be planned, implemented, and used. Five criteria were taken into consideration while planning our CCCR: (a) available clinical and administrative databases ought to be exploited to the maximum extent; (b) open source software should be used; (c) a Web-based interface must be designed; (d) CCCR data must be compatible with population-based cancer registry data; (e) CCCR must be an open system, able to be connected with other data repositories. The amount of work needed for the implementation of a CCCR is inversely linked with the amount of available coded data: the fewer data are available in the input databases as coded variables, the more work will be necessary, for information technology staff, text mining analysis, and registrars (for collecting data from clinical records). A cancer registry in a comprehensive cancer center can be used for several research aspects, such as estimate of the number of cases needed for clinical studies, assessment of biobank specimens with specific characteristics, evaluation of clinical practice and adhesion to clinical guidelines, comparative studies between clinical and population sets of patients, studies on cancer prognosis, and studies on cancer survivorship. PMID:25953447

  15. Factors Associated with Clinical Dental Faculty Research Productivity.

    ERIC Educational Resources Information Center

    Jones, James E.; And Others

    1989-01-01

    A survey of U.S. and Canadian full-time dental school faculty found that research productivity was associated with the total dollar amount of past research funding, career age, training status, colleague utilization in conducting research, and conducting research from planned goals. (Author/MSE)

  16. 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

  17. 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. PMID:26711142

  18. 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.

  19. 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.

  20. 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

  1. Biobanking: The Melding of Research with Clinical Care

    PubMed Central

    Aufox, Sharon

    2013-01-01

    The number of biobanks around the world has increased dramatically, owing in part, to the need for researchers to have access to large numbers of samples for genomic research. Policies for enrolling participants, returning research results and obtaining samples and data can have a far reaching impact on the type of research that can be performed with each biobank. Research using biobank samples includes studies of the impact of environmental and other risk exposures on health, understanding genetic risks for common disease, identification of biomarkers in disease progression and prognosis, and implementation of personalized medicine projects. This research has been instrumental in the progress of genetic and genomic research and translational medicine. This article will highlight some of the controversies and recent research associated with biobanking over the past year. PMID:24159428

  2. 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

  3. Discovering Educational Goals -- A Research Problem.

    ERIC Educational Resources Information Center

    Gagne, Robert M.

    This paper reexamines the primary goals of education as they were stated by educators many years ago as the seven "Cardinal Principals" of public education: (1) Instruction in health, the inculcation of good health habits, and the provision of physical education; (2) the acquisition of the basic skills--reading, writing, oral expression, and…

  4. Asthma: NIH-Sponsored Research and Clinical Trials | NIH MedlinePlus the Magazine

    MedlinePlus

    ... of this page please turn Javascript on. Feature: Asthma Asthma: NIH-Sponsored Research and Clinical Trials Past Issues / Fall 2011 Table of Contents NIH-Sponsored Research Asthma in the Inner City: Recognizing that asthma severity ...

  5. 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

  6. 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

  7. 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

  8. A primer for clinical researchers in the emergency department: part I: ethical and regulatory background.

    PubMed

    Davidson, Andrew; Babl, Franz E

    2010-10-01

    Research is an important part of emergency medicine and provides the scientific underpinning for optimal patient care. Although increasing numbers of emergency physicians participate in research activities, formal research training is currently neither part of emergency physician training in Australia nor easily available for clinicians interested in clinical research. In a two-part series, which is targeted at part-time clinical researchers in the ED, we set out and explain the key elements for conducting high-quality and ethical research. In Part I, we describe important underlying ethical principles for research in humans and explain key regulatory processes and documents pertaining to good clinical research practice in Australia. The ethics of research in children as a particularly vulnerable group will also be addressed. Part II will address important elements of research science and conduct. PMID:20726870

  9. [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

  10. 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. PMID:22718064

  11. 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

  12. 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

  13. 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. PMID:24114730

  14. 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

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

    MedlinePlus

    ... other federal agencies, pharmaceutical companies, universities and nonprofit organizations. Here's how it works. After you enter the ClinicalTrials.gov Web site, you can search for a trial by the name of the disease, the location of the study, the type of treatment or the sponsoring institution. ...

  16. Computational Omics - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The National Cancer Institute's Clinical Proteomic Tumor Analysis Consortium (CPTAC) and the NVIDIA Foundation are pleased to announce funding opportunities in the fight against cancer. Each organization has launched a request for proposals (RFP) that will collectively fund up to $2 million to help to develop a new generation of data-intensive scientific tools to find new ways to treat cancer.

  17. Research and clinical aspects of the late effects of poliomyelitis

    SciTech Connect

    Halstead, L.S.; Wiechers, D.O.

    1986-01-01

    This book contains 32 selections. Some of the titles are: Late effects of Polio: Historical Perspectives; Sleep-Disordered Breathing as a Late Effect of Poliomyelitis; Clinical Subtypes, DNA Repair Efficiency, and Therapeutic Trials in the Post-Polio Syndromes; and Post-Polio Muscle Function.

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

    MedlinePlus

    ... tap into for a comprehensive listing of clinical studies—in the U.S. and abroad—sponsored by the NIH and other federal agencies, pharmaceutical companies, universities and nonprofit ... location of the study, the type of treatment or the sponsoring institution. ...

  19. Theory and Research: The Nexus of Clinical Inference

    ERIC Educational Resources Information Center

    Claeys, Joseph

    2013-01-01

    The practice of individual assessment has been moving toward the empirically derived Cattell-Horn-Carroll (CHC) theory of intellectual ability, which offers a hierarchical taxonomy of cognitive abilities. Current assessment tools provide varying adherence to operationalizing CHC theory, making clinical inference difficult. Expert consensus…

  20. 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…

  1. THE DENTAL RESEARCH CLINIC IN FLORIDA (AS AN EDUCATIONAL AND SERVICE AGENCY).

    ERIC Educational Resources Information Center

    Florida State Dept. of Education, Tallahassee. Technical and Health Occupations Education Section.

    GUIDELINES FOR ORGANIZING AND OPERATING A DENTAL RESEARCH CLINIC WERE DEVELOPED BY THE DIVISION OF VOCATIONAL, TECHNICAL, AND ADULT EDUCATION, THE FLORIDA DENTAL SOCIETY'S SPECIAL COMMITTEE ON EDUCATION OF THE DENTAL ASSISTANT, AND OTHER DENTISTS WORKING CLOSELY WITH DENTAL ASSISTANT PROGRAMS. THE PURPOSES OF THE DENTAL RESEARCH CLINICS ARE TO…

  2. 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…

  3. The Orthogonal Rotation of Factors in Clinical Research: A Critical Note.

    ERIC Educational Resources Information Center

    Loo, Robert

    1979-01-01

    The aims of this note are (a) to present data that show current trends in the choice of factor rotation in clinical research; (b) to propose that oblique rotations are inadequately represented in this literature; and (c) to present specific guidelines for rotation in clinical research. (Author)

  4. Clinical and Research Perspectives on Nonspeech Oral Motor Treatments and Evidence-Based Practice

    ERIC Educational Resources Information Center

    Muttiah, Nimisha; Georges, Katie; Brackenbury, Tim

    2011-01-01

    Purpose: Evidence-based practice (EBP) involves the incorporation of research evidence, clinical expertise, and client values in clinical decision making. One case in which these factors conflict is the use of nonspeech oral motor treatments (NSOMTs) for children with developmental speech sound disorders. Critical reviews of the research evidence…

  5. Issue 1979--Bridging the Gap Between the Basic Sciences and Clinical Practice: Teaching, Research, and Service.

    ERIC Educational Resources Information Center

    DiBiaggio, John A.

    1980-01-01

    Suggestions are made for reducing tension between clinical practice and basic research segments of pharmacy: develop mutual respect among all faculty segments, combine research efforts, modify the reward system for greater equity, increase physical proximity, share experiences through clinics and forums, and combine realism with tradition. (MSE)

  6. 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.

  7. Community-Based Participatory Clinical Research in Obesity by Adolescents: Pipeline for Researchers of the Future

    PubMed Central

    Branch, Robert; Chester, Ann

    2015-01-01

    We propose a novel, untapped opportunity, challenging cultural and man-power barriers to transferring advances in biomedical science knowledge that will improve community health care (Type II Clinical Translational Research) in a medically underserved community. We describe a pilot model in which adolescents apply principles of Community-Based Participatory Research (CBPR) at the epicenter of the obesity diabetes epidemic in rural Appalachia in West Virginia. The model invites minority, financially disadvantaged, and educationally disadvantaged adolescents to become educated on ethics, then provides infrastructure to support study design and conduct of CBPR. This experience demonstrates that these adolescents can efficiently, with quality and integrity, reach into the most vulnerable of communities and their own families to show that the prevalence of obesity is at 50% and diabetes 10.4% (n = 989). Our experience illustrates the infrastructure requirements for this strategy to be successful and emphasizes the substantial benefit that could accrue if the model is successfully sustained. The benefit includes not only the translation of knowledge to influence community lifestyle behavior but also the creation of a pipeline of new biomedical scientists for the future. PMID:20443918

  8. 2012 BRN Symposium - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    Biospecimen Research Network Symposium brings together stakeholders including research investigators, clinicians, industry representatives, hospital administrators and patient advocates to discuss new developments in the field of biospecimen science that address the molecular changes that can occur during collection, processing, and storage of biospecimens.

  9. Handbook of Attachment: Theory, Research, and Clinical Applications.

    ERIC Educational Resources Information Center

    Cassidy, Jude, Ed.; Shaver, Phillip R., Ed.

    The theoretical work on attachment behavior by John Bowlby and Mary Ainsworth spawned one of the broadest, most creative lines of research in twentieth century psychology. This volume compiles articles discussing attachment theory and research, measurement issues, and contributions of recent theoretical and empirical developments to the study of…

  10. Clinical Research: A Psychotherapeutic Assessment Model for Siblings in Care

    ERIC Educational Resources Information Center

    Hindle, Debbie

    2007-01-01

    This paper focuses on the aspects of a qualitative research project that examines an assessment protocol for the placement of siblings in foster care and/or future adoption. A brief description of the background to the study and the research design is given. Evaluating the material from the quantitative instruments used and the psychotherapeutic…

  11. Guideline-defining asthma clinical trials of the National Heart, Lung, and Blood Institute's Asthma Clinical Research Network and Childhood Asthma Research and Education Network.

    PubMed

    Denlinger, Loren C; Sorkness, Christine A; Chinchilli, Vernon M; Lemanske, Robert F

    2007-01-01

    Because of an increasing prevalence, morbidity, and mortality associated with asthma, the National Heart, Lung, and Blood Institute created the Asthma Clinical Research Network and the Childhood Asthma Research and Education Network to improve public health. The objectives of these clinical research networks are to conduct multiple, well-designed clinical trials for rapid evaluation of new and existing therapeutic approaches to asthma and to disseminate laboratory and clinical findings to the health care community. These trials comprise a large proportion of the data driving the treatment guidelines established and reviewed by the National Asthma Education and Prevention Program. This article will review the basic design and major findings of selected Asthma Clinical Research Network and Childhood Asthma Research and Education Network trials involving both adults and children with asthma. Collectively, these studies have helped refine the therapeutic role of existing controller medications, establish standard models for side-effect evaluation and risk-benefit models, validate symptom-based assessments for asthma control, and identify baseline characteristics that might predict individual patient responses. Remaining challenges include shaping the role of novel therapeutics in future guidelines, incorporating pharmacogenomic data in treatment decisions, and establishing better implementation strategies for translation to community settings, all with the goal of reducing the asthma burden on society. PMID:17141853

  12. Terminology development towards harmonizing multiple clinical neuroimaging research repositories

    PubMed Central

    Turner, Jessica A.; Pasquerello, Danielle; Turner, Matthew D.; Keator, David B.; Alpert, Kathryn; King, Margaret; Landis, Drew; Calhoun, Vince D.; Potkin, Steven G.; Tallis, Marcelo; Ambite, Jose Luis; Wang, Lei

    2015-01-01

    Data sharing and mediation across disparate neuroimaging repositories requires extensive effort to ensure that the different domains of data types are referred to by commonly agreed upon terms. Within the SchizConnect project, which enables querying across decentralized databases of neuroimaging, clinical, and cognitive data from various studies of schizophrenia, we developed a model for each data domain, identified common usable terms that could be agreed upon across the repositories, and linked them to standard ontological terms where possible. We had the goal of facilitating both the current user experience in querying and future automated computations and reasoning regarding the data. We found that existing terminologies are incomplete for these purposes, even with the history of neuroimaging data sharing in the field; and we provide a model for efforts focused on querying multiple clinical neuroimaging repositories. PMID:26688838

  13. Clinical research and global health: Mentoring the next generation of health care students

    PubMed Central

    Shah, Sural K.; Nodell, Bobbi; Montano, Silvia M.; Behrens, Chris; Zunt, Joseph R.

    2010-01-01

    Interest in global health and opportunities to conduct clinical research at international sites have increased markedly for health profession trainees. With this increase in demand comes an increase in the need for mentors at international and home institutions to provide guidance with designing, implementing, and analysing clinical research projects that benefit both the trainees and the research site. In this article, we provide an overview of our insights gained through mentoring in the international setting and suggest a series of key points to help ensure an enjoyable and productive international clinical research experience for both trainees and mentors. PMID:20635270

  14. [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

  15. Steps to translate preconditioning from basic research to the clinic

    PubMed Central

    Bahjat, Frances R; Gesuete, Raffaella; Stenzel-Poore, Mary P

    2012-01-01

    Efforts to treat cardiovascular and cerebrovascular diseases often focus on the mitigation of ischemia-reperfusion (I/R) injury. Many treatments or “preconditioners” are known to provide substantial protection against the I/R injury when administered prior to the event. Brief periods of ischemia itself have been validated as a means to achieve neuroprotection in many experimental disease settings, in multiple organ systems, and in multiple species suggesting a common pathway leading to tolerance. In addition, pharmacological agents that act as potent preconditioners have been described. Experimental induction of neuroprotection using these various preconditioning paradigms has provided a unique window into the brain’s endogenous protective mechanisms. Moreover, preconditioning agents themselves hold significant promise as clinical-stage therapies for prevention of I/R injury. The aim of this article is to explore several key steps involved in the preclinical validation of preconditioning agents prior to the conduct of clinical studies in humans. Drug development is difficult, expensive and relies on multi-factorial analysis of data from diverse disciplines. Importantly, there is no single path for the preclinical development of a novel therapeutic and no proven strategy to ensure success in clinical translation. Rather, the conduct of a diverse array of robust preclinical studies reduces the risk of clinical failure by varying degrees depending upon the relevance of preclinical models and drug pharmacology to humans. A strong sense of urgency and high tolerance of failure are often required to achieve success in the development of novel treatment paradigms for complex human conditions. PMID:23504609

  16. Towards automatic recognition of scientifically rigorous clinical research evidence.

    PubMed

    Kilicoglu, Halil; Demner-Fushman, Dina; Rindflesch, Thomas C; Wilczynski, Nancy L; Haynes, R Brian

    2009-01-01

    The growing numbers of topically relevant biomedical publications readily available due to advances in document retrieval methods pose a challenge to clinicians practicing evidence-based medicine. It is increasingly time consuming to acquire and critically appraise the available evidence. This problem could be addressed in part if methods were available to automatically recognize rigorous studies immediately applicable in a specific clinical situation. We approach the problem of recognizing studies containing useable clinical advice from retrieved topically relevant articles as a binary classification problem. The gold standard used in the development of PubMed clinical query filters forms the basis of our approach. We identify scientifically rigorous studies using supervised machine learning techniques (Naïve Bayes, support vector machine (SVM), and boosting) trained on high-level semantic features. We combine these methods using an ensemble learning method (stacking). The performance of learning methods is evaluated using precision, recall and F(1) score, in addition to area under the receiver operating characteristic (ROC) curve (AUC). Using a training set of 10,000 manually annotated MEDLINE citations, and a test set of an additional 2,000 citations, we achieve 73.7% precision and 61.5% recall in identifying rigorous, clinically relevant studies, with stacking over five feature-classifier combinations and 82.5% precision and 84.3% recall in recognizing rigorous studies with treatment focus using stacking over word + metadata feature vector. Our results demonstrate that a high quality gold standard and advanced classification methods can help clinicians acquire best evidence from the medical literature. PMID:18952929

  17. Selective laser hyperthermia of malignant neoplasms: experimental and clinical research

    NASA Astrophysics Data System (ADS)

    Gelfond, Mark L.; Mizgirev, I. V.; Barchuk, A. S.; Hudoley, V. V.; Vasilyev, D. V.; Balluzek, F. V.; Venkov, A. A.; Chaly, Viktor P.; Ter-Martirosyan, Alexander L.

    1999-12-01

    Experimental study of various modes of the semiconductor laser irradiation upon Ehrlich carcinoma in mice was carried out. Optimal patterns for distance laser scanning irradiation resulting in practically complete healing of experimental animals, were found. Selective damage of tumor tissue subjected to laser irradiation at 800 nm was evidenced in the absence of a photosensitizing agent. The results of a clinical trial completely corresponded to the experimental data. The treatment proved to be efficient in all 28 patients.

  18. Sulforaphane: translational research from laboratory bench to clinic.

    PubMed

    Houghton, Christine A; Fassett, Robert G; Coombes, Jeff S

    2013-11-01

    Cruciferous vegetables are widely acknowledged to provide chemopreventive benefits in humans, but they are not generally consumed at levels that effect significant change in biomarkers of health. Because consumers have embraced the notion that dietary supplements may prevent disease, this review considers whether an appropriately validated sulforaphane-yielding broccoli sprout supplement may deliver clinical benefit. The crucifer-derived bioactive phytochemical sulforaphane is a significant inducer of nuclear factor erythroid 2-related factor 2 (Nrf2), the transcription factor that activates the cell's endogenous defenses via a battery of cytoprotective genes. For a broccoli sprout supplement to demonstrate bioactivity in vivo, it must retain both the sulforaphane-yielding precursor compound, glucoraphanin, and the activity of glucoraphanin's intrinsic myrosinase enzyme. Many broccoli sprout supplements are myrosinase inactive, but current labeling does not reflect this. For the benefit of clinicians and consumers, this review summarizes the findings of in vitro studies and clinical trials, interpreting them in the context of clinical relevance. Standardization of sulforaphane nomenclature and assay protocols will be necessary to remove inconsistency and ambiguity in the labeling of currently available broccoli sprout products. PMID:24147970

  19. Silybin and the liver: From basic research to clinical practice

    PubMed Central

    Loguercio, Carmela; Festi, Davide

    2011-01-01

    Herbal products are increasingly used, mainly in chronic liver disease. Extracts of milk thistle, Silymarin and silybin, are the most prescribed natural compounds, with different indications, but with no definitive results in terms of clinical efficacy. This review analyzes the available studies on the effects of the purified product silybin, both as a free and a conjugated molecule, on liver cells or on experimentally induced liver damage, and in patients with liver disease. We searched PUBMED for articles pertaining to the in vitro and in vivo effects of silybin, its antifibrotic, anti-inflammatory, and antioxidant properties, as well as its metabolic effects, combined with the authors’ own knowledge of the literature. Results indicate that the bioavailability of silybin phytosome is higher than that of silymarin and is less influenced by liver damage; silybin does not show significant interactions with other drugs and at doses < 10 g/d has no significant side effects. Experimental studies have clearly demonstrated the antifibrotic, antioxidant and metabolic effects of silybin; previous human studies were insufficient for confirming the clinical efficacy in chronic liver disease, while ongoing clinical trials are promising. On the basis of literature data, silybin seems a promising drug for chronic liver disease. PMID:21633595

  20. State of the Art Laryngeal Imaging: Research and Clinical Implications

    PubMed Central

    Deliyski, Dimitar D.; Hillman, Robert E.

    2010-01-01

    Purpose of Review This paper provides a review of the latest advances in videostroboscopy, videokymography and high-speed videoendoscopy, and outlines the development of new laryngeal imaging modalities based on optical coherence tomography, laser depth-kymography, and magnetic resonance imaging, published in the past 2 years. Recent Findings Videostroboscopy and Videokymography Image quality has improved and several image processing and measurement techniques have been published. High-speed videoendoscopy Significant progress has been made through increased sensitivity and frame rates of the cameras, and the development of facilitative playbacks, phonovibrography and several image segmentation and measurement methods. Clinical evidence was presented through applications in phonosurgery, comparisons with videostroboscopy, normative data, and better understanding of voice production. Optical coherence tomography Latest developments allow for the capture of dynamic high resolution cross-sectional images of the vibrating vocal fold mucosa during phonation. Depth-kymography New laser technique allowing recording of the vertical movements of the vocal folds during phonation in calibrated spatial values. Laryngeal magnetic resonance New methods allow high-resolution imaging of laryngeal tissue microstructure, or measuring of dynamic laryngeal structures during phonation. Summary The endoscopic laryngeal imaging techniques have made significant advances increasing their clinical value, while techniques providing new types of potentially clinically-relevant information have emerged. PMID:20463479