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. 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

  15. 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

  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. 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

  18. 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

  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. 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…

  2. 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)

  3. 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.

  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. 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.

  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. 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

  14. 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

  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 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

  6. 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

  7. 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],…

  8. 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…

  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

    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

  14. 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

  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. 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

  19. 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

  20. 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

  1. 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

  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. 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

  5. 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

  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. 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

  5. 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

  6. 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

  7. 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

  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. 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

  11. 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

  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. 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

  19. 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…

  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. 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

  4. 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

  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. 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

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

    PubMed

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

    2013-12-01

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

  12. 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. DISCOVER-AQ

    Atmospheric Science Data Center

    2015-01-07

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

  14. 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

  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. 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

  6. 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)

  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

    ... 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... May 24, 2012..... Sheraton Suites--Old Science-B. Town Alexandria. Neurobiology-D May 24-25,...

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    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

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  14. 78 FR 22622 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

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    Federal Register 2010, 2011, 2012, 2013, 2014

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    ... 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... Crowne Plaza DC/Silver Spring. Pulmonary Medicine June 3, 2011 Crowne Plaza DC/Silver Spring....

  16. 78 FR 66992 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

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    ... 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........ November 25, 2013 *VA Central Office. Neurobiology-F November 26, 2013 *VA Central...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-20

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Biomedical Laboratory Research and Development and Clinical Science Research and Development Services... May 24, 2012........ Sheraton Suites--Old Town Alexandria. Science-B Neurobiology-D May 24-25,...

  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. 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

  20. 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

  1. 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

  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. 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 ...

  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. 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…

  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. 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

  16. 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...

  17. 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...

  18. 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.

  19. 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.

  20. 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 ...

  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. 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,…

  3. 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…

  4. 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)

  5. 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

  6. 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

  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. 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

  9. 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

  10. 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

  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. 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

  13. 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

  14. 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

  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. 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...

  1. 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

  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 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

  10. 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

  11. 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

  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. 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

  7. 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

  8. 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

  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