Science.gov

Sample records for clinic researchers discover

  1. [The research of basic medical education with clinical practice and culturing of discovering and creative ability for students].

    PubMed

    Yang, Kang-Juan; Jin, Ying-Zi; Zhang, Zi-Bo; Jin, Yan-Hua; Jin, Xiong-Ji; Xiu, Jing-Hui; Sun, Lian-Ping; Liu, Yang; Sheng, Tian-Xin

    2008-05-01

    In order to explore the educational model of combined research aidding basic medical education and clinical practice, the educational form of combined research, teaching and clinical practice was adopted and brought into the education of medical genetics for medical students. The consequence of five-year educational practice has revealed that the educational effects and quality have been obviously increased, and the deeply activated studying initiative, self-studying ability, ability of cooperation, discovering and creative ability have been achieved in culturing practical general medical students with in-depth basic knowledge, great ability and high quality.

  2. Clinical research: techniques to consider before one sets out to discover it all! *

    PubMed Central

    Rozeiu, Alfred M.

    1980-01-01

    In industry, hospital, clinic, laboratory or office, professionals are continually faced with “all size” of problems which can be successfully answered by using investigative scientific methods. The recognition and formulation of an existing problem followed by the desire to seek an answer are the first major steps. Collecting and analyzing data, followed by valid scientific conclusion completes the picture. Professional success means knowing most about something, not something about most. Investigation-research is a particular pattern in weaving, made of organized curiosity, skillful analysis, inventive thinking and professional objectivity. The purpose of the article remains to identify fundamental questions which emerge from clinical observations and practice, to identify and project needed research and to guide the finding of scientific answers.

  3. DISCOVER AQ Research Plane Arrives

    NASA Image and Video Library

    2011-06-28

    James Crawford, principal investigator and scientist based at NASA’s Langley Research Center in Hampton, Va., talks about the DISCOVER-AQ project on board the P-3B NASA research aircraft at Baltimore/Washington International Thurgood Marshall Airport, Tuesday, June 28, 2011, in Baltimore, Md. The aircraft is part of a month-long field campaign designed to improve satellite measurements of air pollution. The name of the experiment -- Deriving Information on Surface conditions from Column and Vertically Resolved Observations Relevant to Air Quality (DISCOVER -- AQ) -- is a mouthful, but its purpose is simple. Come July, the aircraft will be flying spirals over six ground stations in Maryland. Photo Credit: (NASA/Paul E. Alers)

  4. DISCOVER AQ Research Plane Arrives

    NASA Image and Video Library

    2011-06-28

    An unidentified researcher works aboard the P-3B NASA research aircraft at Baltimore/Washington International Thurgood Marshall Airport, Tuesday, June 28, 2011, in Baltimore, Md. The aircraft is part of a month-long field campaign designed to improve satellite measurements of air pollution. The name of the experiment -- Deriving Information on Surface conditions from Column and Vertically Resolved Observations Relevant to Air Quality (DISCOVER -- AQ) -- is a mouthful, but its purpose is simple. Come July, the aircraft will be flying spirals over six ground stations in Maryland. Photo Credit: (NASA/Paul E. Alers)

  5. DISCOVER AQ Research Plane Arrives

    NASA Image and Video Library

    2011-06-28

    WFF Pilots Mike Singer, left, and Shane Dover stand in front of the 117-foot P-3B NASA research aircraft on the tarmac at Baltimore/Washington International Thurgood Marshall Airport, Tuesday, June 28, 2011, in Baltimore, Md. The aircraft is part of a month-long field campaign designed to improve satellite measurements of air pollution. The name of the experiment -- Deriving Information on Surface conditions from Column and Vertically Resolved Observations Relevant to Air Quality (DISCOVER -- AQ) -- is a mouthful, but its purpose is simple. Come July, the aircraft will be flying spirals over six ground stations in Maryland. Photo Credit: (NASA/Paul E. Alers)

  6. DISCOVER AQ Research Plane Arrives

    NASA Image and Video Library

    2011-06-28

    A 117-foot P-3B NASA research aircraft is seen on the tarmac at Baltimore/Washington International Thurgood Marshall Airport, Tuesday, June 28, 2011, in Baltimore, Md. The aircraft is part of a month-long field campaign designed to improve satellite measurements of air pollution. The name of the experiment -- Deriving Information on Surface conditions from Column and Vertically Resolved Observations Relevant to Air Quality (DISCOVER -- AQ) -- is a mouthful, but its purpose is simple. Come July, the aircraft will be flying spirals over six ground stations in Maryland. Photo Credit: (NASA/Paul E. Alers)

  7. DISCOVER AQ Research Plane Arrives

    NASA Image and Video Library

    2011-06-28

    Pilots Shane Dover, left, and Mike Singer are seen on the flight deck of the P-3B NASA research aircraft at Baltimore/Washington International Thurgood Marshall Airport, Tuesday, June 28, 2011, in Baltimore, Md. The aircraft is part of a month-long field campaign designed to improve satellite measurements of air pollution. The name of the experiment -- Deriving Information on Surface conditions from Column and Vertically Resolved Observations Relevant to Air Quality (DISCOVER -- AQ) -- is a mouthful, but its purpose is simple. Come July, the aircraft will be flying spirals over six ground stations in Maryland. Photo Credit: (NASA/Paul E. Alers)

  8. Discovering body site and severity modifiers in clinical texts.

    PubMed

    Dligach, Dmitriy; Bethard, Steven; Becker, Lee; Miller, Timothy; Savova, Guergana K

    2014-01-01

    To research computational methods for discovering body site and severity modifiers in clinical texts. We cast the task of discovering body site and severity modifiers as a relation extraction problem in the context of a supervised machine learning framework. We utilize rich linguistic features to represent the pairs of relation arguments and delegate the decision about the nature of the relationship between them to a support vector machine model. We evaluate our models using two corpora that annotate body site and severity modifiers. We also compare the model performance to a number of rule-based baselines. We conduct cross-domain portability experiments. In addition, we carry out feature ablation experiments to determine the contribution of various feature groups. Finally, we perform error analysis and report the sources of errors. The performance of our method for discovering body site modifiers achieves F1 of 0.740-0.908 and our method for discovering severity modifiers achieves F1 of 0.905-0.929. Results indicate that both methods perform well on both in-domain and out-domain data, approaching the performance of human annotators. The most salient features are token and named entity features, although syntactic dependency features also contribute to the overall performance. The dominant sources of errors are infrequent patterns in the data and inability of the system to discern deeper semantic structures. We investigated computational methods for discovering body site and severity modifiers in clinical texts. Our best system is released open source as part of the clinical Text Analysis and Knowledge Extraction System (cTAKES).

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

    PubMed Central

    Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren

    2016-01-01

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

  10. 2015 USAFA Research Report: Discover Falcon Innovation

    DTIC Science & Technology

    2015-01-01

    Apollo-era telescope to hunt for exoplanets , those planets that are outside our solar system. On the hunt: The Astronautical Research Group and...Observatory Capabilities: • STEM Outreach • Exoplanet research • Astronomy research Equipment: • 24-inch diameter telescope housed in an observatory... exoplanets - to try to solve long- held mysteries: Is there life on other planets? Can other planets sustain human life? The research at the Academy

  11. 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.

  12. 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.

  13. Discovering Research Value in Small Meteorite Craters

    NASA Astrophysics Data System (ADS)

    Cassidy, W. A.

    1995-09-01

    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 there may be many more. The fall occurred about 4000 y ago into a uniform loessy soil, and the craters are well enough preserved so that some of their parameters of impact can be determined by 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 around 10 degrees. Reflecting the low angle of infall, the crater field is elongated with apparent dimensions of 3 x 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 N58 degrees E, but the azimuths of infall determined by excavation of Craters 9 and 10 are N84 degrees E and N77 degrees E, respectively, suggesting that the major axis of the crater field is not yet well determined. This is supported by the elongation of magnetic anomalies over 4 other craters, all of which trend significantly more easterly than the major axis of the crater field. The 3 or 4 largest craters appear to be explosion craters and the others are shock-wave excavations extended by penetration funnels with multi-ton masses preserved within them. There are two ways in which field research on the Campo del Cielo craterfield is found to be useful. (1)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 various existing studies directed toward the interpretation of impact craters on planetary surfaces other than the earth. Given certain

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

    PubMed

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

    2014-01-01

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

  15. Incorporating Topic Assignment Constraint and Topic Correlation Limitation into Clinical Goal Discovering for Clinical Pathway Mining

    PubMed Central

    Xu, Xiao; Wei, Zhijie

    2017-01-01

    Clinical pathways are widely used around the world for providing quality medical treatment and controlling healthcare cost. However, the expert-designed clinical pathways can hardly deal with the variances among hospitals and patients. It calls for more dynamic and adaptive process, which is derived from various clinical data. Topic-based clinical pathway mining is an effective approach to discover a concise process model. Through this approach, the latent topics found by latent Dirichlet allocation (LDA) represent the clinical goals. And process mining methods are used to extract the temporal relations between these topics. However, the topic quality is usually not desirable due to the low performance of the LDA in clinical data. In this paper, we incorporate topic assignment constraint and topic correlation limitation into the LDA to enhance the ability of discovering high-quality topics. Two real-world datasets are used to evaluate the proposed method. The results show that the topics discovered by our method are with higher coherence, informativeness, and coverage than the original LDA. These quality topics are suitable to represent the clinical goals. Also, we illustrate that our method is effective in generating a comprehensive topic-based clinical pathway model.

  16. Discovering synergistic qualities of published authors to enhance translational research.

    PubMed

    Bahr, Nathan J; Cohen, Aaron M

    2008-11-06

    Translational research is the process of bringing together basic scientific research and improvements in patient care. This process, by its very nature, requires a wide range of skills and resources, typically not found within any single individual. This project investigates the synergistic features of published researchers at the Oregon Clinical and Translational Research Institute(OCTRI) to see how scientists with different specializations can be brought together to improve translational research.The investigated features were author connectivity and complementarity of research subjects. Author connectivity was measured by taking the Average Path Length (APL) and cluster coefficients [1] over an OCTRIcoauthor network. A high degree of connectivity, or low APL value, would indicate that a researcher has participated in many collaborations and published many papers with other OCTRI researchers. This would imply that they have some experience we could leverage to build teams for translational research. Subject complementarity was established by using pairs of frequently co-occurring MeSH terms. Those terms were then used to bridge researchers together through indirect Swanson matching [2] and present evidence of topic synergy, or potential collaborative synergy.Our initial investigation supports the development of a collaborative browsing tool to assist the creation of new translational research teams. Such a tool is being developed at the OCTRI and will include a user-centric evaluation in the near future.

  17. 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

  18. Opportunistically discovering usability requirements for a clinical handover system.

    PubMed

    Kaufmann, David; Parry, David; Carlsen, Victoria; Carter, Philip; Parry, Emma; Westbrook, Lucy

    2013-01-01

    Clinical Handover in hospital is a process that can cause a major risk to patients, and be inefficient and time-consuming for staff. Software designed to support such processes needs to be used in a demanding and fast-moving environment. This work formulated Usability Design Requirements for such a handover software system. The requirements have been derived from a usability evaluation at Auckland City Hospital, where the handover was observed in two different environments during a handover improvement process. The requirements were produced using a multi-method, triangulated approach and they may be able to inform the design of systems to support clinical handover. The physical environment and the protocols adopted for handover were changed during this process, with software changes waiting for a larger project. Periods of change in work practice may be particularly favourable times to perform such studies, even if major software changes are not implemented. Staff engagement with the process may also be improved during times of change.

  19. 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…

  20. 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)

  1. Proteomics research to discover markers: what can we learn from Netflix?

    PubMed

    Ransohoff, David F

    2010-02-01

    Research in the field of proteomics to discover markers for detection of cancer has produced disappointing results, with few markers gaining US Food and Drug Administration approval, and few claims borne out when subsequently tested in rigorous studies. What is the role of better mathematical or statistical analysis in improving the situation? This article examines whether a recent successful Netflix-sponsored competition using mathematical analysis to develop a prediction model for movie ratings of individual subscribers can serve to improve studies of markers in the field of proteomics. Netflix developed a database of movie preferences of individual subscribers using a longitudinal cohort research design. Groups of researchers then competed to develop better ways to analyze the data. Against this background, the strengths and weaknesses of research design are reviewed, contrasting the Netflix design with that of studies of biomarkers to detect cancer. Such biomarker studies generally have less-strong design, lower numbers of outcomes, and greater difficulty in even just measuring predictors and outcomes, so the fundamental data that will be used in mathematical analysis tend to be much weaker than in other kinds of research. If the fundamental data that will be analyzed are not strong, then better analytic methods have limited use in improving the situation. Recognition of this situation is an important first step toward improving the quality of clinical research about markers to detect cancer.

  2. 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.

  3. 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…

  4. 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…

  5. Clinical Research Methodology 2: Observational Clinical Research.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

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

  6. Clinical research: regulatory issues.

    PubMed

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

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

    PubMed

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

    2005-01-01

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

  8. 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

  9. Clinical research: up from 'clinical epidemiology'.

    PubMed

    Miettinen, Olli S; Bachmann, Lucas M; Steurer, Johann

    2009-12-01

    Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around 'clinical epidemiology'. We address clinical research in the meaning of quintessentially 'applied' clinical research, which we take to be the foundation of the scientific knowledge base of clinical medicine, of gnosis (dia-, etio-, pro-) in it. More specifically, we address the essence, priorities, and status quo of this research - and argue that the requisite theory of this is not a matter of 'clinical epidemiology' but of theory of clinical research endogenous to clinical (rather than epidemiological) academia.

  10. A case series of clinically undiagnosed hematopoietic neoplasms discovered at autopsy.

    PubMed

    Podduturi, Varsha; Guileyardo, Joseph M; Soto, Luis R; Krause, John R

    2015-06-01

    In the United States, autopsy rates have diminished to less than 5% during the last half of the 20th century and the beginning of the 21st century for a multitude of reasons. Many believe this results in unrecognized malignancies that could have explained a patient's death. We describe six deaths in which hematopoietic neoplasms were identified at autopsy but were not diagnosed clinically. The six undiagnosed hematopoietic malignancy cases discovered at autopsy include four men and two women ranging from 50 to 78 years of age. One patient was African American and five patients were white, all with multiple comorbidities. The tumors included diffuse large B-cell lymphoma, activated B-cell type, intravascular large B-cell lymphoma, ALK-negative anaplastic large cell lymphoma arising in a setting of human immunodeficiency virus, and a myeloid sarcoma. These cases illustrate the importance of the traditional postmortem examination in not only confirming clinical diagnoses but also identifying previously unknown diagnoses. Hematologic malignancies may present with nonspecific clinical manifestations, and this series of cases also emphasizes the necessity for widening the differential diagnosis in patients with unexplained lactic acidosis and hepatic failure to include hematopoietic malignancies since prompt treatment may be lifesaving. Copyright© by the American Society for Clinical Pathology.

  11. Methodologically rigorous clinical research.

    PubMed

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

    2012-06-01

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

  12. 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

  13. 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.

  14. Clinical Research and Clinical Trials

    MedlinePlus

    ... Youth NCMHEP NICHD Publications Data Sharing and Other Resources Research The Human Placenta Project Research and Funding Frequently Asked Questions (FAQs) Meetings Related News and Media The National Children's ... & Selected Staff Profiles Multimedia About NICHD Institute ...

  15. 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…

  16. Ageism and clinical research.

    PubMed

    Briggs, R; Robinson, S; O'Neill, D

    2012-10-01

    Despite being the most significant consumers of health care resources and medications worldwide, recent international research has highlighted the under-representation of older participants from clinical trials. This creates problems for physicians as the patients seen in clinical practice are not representative of those on which medical treatments and interventions have been trialled, and we need to consider whether results (both negative and positive) from these trials are applicable to these patients. Our aim was to gauge whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals. We audited all clinical research proposals submitted to the Research Ethics committee (REC) covering the teaching hospitals attached to Trinity College Dublin (TCD) from July 2008 to July 2011 inclusive, recording exclusion of patients based on an arbitrary upper age limit. Of the 226 relevant trials studied, 31(13.7%) excluded participants based solely on an arbitrary upper age limit. 22 (9.8%) of the relevant trials were submitted by geriatricians, none of which excluded patients based solely on age. Over 50% (12 of 22) trials submitted by neurology/psychiatry excluded patients based on an upper age limit. The mean upper age limit used over all trials as a cut-off was 69.2 years of age. As well as this, the majority of the remaining trials also contained other exclusion criteria, especially those based on cognitive function which further limited participation of older people. While we found that a significant proportion of clinical trials submitted to the TCD REC still excluded patients based arbitrarily on an upper age limit, participation rates of older people seem to be higher in this Irish centre than that seen in international trials. Significant room for improvement still remains however and there needs to be a promotion of greater awareness of the need for developing, testing and licensing medicines so that it mirrors the

  17. Group Designs in Clinical Research.

    ERIC Educational Resources Information Center

    Siegel, Gerald M.; Young, Martin A.

    1987-01-01

    Despite the similarity between single-subject research sessions and clinical sessions, single-subject research designs are not intrinsically more appropriate than group designs for clinical research concerning the communication disordered. (Author/CB)

  18. Research ethics for clinical researchers.

    PubMed

    Harnett, John D; Neuman, Richard

    2015-01-01

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

  19. [Clinical research VI. Clinical relevance].

    PubMed

    Talavera, Juan O; Rivas-Ruiz, Rodolfo

    2011-01-01

    Usually, in clinical practice the maneuver selected is the one that achieves a favorable outcome with a direct percentage of superiority of at least 10 %, or when the number needed to treat is approximately equal to 10. While this percentage difference is practical for estimating the magnitude of an association, we need to differentiate the impact measures (attributable risk, preventable fraction), measures of association (RR, OR, HR), and frequency measures (incidence and prevalence) applicable when the outcome is nominal. And we must identify ways to measure the strength of association and the magnitude of the association when the outcome variable is quantitative. It is not uncommon to interpret the measures of association as if they were impact measures. For example, for a RR of 0.68, it is common to assume a 32 % reduction of the outcome, but we must consider that this is a relative reduction, which comes from relations of 0.4/0.6, 0.04/0.06, or 0.00004/0.00006. However the direct reduction is 20 % (60 % - 40 %), 2 %, and 2 per 100,000, respectively. Therefore, to estimate the impact of a maneuver it is important to have the direct difference and/or NNT.

  20. Developing a clinical research career.

    PubMed

    Nicholson, Caroline

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

  1. Discovering, comparing, and combining moderators of treatment on outcome after randomized clinical trials: a parametric approach.

    PubMed

    Kraemer, Helena Chmura

    2013-05-20

    No one treatment is likely to affect all patients with a disorder in the same way. A treatment highly effective for some may be ineffective or even harmful for others. Statistically significant or not, the effect sizes of many treatments tend to be small. Consequently, emphasis in clinical research is gradually shifting (1) to increased focus on effect sizes and (2) to discovery and documentation of moderators of treatment effect on outcome in randomized clinical trials, that is, personalized medicine, in which individual differences between patients are explicitly acknowledged. How to test a null hypothesis of moderation of treatment outcome is reasonably well known. The focus here is on how, under parametric assumptions, to define the strength of moderation, that is, a moderator effect size, either for scientific purposes or for assessment of clinical significance, in order to compare moderators and choose among them and to develop a composite moderator, which might more strongly moderate the effect of a treatment on outcome than any single moderator that might ultimately provide guidance for clinicians as to whom to prescribe what treatment. Copyright © 2013 John Wiley & Sons, Ltd.

  2. A nurse-run clinic for patients with incidentally discovered small abdominal aortic aneurysms is feasible and cost-effective.

    PubMed

    Griffin, J L; Clarke, G A; Roake, J A; Lewis, D R

    2015-04-01

    Patients with incidentally discovered small abdominal aortic aneurysms (AAA) require assessment by a vascular surgery department for possible enrollment in a surveillance programme. Our unit implemented a vascular nurse-run AAA clinic in October 2010. The aim of this study was to assess the feasibility of a specialist nurse-run small AAA clinic. Demographic and clinical data were collected prospectively for all patients seen in the new vascular nurse clinic between October 2010 and November 2012. A validated AAA operative mortality score was used to aid decision making by the vascular nurse. Some 250 patients were seen in the clinic. 198 (79.2%) patients were enrolled in surveillance, 40 (16%) declined enrollment and 12 (4.8%) were referred to a consultant clinic for further assessment. The majority of patients were male and the mean age was 73.7 years. Co-morbidities included hypertension, a history of cardiovascular disease, and hyperlipidaemia. The majority of referrals were considered to be low operative risk. No aneurysms ruptured whilst under surveillance. A nurse-run clinic that assesses patients with incidentally discovered small AAAs for inclusion in AAA surveillance is a feasible alternative to assessment of these patients in a consultant-run clinic. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  3. A Framework for Evaluating Diagnostic Discordance in Pathology Discovered During Research Studies

    PubMed Central

    Feng, Sherry; Weaver, Donald L.; Carney, Patricia A.; Reisch, Lisa M.; Geller, Berta M.; Goodwin, Andrew; Rendi, Mara H.; Onega, Tracy; Allison, Kim H.; Tosteson, Anna N. A.; Nelson, Heidi D.; Longton, Gary; Pepe, Margaret; Elmore, Joann G.

    2014-01-01

    Context Little is known about the frequency of discordant diagnoses identified during research. Objective To describe diagnostic discordance identified during research and apply a newly designed research framework for investigating discordance. Design Breast biopsy cases (N =407) from registries in Vermont and New Hampshire were independently reviewed by a breast pathology expert. The following research framework was developed to assess those cases: (1) compare the expert review and study database diagnoses, (2) determine the clinical significance of diagnostic discordance, (3) identify and correct data errors and verify the existence of true diagnostic discrepancies, (4) consider the impact of borderline cases, and (5) determine the notification approach for verified disagreements. Results Initial overall discordance between the original diagnosis recorded in our research database and a breast pathology expert was 32.2% (131 of 407). This was reduced to less than 10% after following the 5-step research framework. Detailed review identified 12 cases (2.9%) with data errors (2 in the underlying pathology registry, 3 with incomplete slides sent for expert review, and 7 with data abstraction errors). After excluding the cases with data errors, 38 cases (9.6%) among the remaining 395 had clinically meaningful discordant diagnoses (κ = 0.82; SE, 0.04; 95% confidence interval, 0.76–0.87). Among these 38 cases, 20 (53%) were considered borderline between 2 diagnoses by either the original pathologist or the expert. We elected to notify the pathology registries and facilities regarding discordant diagnoses. Conclusions Understanding the types and sources of diagnostic discordance uncovered in research studies may lead to improved scientific data and better patient care. PMID:24978923

  4. 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 ...

  5. 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 ...

  6. Clinical research before informed consent.

    PubMed

    Miller, Franklin G

    2014-06-01

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

  7. Clinical Research: A Globalized Network

    PubMed Central

    Richter, Trevor A.

    2014-01-01

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

  8. 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

  9. 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…

  10. Overview of clinical research design.

    PubMed

    Hartung, Daniel M; Touchette, Daniel

    2009-02-15

    Basic concepts and terminology of clinical research design are presented for new clinical investigators. Clinical research, research involving human subjects, can be described as either observational or experimental. The findings of all clinical research can be threatened by issues of bias and confounding. Biases are systematic errors in how study subjects are selected or measured, which result in false inferences. Confounding is a distortion in findings that is attributable to mixing variable effects. Uncontrolled observation research is generally more prone to bias and confounding than experimental research. Observational research includes designs such as the cohort study, case-control study, and cross-sectional study, while experimental research typically involves a randomized controlled trial (RCT). The cohort study, which includes the RCT, defines subject allocation on the basis of exposure interest (e.g., drug, disease-management program) and follows the patients to assess the outcomes. The case-control study uses the primary outcome of interest (e.g., adverse event) to define subject allocation, and different exposures are assessed in a retrospective manner. Cross-sectional research evaluates both exposure and outcome concurrently. Each of these design methods possesses different strengths and weaknesses in answering research questions, as well as underlying many study subtypes. While experimental research is the strongest method for establishing causality, it can be difficult to accomplish under many scenarios. Observational clinical research offers many design alternatives that may be appropriate if planned and executed carefully.

  11. Statistical research on the bioactivity of new marine natural products discovered during the 28 years from 1985 to 2012.

    PubMed

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

    2015-01-07

    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.

  12. 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

  13. Metabolomics and Its Application in the Development of Discovering Biomarkers for Osteoporosis Research.

    PubMed

    Lv, Huanhuan; Jiang, Feng; Guan, Daogang; Lu, Cheng; Guo, Baosheng; Chan, Chileung; Peng, Songlin; Liu, Baoqin; Guo, Wenwei; Zhu, Hailong; Xu, Xuegong; Lu, Aiping; Zhang, Ge

    2016-12-02

    Osteoporosis is a progressive skeletal disorder characterized by low bone mass and increased risk of fracture in later life. The incidence and costs associated with treating osteoporosis cause heavy socio-economic burden. Currently, the diagnosis of osteoporosis mainly depends on bone mineral density and bone turnover markers. However, these indexes are not sensitive and accurate enough to reflect the osteoporosis progression. Metabolomics offers the potential for a holistic approach for clinical diagnoses and treatment, as well as understanding of the pathological mechanism of osteoporosis. In this review, we firstly describe the study subjects of osteoporosis and bio-sample preparation procedures for different analytic purposes, followed by illustrating the biomarkers with potentially predictive, diagnosis and pharmaceutical values when applied in osteoporosis research. Then, we summarize the published metabolic pathways related to osteoporosis. Furthermore, we discuss the importance of chronological data and combination of multi-omics in fully understanding osteoporosis. The application of metabolomics in osteoporosis could provide researchers the opportunity to gain new insight into the metabolic profiling and pathophysiological mechanisms. However, there is still much to be done to validate the potential biomarkers responsible for the progression of osteoporosis and there are still many details needed to be further elucidated.

  14. Metabolomics and Its Application in the Development of Discovering Biomarkers for Osteoporosis Research

    PubMed Central

    Lv, Huanhuan; Jiang, Feng; Guan, Daogang; Lu, Cheng; Guo, Baosheng; Chan, Chileung; Peng, Songlin; Liu, Baoqin; Guo, Wenwei; Zhu, Hailong; Xu, Xuegong; Lu, Aiping; Zhang, Ge

    2016-01-01

    Osteoporosis is a progressive skeletal disorder characterized by low bone mass and increased risk of fracture in later life. The incidence and costs associated with treating osteoporosis cause heavy socio-economic burden. Currently, the diagnosis of osteoporosis mainly depends on bone mineral density and bone turnover markers. However, these indexes are not sensitive and accurate enough to reflect the osteoporosis progression. Metabolomics offers the potential for a holistic approach for clinical diagnoses and treatment, as well as understanding of the pathological mechanism of osteoporosis. In this review, we firstly describe the study subjects of osteoporosis and bio-sample preparation procedures for different analytic purposes, followed by illustrating the biomarkers with potentially predictive, diagnosis and pharmaceutical values when applied in osteoporosis research. Then, we summarize the published metabolic pathways related to osteoporosis. Furthermore, we discuss the importance of chronological data and combination of multi-omics in fully understanding osteoporosis. The application of metabolomics in osteoporosis could provide researchers the opportunity to gain new insight into the metabolic profiling and pathophysiological mechanisms. However, there is still much to be done to validate the potential biomarkers responsible for the progression of osteoporosis and there are still many details needed to be further elucidated. PMID:27918446

  15. 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

  16. Yoga clinical research review.

    PubMed

    Field, Tiffany

    2011-02-01

    In this paper recent research is reviewed on the effects of yoga poses on psychological conditions including anxiety and depression, on pain syndromes, cardiovascular, autoimmune and immune conditions and on pregnancy. Further, the physiological effects of yoga including decreased heartrate and blood pressure and the physical effects including weight loss and increased muscle strength are reviewed. Finally, potential underlying mechanisms are proposed including the stimulation of pressure receptors leading to enhanced vagal activity and reduced cortisol. The reduction in cortisol, in turn, may contribute to positive effects such as enhanced immune function and a lower prematurity rate. Copyright © 2010 Elsevier Ltd. All rights reserved.

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

    USDA-ARS?s Scientific Manuscript database

    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...

  18. Stem-Like Memory T Cells Are Discovered | Center for Cancer Research

    Cancer.gov

    T cells are the white blood cells that are the body’s first line of attack against foreign invaders.  When designing immunotherapies to treat cancer the goal is to prolong the immune response of T cells a bit beyond what the body normally does when a bacterium or a virus is encountered.   Nicholas P. Restifo, M.D., working with Luca Gattinoni, M.D., and other colleagues in CCR’s Surgery Branch recently discovered a subset within the human T cell population that may help clinicians to do just  this.

  19. Masters in clinical veterinary research.

    PubMed

    Barr, Frances

    2016-08-20

    A new masters qualification from the BSAVA aims to encourage and support clinical research in practice. As Frances Barr explains, it is aimed at those looking for a professional challenge. British Veterinary Association.

  20. Using data mining tools to discover novel clinical laboratory test batteries.

    PubMed

    Santangelo, Jennifer; Rogers, Patrick; Buskirk, Jason; Mekhjian, Hagop S; Liu, Jianhua; Kamal, Jyoti

    2007-10-11

    Using statistical analysis and data mining tools, we examined possible associations among clinical laboratory orders placed at the Ohio State University Medical Center between January and October of 2006. Upon applying the Frequent Itemset data mining technique to this data set, the results indicated that, while the most frequently ordered battery of tests was not associated with others, some highly associated orders may be good candidates to comprise new test batteries.

  1. Children's rights in clinical research.

    PubMed

    Bragadóttir, H

    2000-01-01

    To address the use of children and children's genetic information in research, analyze Icelandic laws as an example, review existing literature on children in clinical research, and describe nurses' actions as children's advocates. An integrated literature review was conducted using theoretical and empirical literature on children as human subjects in clinical research. Five Icelandic laws were analyzed. Legal protection of children as human subjects is an international issue and is lacking in Icelandic legislation. In spite of an identified need to protect children as human subjects, research on children's rights in clinical research is scarce. Nurses have not taken an active stance in protecting children as human subjects. The recently passed Bill on Health Sector Database in Iceland raises questions about protection of human subjects regardless of age and stature. The effects of this Icelandic case could have international implications regarding centralized health care databases, ownership of data, and related ethical and legal decisions.

  2. Purposive Sampling in Clinical Research.

    ERIC Educational Resources Information Center

    Royeen, Charlotte Brasic; Fortune, Jim Carlton

    This paper identifies typical sampling problems, including improper application of the Central Limit Theorem, that are associated with the probability-based sampling procedures currently used in clinical psychology research. It then presents two alternative research designs, the theory validation model and the extended case study model, which…

  3. Informed consent in clinical research.

    PubMed

    Pick, Andrew; Berry, Shelley; Gilbert, Kayleigh; McCaul, James

    Since increasing numbers of patients are asked to take part in clinical trials, nurses need to be aware of the principles of valid, informed consent. This article explores consent, which aims to protect the rights, safety and wellbeing of patients. In particular, the history of consent in research and the elements involved in obtaining informed consent from potential participants in research studies are discussed.

  4. On research in clinical practice.

    PubMed

    Nanivadekar, Arun

    2010-01-01

    Clinical research implies advancing current knowledge about health care by continually developing and testing new ideas about diseases, products, procedures, and strategies. Although this trait is inherent in human nature, it needs to be encouraged, nurtured, groomed, and channelized by creating a suitable atmosphere for it, providing the necessary resources, inculcating the necessary conceptual and manual skills, and rewarding the efforts and achievements suitably. Language, logic, statistics, and psychology play an important role in acquiring and developing research capability. To be socially relevant and economically viable, clinical research will need to partner with patients and their doctors in identifying what their goals of health care are, what they value, and what they are willing to "buy" in terms of goods and services. Besides, clinical research will need to bring on one platform the sponsors, the researchers, the patients, the payers, and the regulators to ensure that they do not work at cross purposes, that the cost of developing health care measures is scaled down through innovative approaches such as large simple trials, sequential trials, early marketing conditional on post-marketing surveillance, and so on. All these will be possible if day-to-day practice is slowly and systemically transformed into the largest laboratory of clinical research, which it ought to be, by forming networks of research-oriented practices, and popularizing the use of data collection and analysis tools such as Epi Info which are in the public domain.

  5. Visual research in clinical education.

    PubMed

    Bezemer, Jeff

    2017-01-01

    The aim of this paper is to explore what might be gained from collecting and analysing visual data, such as photographs, scans, drawings, video and screen recordings, in clinical educational research. Its focus is on visual research that looks at teaching and learning 'as it naturally occurs' in the work place, in simulation centres and other sites, and also involves the collection and analysis of visual learning materials circulating in these sites. With the ubiquity of digital recording devices, video data and visual learning materials are now relatively cheap to collect. Compared to other domains of education research visual materials are not widely used in clinical education research. The paper sets out to identify and reflect on the possibilities for visual research using examples from an ethnographic study on surgical and inter-professional learning in the operating theatres of a London hospital. The paper shows how visual research enables recognition, analysis and critical evaluation of (1) the hidden curriculum, such as the meanings implied by embodied, visible actions of clinicians; (2) the ways in which clinical teachers design multimodal learning environments using a range of modes of communication available to them, combining, for instance, gesture and speech; (3) the informal assessment of clinical skills, and the intricate relation between trainee performance and supervisor feedback; (4) the potentialities and limitations of different visual learning materials, such as textbooks and videos, for representing medical knowledge. The paper concludes with theoretical and methodological reflections on what can be made visible, and therefore available for analysis, explanation and evaluation if visual materials are used for clinical education research, and what remains unaccounted for if written language remains the dominant mode in the research cycle. Opportunities for quantitative analysis and ethical implications are also discussed. © 2016 John Wiley

  6. Discovering the research priorities of people with diabetes in a multicultural community: a focus group study

    PubMed Central

    Brown, Ken; Dyas, Jane; Chahal, Prit; Khalil, Yesmean; Riaz, Perween; Cummings-Jones, Joy

    2006-01-01

    Background Usually experts decide on which research is worthwhile, yet it is government policy to involve service users in research. There has been a lack of published research about involving patients from minority ethnic groups and people from deprived areas in setting research agendas. In this study we wanted to hear the voices of patients that are not often heard. Aim To find out the research priorities of people with diabetes from an inner city community and compare these with current expert-led research priorities in diabetes. Design of study A qualitative study using a participatory approach with consumer groups. Setting Primary care within inner city Nottingham, UK. Method Thirty-nine adult patients with diabetes with varying ethnic backgrounds recruited from three general practices. Six focus groups carried out in participants' preferred language, analysed using the constant comparative method. Results Nine main themes equating to research priorities were identified. Within these themes, information and awareness, service delivery and primary prevention of diabetes emerged as the main factors. There were no science-based topics and there was more emphasis on culturally influenced research questions, which differed from recent Department of Health priorities. There were several themes about service delivery, patient self-management and screening and prevention of diabetes that overlapped. Conclusions There is some divergence between expert-led and patient-led agendas in research about diabetes. Patient perspectives have a significant influence on research priorities, and there are likely to be several different patient perspectives. PMID:16536961

  7. 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.

  8. 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

  9. Justice in international clinical research.

    PubMed

    Pratt, Bridget; Loff, Bebe

    2011-08-01

    Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines. © 2010 Blackwell Publishing Ltd.

  10. Discovering Drugs with DNA-Encoded Library Technology: From Concept to Clinic with an Inhibitor of Soluble Epoxide Hydrolase.

    PubMed

    Belyanskaya, Svetlana L; Ding, Yun; Callahan, James F; Lazaar, Aili L; Israel, David I

    2017-03-09

    DNA-encoded chemical library technology was developed with the vision of its becoming a transformational platform for drug discovery. The hope was that a new paradigm for the discovery of low-molecular-weight drugs would be enabled by combining the vast molecular diversity achievable with combinatorial chemistry, the information-encoding attributes of DNA, the power of molecular biology, and a streamlined selection-based discovery process. Here, we describe the discovery and early clinical development of GSK2256294, an inhibitor of soluble epoxide hydrolase (sEH, EPHX2), by using encoded-library technology (ELT). GSK2256294 is an orally bioavailable, potent and selective inhibitor of sEH that has a long half life and produced no serious adverse events in a first-time-in-human clinical study. To our knowledge, GSK2256294 is the first molecule discovered from this technology to enter human clinical testing and represents a realization of the vision that DNA-encoded chemical library technology can efficiently yield molecules with favorable properties that can be readily progressed into high-quality drugs.

  11. Molecules discovered that block cancer-associated microRNAs | Center for Cancer Research

    Cancer.gov

    Investigators from the Center for Cancer Research have identified a new class of compounds that block the action of a microRNA associated with the development of human cancers, cardiovascular diseases and immune disorders.  Read more...

  12. Reconsidering paternalism in clinical research.

    PubMed

    Jansen, Lynn A; Wall, Steven

    2017-08-30

    The ethical standards that regulate clinical research have multiple rationales. Among them is the need to protect potential subjects from making imprudent decisions, which extends beyond the soft paternalistic concern to protect people from making uninformed decisions to participate in trials. This article argues that a plausible risk/benefit restriction on clinical trials is presumptively justified by hard paternalism, which in turn is supported by a deeper fairness-based rationale. This presumptive case for hard paternalism in research is not defeated by the alleged right to participate in clinical trials, by concerns about insult or status, by the need to conduct early phase trials that promise little to no benefit to participants, or by the recognition that some potential subjects are altruistically motivated. © 2017 John Wiley & Sons Ltd.

  13. Clinical trials in cancer research.

    PubMed Central

    Gehan, E A

    1979-01-01

    This is a review paper which gives a discussion of various aspects of clinical trials in cancer research. Since the conduct of the first randomized controlled clinical trial in cancer patients in the mid-1950's, substantial progress has been made in the utilization of the clinical trial technique for the evaluation of therapeutic efficiacy. The important elements of a protocol are given with some discussion of items to be considered in designing a protocol. The types of clinical trial (phase I, II, III) are defined, and the place of each phase of study in the context of the search for new treatments is delineated. A comprehensive discussion is given of the elements in the comparative clinical trial (phase III), including objectives, consierations in planning (comparability of treatment groups stratification of patients, feasibility and size of study, and prospective versus retrospective studies). Brief descriptions are given of designs for comparative clinical trials and a trial in oat cell lung carcinoma is discussed in some detail. Finally, some comments and references are given concerning the analysis of clinical trials. PMID:232043

  14. [Intermediate endpoints in clinical research].

    PubMed

    Peters, Sanne A E; Groenwold, Rolf H H; Bots, Michiel L

    2013-01-01

    An intermediate variable such as blood pressure is part of the causal pathway of mechanisms to a clinical outcome, e.g. myocardial infarction. An intervention affects a clinical outcome through its effect on that intermediate variable. In studies designed to assess the effects of interventions an intermediate variable may be used as surrogate for clinical outcomes. Such an endpoint is also known as an intermediate endpoint. Intervention studies with intermediate endpoints are commonly performed in medical research to evaluate the effects of an intervention on clinical outcomes. Intervention studies with an intermediate endpoint are conducted in a smaller study population and with a shorter duration of follow-up than studies using clinical outcomes. An intermediate variable is not eligible as an intermediate endpoint when the intervention also affects other biological mechanisms that subsequently affect the clinical endpoint. Due to a smaller sample size and shorter study duration, side effects of intervention are more difficult to evaluate in studies with an intermediate endpoint than in studies with clinical endpoints.

  15. 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…

  16. 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…

  17. 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…

  18. 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…

  19. [Research activity in clinical biochemistry].

    PubMed

    Jørgensen, Henrik L; Larsen, Birger; Ingwersen, Peter; Rehfeld, Jens F

    2008-09-01

    Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched control group from other medical specialities in Denmark. A list of all physicians registered in Denmark (23,127 persons) was drawn from the database "Laeger.dk". Of these, 5,202 were generalists (not included) while 11,691 were from other specialities. Of the 126 specialists from Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained. 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry compared to 51 for the control group. The number of citations per specialist was 1,844 for Clinical Biochemistry compared to 816 for the control group. The top ten H-indices (of which 8 were in Clinical Biochemistry) ranged from 30 to 69. Both the number of papers and the number of citations were higher for Clinical Biochemistry than for the control group. The difference was most pronounced among professors.

  20. 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…

  1. 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…

  2. Participants' responsibilities in clinical research.

    PubMed

    Resnik, David B; Ness, Elizabeth

    2012-12-01

    Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enroll in a study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one's self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements.

  3. Participants’ responsibilities in clinical research

    PubMed Central

    Resnik, David B; Ness, Elizabeth

    2014-01-01

    Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enrol in a study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one’s self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements. PMID:22822200

  4. Discover the power of light: student research laboratory for optical engineering at ITMO University

    NASA Astrophysics Data System (ADS)

    Tolstoba, N. D.; Saitgalina, A. K.

    2016-09-01

    Russia's student training program continues to set new, ever more difficult goals for itself every year. Nowadays, it has three main aims: the first is to train well-educated professionals; the second is to encourage students' research activity; and last but not least is to draw youth into the arena of global education. This latter point has recently become a key purpose for just about every university in the country. Thus, the Student Research Laboratory for Optical Engineering (SRLOE) at ITMO University strives to provide career guidance for students and to promote light and photon technologies. The article below explores the targets of the SRLOE, its great impact to development and progress in this field, and the new vision of technical education. Today we take for granted all those modern things which didn't exist a couple of decades ago, and life proves that there is a multitude of undiscovered and unexplored technologies within this field. Students all over the world aspire to new heights.

  5. Distribution and clinical impact of functional variants in 50,726 whole-exome sequences from the DiscovEHR study.

    PubMed

    Dewey, Frederick E; Murray, Michael F; Overton, John D; Habegger, Lukas; Leader, Joseph B; Fetterolf, Samantha N; O'Dushlaine, Colm; Van Hout, Cristopher V; Staples, Jeffrey; Gonzaga-Jauregui, Claudia; Metpally, Raghu; Pendergrass, Sarah A; Giovanni, Monica A; Kirchner, H Lester; Balasubramanian, Suganthi; Abul-Husn, Noura S; Hartzel, Dustin N; Lavage, Daniel R; Kost, Korey A; Packer, Jonathan S; Lopez, Alexander E; Penn, John; Mukherjee, Semanti; Gosalia, Nehal; Kanagaraj, Manoj; Li, Alexander H; Mitnaul, Lyndon J; Adams, Lance J; Person, Thomas N; Praveen, Kavita; Marcketta, Anthony; Lebo, Matthew S; Austin-Tse, Christina A; Mason-Suares, Heather M; Bruse, Shannon; Mellis, Scott; Phillips, Robert; Stahl, Neil; Murphy, Andrew; Economides, Aris; Skelding, Kimberly A; Still, Christopher D; Elmore, James R; Borecki, Ingrid B; Yancopoulos, George D; Davis, F Daniel; Faucett, William A; Gottesman, Omri; Ritchie, Marylyn D; Shuldiner, Alan R; Reid, Jeffrey G; Ledbetter, David H; Baras, Aris; Carey, David J

    2016-12-23

    The DiscovEHR collaboration between the Regeneron Genetics Center and Geisinger Health System couples high-throughput sequencing to an integrated health care system using longitudinal electronic health records (EHRs). We sequenced the exomes of 50,726 adult participants in the DiscovEHR study to identify ~4.2 million rare single-nucleotide variants and insertion/deletion events, of which ~176,000 are predicted to result in a loss of gene function. Linking these data to EHR-derived clinical phenotypes, we find clinical associations supporting therapeutic targets, including genes encoding drug targets for lipid lowering, and identify previously unidentified rare alleles associated with lipid levels and other blood level traits. About 3.5% of individuals harbor deleterious variants in 76 clinically actionable genes. The DiscovEHR data set provides a blueprint for large-scale precision medicine initiatives and genomics-guided therapeutic discovery. Copyright © 2016, American Association for the Advancement of Science.

  6. 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.

  7. Completed | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    Prior to the current Clinical Proteomic Tumor Analysis Consortium (CPTAC), previously funded initiatives associated with clinical proteomics research included: Clinical Proteomic Tumor Analysis Consortium (CPTAC 2.0) Clinical Proteomic Technologies for Cancer Initiative (CPTC) Mouse Proteomic Technologies Initiative

  8. 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

  9. [Clinical guidelines and health services research].

    PubMed

    Schütte, U

    2011-05-01

    Doctors are bound to ensure and improve the quality of their own work. This is a significant part of medical professionalism and lasts one's entire working life. In this regard clinical guidelines provide valuable and helpful information because they give recommendations on prevention, diagnosis, treatment, and aftercare based on current evidence. However, in their medical work potential users widely ignore such guidelines. Hence it is necessary to discover barriers to compliance with the guidelines and, based on the findings, to investigate more effective strategies for implementing the guidelines. Analyses and evaluation can be performed by using health services research. Undesirable developments in doctors' daily routines, associated with negative consequences for healthy and ill people, as well as for the economics of health care, can be detected and improvements can be identified systematically. This branch of research has become ever more important - even necessary. It ist likely that the increasing demand for assessing the needs, costs, structural conditions, and quality of health care will confirm the significance of such evaluation.

  10. Biobanking for interdisciplinary clinical research.

    PubMed

    Riegman, P H J; Dinjens, W N M; Oosterhuis, J W

    2007-01-01

    Biobanking nowadays is mostly strongly determined by the specific aims of a research group in charge of the biobank, determining their own standards for the collection and annotation of samples. Often a long period is needed to build up the sample and data collections, especially when long-term follow-up data is required. Such collections need a long-term dedication and proper funding. Neglecting either sample number or annotation can result in insignificant or poor results. However, outcome of translational research does not only depend on the sample quality. In many cases it can also be improved to start the experimental design within a multidisciplinary team composed of clinicians including pathologists, molecular biologists, statisticians, bioinformaticians and tissue resource managers. Such a team, capable of careful evaluation of the numbers needed and which or what part of the samples are to be included, could help in obtaining far better results. Many lines of clinical research could benefit more efficiently from the wealth of information stored in well-preserved disease-oriented tissue sample collections with the proper annotations, when the infrastructure around biobanks and new collection build-up is well organized, standardized and streamlined. Future medical research will refine its scientific questions, demanding even further refinement of corresponding clinical information. In addition, larger sample collections are needed to study for instance multifactorial diseases. Today, the samples are collected for tomorrow, therefore, improvement is needed now in standardization, automated enrichment of annotations from hospital information systems and disease registries, insight in overlapping collections of different forms of tissue banking and cooperation in national and international networks.

  11. 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

  12. Prostate Cancer Clinical Consortium Clinical Research Site:Targeted Therapies

    DTIC Science & Technology

    2015-10-01

    Cornell Medical College Prostate Cancer Research Program (WCMC-PCRP) is a Clinical Research Site of the Prostate Cancer Clinical Trials Consortium...effectively bring novel agents and new biomarker driven trials directly to patients 17 Table of Contents Page 1. Introduction...purpose and scope of the research. The Weill Cornell Medical College Prostate Cancer Research Program (WCMC-PCRP) is a Clinical Research Site of the

  13. Status of human monkeypox: clinical disease, epidemiology and research.

    PubMed

    Damon, Inger K

    2011-12-30

    Monkeypox, a vesiculo-pustular rash illness, was initially discovered to cause human infection in 1970 through the World Health Organization (WHO)-sponsored efforts of the Commission to Certify Smallpox Eradication in Western Africa and the Congo Basin. The virus had been discovered to cause a nonhuman primate rash illness in 1958, and was thus named monkeypox. The causative agents of monkeypox and smallpox diseases both are species of Orthopoxvirus. Orthopoxvirus monkeypox, when it infects humans as an epizootic, produces a similar clinical picture to that of ordinary human smallpox. Since 1970, extensive epidemiology, virology, ecology and public health research has enabled better characterization of monkeypox virus and the associated human disease. This work reviews the progress in this body of research, and reviews studies of this "newly" emerging zoonotic disease.

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

    PubMed

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

    2014-01-01

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

  15. Criteria for critiquing clinical nursing research reports.

    PubMed

    Grant, J S; Davis, L L; Kinney, M R

    1993-06-01

    The primary goal of nursing research is to develop a scientific knowledge base for practice. Postanesthesia nurses are expected to critique nursing research before applying findings to clinical practice. As consumers of research, postanesthesia nurses must be able to employ critical evaluation skills to judge the merit and relevance of research to their clinical practice. This article presents criteria for critiquing clinical nursing research reports to determine their relevance to practice.

  16. A Decade of Research on TLR2 Discovering Its Pivotal Role in Glial Activation and Neuroinflammation in Neurodegenerative Diseases

    PubMed Central

    Hayward, Jin Hee

    2014-01-01

    Toll-like receptors (TLRs) belong to a class of pattern recognition receptors that play an important role in host defense against pathogens. TLRs on innate immune cells recognize a wide variety of pathogen-associated molecular patterns (PAMPs) and trigger innate immune responses. Later, it was revealed that the same receptors are also utilized to detect tissue damage to trigger inflammatory responses in the context of non-infectious inflammation. In the nervous system, different members of the TLR family are expressed on glial cells including astrocytes, microglia, oligodendrocytes, and Schwann cells, implicating their putative role in innate/inflammatory responses in the nervous system. In this regard, we have investigated the function of TLRs in neuroinflammation. We discovered that a specific member of the TLR family, namely TLR2, functions as a master sentry receptor to detect neuronal cell death and tissue damage in many different neurological conditions including nerve transection injury, intracerebral hemorrhage, traumatic brain injury, and hippocampal excitotoxicity. In this review, we have summarized our research for the last decade on the role of TLR2 in neuroinflammation in the above neurological disorders. Our data suggest that TLR2 can be an efficient target to regulate unwanted inflammatory response in these neurological conditions. PMID:24963278

  17. [Clinical research V. Sample size].

    PubMed

    Talavera, Juan O; Rivas-Ruiz, Rodolfo; Bernal-Rosales, Laura Paola

    2011-01-01

    In clinical research it is impossible and inefficient to study all patients with a specific pathology, so it is necessary to study a sample of them. The estimation of the sample size before starting a study guarantees the stability of the results and allows us to foresee the feasibility of the study depending on the availability of patients and cost. The basic structure of sample size estimation is based on the premise that seeks to demonstrate, among other cases, that the observed difference between two or more maneuvers in the subsequent state is real. Initially, it requires knowing the value of the expected difference (δ) and its data variation (standard deviation). These data are usually obtained from previous studies. Then, other components must be considered: a (alpha), percentage of error in the assertion that the difference between means is real, usually 5 %; and β, error rate accepting the claim that the no-difference between the means is real, usually ranging from 15 to 20 %. Finally, these values are substituted into the formula or in an electronic program for estimating sample size. While summary and dispersion measures vary with the type of variable according to the outcome, the basic structure is the same.

  18. Stuttering: Clinical and research update.

    PubMed

    Perez, Hector R; Stoeckle, James H

    2016-06-01

    To provide an update on the epidemiology, genetics, pathophysiology, diagnosis, and treatment of developmental stuttering. The MEDLINE and Cochrane databases were searched for past and recent studies on the epidemiology, genetics, pathophysiology, diagnosis, and treatment of developmental stuttering. Most recommendations are based on small studies, limited-quality evidence, or consensus. Stuttering is a speech disorder, common in persons of all ages, that affects normal fluency and time patterning of speech. Stuttering has been associated with differences in brain anatomy, functioning, and dopamine regulation thought to be due to genetic causes. Attention to making a correct diagnosis or referral in children is important because there is growing consensus that early intervention with speech therapy for children who stutter is critical. For adults, stuttering can be associated with substantial psychosocial morbidity including social anxiety and low quality of life. Pharmacologic treatment has received attention in recent years, but clinical evidence is limited. The mainstay of treatment for children and adults remains speech therapy. A growing body of research has attempted to uncover the pathophysiology of stuttering. Referral for speech therapy remains the best option for children and adults. Copyright© the College of Family Physicians of Canada.

  19. Clinical Trials in Vision Research

    MedlinePlus

    ... the right choice for you. What are the costs of a clinical trial? All medical care provided ... Clinical trials conducted at other locations may involve costs related to standard medical care. These may or ...

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

    PubMed

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

    2016-03-01

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

  1. Measuring Clinical Significance in Rehabilitation Research

    ERIC Educational Resources Information Center

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

    2006-01-01

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

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

    PubMed

    Schwenzer, Karen J

    2011-12-01

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

  3. Extending the rails: how research reshapes clinics.

    PubMed

    Petty, JuLeigh; Heimer, Carol A

    2011-06-01

    The purpose of clinical research is to create the scientific foundation for medical practice. In this way of thinking, the effect on medical practice occurs after the research has been completed. Social studies of science have debunked the standard model of scientific research, observing that changes in practice associated with research occur not just because of the results of research but also because of the practice of research. Drawing on fieldwork in HIV clinics in the US, South Africa,Thailand, and Uganda, we argue that clinical trials shape medical practice by altering the organizations in which both medical treatment and clinical trials take place. Three general processes are central to this transformation: the modification of material environments, the reorganization of bureaucratic relations, and the prioritization of research values. These processes unfold somewhat differently in the clinics of poorer countries than in those of wealthier ones.

  4. Protocol Writing in Clinical Research

    PubMed Central

    Al-Jundi, Azzam

    2016-01-01

    Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition. PMID:28050522

  5. Research leadership: should clinical directors be distinguished researchers?

    PubMed

    Allison, Stephen; Goodall, Amanda H; Bastiampillai, Tarun

    2016-06-01

    Clinical directors established research-led healthcare by combining research, teaching and clinical excellence within the teaching hospitals. This research culture created high clinical standards, which benefited patients, the workforce and healthcare organisations. The current paper explores this research leadership role for clinical directors. It reviews studies arising from the theory of expert leadership, which focuses on the relationship between a leader's core knowledge and organisational performance. More specifically, we examine the expert leader's research track record, the associations with their organisation's performance, and the influence of research activity on clinical excellence. Distinguished researchers still lead the most prestigious teaching hospitals and the most trusted departments of psychiatry in the United States where the clinical directorate structure originated. It is also known that good scholars can improve research output when appointed to leadership positions. This suggests that the clinical director's research track record should be a consideration at a time when research is being embedded in Australia's local health networks. A clinical director's leadership may influence the research performance of their department and contribute to the quality of mental healthcare. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  6. Media | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The Office of Cancer Clinical Proteomics Research (OCCPR) is committed to providing the media with timely and accurate information.  This section offers key resources for patients, cancer researchers, physicians, and media professionals.

  7. Improvement of Clinical Skills through Pharmaceutical Education and Clinical Research.

    PubMed

    Ishizaki, Junko

    2017-01-01

     Professors and teaching staff in the field of pharmaceutical sciences should devote themselves to staying abreast of relevant education and research. Similarly those in clinical pharmacies should contribute to the advancement of pharmaceutical research and the development of next generation pharmacists and pharmaceuticals. It is thought that those who work in clinical pharmacies should improve their own skills and expertise in problem-finding and -solving, i.e., "clinical skills". They should be keen to learn new standard treatments based on the latest drug information, and should try to be in a position where collecting clinical information is readily possible. In the case of pharmacists in hospitals and pharmacies, they are able to aim at improving their clinical skills simply through performing their pharmaceutical duties. On the other hand, when a pharmaceutical educator aims to improve clinical skills at a level comparable to those of clinical pharmacists, it is necessary to devote or set aside considerable time for pharmacist duties, in addition to teaching, which may result in a shortage of time for hands-on clinical practice and/or in a decline in the quality of education and research. This could be a nightmare for teaching staff in clinical pharmacy who aim to take part in such activities. Nonetheless, I believe that teaching staff in the clinical pharmacy area could improve his/her clinical skills through actively engaging in education and research. In this review, I would like to introduce topics on such possibilities from my own experiences.

  8. Database on veterinary clinical research in homeopathy.

    PubMed

    Clausen, Jürgen; Albrecht, Henning

    2010-07-01

    The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.

  9. Antiphospholipid Syndrome Clinical Research Task Force report.

    PubMed

    Erkan, D; Derksen, R; Levy, R; Machin, S; Ortel, T; Pierangeli, S; Roubey, R; Lockshin, M

    2011-02-01

    The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing guidelines for researchers to help improve the quality of APS research; and b) prioritizing the ideas for a well-designed multicenter clinical trial and discussing the pragmatics of getting such a trial done. Following a systematic working algorithm, the Task Force identified five major issues that impede APS clinical research and the ability to develop evidence-based recommendations for the management of aPL-positive patients: (1) aPL detection has been based on partially or non-standardized tests, and clinical (and basic) APS research studies have included patients with heterogeneous aPL profiles with different clinical event risks; (2) clinical (and basic) APS research studies have included a heterogeneous group of patients with different aPL-related manifestations (some controversial); (3) thrombosis and/or pregnancy risk stratification and quantification are rarely incorporated in APS clinical research; (4) most APS clinical studies include patients with single positive aPL results and/or low-titer aPL ELISA results; furthermore, study designs are mostly retrospective and not population based, with limited number of prospective and/or controlled population studies; and (5) lack of the understanding the particular mechanisms of aPL-mediated clinical events limits the optimal clinical study design. The Task Force recommended that there is an urgent need for a truly international collaborative approach to design and conduct well-designed prospective large-scale multi-center clinical trials of patients with persistent and clinically significant aPL profiles. An international collaborative meeting to formulate a good research question using 'FINER' (Feasible; Interesting

  10. Critical issues in clinical periodontal research.

    PubMed

    Preshaw, Philip M

    2012-06-01

    As periodontal researchers and clinicians, we are challenged every day to make decisions relating to the clinical management of our patients and about how best to conduct clinical periodontal research. This volume of Periodontology 2000 addresses some of the critical issues in contemporary clinical periodontics and periodontal research that are of direct relevance to clinicians, researchers, teachers and students. The 11 review articles in this volume of Periodontology 2000 focus on aspects of periodontal research methodology and clinical periodontology. In terms of research methodology, the articles aim to inform the reader on topics relating to randomized controlled trials in periodontal research, evidence-based dentistry, calibration of clinical examiners and statistics relevant to periodontal research. The clinical periodontology articles address issues relating to decisions on retaining periodontally compromised teeth or replacing them with implants, periodontal management in the patient with osteoporosis, surgical approaches for root coverage and the emerging science of advanced regenerative technologies, including the use of stem cells, for periodontal regeneration. It is hoped that these critical reviews will address many of the dilemmas that confront us on a regular basis and provide practical guidance to those engaged in both clinical periodontology and clinical periodontal research. © 2012 John Wiley & Sons A/S.

  11. 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)

  12. Developing Clinical Research Relationship: Views from Within.

    PubMed

    Zvonareva, Olga; Akrong, Lloyd

    2015-12-01

    The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor-researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in-depth interviews conducted in Ghana and South Africa with respondents at different stages of involvement in clinical research, ranging from no experience in clinical research to enrollment in several clinical trials. The perspectives of all respondents were largely congruent and rooted in the common view that clinical research contributed to the improvement of local health. They went beyond the researcher/participant versus doctor/patient dichotomy, long established in research ethics, and preferred to view participants and investigators as partners working together to find ways to address local health needs. The conceptualization of investigator-participant relations as a partnership reinforced expectations of care, transparency and accountability, which were viewed as necessary expressions of mutuality and respect within equal collaborations. It is important to engage with these views in order to avoid antagonizing societal expectations and to build up long-term public trust, crucial for the continuous operation of clinical research. © 2014 John Wiley & Sons Ltd.

  13. Health economics in clinical research.

    PubMed

    Manns, Braden J

    2015-01-01

    The pressure for health care systems to provide more resource intensive health care and newer, more costly, therapies is significant, despite limited health care budgets. As such, demonstration that a new therapy is effective is no longer sufficient to ensure that it is funded within publicly funded health care systems. The impact of a therapy on health care costs is also an important consideration for decision-makers who must allocate scarce resources. The clinical benefits and costs of a new therapy can be estimated simultaneously using economic evaluation, the strengths and limitations of which are discussed herein. In addition, this chapter includes discussion of the important economic outcomes that can be collected within a clinical trial (alongside the clinical outcome data) enabling consideration of the impact of the therapy on overall resource use, thus enabling performance of an economic evaluation, if the therapy is shown to be effective.

  14. Assistant Clinical Investigator | Center for Cancer Research

    Cancer.gov

    This is an exciting training opportunity intended for physicians interested in dedicating their careers to clinical research. Come join a vibrant, multidisciplinary research community featuring: flexible funding that supports innovative, high-impact bench-to-bedside research, access to the largest hospital in the world devoted exclusively to clinical research, extensive shared research resources, and availability of a broad range of scientific and clinical expertise. The Clinical Investigator Development Program (CIDP) assists board-eligible/board-certified translational researchers to transition from a mentored position to that of an independent investigator in laboratory-based or patient-oriented research in academia, or comparable positions in government and industry. Potential areas of interest include: medical oncology, pediatric hematology-oncology, radiation oncology, surgical oncology, pathology, neuro-oncology and urology. Program objectives are to: develop competence and skills in study design, protocol development and patient-oriented research; acquire knowledge related to the ethical and regulatory issues of conducting clinical research involving human subjects; gain direct experience with the collection and management of research data; and learn about function, development, organization and leadership of a multidisciplinary clinical research team.

  15. 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…

  16. 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…

  17. Rare Diseases Clinical Research Network

    MedlinePlus

    ... participate in research! Register Today For Patients and Families Find Patient Advocacy Groups The RDCRN Coalition of Patient Advocacy Groups (RDCRN-CPAG) represents the perspective and interests of all patient advocacy organizations associated ...

  18. Clinical research: A personal perspective

    PubMed Central

    Nanivadekar, Arun S.

    2017-01-01

    Research ought to be inculcated as an attitude during the formative years of every health-care professional. The core elements of research are curiosity, observation, reasoning, and experimentation. These suggestions are supported with suitable examples. Medical advisers in the pharmaceutical industry are in a unique position to act as facilitators of such a process. The tools they can use are also suggested. PMID:28194336

  19. 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.

  20. Double agency in clinical research.

    PubMed

    Edwards, Marie; Chalmers, Karen

    2002-06-01

    The current focus on evidence-based practice in nursing may result in nurses playing 2 roles concurrently--that is, acting as researcher and caregiver at the same time and with the same people. Given the fiduciary nature of the patient-caregiver relationship, this double agency can give rise to problems, both real and perceived. In this paper, the issues associated with assuming dual roles in research with humans will be examined, particularly in relation to recruitment and informed consent, data collection, and participant withdrawal from a study. In addition, strategies to prevent or minimize problems related to double agency are identified, with attention to the guidance provided by professional codes of ethics and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.

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

    PubMed

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

    2015-06-01

    Translational bioinformatics and clinical research (biomedical) informatics are the primary domains related to informatics activities that support translational research. Translational bioinformatics focuses on computational techniques in genetics, molecular biology, and systems biology. Clinical research (biomedical) informatics involves the use of informatics in discovery and management of new knowledge relating to health and disease. This article details 3 projects that are hybrid applications of translational bioinformatics and clinical research (biomedical) informatics: The Cancer Genome Atlas, the cBioPortal for Cancer Genomics, and the Memorial Sloan Kettering Cancer Center clinical variants and results database, all designed to facilitate insights into cancer biology and clinical/therapeutic correlations. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Qualitative research: adding drive and dimension to clinical research.

    PubMed

    Rusinová, Katerĭna; Pochard, Frédéric; Kentish-Barnes, Nancy; Chaize, Marine; Azoulay, Elie

    2009-01-01

    Qualitative research and its methods stem from the social sciences and can be used to describe and interpret complex phenomena that involve individuals' views, beliefs, preferences, and subjective responses to places and people. Thus, qualitative research explores the many subjective factors that may influence patient outcomes, staff well-being, and healthcare quality, yet fail to lend themselves to the hypothesis-testing approach that characterizes quantitative research. Qualitative research is valuable in the intensive care unit to explore organizational and cultural issues and to gain insight into social interactions, healthcare delivery processes, and communication. Qualitative research generates explanatory models and theories, which can then serve to devise interventions, whose efficacy can be studied quantitatively. Thus, qualitative research works synergistically with quantitative research, providing new impetus to the research process and a new dimension to research findings. Qualitative research starts with conceptualizing the research question, choosing the appropriate qualitative strategy, and designing the study; rigorous methods specifically designed for qualitative research are then used to conduct the study, analyze the data, and verify the findings. The researcher is the data-collecting instrument, and the data are the participants' words and behaviors. Data coding methods are used to describe experiences, discover themes, and build theories. In this review, we outline the rationale and methods for conducting qualitative research to inform critical care issues. We provide an overview of available qualitative methods and explain how they can work in close synergy with quantitative methods. To illustrate the effectiveness of combining different research methods, we will refer to recent qualitative studies conducted in the intensive care unit.

  3. Optimizing Clinical Research Participant Selection with Informatics.

    PubMed

    Weng, Chunhua

    2015-11-01

    Clinical research participants are often not reflective of 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.

  4. Retooling Institutional Support Infrastructure for Clinical Research

    PubMed Central

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

    2016-01-01

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

  5. 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.

  6. Translating research findings to clinical nursing practice.

    PubMed

    Curtis, Kate; Fry, Margaret; Shaban, Ramon Z; Considine, Julie

    2017-03-01

    To describe the importance of, and methods for, successfully conducting and translating research into clinical practice. There is universal acknowledgement that the clinical care provided to individuals should be informed on the best available evidence. Knowledge and evidence derived from robust scholarly methods should drive our clinical practice, decisions and change to improve the way we deliver care. Translating research evidence to clinical practice is essential to safe, transparent, effective and efficient healthcare provision and meeting the expectations of patients, families and society. Despite its importance, translating research into clinical practice is challenging. There are more nurses in the frontline of health care than any other healthcare profession. As such, nurse-led research is increasingly recognised as a critical pathway to practical and effective ways of improving patient outcomes. However, there are well-established barriers to the conduct and translation of research evidence into practice. This clinical practice discussion paper interprets the knowledge translation literature for clinicians interested in translating research into practice. This paper is informed by the scientific literature around knowledge translation, implementation science and clinician behaviour change, and presented from the nurse clinician perspective. We provide practical, evidence-informed suggestions to overcome the barriers and facilitate enablers of knowledge translation. Examples of nurse-led research incorporating the principles of knowledge translation in their study design that have resulted in improvements in patient outcomes are presented in conjunction with supporting evidence. Translation should be considered in research design, including the end users and an evaluation of the research implementation. The success of research implementation in health care is dependent on clinician/consumer behaviour change and it is critical that implementation strategy

  7. 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.

  8. CLARA: an integrated clinical research administration system

    PubMed Central

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

    2014-01-01

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

  9. Anatomy and histology of the newly discovered adipose sac structure within the labia majora: international original research.

    PubMed

    Ostrzenski, Adam; Krajewski, Pawel; Davis, Kern

    2016-09-01

    To determine whether there is any new anatomical structure present within the labia majora. A case serial study was executed on eleven consecutive fresh human female cadavers. Stratum-by-stratum dissections of the labia majora were performed. Twenty-two anatomic dissections of labia majora were completed. Eosin and Hematoxylin agents were used to stain newly discovered adipose sac's tissues of the labia majora and the cylinder-like structures, which cover condensed adipose tissues. The histology of these two structures was compared. All dissected labia majora demonstrated the presence of the anatomic existence of the adipose sac structure. Just under the dermis of the labia majora, the adipose sac was located, which was filled with lobules containing condensed fatty tissues in the form of cylinders. The histological investigation established that the well-organized fibro-connective-adipose tissues represented the adipose sac. The absence of descriptions of the adipose sac within the labia majora in traditional anatomic and gynecologic textbooks was noted. In this study group, the newly discovered adipose sac is consistently present within the anatomical structure of the labia majora. The well-organized fibro-connective-adipose tissue represents microscopic characteristic features of the adipose sac.

  10. Modern Clinical Research on LSD

    PubMed Central

    Liechti, Matthias E

    2017-01-01

    All modern clinical studies using the classic hallucinogen lysergic acid diethylamide (LSD) in healthy subjects or patients in the last 25 years are reviewed herein. There were five recent studies in healthy participants and one in patients. In a controlled setting, LSD acutely induced bliss, audiovisual synesthesia, altered meaning of perceptions, derealization, depersonalization, and mystical experiences. These subjective effects of LSD were mediated by the 5-HT2A receptor. LSD increased feelings of closeness to others, openness, trust, and suggestibility. LSD impaired the recognition of sad and fearful faces, reduced left amygdala reactivity to fearful faces, and enhanced emotional empathy. LSD increased the emotional response to music and the meaning of music. LSD acutely produced deficits in sensorimotor gating, similar to observations in schizophrenia. LSD had weak autonomic stimulant effects and elevated plasma cortisol, prolactin, and oxytocin levels. Resting-state functional magnetic resonance studies showed that LSD acutely reduced the integrity of functional brain networks and increased connectivity between networks that normally are more dissociated. LSD increased functional thalamocortical connectivity and functional connectivity of the primary visual cortex with other brain areas. The latter effect was correlated with subjective hallucinations. LSD acutely induced global increases in brain entropy that were associated with greater trait openness 14 days later. In patients with anxiety associated with life-threatening disease, anxiety was reduced for 2 months after two doses of LSD. In medical settings, no complications of LSD administration were observed. These data should contribute to further investigations of the therapeutic potential of LSD in psychiatry. PMID:28447622

  11. Untapped Potential of Observational Research to Inform Clinical Decision Making: American Society of Clinical Oncology Research Statement.

    PubMed

    Visvanathan, Kala; Levit, Laura A; Raghavan, Derek; Hudis, Clifford A; Wong, Sandra; Dueck, Amylou; Lyman, Gary H

    2017-06-01

    ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.

  12. Clinical research in surgery: threats and opportunities.

    PubMed

    Ceelen, Wim P

    2014-01-01

    Surgery is a discipline which profoundly affects human integrity. Therefore, there is an ethical and scientific imperative that surgical practice depends on the best possible trial-based evidence. Traditionally, the quality and quantity of clinical research have been lagging behind other disciplines in clinical medicine. However, recent collaborative initiatives, such as the IDEAL framework which tests surgical innovation, international registries, and quality assurance platforms, the development of modified randomized controlled trials and alternative trial designs as well as the impending reforms of the regulatory framework surrounding nonpharmaceutical interventions and devices offer significant and timely opportunities to enhance the relevance of clinical research in surgery. Here, we provide an overview of the current state of clinical research in surgery, identify possible obstacles, and discuss realistic and emerging solutions that have the potential to change the way surgical research is organized, funded, and translated to the patient's benefit.

  13. Research in clinical laboratory science: professionals' involvement.

    PubMed

    Laudicina, Rebecca; Fenn, JoAnn P; Freeman, Vickie; McCoy, Carol; McLane, Mary Ann; Mundt, Lillian; Polancic, Joan; Randolph, Tim; Shanahan, Kristy

    2011-01-01

    To describe current qualitative and quantitative aspects of research engagement and other scholarly activities conducted by clinical laboratory science (CLS) professionals across a range of employment settings. A link to a 3-part online survey was sent by electronic mail to 7,572 members of the American Society for Clinical Laboratory Science and 500 program directors. email message, on-line survey all ASCLS members and all directors of accredited clinical laboratory educational programs Quantitative and qualitative measures of professionals' engagement in research and other scholarly activities 556 of 7572 (7.3%) persons completed the survey. Thirty-two percent of survey respondents reported spending between 1 to > 40 work hours per week conducting research with 68% of respondents not participating in research activities. Conducting research is an employment requirement for 18% of survey participants. Twenty-nine percent of respondents have published at least one research article, and 47% of respondents who conduct research have published studies in the journal Clinical Laboratory Science. More than 57% of respondents participate in non-research scholarly activities as part of their employment. CLS professionals who conduct research are more likely to do applied, clinical, or educational research than other types of research. Fifty-seven percent of respondents who conduct research lack external funding for their work. Ninety-three percent of total research dollars is obtained by respondents who hold the Ph.D. degree. The perception of the importance of conducting research varies by employment position. Barriers to participation in research include lack of inclusion of research in the job description, time constraints, inadequate research funding, limited opportunity, and lack of space and equipment. CLS professionals participate in research in limited numbers, and are more likely to engage in non-research types of scholarly activities. Numerous barriers are

  14. Individual Library Research Clinics for College Freshmen.

    ERIC Educational Resources Information Center

    Becker, Karen A.

    1993-01-01

    Describes a program of Library Research Clinics developed at Northern Illinois University to teach bibliographic instruction (BI) to one or two students at a time as an alternative to teaching BI in large first-year English classes. Implementation of the clinics with educationally disadvantaged students and with honor students is reviewed.…

  15. 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)

  16. 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)

  17. 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

  18. Statistical reporting of clinical pharmacology research.

    PubMed

    Ring, Arne; Schall, Robert; Loke, Yoon K; Day, Simon

    2017-03-21

    Research in clinical pharmacology covers a wide range of experiments, trials and investigations: clinical trials, systematic reviews and meta-analyses of drug usage after market approval, the investigation of pharmacokinetic-pharmacodynamic relationships, the search for mechanisms of action or for potential signals for efficacy and safety using biomarkers. Often these investigations are exploratory in nature, which has implications for the way the data should be analysed and presented. Here we summarize some of the statistical issues that are of particular importance in clinical pharmacology research.

  19. 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)

  20. 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)

  1. Electronic health records to facilitate clinical research.

    PubMed

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

    2017-01-01

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

  2. Public information about clinical trials and research.

    PubMed

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  3. A Novel Repressor of the ica Locus Discovered in Clinically Isolated Super-Biofilm-Elaborating Staphylococcus aureus

    PubMed Central

    Yu, Liansheng; Hisatsune, Junzo; Hayashi, Ikue; Tatsukawa, Nobuyuki; Sato’o, Yusuke; Mizumachi, Emiri; Kato, Fuminori; Hirakawa, Hideki; Pier, Gerald B.

    2017-01-01

    ABSTRACT Staphylococcus aureus TF2758 is a clinical isolate from an atheroma and a super-biofilm-elaborating/polysaccharide intercellular adhesin (PIA)/poly-N-acetylglucosamine (PNAG)-overproducing strain (L. Shrestha et al., Microbiol Immunol 60:148–159, 2016, https://doi.org/10.1111/1348-0421.12359). A microarray analysis and DNA genome sequencing were performed to identify the mechanism underlying biofilm overproduction by TF2758. We found high transcriptional expression levels of a 7-gene cluster (satf2580 to satf2586) and the ica operon in TF2758. Within the 7-gene cluster, a putative transcriptional regulator gene designated rob had a nonsense mutation that caused the truncation of the protein. The complementation of TF2758 with rob from FK300, an rsbU-repaired derivative of S. aureus strain NCTC8325-4, significantly decreased biofilm elaboration, suggesting a role for rob in this process. The deletion of rob in non-biofilm-producing FK300 significantly increased biofilm elaboration and PIA/PNAG production. In the search for a gene(s) in the 7-gene cluster for biofilm elaboration controlled by rob, we identified open reading frame (ORF) SAOUHSC_2898 (satf2584). Our results suggest that ORF SAOUHSC_2898 (satf2584) and icaADBC are required for enhanced biofilm elaboration and PIA/PNAG production in the rob deletion mutant. Rob bound to a palindromic sequence within its own promoter region. Furthermore, Rob recognized the TATTT motif within the icaR-icaA intergenic region and bound to a 25-bp DNA stretch containing this motif, which is a critically important short sequence regulating biofilm elaboration in S. aureus. Our results strongly suggest that Rob is a long-sought repressor that recognizes and binds to the TATTT motif and is an important regulator of biofilm elaboration through its control of SAOUHSC_2898 (SATF2584) and Ica protein expression in S. aureus. PMID:28143981

  4. The Clinical Research Landscape in Rhode Island.

    PubMed

    Mao, George; Ramratnam, Bharat

    2017-01-06

    To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. During 2011-2016, 1651 clinical studies were registered in clinicaltrials.gov. Nearly a third of all clinical studies were in oncology (21%) and cardiovascular diseases (10%). Alzheimer's dementia, breast cancer, HIV, and hepatitis C accounted for nearly 17% of all clinical trials. Seventy-five percent (75%) of clinical trials in RI were conducted in hospitals affiliated with Lifespan or Care New England. Financial support for clinical trials largely came from industry (60%) with 23% being supported by the National Institutes of Health (NIH). The rest are funded by nonprofit organizations, charitable foundations, educational institutions, and unlisted concerns. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].

  5. Keeping clinicians in clinical research: the Clinical Research/Reproductive Scientist Training Program.

    PubMed

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

    2009-03-01

    In recent years the need for translational and clinical research has increased, whereas the number of physicians involved in clinical research has diminished. There is clearly a need for formalized academic training in the quantitative and methodologic principles of clinical research in reproductive medicine. The Clinical Research/Reproductive Scientist Training Program (CREST), a program supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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 and attend intensive weekend seminars at the National Institutes of Health (NIH) as well as CREST seminars at the annual meeting of the 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.

  6. A review of clinical research in orthodontics.

    PubMed

    Tulloch, J F; Antczak-Bouckoms, A A; Tuncay, O C

    1989-06-01

    The orthodontic journals should provide valid and reliable information that helps clinicians make appropriate decisions about patient care. The nature of the published literature has not been categorized. The American Journal of Orthodontics and Dentofacial Orthopedics (formerly the American Journal of Orthodontics) was reviewed for the years 1976, 1981, and 1986, to determine the frequency of clinical articles, the topics reported, the study designs used to obtain information, the senior author affiliation, and the major funding sources. This review demonstrates that more than half the articles in this Journal report data on patients, with the majority focusing on the evaluation or description of therapeutic interventions. Academic institutions contribute the majority of the clinical research, although only a few student theses are published. The major support for this work continues to be from departmental resources with little external funding. Despite the introduction of powerful research designs such as randomized clinical trials, these methods have not been widely adopted for orthodontic clinical research. The case report (study containing fewer than 10 patients with no control nor comparison group) continues to be the most frequently published format. Clinicians should become aware of the inherent weakness in the research designs generally used and recognize the limited information that can be obtained from such methods. Support for this research needs to be greatly expanded if the more powerful type of study required to provide valid and reliable clinical information is to be continued.

  7. How do researchers decide early clinical trials?

    PubMed

    Grankvist, Hannah; Kimmelman, Jonathan

    2016-06-01

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

  8. Clinical Research Informatics Contributions from 2015.

    PubMed

    Daniel, C; Choquet, R

    2016-11-10

    To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2015. 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 review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was finally organized to conclude on the selection of best papers. Among the 579 returned papers published in the past year in the various areas of Clinical Research Informatics (CRI) - i) methods supporting clinical research, ii) data sharing and interoperability, iii) re-use of healthcare data for research, iv) patient recruitment and engagement, v) data privacy, security and regulatory issues and vi) policy and perspectives - the full review process selected four best papers. The first selected paper evaluates the capability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) to support the representation of case report forms (in both the design stage and with patient level data) during a complete clinical study lifecycle. The second selected paper describes a prototype for secondary use of electronic health records data captured in non-standardized text. The third selected paper presents a privacy preserving electronic health record linkage tool and the last selected paper describes how big data use in US relies on access to health information governed by varying and often misunderstood legal requirements and ethical considerations. A major trend in the 2015 publications is the analysis of observational, "nonexperimental" information and the potential biases and confounding factors hidden in the data that will have to be carefully taken into account to validate new predictive models. In addiction, researchers have to understand

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

    ERIC Educational Resources Information Center

    McMahon, Jenny; McGannon, Kerry R.

    2016-01-01

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

  10. Statistics in clinical research: Important considerations.

    PubMed

    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.

  11. NASA Researchers Discover “Bladed Terrain” on Pluto is Made of Frozen Methane (Video News File)

    NASA Image and Video Library

    2017-09-22

    NASA has identified large formations of frozen methane on the surface of Pluto that are as tall as skyscrapers. Researchers at NASA’s Ames Research Center in Silicon Valley used high resolution maps from the New Horizons flyby of Pluto in 2015 to understand these dramatic structures. The “bladed terrain” occurs only at high altitudes and in the region around the equator of Pluto. These jagged spires are thought to be created by an erosion process as the methane ice sublimates into gas. Researchers hope to use their findings to fill in the details of the areas of Pluto that were only measured in low resolution.

  12. Framework conditions facilitating paediatric clinical research

    PubMed Central

    2011-01-01

    The use of unlicensed and "off-label" medicines in children is widespread. Between 50-80% of the medicines currently administered to children have neither been tested nor authorized for their use in the paediatric population which represents approximately 25% of the whole European population. On 26 January 2007, entered into force the European Regulation of Paediatric Medicines. It aims at the quality of research into medicines for children but without subjecting the paediatric population to unnecessary clinical trial. This article addresses ethical and legal issues arising from the regulation and makes recommendations for the framework conditions facilitating the development of clinical research with children. PMID:21345195

  13. [Clinical research III. The causality studies].

    PubMed

    Talavera, Juan O; Wacher-Rodarte, Niels H; Rivas-Ruiz, Rodolfo

    2011-01-01

    The need to solve a clinical problem leads us to establish a starting point to address (risk, prognosis or treatment studies), all these cases seek to attribute causality. Clinical reasoning described in the book Clinical Epidemiology. The architecture of clinical research, offers a simple guide to understanding this phenomenon. And proposes three basic components: baseline, maneuver and outcome. In this model, different systematic errors (bias) are described, which may be favored by omitting characteristics of the three basic components. Thus, omissions in the baseline characteristics cause an improper assembly of the population and susceptibility bias, omissions in the application or evaluation of the maneuver provoke performance bias, and omissions in the assessment of out-come cause detection bias and transfer bias. Importantly, if this way of thinking facilitates understanding of the causal phenomenon, the appropriateness of the variables to be selected in the studies to which attribute or not causality, require additional arguments for evaluate clinical relevance.

  14. Clinical Research Trials | NIH MedlinePlus the Magazine

    MedlinePlus

    ... A Clinical Study Find You How does clinical research work? Visit our website and click on New National Institutes of Health (NIH) Clinical Research Awareness Website The NIH Clinical Center has joined ...

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

    PubMed

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

    2016-01-01

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

  16. 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

  17. The Louisiana Clinical Data Research Network: Leveraging Regional and National Resources to Improve Clinical Research Efficiency

    PubMed Central

    Parke, Courtney; Cook, Julia; Carton, Thomas; Rao, Sohail

    2014-01-01

    Background Mapping of the human genome and technological advancements allowing storage and rapid retrieval of healthcare data have heralded a new phase in clinical medicine and have served as a catalyst for the advent of personalized medicine. The use of health information databases provides a unique opportunity to investigate questions of great complexity and real-world application in a way that is most useful in providing high quality, safe, and cost-effective clinical care to patients. Methods The Louisiana Clinical Data Research Network (LACDRN) aims to streamline the workflow of multiinstitutional clinical studies and to dramatically expand the clinical research resources available to local investigators. The LACDRN contains health information for more than 1 million patients in Southeast Louisiana and is a rich resource for researchers to conduct retrospective or observational trials and to recruit patients for prospective studies. Results The LACDRN is part of a large-scale initiative by the Patient-Centered Outcomes Research Institute to create a national electronic health record network that enables the timely initiation and completion of comparative effectiveness research in a coordinated effort. For the first time, network research will be guided in part by input from patients and caregivers, increasing their engagement in the research process. Conclusion The establishment of the LACDRN is a unique opportunity for clinicians to take part in an innovative national initiative designed to offer new clinical research options for patients and to carry out cutting-edge translational, clinical, and health services research. PMID:25598739

  18. Blockchain technology for improving clinical research quality.

    PubMed

    Benchoufi, Mehdi; Ravaud, Philippe

    2017-07-19

    Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key to addressing these challenges and should draw the attention of the whole clinical research community.Blockchain brings the Internet to its definitive decentralisation goal. The core principle of Blockchain is that any service relying on trusted third parties can be built in a transparent, decentralised, secure "trustless" manner at the top of the Blockchain (in fact, there is trust, but it is hardcoded in the Blockchain protocol via a complex cryptographic algorithm). Therefore, users have a high degree of control over and autonomy and trust of the data and its integrity. Blockchain allows for reaching a substantial level of historicity and inviolability of data for the whole document flow in a clinical trial. Hence, it ensures traceability, prevents a posteriori reconstruction and allows for securely automating the clinical trial through what are called Smart Contracts. At the same time, the technology ensures fine-grained control of the data, its security and its shareable parameters, for a single patient or group of patients or clinical trial stakeholders.In this commentary article, we explore the core functionalities of Blockchain applied to clinical trials and we illustrate concretely its general principle in the context of consent to a trial protocol. Trying to figure out the potential impact of Blockchain implementations in the setting of clinical trials will shed new light on how modern clinical trial methods could evolve and benefit from Blockchain technologies in order to tackle the aforementioned challenges.

  19. 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…

  20. 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"…

  1. Proteogenomics | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    Proteogenomics, or the integration of proteomics with genomics and transcriptomics, is an emerging approach that promises to advance basic, translational and clinical research.  By combining genomic and proteomic information, leading scientists are gaining new insights due to a more complete and unified understanding of complex biological processes.

  2. 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…

  3. Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University.

    PubMed

    Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

    2017-01-01

     The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.

  4. 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

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

    PubMed

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

    2012-01-01

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

  6. 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…

  7. 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…

  8. Sampling methods in Clinical Research; an Educational Review.

    PubMed

    Elfil, Mohamed; Negida, Ahmed

    2017-01-01

    Clinical research usually involves patients with a certain disease or a condition. The generalizability of clinical research findings is based on multiple factors related to the internal and external validity of the research methods. The main methodological issue that influences the generalizability of clinical research findings is the sampling method. In this educational article, we are explaining the different sampling methods in clinical research.

  9. Factors influencing nurses' participation in clinical research.

    PubMed

    Jacobson, Ann F; Warner, Andrea M; Fleming, Eileen; Schmidt, Bruce

    2008-01-01

    Clinical research is necessary for developing nursing's body of knowledge and improving the quality of gastroenterology nursing care. The support and participation of nursing staff are crucial to conducting interventional research. Identification of characteristics of nurses and their work settings that facilitate or impede participation in research is needed. The purpose of this descriptive correlational study was to examine the effect of personal and professional characteristics and attitudes about nursing research on staff nurses' participation in a clinical nursing research project. A questionnaire measuring nurses' attitudes, perceptions of availability of support, and research use was distributed to staff nurses working on an endoscopy lab and two same-day surgery units where a nursing research study had recently been conducted. Investigator-developed items measured nurses' attitudes about the utility and feasibility of the interventions tested in the original study. A total of 36 usable questionnaires comprised the sample. Factor analysis of the two questionnaires resulted in three-factor (Importance of Research, Interest in Research, and Environment Support of Research) and two-factor (Value of Cognitive-Behavioral Interventions [CBIs] and Participation in Study) solutions, respectively. There were no statistically significant differences in mean scores for the five factors between nurses who did (n = 19) and those who did not (n = 17) participate in the original study. The Participation in Research Factor was significantly negatively correlated with years in nursing (r = -.336, p < .05) and positively correlated with the importance of research factor (r = .501, p < .01). Importance of research was negatively correlated with years in nursing (r = -.435, p < .01) and positively correlated with value of CBI (r = .439, p < .01) and participation in study (r = .501, p < .01). Findings from the study will contribute to the body of knowledge about factors that

  10. 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.

  11. 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.

  12. Clinical Research Associate II | Center for Cancer Research

    Cancer.gov

    Prepares and presents technical reports, abstracts, manuscripts, and other scientific presentations Secures electronic file transmissions of medical records, tests (ECG, MRI, CT, etc.) through various portals that are provided by trial sponsors Develops Standard Operating Procedures, templates and flow diagrams to enhance workflow Monitors/prepares budget operating reports Provides project management support with planning and development of project schedules and deliverables Develops and tracks project timelines and milestones Prepares status reports and monitoring progress ensuring adherence to deadlines Assists the research nurses with queries from research sponsors Maintains relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs) and field CRAs Provides assistance to the clinical investigators and teams to reinforce and enhance a GCP culture Assists other CRAs and Project Managers in the development of team processes and study-related documents

  13. Fetal cardiac interventions: clinical and experimental research

    PubMed Central

    Humuruola, Gulimila

    2016-01-01

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

  14. 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. © 2016 American Cancer Society.

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

    PubMed Central

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

    2012-01-01

    Abstract Purpose To design and evaluate a research mentor training curriculum for clinical and translational researchers. The resulting 8‐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 A total of 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 translational research mentors. Given success across 16 diverse sites, this training may serve as a national model. Clin Trans Sci 2013; Volume 6: 26–33 PMID:23399086

  16. Clinical Research Nurse III | Center for Cancer Research

    Cancer.gov

    Alert physicians of adverse events, abnormal outcomes or problematic trends, specifically in regards to protocol mandates. Coordinate various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents. Draft source documents to be used in new studies. Provide assistance for all aspects of the protocol lifecycle including initial IND submission, IRB submission, continuing review applications, protocols, protocol amendments, annual reports, and protocol inactivation with IRB and FDA. Create and maintain an IRB database of approved amendment descriptions. Assist the Principal Investigator in data collection (including patient specimens) and data analysis; the writing of interim reports, annual protocol reports, and scientific publications; the interpretation of research data for the protocol team; and with performing site visits. Complete flow sheets and case report forms according to the provisions of approved investigational protocols. Coordinate Clinical Trial Agreement requirements with applicable Clinical Research Oversight Managers (e.g., safety reporting requirements) and data management, if data is to be provided to third party at end of trial. Follow up on monitoring reports to ensure that identified problems are adequately addressed and resolved. Work with the Clinical Trials Management Clinical Research Oversight Manager to ensure consistency of case report forms with the management plan and coordinate site initiation and other monitoring site visits with all necessary parties. Appropriately screen and collect blood samples from patients and donors. Assist in the management of patient files, copying and organizing research data. Collaborate with the patient’s community physician and other health care providers to further the continuity of care and protect the integrity of the clinical research trial/data. Conduct updates for clinical staff on patient care, protocol process and

  17. 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

  18. Bringing ayahuasca to the clinical research laboratory.

    PubMed

    Riba, Jordi; Barbanoj, Manel J

    2005-06-01

    Since the winter of 1999, the authors and their research team have been conducting clinical studies involving the administration of ayahuasca to healthy volunteers. The rationale for conducting this kind of research is twofold. First, the growing interest of many individuals for traditional indigenous practices involving the ingestion of natural psychotropic drugs such as ayahuasca demands the systematic study of their pharmacological profiles in the target species, i.e., human beings. The complex nature of ayahuasca brews combining a large number of pharmacologically active compounds requires that research be carried out to establish the safety and overall pharmacological profile of these products. Second, the authors believe that the study of psychedelics in general calls for renewed attention. Although the molecular and electrophysiological level effects of these drugs are relatively well characterized, current knowledge of the mechanisms by which these compounds modify the higher order cognitive processes in the way they do is still incomplete, to say the least. The present article describes the development of the research effort carried out at the Autonomous University of Barcelona, commenting on several methodological aspects and reviewing the basic clinical findings. It also describes the research currently underway in our laboratory, and briefly comments on two new studies we plan to undertake in order to further our knowledge of the pharmacology of ayahuasca.

  19. Postdoctoral Clinical-Research Training in Psychiatry

    PubMed Central

    Reynolds, Charles F.; Martin, Christopher; Brent, David; Ryan, Neal; Dahl, Ronald E.; Pilkonis, Paul; Marcus, Marsha D.; Kupfer, David J.

    2009-01-01

    The authors describe a model for teaching grant writing and other research survival skills to postdoctoral clinical-research fellows in psychiatry and for improving research mentoring. Over the past 4 years, the authors have developed a course on writing grant applications for postdoctoral clinical-research fellows, using peer-review processes modeled after a National Institutes of Health study section. At the same time, the authors have clarified expectations of mentors in ways designed to help fellows prepare “K” (Research Career Development) applications and to receive mentored practice in skills being taught in the course. Sixteen of 30 fellows have succeeded in receiving their first extramural support by the end of their two-year fellowship tenure or during the succeeding year. The authors conclude that by teaching grant-writing skills in a supportive peer environment, providing peer review of proposals, and sharpening expectations of mentors, it may be possible to reduce the time between the end of fellowship and the receipt of the first extramural grant. PMID:19617924

  20. Standard operating procedures for clinical research departments.

    PubMed

    Kee, Ashley Nichole

    2011-01-01

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

  1. [Ear keloid and clinical research progress].

    PubMed

    Du, Guangyuan; Zhu, Jiang

    2014-04-01

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

  2. 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

  3. Partners | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    Developmental Studies Hybridoma Bank at the University of Iowa NCI’s OCCPR works closely with The University of Iowa's Developmental Studies Hybridoma Bank (DSHB) that distributes all hybridomas and monoclonal antibodies from NCI's Clinical Proteomic Technologies for Cancer initiative (CPTC). DSHB supplies researchers with monoclonal antibodies, which may be ordered as tissue culture supernatants, ascites, or concentrate; selected hybridomas are also available as frozen or growing cells.

  4. 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.

  5. Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective.

    PubMed

    Ripley, Elizabeth B D; Macrina, Frank L; Markowitz, Monika

    2006-12-01

    REGULATORY GUIDELINES LEAVE determination of coercion and undue influence of research participants open to interpretation. A web-based survey was conducted of the research ethics committees members at Virginia Commonwealth University (VCU) to evaluate their perspectives on paying participants in clinical research via general questions, as well as 8 short cases involving hypertension placebo-controlled trials, a pilot exercise study, a survey of substance abusers, a healthy-volunteer pharmacokinetic study, a twin study involving DNA samples, and an asthma medication study in children. Research ethics committee members were asked to state what payment they would consider appropriate for a given type of protocol. The results suggest that risk, time required, reimbursement for expenses, and inconvenience were important in determining appropriate payment, while income and funding source were not. The case studies revealed wide variation in recommended payments both within type of study and between studies.

  6. 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

  7. Distal symmetrical polyneuropathy: definition for clinical research.

    PubMed

    England, J D; Gronseth, G S; Franklin, G; Miller, R G; Asbury, A K; Carter, G T; Cohen, J A; Fisher, M A; Howard, J F; Kinsella, L J; Latov, N; Lewis, R A; Low, P A; Sumner, A J

    2005-01-01

    The objective of this report was to develop a case definition of "distal symmetrical polyneuropathy" to standardize and facilitate clinical research and epidemiological studies. A formalized consensus process was employed to reach agreement after a systematic review and classification of evidence from the literature. The literature indicates that symptoms alone have relatively poor diagnostic accuracy in predicting the presence of polyneuropathy; signs are better predictors of polyneuropathy than symptoms; and single abnormalities on examination are less sensitive than multiple abnormalities in predicting the presence of polyneuropathy. The combination of neuropathic symptoms, signs, and electrodiagnostic findings provides the most accurate diagnosis of distal symmetrical polyneuropathy. A set of case definitions was rank ordered by likelihood of disease. The highest likelihood of polyneuropathy (useful for clinical trials) occurs with a combination of multiple symptoms, multiple signs, and abnormal electrodiagnostic studies. A modest likelihood of polyneuropathy (useful for field or epidemiological studies) occurs with a combination of multiple symptoms and multiple signs when the results of electrodiagnostic studies are not available. A lower likelihood of polyneuropathy occurs when electrodiagnostic studies and signs are discordant. For research purposes, the best approach for defining distal symmetrical polyneuropathy is a set of case definitions rank ordered by estimated likelihood of disease. The inclusion of this formalized case definition in clinical and epidemiological research studies will ensure greater consistency of case selection.

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

    PubMed

    Talavera, Juan O

    2011-01-01

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

  9. Nursing research. Components of a clinical research study.

    PubMed

    Bargagliotti, L A

    1988-09-01

    Nursing research is the systematic collection and analysis of data about clinically important phenomena. While there are norms for conducting research and rules for using certain research procedures, the reader must always filter the research report against his or her nursing knowledge. The most common questions a reader should ask are "Does it make sense? Can I think of any other reasonable explanation for the findings? Do the findings fit what I have observed?" If the answers are reasonable, research findings from carefully conducted studies can provide a basis for making nursing decisions. One of the earliest accounts of nursing research, which indicates the power of making systematic observations, was Florence Nightingale's study. It compared deaths among soldiers in the Crimean War with deaths of soldiers in the barracks of London. Her research demonstrated that soldiers in the barracks had a much higher death rate than did the soldiers at war. On the basis of the study, sanitary conditions in the barracks were changed substantially.

  10. [Patient safety in clinical intervention research].

    PubMed

    Brekelmans, Cecile T M; Kenter, Marcel J H; Bouter, Lex M; Koëter, Gerard H

    2011-01-01

    In clinical intervention research, the monitoring of patient safety is essential. In December 2009, a symposium on the role of the different parties involved was organised. Research starts with a robust protocol with a section dealing with interim decision-making and procedures for reporting during the research. After the approval by an accredited Ethics Committee, the responsibility for the patient safety primarily lies with the investigators and sponsor (in the case of investigator-initiated research generally the Institutional Board of Directors). In addition, the appointment of a Data and Safety Monitoring Committee (DSMC) has become more frequent during recent years. This committee monitors the safety of patients by means of evaluation of interim results and advises the sponsor accordingly. The decision process concerning premature ending is a clinical decision, which should not exclusively be based on exceeding a statistical limit. The focus of the DSMC should be on safety issues; only in exceptional cases should a trial be discontinued because of clear efficacy, or the lack of it.

  11. 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

  12. [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.

  13. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort.

    PubMed

    Lam, Raymond W; Milev, Roumen; Rotzinger, Susan; Andreazza, Ana C; Blier, Pierre; Brenner, Colleen; Daskalakis, Zafiris J; Dharsee, Moyez; Downar, Jonathan; Evans, Kenneth R; Farzan, Faranak; Foster, Jane A; Frey, Benicio N; Geraci, Joseph; Giacobbe, Peter; Feilotter, Harriet E; Hall, Geoffrey B; Harkness, Kate L; Hassel, Stefanie; Ismail, Zahinoor; Leri, Francesco; Liotti, Mario; MacQueen, Glenda M; McAndrews, Mary Pat; Minuzzi, Luciano; Müller, Daniel J; Parikh, Sagar V; Placenza, Franca M; Quilty, Lena C; Ravindran, Arun V; Salomons, Tim V; Soares, Claudio N; Strother, Stephen C; Turecki, Gustavo; Vaccarino, Anthony L; Vila-Rodriguez, Fidel; Kennedy, Sidney H

    2016-04-16

    Major Depressive Disorder (MDD) is among the most prevalent and disabling medical conditions worldwide. Identification of clinical and biological markers ("biomarkers") of treatment response could personalize clinical decisions and lead to better outcomes. This paper describes the aims, design, and methods of a discovery study of biomarkers in antidepressant treatment response, conducted by the Canadian Biomarker Integration Network in Depression (CAN-BIND). The CAN-BIND research program investigates and identifies biomarkers that help to predict outcomes in patients with MDD treated with antidepressant medication. The primary objective of this initial study (known as CAN-BIND-1) is to identify individual and integrated neuroimaging, electrophysiological, molecular, and clinical predictors of response to sequential antidepressant monotherapy and adjunctive therapy in MDD. CAN-BIND-1 is a multisite initiative involving 6 academic health centres working collaboratively with other universities and research centres. In the 16-week protocol, patients with MDD are treated with a first-line antidepressant (escitalopram 10-20 mg/d) that, if clinically warranted after eight weeks, is augmented with an evidence-based, add-on medication (aripiprazole 2-10 mg/d). Comprehensive datasets are obtained using clinical rating scales; behavioural, dimensional, and functioning/quality of life measures; neurocognitive testing; genomic, genetic, and proteomic profiling from blood samples; combined structural and functional magnetic resonance imaging; and electroencephalography. De-identified data from all sites are aggregated within a secure neuroinformatics platform for data integration, management, storage, and analyses. Statistical analyses will include multivariate and machine-learning techniques to identify predictors, moderators, and mediators of treatment response. From June 2013 to February 2015, a cohort of 134 participants (85 outpatients with MDD and 49 healthy participants

  14. Discovering Researcher Subjectivities, Perceptions, and Biases: A Critical Examination of Myths, Metaphors, and Meanings Inherent in University-School Collaborative Action Research Projects.

    ERIC Educational Resources Information Center

    Dana, Nancy Fichtman

    This paper describes a collaborative action research project conducted by a university researcher and a group of elementary school teachers. It examines the role the researcher plays when educational change is initiated by practitioners and the nature of the relationship that develops between researcher and practitioners throughout the change…

  15. Towards a clinical methodology for neuropsychopharmacological research.

    PubMed

    Ban, Thomas A

    2007-06-01

    Neuropsychopharmacology is dedicated to the study of the pathophysiology and treatment of mental pathology with the employment of centrally acting drugs. In neuropsychopharmacological research the clinical effects of a psychotropic drug are linked to the effects of the substance on brain structures involved in its mode of action. It is assumed, that knowledge about the mode of action of a selectively effective psychotropic drug will provide clues about the pathophysiology of the illness, and conversely, that knowledge about the pathophysiology of an illness, will provide clues for developing clinically more effective psychotropic drugs. Since the currently employed clinical methodology for the demonstration of therapeutic efficacy links the mode of action of psychotropic drugs to pharmacologically heterogeneous populations, neuropsychopharmacological research does not provide the necessary feedback for developing more effective drugs. To resolve the pharmacological heterogeneity within currently used diagnoses, attempts were made to split syndrome-based psychiatric diagnoses into discrete neurobiological deficits, and to replace traditional psychiatric nosology by a genetic psychiatric nosology. Yet, to date, there is no alternative methodology to psychopathology-based psychiatric nosology for classifying mental pathology in a clinically relevant manner. As we are moving from the "neurotransmitter era" to a "genetic era" in neuropsychopharmacology, the need for identifying pharmacologically homogenous populations is becoming imminent. All primary targets of psychotropic drugs in the brain are encoded by genes which are identified, and any nosologic entity or psychiatric syndrome that corresponds with a treatment responsive population is a candidate for the generation of genetic hypotheses relevant to mental illness. Recognition that progress in neuropsychopharmacology, and molecular genetic research, depends on the speed clinical research can resolve the

  16. [Alfredo Lanari, a clinical research style].

    PubMed

    Romero, Lucía

    2012-01-01

    The institutionalization of clinical research in Argentina reached its point of greatest maturity with the creation, in 1957, of the Institute of Medical Investigations (Instituto de Investigaciones Médicas) of the Faculty of Medicine of the Universidad de Buenos Aires, and the drive of the man who was its director for almost 20 years, Alfredo Lanari. In this paper I analyze the ways in which he generated a style of clinical research and a referential position in local medical field that allowed him to carry out said institutional realization. This achievement was the result of a personal enterprise and at the same time part of a larger context of transformations within the medical discipline world-wide and at the Universidad de Buenos Aires. This study was carried out combining oral and documentary sources, such as interviews with physicians at the Institute of Medical Investigations, members of the journal Medicina and of the Argentine Society of Clinical Investigation (Sociedad Argentina de Investigación Clínica), as well as academic files and scientific articles.

  17. Department of Veterans Affairs Geriatric Research, Education and Clinical Centers: translating aging research into clinical geriatrics.

    PubMed

    Supiano, Mark A; Alessi, Cathy; Chernoff, Ronni; Goldberg, Andrew; Morley, John E; Schmader, Kenneth E; Shay, Kenneth

    2012-07-01

    Department of Veterans Affairs (VA) Geriatric Research, Education and Clinical Centers (GRECCs) originated in 1975 in response to the rapidly aging veteran population. Since its inception, the GRECC program has made major contributions to the advancement of aging research, geriatric training, and clinical care within and outside the VA. GRECCs were created to conduct translational research to enhance the clinical care of future aging generations. GRECC training programs also provide leadership in educating healthcare providers about the special needs of older persons. GRECC programs are also instrumental in establishing robust clinical geriatric and aging research programs at their affiliated university schools of medicine. This report identifies how the GRECC program has successfully adapted to changes that have occurred in VA since 1994, when the program's influence on U.S. geriatrics was last reported, focusing on its effect on advancing clinical geriatrics in the last 10 years. This evidence supports the conclusion that, after more than 30 years, the GRECC program remains a vibrant "jewel in the crown of the VA" and is poised to make contributions to aging research and clinical geriatrics well into the future. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

  18. Adherence in AIDS clinical trials: a framework for clinical research and clinical care.

    PubMed

    Ickovics, J R; Meisler, A W

    1997-04-01

    Assessment of adherence within AIDS clinical trials is a critical component of the successful evaluation of therapeutic outcomes. Poor medication adherence can result in the misinterpretation of clinical trial data. Research on factors affecting adherence in AIDS clinical trials has been scarce, and few investigations have evaluated strategies for enhancing patient participation. One reason may be the absence of a conceptual framework to guide research. Consistent with previous research on medical adherence, we propose a framework whereby factors affecting adherence in AIDS clinical trials can be categorized as characteristics of the: (a) individual, (b) treatment regimen, (c) patient-provider relationship, (d) clinical setting, and (e) disease. This framework is used as a heuristic for reviewing studies that examine factors affecting adherence in AIDS clinical trials. Suggestions for future research and clinical intervention are provided. These efforts are timely because adherence is now the center of attention in discourse about the efficacy of the new class of protease inhibitor drugs; non-adherence has been linked to viral resistance and drug failure. Efforts to identify factors that influence adherence to AIDS clinical trials can inform future attempts to improve adherence and retention. Better adherence protects the scientific integrity of AIDS clinical trials, promoting more efficient and accurate evaluations of therapeutic value. Accelerated access to new treatments may follow, ultimately enhancing patient care.

  19. Clinical Research Strategies for Fructose Metabolism12

    PubMed Central

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

    2014-01-01

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

  20. 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

  1. Clinical research strategies for fructose metabolism.

    PubMed

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

    2014-05-01

    Fructose and simple sugars are a substantial part of the western diet, and their influence on human health remains controversial. Clinical studies in fructose nutrition have proven very difficult to conduct and interpret. NIH and USDA sponsored a workshop on 13-14 November 2012, "Research Strategies for Fructose Metabolism," to identify important scientific questions and parameters to be considered while designing clinical studies. Research is needed to ascertain whether there is an obesogenic role for fructose-containing sugars via effects on eating behavior and energy balance and whether there is a dose threshold beyond which these sugars promote progression toward diabetes and liver and cardiovascular disease, especially in susceptible populations. Studies tend to fall into 2 categories, and design criteria for each are described. Mechanistic studies are meant to validate observations made in animals or to elucidate the pathways of fructose metabolism in humans. These highly controlled studies often compare the pure monosaccharides glucose and fructose. Other studies are focused on clinically significant disease outcomes or health behaviors attributable to amounts of fructose-containing sugars typically found in the American diet. These are designed to test hypotheses generated from short-term mechanistic or epidemiologic studies and provide data for health policy. Discussion brought out the opinion that, although many mechanistic questions concerning the metabolism of monosaccharide sugars in humans remain to be addressed experimentally in small highly controlled studies, health outcomes research meant to inform health policy should use large, long-term studies using combinations of sugars found in the typical American diet rather than pure fructose or glucose. © 2014 American Society for Nutrition.

  2. Information technology for clinical, translational and comparative effectiveness research. Findings from the section clinical research informatics.

    PubMed

    Daniel, C; Choquet, R

    2013-01-01

    To summarize advances of excellent current research in the new emerging field of Clinical Research Informatics. Synopsis of four key articles selected for the IMIA Yearbook 2013. The selection was performed by querying PubMed and Web of Science with predefined keywords. From the original set of 590 papers, a first subset of 461 articles which was in the scope of Clinical Research Informatics was refined into a second subset of 79 relevant articles from which 15 articles were retained for peer-review. The four selected articles exemplify current research efforts conducted in the areas of data representation and management in clinical trials, secondary use of EHR data for clinical research, information technology platforms for translational and comparative effectiveness research and implementation of privacy control. The selected articles not only illustrate how innovative information technology supports classically organized randomized controlled trials but also demonstrate that the long promised benefits of electronic health care data for research are becoming a reality through concrete platforms and projects.

  3. Guidelines for Clinical Research in Developing Countries.

    PubMed

    Vray, Muriel; Simon, François; Bompart, François

    2007-01-01

    On the basis of a review of current clinical research conditions in developing countries, guidelines have been formulated to ensure scientific validity as well as adherence to universal ethical principles. The main recommendation is that projects should be reviewed by two Institutional Review Boards, one in the country where the Study Sponsor is based, and another in the country where the study is being carried out. In addition, an independent Data Safety Monitoring Board should be set up and systems established to ensure the effective reporting of Serious Adverse Events and to specify the Sponsor's obligations after the end of the Study.

  4. The Weiland Medal: Clinical Research in Hand Surgery

    PubMed Central

    Chung, Kevin C.

    2015-01-01

    Clinical research designed to enhance the quality of healthcare has always received a great deal of national attention. Outcomes studies, clinical trials, and evidence-based research are key components of clinical research that have advanced the field of hand surgery. The purpose of the Weiland Award is to encourage innovations and progress in clinical research in hand surgery for the betterment of patients and to promote hand surgery’s visibility in American medicine. This article will highlight my efforts in clinical research through three specific research themes: (1) outcomes research, (2) economic analysis, and (3) evidence-based research and quality assessment in healthcare. PMID:20117312

  5. 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

  6. Applying Research on Family Violence to Clinical Practice.

    ERIC Educational Resources Information Center

    Gelles, Richard J.

    1982-01-01

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

  7. 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

  8. Menstrual questionnaires for clinical and research use.

    PubMed

    Matteson, Kristen A

    2017-04-01

    Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB. Copyright © 2016. Published by Elsevier Ltd.

  9. The Effectiveness of DISCOVER.

    ERIC Educational Resources Information Center

    Engel, Elaine Frances

    Computer assisted career guidance (CACG) systems have been around for at least the past 20 years in career guidance centers. There are two types of systems: information retrieval and guidance interaction. This study investigated the effectiveness of DISCOVER in facilitating career decisions among college students. DISCOVER is a systematic career…

  10. Anaphylaxis: clinical concepts and research priorities.

    PubMed

    Brown, Simon G A

    2006-04-01

    Anaphylaxis is a severe immediate-type hypersensitivity reaction characterized by life-threatening upper airway obstruction bronchospasm and hypotension. Although many episodes are easy to diagnose by the combination of characteristic skin features with other organ effects, this is not always the case and a workable clinical definition of anaphylaxis and useful biomarkers of the condition have been elusive. A recently proposed consensus definition is ready for prospective validation. The cornerstones of management are the supine position, adrenaline and volume resuscitation. An intramuscular dose of adrenaline is generally recommended to initiate treatment. If additional adrenaline is required, then a controlled intravenous infusion might be more efficacious and safer than intravenous bolus administration. Additional bronchodilator treatment with continuous salbutamol and corticosteroids are used for severe and/or refractory bronchospasm. Aggressive volume resuscitation, selective vasopressors, atropine (for bradycardia), inotropes that bypass the beta-adrenoreceptor and bedside echocardiographic assessment should be considered for hypotension that is refractory to treatment. Management guidelines continue to be opinion- and consensus-based, with retrospective studies accounting for the vast majority of clinical research papers on the topic. The clinical spectrum of anaphylaxis including major disease subgroups requires clarification, and validated scoring systems and outcome measures are needed to enable good-quality prospective observational studies and randomized controlled trials. A systematic approach with multicentre collaboration is required to improve our understanding and management of this disease.

  11. 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…

  12. Evaluation of Clinical Research Training Programs Using the Clinical Research Appraisal Inventory

    PubMed Central

    Lipira, Lauren; Jeffe, Donna B.; Krauss, Melissa; Garbutt, Jane; Piccirillo, Jay; Evanoff, Bradley; Fraser, Victoria

    2010-01-01

    Abstract The purpose of this study was to measure change in clinical research self‐efficacy after participating in KL2, postdoctoral and predoctoral clinical research training programs at Washington University School of Medicine. We surveyed program participants using a 76‐item version of the Clinical Research Appraisal Inventory (CRAI). Principal components analysis (PCA) examined the CRAI’s underlying factor structure; Cronbach alpha measured the internal consistency of items on each subscale and the overall CRAI. CRAI score changes from baseline to 1‐year follow‐up were assessed using repeated‐measures analysis of variance. All 29 KL2, 47 postdoctoral, and 31 TL1 scholars enrolled 2006–2009 (mean age 31.6 years, range 22–44; 59.6% female; 65.4% white) completed baseline surveys. Of these participants, 22 KL2, 17 postdoctoral, and 21 TL1 scholars completed the 1‐year follow‐up assessment. PCA resulted in a seven‐factor solution with 69 items (alphas > 0.849 for each subscale and 69‐item CRAI). Significant improvements at 1‐year follow‐up were observed across all programs for Study Design/Data Analysis (p= .016), Interpreting/Reporting/Presenting (p= .034), and overall CRAI (p= .050). Differences between programs were observed for all but one subscale (each p < .05). Clinical research self‐efficacy increased 1 year after clinical research training. Whether this short‐term outcome correlates with long‐term clinical research productivity, requires further study. Clin Trans Sci 2010; Volume 3: 243–248. PMID:21442017

  13. How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

    PubMed

    Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

    2017-09-18

    Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

  14. Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators.

    PubMed

    Jones, Carolynn Thomas; Hastings, Clare; Wilson, Lynda Law

    2015-01-01

    There has been limited research to document differences in roles between nurses and non-nurses who assume clinical research coordination and management roles. Several authors have suggested that there is no acknowledged guidance for the licensure requirements for research study coordinators and that some non-nurse research coordinators may be assuming roles that are outside of their legal scopes of practice. There is a need for further research on issues related to the delegation of clinical research activities to non-nurses. This study used nominal group process focus groups to identify perceptions of experienced research nurse managers at an academic health science center in the Southern United States about the clinical research activities that are being performed by non-nurse clinical research coordinators without supervision that they believed should only be performed by a nurse or under the supervision of a nurse. A total of 13 research nurse managers volunteered to be contacted about the study. Of those, 8 participated in two separate nominal group process focus group sessions. The group members initially identified 22 activities that they felt should only be performed by a nurse or under the direct supervision of a nurse. After discussion and clarification of results, activities were combined into 12 categories of clinical research activities that participants believed should only be performed by a nurse or under the direct supervision of a nurse. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. [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.

  16. Antidepressants and psychotherapy: a clinical research review

    PubMed Central

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

    2005-01-01

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

  17. 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

  18. Interrupted time series analysis in clinical research.

    PubMed

    Matowe, Lloyd K; Leister, Cathie A; Crivera, Concetta; Korth-Bradley, Joan M

    2003-01-01

    To demonstrate the usefulness of interrupted time series analysis in clinical trial design. A safety data set of electrocardiographic (ECG) information was simulated from actual data that had been collected in a Phase I study. Simulated data on 18 healthy volunteers based on a study performed in a contract research facility were collected based on single doses of an experimental medication that may affect ECG parameters. Serial ECGs were collected before and during treatment with the experimental medication. Data from 7 real subjects receiving placebo were used to simulate the pretreatment phase of time series; data from 18 real subjects receiving active treatment were used to simulate the treatment phase of the time series. Visual inspection of data was performed, followed by tests for trend, seasonality, and autocorrelation by use of SAS. There was no evidence of trend, seasonality, or autocorrelation. In 11 of 18 simulated individuals, statistically significant changes in QTc intervals were observed following treatment with the experimental medication. A significant time of day and treatment interaction was observed in 4 simulated patients. Interrupted time series analysis techniques offer an additional tool for the study of clinical situations in which patients must act as their own controls and where serial data can be collected at evenly distributed intervals.

  19. 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.

  20. Methods for clinical research involving cannabis administration.

    PubMed

    Gorelick, David A; Heishman, Stephen J

    2006-01-01

    Better scientific understanding of cannabis effects and the development of treatments for cannabis dependence require clinical studies involving cannabis administration. Cannabis can be administered by smoking a plant-derived cigarette or by oral or intravenous administration of delta9-tetrahydrocannabinol (THC), the primary psychoactive chemical in cannabis. The smoked route is most commonly used outside the laboratory, but is subject to wide variation in absorbed dose. Oral synthetic THC is a legally marketed medication (dronabinol), also subject to wide pharmacokinetic variation, but offering a greater safety margin because of slower onset of action and lower potency. Intravenous THC offers precise investigator control of dose and timing. Acute adverse effects of cannabis administration include tachycardia, orthostatic hypotension, pulmonary irritation (if smoked), motor incoordination, cognitive impairment, anxiety, paranoia, and psychosis. Screening of research subjects should identify and exclude those with risk factors for such events, e.g., a history of significant cardiovascular, pulmonary, or psychiatric disorders. Monitoring of subjects during cannabis administration should include heart rate, blood pressure, and mental status. Subjects should not be discharged from research participation until reevaluation has shown that they have returned to baseline status.

  1. Placebos in clinical practice and research.

    PubMed Central

    De Deyn, P P; D'Hooge, R

    1996-01-01

    The main current application of placebo is in clinical research. The term placebo effect refers to diverse non-specific, desired or non-desired effects of substances or procedures and interactions between patient and therapist. Unpredictability of the placebo effect necessitates placebo-controlled designs for most trials. Therapeutic and diagnostic use of placebo is ethically acceptable only in few well-defined cases. While "therapeutic" application of placebo almost invariably implies deception, this is not the case for its use in research. Conflicts may exist between the therapist's Hippocratic and scientific obligations. The authors provide examples in neuropsychiatry, illustrating that objective scientific data and well-considered guidelines may solve the ethical dilemma. Placebo control might even be considered an ethical obligation but some provisos should be kept in mind: (a) no adequate therapy for the disease should exist and/or (presumed) active therapy should have serious side-effects; (b) placebo treatment should not last too long; (c) placebo treatment should not inflict unacceptable risks, and (d) the experimental subject should be adequately informed and informed consent given. PMID:8798935

  2. 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.

  3. New Apollo asteroid discovered

    NASA Astrophysics Data System (ADS)

    Bell, Peter M.

    A new asteroid that periodically crosses the earth's orbit was recently discovered when two components of a rare split comet were photographed. The asteroid has been made a possible candidate for an asteroid rendezvous mission under study at Jet Propulsion Laboratory. The newly discovered body, 1982 DB, is a member of a group of earth-orbit-crossing objects called Apollo asteroids. They are maverick asteroids in unique orbits outside the main asteroid belt between Mars and Jupiter.

  4. 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

  5. Data Model Considerations for Clinical Effectiveness Researchers

    PubMed Central

    Kahn, Michael G.; Batson, Deborah; Schilling, Lisa M.

    2013-01-01

    Introduction Growing adoption of electronic health records and increased emphasis on the reuse and integration of clinical care and administration data require a robust informatics infrastructure to inform health care effectiveness in real-world settings. The Scalable Architecture for Federated Translational Inquiries Network (SAFTI Net) was one of 3 projects receiving Agency for Healthcare Quality and Research funds to create a scalable, distributed network to support Comparative Effectiveness Research. SAFTINet’s method of extracting and compiling data from disparate entities requires the use of a shared common data model. Data Models Focusing on the needs of CER investigators, in addition to other project considerations, we examined the suitability of several data models. Data modeling is the process of determining which data elements will be stored and how they will be stored, including their relationships and constraints. Addressing compromises between complexity and usability is critical to modeling decisions. Case Study The SAFTINet project provides the case study for describing data model evaluation. A sample use case defines a cohort of asthma subjects that illustrates the need to identify patients by age, diagnoses, and medication use while excluding those with diagnoses that may often be misdiagnosed as asthma. Discussion The SAFTINet team explored several data models against a set of technical and investigator requirements to select a data model that best fit its needs and was conducive to expansion with new research requirements. Although SAFTINet ultimately chose the Observation Medical Outcomes Partnership common data model, other valid options exist and prioritization of requirements is dependent upon many factors. PMID:22692260

  6. 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 the...

  7. 77 FR 23810 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-20

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

  8. 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 for...

  9. 78 FR 28292 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

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

  10. Decline of clinical research in academic medical centers.

    PubMed

    Meador, Kimford J

    2015-09-29

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

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

    PubMed

    Furukawa, Toshiaki

    2012-06-01

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

  12. 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.

  13. Role of the clinical research nurse in tissue viability.

    PubMed

    Hemingway, Beverley; Storey, Carron

    Opportunities for nurses to be involved in clinical research have increased with the growing emphasis on research in the NHS. This article examines the experiences of two registered nurses adapting to the role of clinical research nurse in a pressure ulcer programme of research. The challenges, rewards and strategies involved are discussed.

  14. Introduction to the special section: More than measurement error: Discovering meaning behind informant discrepancies in clinical assessments of children and adolescents.

    PubMed

    De Los Reyes, Andres

    2011-01-01

    Discrepancies often arise among multiple informants' reports of child and adolescent psychopathology and related constructs (e.g., parenting, family relationship quality and functioning, parental monitoring). Recently, studies using various designs (laboratory, longitudinal, randomized controlled trial, meta-analysis) have revealed that discrepancies among informants' reports (a) yield important information regarding where children express behaviors (time course, features of the context[s] of behavioral expression) and about the informants who observe their expression, (b) demonstrate stability over time in both community and clinic settings, (c) predict poor child and adolescent outcomes in ways that the individual informants' reports do not, and (d) can be used to identify meaningful treatment outcomes patterns within randomized controlled trials. Using existing data sources, the articles in this special section expand upon this emerging body of research. In particular, the articles illustrate how clinical science and practice can use informant discrepancies to increase understanding of the causes and consequences of, as well as treatments for, child and adolescent psychopathology.

  15. [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.

  16. Enrolling Minority and Underserved Populations in Cancer Clinical Research

    PubMed Central

    Wallington, Sherrie Flynt; Dash, Chiranjeev; Sheppard, Vanessa B.; Goode, Tawara D.; Oppong, Bridget A.; Dodson, Everett E.; Hamilton, Rhonda N.; Adams-Campbell, Lucile L.

    2015-01-01

    Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials—a “gold standard.” Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. It is increasingly necessary to be aware of defining characteristics such as location and culture of the populations from which research participants are enrolled. Little research has examined the effect of location and cultural competency in adapting clinical trial research for minority and underserved communities on accrual for clinical trials. Utilizing embedded community academic sites, the authors applied cultural competency frameworks to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials. This strategy resulted in successful accrual of participants to new clinical research trials, specifically targeting participation from minority and underserved communities in metropolitan Washington, DC. From 2012 to 2014, a total of 559 participants enrolled across six non-therapeutic clinical trials, representing a 62% increase in the enrollment of blacks in clinical research. Embedding cancer prevention programs and research in the community was shown to be yet another important strategy in the arsenal of approaches that can potentially enhance clinical research enrollment and capacity. The analyses showed that the capacity to acquire cultural knowledge about patients—their physical locales, cultural values, and environments in which they live—is essential to recruiting culturally and ethnically diverse population samples. PMID:26470805

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

    PubMed

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

    2010-06-21

    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.

  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. PS2-08: “I Didn’t Know They Did That!” Discovering and Maximizing the Capacity of the HMO Research Network

    PubMed Central

    Thompson, Ella; Greene, Sarah; Johnson, Karin; Larson, Eric; Steiner, John

    2012-01-01

    Background/Aims The HMO Research Network (HMORN) is a national consortium of research centers working within or in close partnership with integrated health systems. HMORN sites conduct public domain health research on a wide range of diseases and cross-cutting topics. While the HMORN has established large topical research networks, the HMORN’s collective capacity remains relatively untapped for the majority of topics. We illustrate the variation and concentration of topical and methodological expertise across the Network, and suggest ways the HMORN could leverage existing capacities more fully. Methods Written surveys indicating ongoing local research capacity were completed by 14 HMORN sites in the 2nd quarter of 2011. Sites classified 45 research topics as “Powerhouse area” (multiple studies per year, particular depth or breadth exists), “Some Expertise” or “Not an emphasis.” These survey data were collected, synthesized and tabulated by the HMO Collaboratory team. We will survey the remaining 5 HMORN sites prior to HMORN 2012 and report capacity information for the entire Network. Results Eleven of the 14 delivery systems (78.6%) directly owns or partners closely with an insurance entity; HMOs were a major component of these systems. Special research capacities of HMORN centers include facilities to fill prescriptions, facilities to perform research lab tests, survey departments, and dedicated research clinics. While significant capacity exists across the Network in topics with well established consortia (e.g., cancer, cardiovascular disease, infectious disease), capacity existed in multiple centers for every topic surveyed. Multiple HMORN centers reported “powerhouse areas” on topics around which the HMORN has not significantly mobilized. These included alcohol and drug abuse, arthritis, neurological disorders, oral health, aging, health disparities, pain management, pediatrics, and reproductive health among others. Discussion Many

  20. A European perspective--the European clinical research infrastructures network.

    PubMed

    Demotes-Mainard, J; Kubiak, C

    2011-11-01

    Evaluating research outcomes requires multinational cooperation in clinical research for optimization of treatment strategies and comparative effectiveness research, leading to evidence-based practice and healthcare cost containment. The European Clinical Research Infrastructures Network (ECRIN) is a distributed ESFRI (European Strategy Forum on Research Infrastructures) 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 potential. Servicing multinational trials started during its preparatory phase, and ECRIN will now apply for an ERIC (European Research Infrastructures Consortium) status by 2011. By creating a single area for clinical research in Europe, this achievement will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of the research and education capacity, tackling the major societal challenges starting with the area of healthy ageing, and removing barriers to bring ideas to the market.

  1. 76 FR 24974 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

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

  2. Functional MRI in children: clinical and research applications.

    PubMed

    Leach, James L; Holland, Scott K

    2010-01-01

    Functional MRI has become a critical research tool for evaluating brain function and developmental trajectories in children. Its clinical use in children is becoming more common. This presentation will review the basic underlying physiologic and technical aspects of fMRI, review research applications that have direct clinical relevance, and outline the current clinical uses of this technology.

  3. Development and interim results of a clinical research training fellowship.

    PubMed

    Gordon, S M; Dionne, R A

    2007-08-01

    While the ability to base clinical training and patient care on scientific evidence is highly dependent on the results of translational and clinical research, a shortage of trained clinical investigators delays advances upon which to base evidence-based therapeutics. In response to this perceived shortage, a clinical research training program was developed in the Division of Intramural Research at the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) as a prototype for training health professionals in clinical research methodologies and their application to oral-craniofacial problems. All but one of the trainees initiated at least one clinical trial leading to a scientific publication. Of eleven fellows, ten completed the program with diverse outcomes: four trainees have entry-level academic or equivalent research positions; three trainees continued on to Ph.D. programs; one is completing a postdoctoral fellowship combined with clinical specialty training; one is completing a clinical residency; and two are in clinical practice. Six of the trainees received NIH funding, or the equivalent, in the NIH Intramural Research Program. These outcomes suggest that a program focused on translational and clinical research training is a successful strategy for improving the future supply of clinical researchers to support evidence-based practices and therapeutic innovation.

  4. 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.

  5. Monitoring clinical research: an obligation unfulfilled.

    PubMed Central

    Weijer, C; Shapiro, S; Fuks, A; Glass, K C; Skrutkowska, M

    1995-01-01

    The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research. PMID:7780907

  6. Chandra Discovers Cosmic Cannonball

    NASA Astrophysics Data System (ADS)

    2007-11-01

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

  7. Lightest exoplanet yet discovered

    NASA Astrophysics Data System (ADS)

    2009-04-01

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

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

    PubMed

    Hadi, Muhammad Abdul; José Closs, S

    2016-06-01

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

  9. 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)

  10. 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)

  11. Clinical Investigator Development Program | Center for Cancer Research

    Cancer.gov

    Clinical Investigator Development Program Application Deadline:  September 30, 2017 Program Starts: July 1, 2018 The NCI Center for Cancer Research (CCR) is pleased to announce our annual call for applications for an exciting training opportunity intended for physicians interested in dedicating their careers to clinical research. Come join a vibrant, multidisciplinary research community where hallmarks are:

  12. Conducting research in clinical psychology practice: Barriers, facilitators, and recommendations.

    PubMed

    Smith, Kirsten V; Thew, Graham R

    2017-09-01

    The combination of clinical psychologists' therapeutic expertise and research training means that they are in an ideal position to be conducting high-quality research projects. However, despite these skills and the documented benefits of research to services and service users, research activity in practice remains low. This article aims to give an overview of the advantages of, and difficulties in conducting research in clinical practice. We reviewed the relevant literature on barriers to research and reflected on our clinical and research experiences in a range of contexts to offer practical recommendations. We considered factors involved in the planning, sourcing support, implementation, and dissemination phases of research, and outline suggestions to improve the feasibility of research projects in post-qualification roles. We suggest that research leadership is particularly important within clinical psychology to ensure the profession's continued visibility and influence within health settings. Clinical implications Emerging evidence suggests that clinical settings that foster research are associated with better patient outcomes. Suggestions to increase the feasibility of research projects in clinical settings are detailed. Limitations The present recommendations are drawn from the authors' practical experience and may need adaptation to individual practitioners' settings. This study does not attempt to assess the efficacy of the strategies suggested. © 2017 The Authors. British Journal of Clinical Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

  13. Defining the primary research question in veterinary clinical studies.

    PubMed

    Giuffrida, Michelle A

    2016-09-01

    A thoughtful, clearly defined research question should be the foundation of any clinical trial or research study. The research question helps determine key study methods, and defining a specific research question helps avoid problems with inadequate sample size, inappropriate design, or multiple statistical comparisons. Rationales and strategies for formulating research questions and using them to define study protocols are discussed, with a focus on application in clinical trials.

  14. 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.

  15. Discovering Hidden Voices.

    ERIC Educational Resources Information Center

    Collins, Carol

    1991-01-01

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

  16. DISCOVER-AQ

    Atmospheric Science Data Center

    2017-01-31

    ... DISCOVER-AQ ) is a four-year campaign to improve the use of satellites to monitor air quality for public health and environmental benefit. ... will enable more effective use of current and future satellites to diagnose ground level conditions influencing air quality. ...

  17. Discovering Mendeleev's Model.

    ERIC Educational Resources Information Center

    Sterling, Donna

    1996-01-01

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

  18. Discovering the Artist Within.

    ERIC Educational Resources Information Center

    Hamill, Sam

    1999-01-01

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

  19. Discovering Mendeleev's Model.

    ERIC Educational Resources Information Center

    Sterling, Donna

    1996-01-01

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

  20. Highly effective cystic fibrosis clinical research teams: critical success factors.

    PubMed

    Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W

    2014-08-01

    Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.

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

    MedlinePlus

    ... that work in people, and there are clinical trials going on all the time in virtually every area of medical research. People who volunteer to take part in clinical trials do so for several reasons, including the chance ...

  2. On improving research methodology in clinical trials.

    PubMed

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

    2008-06-01

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

  3. 77 FR 20489 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-04

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

  4. 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.

  5. 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.

  6. 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

  7. [Clinical researchers and pharmaceutical industry. Dangerous liaisons].

    PubMed

    Roos, J C

    1999-08-07

    Pharmaceutical industry and physician-investigators are mutually dependent for the development of new drugs and clinical trials of such drugs. Under pressure of increasing market orientation, clinical scientific investigations shift more and more from fundamental to clinical drug trials, the results of which sometimes do not justify the excitement with which they are presented in the scientific and lay press. More room and means should be given to less market oriented studies, addressing more fundamental clinical problems. Financial affiliation with the industry may influence the doctors' mind and the presentation and type of investigation. Apart from this type of intellectual subjection there is a form of financial subjugation of doctors to the industry, by participating in so-called 'postmarketing surveillance studies' which they in fact are not, that have no scientific value whatsoever, but only serve the financial interest of the participating doctor and the industry.

  8. CPTAC | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) is a national effort to accelerate the understanding of the molecular basis of cancer through the application of large-scale proteome and genome analysis, or proteogenomics.

  9. Clinical nurse educators as agents for change: increasing research utilization.

    PubMed

    Milner, F Margaret; Estabrooks, C A; Humphrey, C

    2005-11-01

    The purpose of this study was to examine the determinants of research utilization among clinical nurse educators. The primary goal for clinical nurse educators is the facilitation of professional development of practicing nurses. Responsibilities include promoting best practice by mentoring others, acting as an information source, and assisting in the development of policies and procedures based on available research evidence. Using Rogers' (Diffusion of Innovations, 4th edn., The Free Press, New York) diffusion of innovations theory as a theoretical foundation, we conducted a secondary analysis to test a predictive model of research utilization using linear regression. Results show that educators report significantly higher research use than staff nurses and managers. Predictors of research utilization include attitude toward research, awareness of information based on research, and involvement in research activities. Localite communication predicted conceptual research use and mass media predicted symbolic use, lending support to the idea that overall, instrumental, conceptual, and symbolic research utilization are conceptually different from one another. Our findings show that the research utilization behaviors of clinical nurse educators position them to facilitate evidence-based nursing practice in organizations. We discuss the theoretical, conceptual, and nursing role implications of our findings for nursing practice, education, and research. Suggestions for future research includes studying actual use of research findings of clinical nurse educators and designing intervention studies that assesses the effectiveness of clinical nurse educators as facilitators of research utilization in organizations.

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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)

  16. Quality of Reporting in Clinical Pharmacy Research.

    ERIC Educational Resources Information Center

    Ilersich, A. Lane; And Others

    1990-01-01

    Original research articles from three major pharmacy journals were reviewed to determine the quality of reporting research. Articles were evaluated for method of recruitment and/or randomization; statistical analysis; inclusion/exclusion criteria; subject blinding; objective assessment; treatment complications; loss to followup; number of…

  17. Assessing research participants' perceptions of their clinical research experiences.

    PubMed

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

    2011-12-01

    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. Research participants enrolled in 12 focus groups, consisting of: (1) individuals with disorders undergoing interventions; (2) in natural history studies; or (3) healthy volunteers. Research professionals participated in six separate groups of: (1) institutional review board members, ethicists, and Research Subject Advocates; (2) research nurses/coordinators; or (3) investigators. Focus groups used standard methodologies. Eighty-five participants and 29 professionals enrolled at eight 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. 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. On the basis of these insights, we propose specific actions to enhance participant recruitment, retention, and satisfaction. © 2011 Wiley Periodicals, Inc.

  18. The several Cs of translational clinical research

    PubMed Central

    Nathan, David G.

    2005-01-01

    Perhaps because I am a veteran of the “good old days” (they were really quite bad), young physicians who hope to become clinical investigators often ask me how they might establish their careers. Many are more than a little worried about their futures and often have trouble envisioning a career path that is financially secure for themselves and their families. The grumbling of clinical investigators a few years their senior enhances their angst. So I try to encourage these young physicians because I know the great intellectual (if not monetary) rewards of the field and because I know that the future of medicine absolutely depends on clinical investigators. The following is what I try to say to them. PMID:15841166

  19. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... Development and Clinical Science Research and Development Services Scientific Merit Review Board, Notice of... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... science research. The panel meetings will be open to the public for approximately one-half hour at the...

  20. [Effect of data management quality on clinical research evidence evaluation].

    PubMed

    Gao, Hong-yang; Li, Qing-na; Zhao, Yang; Li, Bo; Rui, Gao

    2015-02-01

    Current clinical evaluation of literature quality has various ways. Most of them lay special emphasis on the evaluation of the design quality, but the evaluation of the implementation process quality is not perfect. Especially data management is not fully emphasized during the enforcement of clinical trials. Data from clinical research were bases for evaluating clinical findings. Although strict specifications and requirements for data management might be strictly written clearly in research protocols, they were not embodied in current clinical research evidence evaluation system. Data management is an important part of implementing the whole clinical trial process, which is a comprehensive reflection of data collecting, logging, sorting, and managing. Its objective is to obtain high quality research data for statistical analysis, thereby coming to a true and reliable conclusion. In order to overall evaluating clinical design and implement, we suggest that present quality evaluation indicators of clinical trails should be completed, and add data management quality evaluation during the whole implement process. Data management plans, standards and requirements for data checking, and management regulations for disobeying data and exception data should be added in quality evaluation indicators for clinical research evidence. The effect of data management quality on clinical research evidence evaluation should be emphasized.

  1. [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

  2. 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…

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

    ERIC Educational Resources Information Center

    National Academies Press, 2011

    2011-01-01

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

  4. 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. 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…

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

    PubMed

    Manja, Veena; Lakshminrusimha, Satyan

    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.

  7. AIDS--Challenges to Basic and Clinical Biomedical Research.

    ERIC Educational Resources Information Center

    Fauci, Anthony S.

    1989-01-01

    Clinical trials and access to therapeutic drugs pose dilemmas for researchers, physicians, and AIDS patients. The National Institute of Allergy and Infectious Diseases, recognizing the need for greater access to drugs by a broader spectrum of the infected population, is establishing the Community Programs for Clinical Research on AIDS. (Author/MLW)

  8. 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…

  9. International Partnerships for Clinical Cancer Research

    Cancer.gov

    CGH co-sponsors the 2015 International Symposium on Cancer Clinical Trials and related meetings held in partnership with the Japanese National Cancer Center (JNCC) and Embassies of France, Korea, United Kingdom (UK), and United States (US) in Tokyo on May 14 - 15, 2015.

  10. 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)

  11. 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…

  12. Translating Patient Safety Research Into Clinical Practice

    DTIC Science & Technology

    2005-01-01

    controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy . Measures of outcomes... polypharmacy . Am J Med. 1996 100(4):428–37. 40. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington DC

  13. Patients' refusal to participate in clinical research.

    PubMed

    van den Berg, L; Lobatto, R M; Zuurmond, W W; de Lange, J J; Wagemans, M F; Bezemer, P D

    1997-05-01

    The number of protocol-eligible patients, refusing to participate in a clinical trial is often not mentioned. The aim of this study is to report the number of refusers and to evaluate the reasons for not participating in a clinical study concerning post-operative pain relief and to assess the potential influence on the final study results. Patients refusing to participate in the study were recorded and evaluated for reasons of refusal. The post-operative pain relief techniques applied in this trial are commonly used, but nevertheless the refusal rate was higher than expected. When it was mentioned that an epidural technique was a part of the trial, 16.7% of the total protocol-eligible group refused. The responses of those offered an epidural could be divided into two groups: the adamant pros and cons to this technique. It can be concluded that in order to be able to judge the validity of results and thus for good clinical practice, the number of patients refusing to participate in a clinical trial and their reasons, should be mentioned in all publications.

  14. 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…

  15. 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)

  16. Digital Discover of Ephemeral Ponds

    DTIC Science & Technology

    2012-08-01

    ER D C/ CE RL T R - 12 -2 1 Center Directed Research Program Digital Discover of Ephemeral Ponds En gi ne er R es ea rc h an d D ev el...r.mapcalc formula : r.terraflow lidar_elev filled=elev_filled \\ accum=elev_accum memory=2000 \\ dir=elev_dir swater=elev_sink tci =elev_tci...J. D., M. Shapiro, W. D. Goran, and D. P. Gerdes. 1992. Geographic Resources Analysis Support System (GRASS) Version 4.0 User’s Reference Manual . N

  17. 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.

  18. [Ethics in clinical research. World Medical Association].

    PubMed

    Villalobos, J J

    1990-07-01

    Ethics is the branch of Philosophy that treats the essential; the origin and the obligatory character of the moral, for that reason it relates with the man conscience; it deals with the knowledge and acceptation of the right and the rejection of the evil (wrong). This is subordinated to the will of the man who is free to decide between the right and the evil. The purpose of biomedical research involving human subjects must help to improve diagnostic, therapeutic and prophylactic procedures and to understand the aetiology and pathogenesis of a disease. In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazard. This applies especially to biomedical research. Medical progress is based on research which ultimately must rely in part on experimentation involving human subjects. The World Medical Association has prepared the recommendations described in this article as a guide to every physician in biomedical research involving human subjects.

  19. Investigators’ Perspectives on Translating Human Microbiome Research into Clinical Practice

    PubMed Central

    Slashinski, Melody J.; Whitney, Simon N.; Achenbaum, Laura S.; Keitel, Wendy A.; McCurdy, Sheryl A.; McGuire, Amy L.

    2013-01-01

    Background Human microbiome research has the potential to transform the practice of medicine, fundamentally shifting the ways in which we think not only about human health, illness, and disease, but also about clinical practice and public health interventions. Drawing from a larger qualitative study on ethical, legal, and social dimensions of human microbiome research, in this article we document perspectives related to the translation of human microbiome research into clinical practice, focusing particularly on implications for health, illness, and disease. Methods We conducted 60 in-depth, semi-structured interviews (2009–2010) with 63 researchers and National Institutes of Health project leaders (“investigators”) involved with human microbiome research. Interviews explored a range of ethical, legal, and social implications of human microbiome research, including investigators’ perspectives on potential strategies for translating findings to clinical practice. Using thematic content analysis, we identified and analyzed emergent themes and patterns. Results We identified three themes: (1) Investigators’ general perspectives on the clinical utility of human microbiome research, (2) Investigators’ perspectives on antibiotic use, overuse, and misuse, and (3) Investigators’ perspectives concerning future challenges of translating data to clinical practice. Conclusion The issues discussed by investigators concerning the clinical significance of human microbiome research, including embracing a new paradigm of health and disease, the importance of microbial communities, and clinical utility, will be of critical importance as this research moves forward. PMID:23615375

  20. Quality Assurance in Biobanking for Pre-Clinical Research

    PubMed Central

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

    2016-01-01

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

  1. Clinical and molecular research of neuroacanthocytosis★

    PubMed Central

    Zhang, Lihong; Wang, Suping; Lin, Jianwen

    2013-01-01

    Neuroacanthocytosis is an autosomal recessive or dominant inherited disease characterized by widespread, non-specific nervous system symptoms, or spiculated “acanthocytic” red blood cells. The clinical manifestations typically involve chorea and dystonia, or a range of other movement disorders. Psychiatric and cognitive symptoms may also be present. The two core neuroacanthocytosis syndromes, in which acanthocytosis is atypical, are autosomal recessive chorea-acanthocytosis and X-linked McLeod syndrome. Acanthocytes are found in a smaller proportion of patients with Huntington's disease-like 2 and pantothenate kinase-associated neurodegeneration. Because the clinical manifestations are diverse and complicated, in this review we present features of inheritance, age of onset, neuroimaging and laboratory findings, as well as the spectrum of central and peripheral neurological abnormalities and extraneuronal involvement to help distinguish the four specific syndromes. PMID:25206731

  2. [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).

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

    PubMed

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

    2014-01-01

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

  4. Barriers to Clinical Research in Latin America.

    PubMed

    Chomsky-Higgins, Kathryn; Miclau, Theodore A; Mackechnie, Madeline C; Aguilar, Dino; Avila, Jorge Rubio; Dos Reis, Fernando Baldy; Balmaseda, Roberto; Barquet, Antonio; Ceballos, Alfredo; Contreras, Fernando; Escalante, Igor; Elias, Nelson; Vincenti, Sergio Iriarte; Lozano, Christian; Medina, Fryda; Merchan, Gavino; Segovia, Julio; Guerado, Enrique; Quintero, Jose Eduardo; Morshed, Saam; Bhandari, Mohit; Miclau, Theodore

    2017-01-01

    Enhancing health research capacity in developing countries is a global health priority. Understanding the orthopedic burden of disease in Latin America will require close partnership between more-developed and less-developed countries. To this end, the Osteosynthesis and Trauma Care Foundation assembled a research consortium of Latin-American orthopedic leaders. Prior to the meeting, we surveyed attendees on perceived barriers to conducting research at their institutions. During the event, working groups discussed these barriers, developed strategies for addressing them, and planned future steps for collaboration. The participants established the need for global relationships that allow colleagues from Latin America to access to training and established investigational infrastructure of North American centers to address research questions relevant to their communities. As a result of the discussion, the International Orthopaedic Multicenter Study (INORMUS) in Fracture Care was initiated. Since then, an expanded international working group, Associación de Cirujanos Traumatológicos en las Americas (ACTUAR), has been created with the purpose of promoting increased global partnership for research capacity development.

  5. Barriers to Clinical Research in Latin America

    PubMed Central

    Chomsky-Higgins, Kathryn; Miclau, Theodore A.; Mackechnie, Madeline C.; Aguilar, Dino; Avila, Jorge Rubio; dos Reis, Fernando Baldy; Balmaseda, Roberto; Barquet, Antonio; Ceballos, Alfredo; Contreras, Fernando; Escalante, Igor; Elias, Nelson; Vincenti, Sergio Iriarte; Lozano, Christian; Medina, Fryda; Merchan, Gavino; Segovia, Julio; Guerado, Enrique; Quintero, Jose Eduardo; Morshed, Saam; Bhandari, Mohit; Miclau, Theodore

    2017-01-01

    Enhancing health research capacity in developing countries is a global health priority. Understanding the orthopedic burden of disease in Latin America will require close partnership between more-developed and less-developed countries. To this end, the Osteosynthesis and Trauma Care Foundation assembled a research consortium of Latin-American orthopedic leaders. Prior to the meeting, we surveyed attendees on perceived barriers to conducting research at their institutions. During the event, working groups discussed these barriers, developed strategies for addressing them, and planned future steps for collaboration. The participants established the need for global relationships that allow colleagues from Latin America to access to training and established investigational infrastructure of North American centers to address research questions relevant to their communities. As a result of the discussion, the International Orthopaedic Multicenter Study (INORMUS) in Fracture Care was initiated. Since then, an expanded international working group, Associación de Cirujanos Traumatológicos en las Americas (ACTUAR), has been created with the purpose of promoting increased global partnership for research capacity development. PMID:28459047

  6. Discovering system requirements

    SciTech Connect

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

    1996-07-01

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

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

    PubMed

    Zhang, Zhongheng

    2015-11-01

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

  8. Clinical research within the chiropractic profession: status, needs and recommendations.

    PubMed

    Sawyer, C; Haas, M; Nelson, C; Elkington, W

    1997-01-01

    In the current climate of accountability, health care financing reform and the demand on all health professions for evidence, there is an urgent need to expand clinical research activity within the profession. Those randomized clinical trials that have been reported in the literature have focused primarily on low back and headache pain. Only recently have studies been initiated to investigate the effectiveness of chiropractic interventions for conditions other than back pain. The ability of chiropractic colleges to develop research infrastructures and productive clinical research programs depends on removing or minimizing a number of impediments. A shortage of chiropractic clinicians who have the experience and training to conduct clinical research is compounded by a dependency on tuition revenue, limited external funding and a lack of institutional emphasis on research. The profession generally, and chiropractic colleges specifically, must address the impediments that limit the growth of research capacity. We present several recommendations and the action steps required to achieve specific outcomes.

  9. An Integrative Review of Engaging Clinical Nurses in Nursing Research.

    PubMed

    Scala, Elizabeth; Price, Carrie; Day, Jennifer

    2016-07-01

    To review the literature for best practices for engaging clinical nurses in nursing research. Review of the research and nonresearch papers published between 2005 and 2015 that answered the evidence-based practice (EBP) question: what are the best practices for engaging clinical nursing staff in nursing research? PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Joanna Briggs Institute, and Cochrane were searched using a combination of controlled vocabulary and key words. Nineteen papers that answered the EBP question were selected for review. It can be difficult to involve clinical nurses in research. There are multiple factors to consider when nursing leadership looks to engage clinical nurses in nursing research. Nurse leaders can take many approaches to engage clinical nurses in research. Each organization must perform its own assessment to identify areas of opportunity. Nursing leadership can take these areas of opportunity to structure a multifaceted approach to support clinical staff in the conduct and dissemination of nursing research. The evidence from this review offers EBP recommendations as well as reports on the gaps in the literature related to best practices for engaging clinical nurses in nursing research. © 2016 Sigma Theta Tau International.

  10. Dive and discover: Expeditions to the seafloor

    NASA Astrophysics Data System (ADS)

    Ayers Lawrence, Lisa

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

  11. Dive and discover: Expeditions to the seafloor

    NASA Astrophysics Data System (ADS)

    Lawrence, Lisa Ayers

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

  12. 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

  13. Developing a Mentorship Program for Clinical Researchers

    ERIC Educational Resources Information Center

    Blixen, Carol E.; Papp, Klara K.; Hull, Alan L.; Rudick, Richard A.; Bramstedt, Katrina A.

    2007-01-01

    Introduction: In academic health centers, the number of physician investigators and the number of research studies headed by clinicians has been declining. The U.S. Institute of Medicine and the National Institutes of Health suggest improved mentoring is important to reversing these trends. Methods: This is a case study review of the role of…

  14. Developing a Mentorship Program for Clinical Researchers

    ERIC Educational Resources Information Center

    Blixen, Carol E.; Papp, Klara K.; Hull, Alan L.; Rudick, Richard A.; Bramstedt, Katrina A.

    2007-01-01

    Introduction: In academic health centers, the number of physician investigators and the number of research studies headed by clinicians has been declining. The U.S. Institute of Medicine and the National Institutes of Health suggest improved mentoring is important to reversing these trends. Methods: This is a case study review of the role of…

  15. Clinical Assessment Research with Older Adults.

    ERIC Educational Resources Information Center

    La Rue, Asenath; Markee, Taryn

    1995-01-01

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

  16. 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…

  17. Partners | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    Awardees and Affiliated Institutions Agilent Technologies, Inc., Cambridge, MA Baylor College of Medicine, Houston, TX Biomedical Hosting LLC, Arlington, MA Brigham and Women’s Hospital, Cambridge, MA Brown University, Providence, RI Cell Signaling Technology, Danvers, MA Chang Gung University, Molecular Medicine Research Center, Taoyuan City, Taiwan Dana-Farber Cancer Institute, Boston, MA Fluidigm Corp., Cambridge, MA

  18. 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.

  19. 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

  20. Objectives | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The overall objective of CPTAC is to systematically identify proteins that derive from alterations in cancer genomes and related biological processes, in order to understand the molecular basis of cancer that is not fully elucidated or not possible through genomics and to accelerate the translation of molecular findings into the clinic.  This is to be achieved through enhancing our understanding of cancer genome biology by adding a complementary functional layer of protein biology (a “proteogenome” approach) that refines/prioritizes driver genes, enhances understanding of pathogenesis

  1. Clinical Research Nursing: A Critical Resource in the National Research Enterprise

    PubMed Central

    Hastings, Clare E.; Fisher, Cheryl A.; McCabe, Margaret A.

    2012-01-01

    Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to deliver prevention strategies, treatments and cures based on scientific innovations faster 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

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

    PubMed

    Wolfe, B; Jordan, J R

    2000-01-01

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

  3. A metadata schema for data objects in clinical research.

    PubMed

    Canham, Steve; Ohmann, Christian

    2016-11-24

    A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme. The relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored. A scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described. The metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.

  4. Social phobia: research and clinical practice.

    PubMed

    Alnaes, R

    2001-01-01

    Social phobia is a pervasive pattern of social inhibition, feelings of inadequacy, and hypersensitivity, occurring in about 18% of the clinical population. Despite good results with cognitive-behavioural treatment, social phobia seems to be a chronic disorder with several complications. The author describes an analysis of a divorced woman who was exposed to an early premature sexual seduction by her father, abruptly terminated because of an accident. The loss of the father was repaired by a delusional system as defence against the re-emergence of a catastrophic situation. Her compulsion to repeat the traumatic situation was seen in symbolic attempts to reproduce the lost experience of forbidden pleasure with other men, ending in hopeless affairs. According to DSM-IV the patient had-besides social phobia-several personality disturbances, clinically manifested by weak ego boundaries, an unclear identity, and low self-esteem. Cognitive-behavioural therapy and psychopharmaca were without any effect. The childhood experiences were repeated in the context of the analysis and worked through, especially the pre-oedipal and oedipal conflicts. Important repeating themes were "crime", guilt, and punishment. After 3 years of analysis it was possible for the patient to expose herself to anxiety-producing situations with less symptoms. It was possible for her to withdraw the projections and take more responsibility for the unconscious sexual and aggressive impulses. At the 5-year follow-up her satisfactions had become more realistic and she became involved in a positive relationship.

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

    PubMed

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

    2011-04-01

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

  6. 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.

  7. [Clinical research IX. From the clinical judgment to the clinical trial].

    PubMed

    Talavera, Juan O; Rivas-Ruiz, Rodolfo

    2012-01-01

    Two strategies to understand and document causality are: 1) clinical reasoning (CR) and 2) clinical trial (CT). CR identifies: basal state, maneuver and outcome. These components show us the complex of causality, its identification and control allows us to avoid systematic errors, such as: at baseline-improper assembly and susceptibility bias, during the application of the maneuver-performance bias, and at measurement of outcome-detection and transfer bias. In the CT tactics attempt to separate the effect of the main maneuver from the effect of other components that participate in causality previously described in CR. CT takes advantage of its characteristics: the opportunity to manipulate the maneuver and the temporality into the causal relationship. Some features to highlight are: the allocation of the maneuver, blinding of the maneuver, the feasibility of early interruption of the maneuver, the analysis according to maneuver adherence, the groups to compare, the timing of comparative maneuver, and the informed consent. Each occasion the clinician applies all this knowledge and skills, in a conscious way and structured, he improves his efficiency and align medical practice with clinical research.

  8. Clinical Nursing Knowledge Research; Implications for Nursing Education.

    ERIC Educational Resources Information Center

    Diekelmann, Nancy L.; And Others

    A new way to view the nursing curriculum is presented based on Heideggerian phenomenology and clinical nursing knowledge research. A restructuring of the nursing curriculum based on this approach allows researchers to generate new research questions and has implications for alternative curricular and instructional practices. In addition, this…

  9. 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

  10. Considerations in establishing an oral disease clinical research center.

    PubMed

    Barnett, M L; Pihlstrom, B L

    2010-10-01

    Oral Diseases (2010) 16, 586-591 High quality clinical research is necessary to improve oral health and translate research findings to the practice of dentistry. This has led many academic institutions to consider establishing a formal clinical research center. This is not a trivial undertaking and requires that the center have an appropriate physical infrastructure, trained investigators with recognized expertise in the planning and conduct of high quality clinical research, and very importantly, a financial plan to assure its long-term sustainability. The purpose of this paper is to provide some guidance and practical advice with respect to factors that should be considered in developing and maintaining a successful oral disease clinical research center. © 2010 John Wiley & Sons A/S.

  11. Core assumptions and research opportunities in clinical communication.

    PubMed

    Salmon, Peter; Young, Bridget

    2005-09-01

    Contemporary clinical communication teaching and research reflect the axiomatic importance of building a clinical relationship and of empowering patients as partners. The apparent moral unassailability of these principles has inhibited their scientific scrutiny. By questioning this current hegemony in communication teaching and research, our objective is to identify research opportunities that remain to be fully exploited. We identify assumptions in current communication literature and evaluate them from the perspective of relevant empirical and theoretical literature. The view that the clinical relationship is an objective thing which needs to be 'built' can lead researchers to neglect factors within patients that influence their subjective sense of the relationship. The model of partnership is hard to reconcile with patients' vulnerability and associated dependency needs. The widespread use of the term 'communication skills' emphasises processes at a skill level at the expense of those at levels of cognition, emotion, and value. Research is needed into: the extent to which patients' sense of relationship arises from factors outside the relationship; the implications of their vulnerability and dependency for clinical relationships; and the processes at the level of cognition, emotion and value, as well as skill, that are entailed in clinical communication and in communication teaching. RESEARCH AND PRACTICE IMPLICATIONS: Pursuing the research opportunities that we have identified will enhance the theoretical validity and practical relevance of clinical communication research and teaching.

  12. Integrative data analysis in clinical psychology research.

    PubMed

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

    2013-01-01

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

  13. 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

  14. Visual Acuity Reporting in Clinical Research Publications.

    PubMed

    Tsou, Brittany C; Bressler, Neil M

    2017-06-01

    Visual acuity results in publications typically are reported in Snellen or non-Snellen formats or both. A study in 2011 suggested that many ophthalmologists do not understand non-Snellen formats, such as logarithm of the Minimum Angle of Resolution (logMAR) or Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores. As a result, some journals, since at least 2013, have instructed authors to provide approximate Snellen equivalents next to non-Snellen visual acuity values. To evaluate how authors currently report visual acuity and whether they provide Snellen equivalents when their reports include non-Snellen formats. From November 21, 2016, through December 14, 2016, one reviewer evaluated visual acuity reporting among all articles published in 4 ophthalmology clinical journals from November 2015 through October 2016, including 3 of 4 journals that instructed authors to provide Snellen equivalents for visual acuity reported in non-Snellen formats. Frequency of formats of visual acuity reporting and frequency of providing Snellen equivalents when non-Snellen formats are given. The 4 journals reviewed had the second, fourth, fifth, and ninth highest impact factors for ophthalmology journals in 2015. Of 1881 articles reviewed, 807 (42.9%) provided a visual acuity measurement. Of these, 396 (49.1%) used only a Snellen format; 411 (50.9%) used a non-Snellen format. Among those using a non-Snellen format, 145 (35.3%) provided a Snellen equivalent while 266 (64.7%) provided only a non-Snellen format. More than half of all articles in 4 ophthalmology clinical journals fail to provide a Snellen equivalent when visual acuity is not in a Snellen format. Since many US ophthalmologists may not comprehend non-Snellen formats easily, these data suggest that editors and publishing staff should encourage authors to provide Snellen equivalents whenever visual acuity data are reported in a non-Snellen format to improve ease of understanding visual acuity measurements.

  15. [Application of Delphi method in traditional Chinese medicine clinical research].

    PubMed

    Bi, Ying-fei; Mao, Jing-yuan

    2012-03-01

    In recent years, Delphi method has been widely applied in traditional Chinese medicine (TCM) clinical research. This article analyzed the present application situation of Delphi method in TCM clinical research, and discussed some problems presented in the choice of evaluation method, classification of observation indexes and selection of survey items. On the basis of present application of Delphi method, the author analyzed the method on questionnaire making, selection of experts, evaluation of observation indexes and selection of survey items. Furthermore, the author summarized the steps of application of Delphi method in TCM clinical research.

  16. Clinical and translational research in pneumocystis and pneumocystis pneumonia.

    PubMed

    Huang, L

    2011-02-01

    Pneumocystis pneumonia (PcP) remains a significant cause of morbidity and mortality in immunocompromised persons, especially those with human immunodeficiency virus (HIV) infection. Pneumocystis colonization is described increasingly in a wide range of immunocompromised and immunocompetent populations and associations between Pneumocystis colonization and significant pulmonary diseases such as chronic obstructive pulmonary disease (COPD) have emerged. This mini-review summarizes recent advances in our clinical understanding of Pneumocystis and PcP, describes ongoing areas of clinical and translational research, and offers recommendations for future clinical research from researchers participating in the "First centenary of the Pneumocystis discovery".

  17. 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

  18. Student Discovers New Pulsar

    NASA Astrophysics Data System (ADS)

    2010-01-01

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

  19. Discovering the Expanding Universe

    NASA Astrophysics Data System (ADS)

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

    2009-03-01

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

  20. Integrating Bioethics into Clinical and Translational Science Research: A Roadmap

    PubMed Central

    Shapiro, Robyn S.; Layde, Peter M.

    2008-01-01

    Abstract Recent initiatives to improve human health emphasize the need to effectively and appropriately translate new knowledge gleaned from basic biomedical and behavioral research to clinical and community application. To maximize the beneficial impact of scientific advances in clinical practice and community health, and to guard against potential deleterious medical and societal consequences of such advances, incorporation of bioethics at each stage of clinical and translational science research is essential. At the earliest stage, bioethics input is critical to address issues such as whether to limit certain areas of scientific inquiry. Subsequently, bioethics input is important to assure not only that human subjects trials are conducted and reported responsibly, but also that results are incorporated into clinical and community practices in a way that promotes and protects bioethical principles. At the final stage of clinical and translational science research, bioethics helps to identify the need and approach for refining clinical practices when safety or other concerns arise. The framework we present depicts how bioethics interfaces with each stage of clinical and translational science research, and suggests an important research agenda for systematically and comprehensively assuring bioethics input into clinical and translational science initiatives. PMID:20443821

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

    PubMed

    Tabarrai, Malihe; Qaraaty, Marzie; Aliasl, Jale

    2016-05-01

    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. 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. 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. Considering a history of several thousand years, the Iranian traditional medicine is a great venue for students. To

  2. Genes, molecules and patients—Emerging topics to guide clinical pain research

    PubMed Central

    Sikandar, Shafaq; Patel, Ryan; Patel, Sital; Sikander, Sanam; Bennett, David L.H.; Dickenson, Anthony H.

    2013-01-01

    This review selectively explores some areas of pain research that, until recently, have been poorly understood. We have chosen four topics that relate to clinical pain and we discuss the underlying mechanisms and related pathophysiologies contributing to these pain states. A key issue in pain medicine involves crucial events and mediators that contribute to normal and abnormal pain signaling, but remain unseen without genetic, biomarker or imaging analysis. Here we consider how the altered genetic make-up of familial pains reveals the human importance of channels discovered by preclinical research, followed by the contribution of receptors as stimulus transducers in cold sensing and cold pain. Finally we review recent data on the neuro-immune interactions in chronic pain and the potential targets for treatment in cancer-induced bone pain. PMID:23500200

  3. Annual Research Review: Resilience--clinical implications.

    PubMed

    Rutter, Michael

    2013-04-01

    It is a universal finding that there is huge heterogeneity in people's responses to all kinds of stress and adversity. Resilience is an interactive phenomenon that is inferred from findings indicating that some individuals have a relatively good outcome despite having experienced serious adversities. Resilience can only be inferred if there has been testing of environmental mediation of risks and quantification of the degree of risk. The use of 'natural experiments' to test environmental mediation is briefly discussed. The literature is then reviewed on features associated with resilience in terms of (a) those that are neutral or risky in the absence of the risk experience (such as adoption); (b) brief exposure to risks and inoculation effects; (c) mental features (such as planning, self-regulation or a sense of personal agency); (d) features that foster those mental features; (e) turning point effects; (f) gene-environment interactions; (g) social relationships and promotive effects; and (h) the biology of resilience. Clinical implications are considered with respect to (a) conceptual implications; (b) prevention; and (c) treatment. Resilience findings do not translate into a clear programme of prevention and treatment, but they do provide numerous leads that focus on the dynamic view of what may be involved in overcoming seriously adverse experiences. © 2012 The Author. Journal of Child Psychology and Psychiatry © 2012 Association for Child and Adolescent Mental Health.

  4. [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.

  5. 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

  6. 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

  7. Clinical Research Informatics for Big Data and Precision Medicine.

    PubMed

    Weng, C; Kahn, M G

    2016-11-10

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

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

    SciTech Connect

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

    2015-01-01

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

  9. Clinical significance in nursing research: A discussion and descriptive analysis.

    PubMed

    Polit, Denise F

    2017-05-10

    It is widely understood that statistical significance should not be equated with clinical significance, but the topic of clinical significance has not received much attention in the nursing literature. By contrast, interest in conceptualizing and operationalizing clinical significance has been a "hot topic" in other health care fields for several decades. The major purpose of this paper is to briefly describe recent advances in defining and quantifying clinical significance. The overview covers both group-level indicators of clinical significance (e.g., effect size indexes), and individual-level benchmarks (e.g., the minimal important change index). A secondary purpose is to describe the extent to which developments in clinical significance have penetrated the nursing literature. A descriptive analysis of a sample of primary research articles published in three high-impact nursing research journals in 2016 was undertaken. A total of 362 articles were electronically searched for terms relating to statistical and clinical significance. Of the 362 articles, 261 were reports of quantitative studies, the vast majority of which (93%) included a formal evaluation of the statistical significance of the results. By contrast, the term "clinical significance" or related surrogate terms were found in only 33 papers, and most often the term was used informally, without explicit definition or assessment. Raising consciousness about clinical significance should be an important priority among nurse researchers. Several recommendations are offered to improve the visibility and salience of clinical significance in nursing science. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Gender identity, research self-efficacy and research intention in trainee clinical psychologists in the UK.

    PubMed

    Wright, Anne B; Holttum, Sue

    2012-01-01

    This study tested, with a sample of United Kingdom (UK) trainee clinical psychologists, part of an existing model of factors that influence clinical psychologists' levels of research activity, in which gender identity is hypothesized to influence research self-efficacy and this in turn strength of intention to do research. A sample of 121 trainee clinical psychologists (56 men and 65 women) completed a measure of gender identity, research intention, and a research self-efficacy scale. Results indicated no differences in levels of research intention or research self-efficacy between the biological sexes or according to category-based gender identities (masculine and feminine). However, masculinity as a scale quantity was statistically significantly related to stronger research intention, preference for conducting quantitative research and research self-efficacy. Multiple regression analysis provided evidence that research self-efficacy may mediate between masculinity and strength of research intention. Research self-efficacy was the strongest predictor of intention to do research in the future. Findings have relevance for clinical psychology training as research activity directly impacts upon advances in the discipline of clinical psychology, implementation of research into practice, and evaluation of psychological therapies. Copyright © 2010 John Wiley & Sons, Ltd.

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

    PubMed

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

    2015-12-01

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

  12. Clinical code set engineering for reusing EHR data for research: A review.

    PubMed

    Williams, Richard; Kontopantelis, Evangelos; Buchan, Iain; Peek, Niels

    2017-06-01

    The construction of reliable, reusable clinical code sets is essential when re-using Electronic Health Record (EHR) data for research. Yet code set definitions are rarely transparent and their sharing is almost non-existent. There is a lack of methodological standards for the management (construction, sharing, revision and reuse) of clinical code sets which needs to be addressed to ensure the reliability and credibility of studies which use code sets. To review methodological literature on the management of sets of clinical codes used in research on clinical databases and to provide a list of best practice recommendations for future studies and software tools. We performed an exhaustive search for methodological papers about clinical code set engineering for re-using EHR data in research. This was supplemented with papers identified by snowball sampling. In addition, a list of e-phenotyping systems was constructed by merging references from several systematic reviews on this topic, and the processes adopted by those systems for code set management was reviewed. Thirty methodological papers were reviewed. Common approaches included: creating an initial list of synonyms for the condition of interest (n=20); making use of the hierarchical nature of coding terminologies during searching (n=23); reviewing sets with clinician input (n=20); and reusing and updating an existing code set (n=20). Several open source software tools (n=3) were discovered. There is a need for software tools that enable users to easily and quickly create, revise, extend, review and share code sets and we provide a list of recommendations for their design and implementation. Research re-using EHR data could be improved through the further development, more widespread use and routine reporting of the methods by which clinical codes were selected. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  13. Independent Clinical Research May Alleviate Disparities in Cancer Treatment

    PubMed Central

    Zwitter, Matjaz

    2016-01-01

    Disparities in cancer care are a reality of the modern world. Unfortunately, current clinical research is in the hands of for-profit pharmaceutical companies and of researchers from the developed world. Problems specific to cancer care in developing countries and among deprivileged populations are ignored. Independent clinical research can offer new valuable knowledge and identify affordable and cost-effective treatments. As such, research not depending on commercial sponsors should become one of the important avenues to alleviate the problem of cancer disparities. PMID:28083547

  14. Clinical research: making it work in the outpatient dialysis facility.

    PubMed

    Doss, Sheila; Schiller, Brigitte; Fox, Rosemary; Moran, John

    2009-01-01

    Performing clinical research in the outpatient dialysis facility can be very challenging. Research protocols define time-specific and detailed procedures to be performed. In dialysis units where staff members are responsible for the delivery of life-sustaining therapy to an aging end stage renal disease patient population with multiple co-morbidities, these requirements can easily be considered too burdensome to be implemented successfully. In the authors'facility, clinical research has been successfully implemented with a close team approach supported by a dedicated research group and unit staff

  15. DISCOVER in Middle School: Identifying Gifted Minority Students.

    ERIC Educational Resources Information Center

    Sarouphim, Ketty M.

    This study investigated the effectiveness of a performance-based assessment (DISCOVER (Discovering Intellectual Strengths and Capabilities through Observation while allowing for Varied Ethnic Responses)) in identifying gifted minority middle school students. Research questions focused on examining the alignment between DISCOVER and Gardner's…

  16. Clinical data mining and research in the allergy office.

    PubMed

    Dalan, Dan

    2010-06-01

    More data are anticipated from the expected increase in use of electronic health records (EHRs). Upcoming initiatives require reporting of quality measures, meaningful use of clinical decision support, alert systems, and pharmacovigilance - knowledge resulting through use of EHRs. Data mining is a new tool that will help us manage information and derive knowledge from these data, and is a part of evolving new disciplines of informatics and knowledge management. Studies are reported from smaller clinic data marts to larger repositories and warehouses in various health systems, biomedical registries, and the medical literature on the Internet. Data mining technologies show promise and challenges. Outcome measures as structured data and narrative text can be mined with human assistance and newer automated natural language processing software. Despite advances, the growing diversity of clinic EHRs lack integration and interoperability with Internet-based biomedical databases. Allergists have the capability to mine clinic EHRs to discover new information, which may be hidden in charts. A central allergy computer can serve not just as a registry but also allows functionalities to enable EHRs' meaningful use. Harmonization of technological and organizational standards will allow seamless use of new natural language processing (NLP) tools and ontologies through a semantic web.

  17. 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.

  18. Cyclotrons for clinical and biomedical research with PET

    SciTech Connect

    Wolf, A.P.

    1987-01-01

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

  19. [Progress of orthodontics in the clinical and basic research].

    PubMed

    Zhao, Zhi-He

    2008-06-01

    In recent years, clinical diagnostic and treatment techniques of orthodontics have been developed rapidly. The orthopedic mechanism of malocclusion has been the hot spot of basic research of orthodontics.

  20. 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.

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

    PubMed

    Halkoaho, Arja; Matveinen, Mari; Leinonen, Ville; Luoto, Kirsi; Keränen, Tapani

    2013-12-12

    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. 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. 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. 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.

  2. Excluded, not dismissed: enhancing benefit in clinical research.

    PubMed

    Nardell, Maria; Chhabra, Akansha; Pal, Lubna

    2013-01-01

    Participation in clinical research projects may allow an opportunity for early detection of covert diseases and subclinical disorders in asymptomatic volunteers from study-specific screening process. Exclusion of a potential participant due to failure to meet inclusion criteria eliminates any possibility of potential for research related benefit, as may exist for those that are deemed eligible and allowed to proceed with participation in the specific research study. Although the institutional bodies overseeing conduct of clinical research strive to ensure an ongoing scrutiny and prioritization of participants' wellbeing, we perceive that these mechanisms fall short as regards the interests of those volunteers who are subsequently excluded from participation in clinical research of relevance. While provision of ancillary care to address health concerns that are unmasked during the screening process may be an optimal strategy, the likelihood of successfully implementing this latter concept in current times of fiscal constraints is slim to nonexistent. Through this submission, we hope to initiate a dialogue within the research community regarding whether the current paradigm of conduct of clinical research be modified to include some degree of consideration for the screened out. We herein propose that for those volunteering for disease/disorder specific clinical research, some added degree of benefit can be assured to the screened out population through the provision of targeted health education or counseling.

  3. Managing clinically significant findings in research: the UK10K example.

    PubMed

    Kaye, Jane; Hurles, Matthew; Griffin, Heather; Grewal, Jasote; Bobrow, Martin; Timpson, Nic; Smee, Carol; Bolton, Patrick; Durbin, Richard; Dyke, Stephanie; Fitzpatrick, David; Kennedy, Karen; Kent, Alastair; Muddyman, Dawn; Muntoni, Francesco; Raymond, Lucy F; Semple, Robert; Spector, Tim

    2014-09-01

    Recent advances in sequencing technology allow data on the human genome to be generated more quickly and in greater detail than ever before. Such detail includes findings that may be of significance to the health of the research participant involved. Although research studies generally do not feed back information on clinically significant findings (CSFs) to participants, this stance is increasingly being questioned. There may be difficulties and risks in feeding clinically significant information back to research participants, however, the UK10K consortium sought to address these by creating a detailed management pathway. This was not intended to create any obligation upon the researchers to feed back any CSFs they discovered. Instead, it provides a mechanism to ensure that any such findings can be passed on to the participant where appropriate. This paper describes this mechanism and the specific criteria, which must be fulfilled in order for a finding and participant to qualify for feedback. This mechanism could be used by future research consortia, and may also assist in the development of sound principles for dealing with CSFs.

  4. Managing clinically significant findings in research: the UK10K example

    PubMed Central

    Kaye, Jane; Hurles, Matthew; Griffin, Heather; Grewal, Jasote; Bobrow, Martin; Timpson, Nic; Smee, Carol; Bolton, Patrick; Durbin, Richard; Dyke, Stephanie; Fitzpatrick, David; Kennedy, Karen; Kent, Alastair; Muddyman, Dawn; Muntoni, Francesco; Raymond, Lucy F; Semple, Robert; Spector, Tim

    2014-01-01

    Recent advances in sequencing technology allow data on the human genome to be generated more quickly and in greater detail than ever before. Such detail includes findings that may be of significance to the health of the research participant involved. Although research studies generally do not feed back information on clinically significant findings (CSFs) to participants, this stance is increasingly being questioned. There may be difficulties and risks in feeding clinically significant information back to research participants, however, the UK10K consortium sought to address these by creating a detailed management pathway. This was not intended to create any obligation upon the researchers to feed back any CSFs they discovered. Instead, it provides a mechanism to ensure that any such findings can be passed on to the participant where appropriate. This paper describes this mechanism and the specific criteria, which must be fulfilled in order for a finding and participant to qualify for feedback. This mechanism could be used by future research consortia, and may also assist in the development of sound principles for dealing with CSFs. PMID:24424120

  5. 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

  6. 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)

  7. 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,…

  8. Office Overview | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The Office of Cancer Clinical Proteomics Research (OCCPR) at the National Cancer Institute (NCI) aims to improve prevention, early detection, diagnosis, and treatment of cancer by enhancing the understanding of the molecular mechanisms of cancer, advancing proteome/proteogenome science and technology development through community resources (data and reagents), and accelerating the translation of molecular findings into the clinic.

  9. 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…

  10. 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,…

  11. 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.

  12. Developing Research Programs in Clinical and Translational Nutrition

    PubMed Central

    Moore, Frederick A.; Ziegler, Thomas R.; Heyland, Daren K.; Marik, Paul E.; Bistrian, Bruce R.

    2011-01-01

    Most clinicians believe that nutrition support therapy improves outcome in hospitalized patients. Unfortunately, few patients receive optimal nutrition management. A lack of strong, well-designed research studies may prevent the medical/surgical community from fully embracing the practice. More quality research is needed. This article discusses 3 potential strategies to improve research activity in clinical nutrition: increase funding of nutrition research, foster young physician training in nutrition and research, and attract nutrition researchers to our national nutrition society meetings. The best chance for this process to succeed is for the national nutrition societies to partner with medical and surgical subspecialty societies to develop larger scale clinical and translational research programs. PMID:21149841

  13. The Social Value of Knowledge and International Clinical Research.

    PubMed

    Wenner, Danielle M

    2015-08-01

    In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context-dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings. © 2013 John Wiley & Sons Ltd.

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

    PubMed

    Shah, Baiju R; Lipscombe, Lorraine L

    2015-06-01

    With the advent of the digitization of large amounts of information and the computer power capable of analyzing this volume of information, data mining is increasingly being applied to medical research. Datasets created for administration of the healthcare system provide a wealth of information from different healthcare sectors, and Canadian provinces' single-payer universal healthcare systems mean that data are more comprehensive and complete in this country than in many other jurisdictions. The increasing ability to also link clinical information, such as electronic medical records, laboratory test results and disease registries, has broadened the types of data available for analysis. Data-mining methods have been used in many different areas of diabetes clinical research, including classic epidemiology, effectiveness research, population health and health services research. Although methodologic challenges and privacy concerns remain important barriers to using these techniques, data mining remains a powerful tool for clinical research. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

  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. 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

  17. Physician participation in clinical research and trials: issues and approaches

    PubMed Central

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

    2011-01-01

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

  18. The power of clinical nursing research: engage clinicians, improve patients' lives, and forge a professional legacy.

    PubMed

    Gawlinski, Anna

    2008-07-01

    Sparked by the Institute of Medicine's report titled Crossing the Quality Chasm, research-based decision making has been emphasized for improving care. Patients should receive care that is based on the best available scientific knowledge, and care should not vary from clinician to clinician or from place to place. Implementing research-based practices at the bedside is a complex endeavor. It is all too easy to discover that clinically important research findings are either not known by practitioners or not being used in actual practice. Efforts to instill and sustain research-based practices improve significantly when staff nurses are involved with the research from the start. Institutions that are effective in involving clinicians have built a foundation of infrastructures that enable processes for engaging clinicians to take place. What distinguishes effective from ineffective hospital nursing research and evidence-based practice programs is the presence of structures whereby processes can occur that (1) unleash the creativity of staff by securing their involvement early, (2) educate staff by involving them, (3) create internal expertise for research and evidence-based practice, and (4) ensure that patients experience principled implementation of research-based practices to improve their lives. This article describes infrastructures that can ensure and sustain research-based practices while unleashing the talent and creativity of clinicians as they question practice and ponder the merits of current research. Fostering participation in such clinical inquiry will summon professional growth, influence the lives of patients, and help each nurse develop a unique personal professional legacy.

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

    PubMed

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

    2015-01-01

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

  20. 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

  1. TwoPhaseInd: an R package for estimating gene-treatment interactions and discovering predictive markers in randomized clinical trials.

    PubMed

    Wang, Xiaoyu; Dai, James Y

    2016-11-01

    In randomized clinical trials, identifying baseline genetic or genomic markers for predicting subgroup treatment effects is of rising interest. Outcome-dependent sampling is often employed for measuring markers. The R package TwoPhaseInd implements a number of efficient statistical methods we developed for estimating subgroup treatment effects and gene-treatment interactions, exploiting the gene-treatment independence dictated by randomization, including the case-only estimator, the maximum estimated likelihood estimator and the semiparametric maximum likelihood estimator for parameters in a logistic model. For rare failure events subject to censoring, we have proposed efficient augmented case-only designs, a variation of the case-cohort design, to estimate genetic associations and subgroup treatment effects in a Cox regression model. The R package is computationally scalable to genome-wide studies, as illustrated by an example from Women's Health Initiative.

  2. Oral care clinical trials at Hill Top Research.

    PubMed

    Mason, S

    2001-01-01

    Oral health care products generally require laboratory or clinical testing prior to being introduced to the market. Companies that develop such products have three options for such testing--their own facilities, dental schools, or clinical research organizations (CROs). Laboratory or clinical trials involving subjects can be conducted to test claims of safety and efficacy as well as cosmetic and therapeutic claims. CROs, which conduct such research on a fee-for-service basis in an independent environment, are an attractive alternative in many cases.

  3. Effects of Disclosing Financial Interests on Attitudes Toward Clinical Research

    PubMed Central

    Hall, Mark A.; Dinan, Michaela A.; DePuy, Venita; Friedman, Joëlle Y.; Allsbrook, Jennifer S.; Sugarman, Jeremy

    2008-01-01

    Background The effects of disclosing financial interests to potential research participants are not well understood. Objective To examine the effects of financial interest disclosures on potential research participants’ attitudes toward clinical research. Design and Participants Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Measurements Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Results Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Conclusions Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research. Electronic supplementary material The online version of this article (doi:10.1007/s11606-008-0590-4) contains supplementary material, which is available to authorized users. PMID:18386101

  4. Clinicians' experiences with the fragile X clinical and research consortium.

    PubMed

    Liu, Jessica A; Hagerman, Randi J; Miller, Robert M; Craft, Lisa T; Finucane, Brenda; Tartaglia, Nicole; Berry-Kravis, Elizabeth M; Sherman, Stephanie L; Kidd, Sharon A; Cohen, Jeffrey

    2016-12-01

    The objectives of the study were to assess the attitudes and experiences of clinicians involved in a consortium of clinics serving people with fragile X-associated disorders to gauge satisfaction with the consortium and its efforts to improve quality of life for patients and the community. An internet survey was sent to 26 fragile X (FX) clinic directors participating in the Fragile X Clinical and Research Consortium (FXCRC). Respondents were asked to complete 19 questions on consortium performance and outcomes relevant for their own clinic. The response rate was 84% (22/26), with two surveys providing incomplete data. Assistance with clinic establishment, opportunities for research collaborations, and access to colleagues and information were highly valued. Approximately 76% of clinicians reported improvements in patient care and 60% reported an increase in patient services. There was a 57% increase in participation in a FX-related clinical trial among clinics since joining the FXCRC (24% vs. 81%). Overall, respondents reported primarily positive experiences from participation in the FXCRC. Common suggestions for improvement included additional financial support and increased utilization of collected patient data for research purposes. Additionally, a Clinic Services Checklist was administered annually to examine changes in services offered over time. There were several important changes regarding the provision of services by clinics, often with multiple clinics changing with respect to a service. In conclusion, the FXCRC has led to the establishment and sustainment of fragile X clinics in the U.S., fostered cooperation among fragile X clinicians, and provided clinics with a platform to share recommendations and best practices to maximize quality of life for their patients and the overall fragile X community. The results from the survey and checklist also provide suggestions to strengthen the FXCRC and enhance future collaborations among FXCRC members. © 2016

  5. US-LA CRN Clinical Cancer Research in Latin America

    Cancer.gov

    The United States – Latin America Cancer Research Network (US-LA CRN) convened its Annual Meeting, in coordination with the Ministry of Health of Chile to discuss the Network’s first multilateral clinical research study: Molecular Profiling of Breast Cancer (MPBC).

  6. 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

  7. 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 Development...

  8. Cannabis in Pain Treatment: Clinical and Research Considerations.

    PubMed

    Savage, Seddon R; Romero-Sandoval, Alfonso; Schatman, Michael; Wallace, Mark; Fanciullo, Gilbert; McCarberg, Bill; Ware, Mark

    2016-06-01

    Cannabinoids show promise as therapeutic agents, particularly as analgesics, but their development and clinical use has been complicated by recognition of their botanical source, cannabis, as a substance of misuse. Although research into endogenous cannabinoid systems and potential cannabinoid pharmaceuticals is slowly increasing, there has been intense societal interest in making herbal (plant) cannabis available for medicinal use; 23 U.S. States and all Canadian provinces currently permit use in some clinical contexts. Whether or not individual professionals support the clinical use of herbal cannabis, all clinicians will encounter patients who elect to use it and therefore need to be prepared to advise them on cannabis-related clinical issues despite limited evidence to guide care. Expanded research on cannabis is needed to better determine the individual and public health effects of increasing use of herbal cannabis and to advance understanding of the pharmaceutical potential of cannabinoids as medications. This article reviews clinical, research, and policy issues related to herbal cannabis to support clinicians in thoughtfully advising and caring for patients who use cannabis, and it examines obstacles and opportunities to expand research on the health effects of herbal cannabis and cannabinoids. Herbal cannabis is increasingly available for clinical use in the United States despite continuing controversies over its efficacy and safety. This article explores important considerations in the use of plant Cannabis to better prepare clinicians to care for patients who use it, and identifies needed directions for research. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  9. Research in neurosurgical training: clinical reviews and trials.

    PubMed

    Teasdale, G M

    1997-01-01

    A well prepared intellectual basis is at least as important as a sound technical training for a safe, successful Neurosurgeon. Correct decisions depend as much upon clinical information and experience as upon biomedical theory and an appreciation of the science of real life clinical research is more valuable than experience in laboratory techniques. Understanding of what makes up a good study, providing a reliable basis for clinical practice, is best gained through the training conducting personal research. The training must provide an enquiring, motivating, intellectual environment, as well as disciplined organisation and support. Successful clinical research is difficult and demanding but is one of the clearest testimonies to the quality of both trainer and trainees.

  10. Interactive financial decision support for clinical research trials.

    PubMed

    Holler, Benjamin; Forgione, Dana A; Baisden, Clinton E; Abramson, David A; Calhoon, John H

    2011-01-01

    The purpose of this article is to describe a decision support approach useful for evaluating proposals to conduct clinical research trials. Physicians often do not have the time or background to account for all the expenses of a clinical trial. Their evaluation process may be limited and driven by factors that do not indicate the potential for financial losses that a trial may impose. We analyzed clinical trial budget templates used by hospitals, health science centers, research universities, departments of medicine, and medical schools. We compiled a databank of costs and reviewed recent research trials conducted by the Department of Cardiothoracic Surgery in a major academic health science center. We then developed an interactive spreadsheet-based budgetary decision support approach that accounts for clinical trial income and costs. It can be tailored to provide quick and understandable data entry, accurate cost rates per subject, and clear go/no-go signals for the physician.

  11. 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

  12. Common Metrics to Assess the Efficiency of Clinical Research

    PubMed Central

    Rubio, Doris McGartland

    2014-01-01

    The Clinical and Translational Science Award (CTSA) Program was designed by the National Institutes of Health (NIH) to develop processes and infrastructure for clinical and translational research throughout the United States. The CTSA initiative now funds 61 institutions. In 2012, the National Center for Advancing Translational Sciences, which administers the CTSA Program, charged the Evaluation Key Function Committee of the CTSA Consortium to develop common metrics to assess the efficiency of clinical research processes and outcomes. At this writing, the committee has identified 15 metrics in 6 categories. It has also developed a standardized protocol to define, pilot-test, refine, and implement the metrics. The ultimate goal is to learn critical lessons about how to evaluate the processes and outcomes of clinical research within the CTSAs and beyond. This article describes the work involved in developing and applying common metrics and benchmarks of evaluation. PMID:23960270

  13. Common metrics to assess the efficiency of clinical research.

    PubMed

    Rubio, Doris McGartland

    2013-12-01

    The Clinical and Translational Science Award (CTSA) program was designed by the National Institutes of Health (NIH) to develop processes and infrastructure for clinical and translational research throughout the United States. The CTSA initiative now funds 61 institutions. In 2012, the National Center for Advancing Translational Sciences, which administers the CTSA Program, charged the Evaluation Key Function Committee of the CTSA Consortium to develop common metrics to assess the efficiency of clinical research processes and outcomes. At this writing, the committee has identified 15 metrics in six categories. It has also developed a standardized protocol to define, pilot test, refine, and implement the metrics. The ultimate goal is to learn critical lessons about how to evaluate the processes and outcomes of clinical research within the CTSAs and beyond. This article describes the work involved in developing and applying common metrics and benchmarks of evaluation.

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

    PubMed

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

    2013-08-01

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

  15. 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. © 2016 John Wiley & Sons Australia, Ltd.

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

    PubMed Central

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

    2008-01-01

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

  17. Researchers' and clinicians' perceptions of recruiting participants to clinical research: a thematic meta-synthesis.

    PubMed

    Newington, Lisa; Metcalfe, Alison

    2014-06-01

    Recruiting the desired number of research participants is frequently problematic with resulting financial and clinical implications. The views of individuals responsible for participant recruitment have not been previously reviewed. This systematic review and thematic meta-synthesis explores researchers' and clinicians' experiences and perceptions of recruiting participants to clinical research, with the aim of informing improved recruitment systems and strategies. Studies published between January 1995 and May 2013 were identified from: Ovid MEDLINE, Ovid EMBASE, Ovid PSYCHINFO, ASSIA, British Nursing Index, Scopus, Web of Science, CINAHL and PubMed. Included studies were original peer reviewed research, with qualitative methodologies and an aim of exploring the views of clinicians and/or researchers on recruitment to clinical research. Studies discussing the recruitment of patients unable to give informed consent were excluded. The findings sections of the relevant studies were free coded to identify key concepts which were grouped into hierarchical themes. The quality of the identified studies was assessed and the relative contribution of each paper was checked to ensure individual studies did not dominate in any theme. Eighteen relevant papers were identified which examined the views of researchers and clinicians in 10 clinical specialties. Five main themes emerged: building a research community, securing resources, the nature of research, professional identities and recruitment strategies. The views of researchers and clinicians were similar, although the role of 'researcher' was inconsistently defined. The general experience of recruiting participants to clinical research was one of competition and compromise. Competition arose over funding, staffing and participants, and between clinical and research responsibilities. Compromise was needed to create study designs that were acceptable to patients, clinicians and researchers. Forging relationships between

  18. Factor structure of the Clinical Research Appraisal Inventory (CRAI).

    PubMed

    Mills, Britain A; Caetano, Raul; Rhea, Arianne E

    2014-03-01

    The Clinical Research Appraisal Inventory (CRAI) is a 92-item measure covering 10 domains of research self-efficacy. A known behavioral antecedent, reliable and valid measures of self-efficacy represent a potentially useful tool in the evaluation of research training program efficacy. However, few formal psychometric studies of this instrument exist. Using exploratory factor analysis, we examine the CRAI's dimensional structure in a new sample of clinical research trainees. In contrast to the multidimensional solutions reported previously, CRAI responses in the present sample were unambiguously one-dimensional (as suggested by a dominant single Eigenvalue and parallel analysis). This discrepant finding may reflect sample differences in research experience, as unlike previous studies, participants had all already obtained a professional degree. The CRAI's dimensional structure may coalesce into a smaller number of factors as research experience is acquired, and investigators should be mindful of this possibility in future studies of the instrument.

  19. Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs)

    PubMed Central

    Dolor, Rowena J.; Schmit, Kristine M.; Graham, Deborah G.; Fox, Chester H.; Baldwin, Laura Mae

    2015-01-01

    Background There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Methods Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. Results The “Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks” offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Conclusion Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. PMID:25381071

  20. Guidance for researchers developing and conducting clinical trials in practice-based research networks (PBRNs).

    PubMed

    Dolor, Rowena J; Schmit, Kristine M; Graham, Deborah G; Fox, Chester H; Baldwin, Laura Mae

    2014-01-01

    There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. The "Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks" offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. © Copyright 2014 by the American Board of Family Medicine.

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

    PubMed

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

    2011-06-16

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

  2. In Defense of a Social Value Requirement for Clinical Research.

    PubMed

    Wendler, David; Rid, Annette

    2017-02-01

    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

  3. Clinical research education study teams: a research curriculum for obstetric and gynecology residents.

    PubMed

    Brubaker, Linda; Kenton, Kimberly

    2011-06-01

    Research education is a requirement for obstetrics and gynecology residents. Most obstetrics and gynecology residencies struggle with barriers to efficient, effective research education and productivity for their residents. These barriers include constraints on faculty time, lack of intrinsic desire within individual residents, and lack of relevant outcome measures. We developed an efficient, novel research education curriculum that overcomes many of these barriers and provides obstetrics and gynecology residents with a structured format that maximizes the likelihood of a successful, positive research experience. Since the start of the Clinical Research Education Study Team program, the graduating resident cohorts reliably complete and present prospective research projects, including three registered randomized trials. Residency-wide support for other team research has grown dramatically. The residents' work was acknowledged with several research awards, which further reinforces the positive perception of the program. The certainty of completion of their research requirement relieved our residents of the anxiety commonly reported by residents nearing graduation. The Clinical Research Education Study Team program's team design makes efficient use of faculty time. In addition, Clinical Research Education Study Team mentors also have incorporated junior faculty members who wish to improve their own research education skills. We offer our experience with this program in hopes that it may be of value to other programs that wish to improve their resident research education curriculum. It remains important for residents to acquire research skills before continuing into practice or fellowship. The Clinical Research Education Study Team program facilitates this education in an efficient, organized manner.

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

    PubMed

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

    2014-11-01

    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.

  5. 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

  6. 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.

  7. Articulating and responding to uncertainties in clinical research.

    PubMed

    Djulbegovic, Benjamin

    2007-01-01

    This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified. The paper further shows that the still ongoing debate about the usage of "equipoise" vs. "uncertainty principle" vs. "indifference" as an entry criterion to clinical trials actually refers to the question "whose uncertainty counts". This question is intimately linked to the control of research agenda, which is not quantifiable and hence is not solvable to equal acceptability to all interested parties. The author finally shows that there is a predictable relation between [acknowledgement of] uncertainty (the moral principle) on which trials are based and the ultimate outcomes of clinical trials. That is, [acknowledgement of] uncertainty determines a pattern of success in medicine and drives clinical discoveries.

  8. Trial design and endpoints in clinical transplant research.

    PubMed

    Knight, Simon R; Morris, Peter J; Schneeberger, Stefan; Pengel, Liset H M

    2016-08-01

    The number of clinical trials in solid organ transplantation is progressively increasing year on year, but the quality of design and reporting still varies considerably. The constraints on organ availability, improving short-term outcomes, ethics and timescales involved in organ transplantation present unique challenges for trials in this field. An understanding of the methodology and potential pitfalls in clinical research is essential both to interpret trial results and to design robust studies. This review summarizes the scope and quality of reporting in existing transplant clinical trials and details aspects of clinical trial methodology with particular relevance to transplantation. We highlight initiatives designed to improve the quality of this process to ensure that the results of clinical trials are robust, well reported and of use in everyday clinical practice. © 2016 Steunstichting ESOT.

  9. Qualitative Research in Palliative Care: Applications to Clinical Trials Work.

    PubMed

    Lim, Christopher T; Tadmor, Avia; Fujisawa, Daisuke; MacDonald, James J; Gallagher, Emily R; Eusebio, Justin; Jackson, Vicki A; Temel, Jennifer S; Greer, Joseph A; Hagan, Teresa; Park, Elyse R

    2017-08-01

    While vast opportunities for using qualitative methods exist within palliative care research, few studies provide practical advice for researchers and clinicians as a roadmap to identify and utilize such opportunities. To provide palliative care clinicians and researchers descriptions of qualitative methodology applied to innovative research questions relative to palliative care research and define basic concepts in qualitative research. Body: We describe three qualitative projects as exemplars to describe major concepts in qualitative analysis of early palliative care: (1) a descriptive analysis of clinician documentation in the electronic health record, (2) a thematic content analysis of palliative care clinician focus groups, and (3) a framework analysis of audio-recorded encounters between patients and clinicians as part of a clinical trial. This study provides a foundation for undertaking qualitative research within palliative care and serves as a framework for use by other palliative care researchers interested in qualitative methodologies.

  10. 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

  11. 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.

  12. Parental perceptions of clinical research in the pediatric emergency department.

    PubMed

    Abernethy, Lucy E; Paulsen, Elizabeth L; Monuteaux, Michael C; Berry, Mark P; Neuman, Mark I

    2013-08-01

    There is a paucity of information about parental perceptions of clinical research in children, particularly in the emergency department (ED) setting. Parents accompanying their child to the ED completed a self-administered survey gauging perceptions of research and willingness to enroll a child in a clinical research study. Factor analysis was used to correlate survey responses into domains representing parents' feeling about participation in a research study. Logistic regression was used to assess the predictors of caregivers' amenability to research participation for their child. Three hundred eighty-eight parents were enrolled. Most subjects were willing to enroll their child in a study involving follow-up after ED care (87%) and collection of a urine or saliva sample (79% and 81%, respectively) and extant blood (69%). Fewer were amenable to studies that involve an investigational medication (26%) or additional phlebotomy (27%). Overall, more than 90% of parents felt that research was needed to help other children and was conducted in a way that is morally right, and 25% felt that research may compromise their child's confidentiality. Factor analyses yielded 3 factors that accounted for the variance across the survey questions. Patient and parent demographics, including the patient's triage acuity level, were not associated with willingness to participate in research. Most parents are amenable to having their child participate in a research study in the ED setting. Most parents share a sense of altruism that research is needed to help children, and this belief is predictive of willingness to participate in a research study.

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

    PubMed Central

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

    2013-01-01

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

  14. Comparative audit of clinical research in pediatric neurology.

    PubMed

    Al-Futaisi, Amna; Shevell, Michael

    2004-11-01

    Clinical research involves direct observation or data collection on human subjects. This study was conducted to evaluate the profile of pediatric neurology clinical research over a decade. Trends in pediatric neurology clinical research were documented through a systematic comparative review of articles published in selected journals. Eleven journals (five pediatric neurology, three general neurology, three general pediatrics) were systematically reviewed for articles involving a majority of human subjects less than 18 years of age for the years 1990 and 2000. Three hundred thirty-five clinical research articles in pediatric neurology were identified in the 11 journals for 1990 and 398 for 2000, a 19% increase. A statistically significant increase in analytic design (21.8% vs 39.5%; P = .01), statistical support (6% vs 16.6%; P < .0001), and multidisciplinary team (69.9% vs 87%; P = .003) was observed. In terms of specific study design, a significant decline in case reports (34.3% vs 10.3%; P < .0001) and an increase in case-control studies (11.3% vs 22.9%; P = .02) were evident over the 10-year interval. This comparative audit revealed that there has been a discernible change in the methodology profile of clinical research in child neurology over a decade. Trends apparently suggest a more rigorous approach to study design and investigation in this field.

  15. Providing premedical students with quality clinical and research experience

    PubMed Central

    Davis, James; Anderson, Maggie; Stankevitz, Kristen

    2014-01-01

    Undergraduate premedical students face a prodigious decision as they work to determine whether to pursue a profession in medicine. Experience in clinical medicine and research is essential to inform students what it might be like to be a physician. Undergraduates, however, face a number of obstacles to obtaining the kind of quality clinical and research experience needed to best inform them on this decision. Growing regulations designed to protect patient confidentiality, though undeniably important, pose a barrier to students seeking patient contact. Traditional passive physician shadowing often does not provide ample opportunities for one-on-one patient interaction or problem solving. Finally, research opportunities available to students typically are not associated with clinical work and therefore do not provide an experiential model of how empirical evidence informs medical practice. This report provides a description of the University of Wisconsin Tobacco Science Scholars Program, a pilot program designed to grapple with some of these barriers. The program provides supervision for students so that they might fulfill institutional requirements required for patient contact, provides an active model of clinical patient interaction and problem solving, and provides access to research that is integrated into the student’s clinical experience so the student might better understand the nature of research-based evidence in medicine. Program details and limitations are discussed. PMID:24734413

  16. Clinical and Translational Research and Community Engagement: Implications for Researcher Capacity Building

    PubMed Central

    Martinez, Linda Sprague; Russell, Beverley; Rubin, Carolyn Leung; Leslie, Laurel K.; Brugge, Doug

    2012-01-01

    Abstract This research sought to better understand how clinical and translational research is defined and perceived by community service providers. In addition, the research sought to elicit how the perspectives of service providers may hinder or facilitate collaborative research efforts. The study employed a qualitative methodology, focus groups. A nonprobability sampling strategy was used to recruit participants from three neighborhoods in the Tufts University’s catchment area. Focus group findings add to the nascent body of literature on how community partners view clinical and translational research and researchers. Findings indicate that cultural disconnects, between researchers and community partners exist, as does mistrust, all of which serve as potential barriers to community research partnerships. This paper suggests rethinking the business of community engagement in researcher, particularly as it relates to building research capacity to approach, engage, and partner with communities. Clin Trans Sci 2012; Volume 5: 329–332 PMID:22883610

  17. Clinical Research Ethics: Considerations for the Radiation Oncologist.

    PubMed

    Koyfman, Shlomo A; Yom, Sue S

    2017-10-01

    Consideration of clinical research ethics in radiation oncology is underexplored relative to other areas of oncology. A number of ethical challenges related to informed consent, randomization, conflicts of interest, and scientific validity and social value are shared with other areas of medicine, although their exact inflections are specific to radiation oncology. In addition, there are unique concerns in radiation oncology arising from the rapid evolution and uneven distribution of radiation technologies; the greater unfamiliarity of the general public and research oversight committees in regard to radiation oncology clinical practice; and the high complexity of managing most radiation oncology research, much of which is carried out in high-acuity multidisciplinary oncologic settings. To produce the best research, adherence to the highest ethical standards should be pursued as an integral component of all radiation oncology research. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Exploring the value of qualitative research films in clinical education.

    PubMed

    Toye, Fran; Jenkins, Sue; Seers, Kate; Barker, Karen

    2015-11-27

    Many healthcare professionals use both quantitative and qualitative research to inform their practice. The usual way to access research findings is through peer-reviewed publications. This study aimed to understand the impact on healthcare professionals of watching and discussing a short research based film. The film, 'Struggling to be me' portrays findings from a qualitative synthesis exploring people's experiences of chronic pain, and was delivered as part of an inter-professional postgraduate e-learning module. The innovation of our study is to be the first to explore the impact of qualitative research portrayed through the medium of film in clinical education. All nineteen healthcare professionals enrolled on the course in December 2013 took part in on-line interviews or focus groups. We recorded and transcribed the interviews verbatim and used the methods of Grounded Theory to analyse the interview transcripts. Watching and discussing the film became a stimulus for learning : (a) A glimpse beneath the surface explored a pro-active way of seeing the person behind the pain (b) Pitfalls of the Medical Model recognised the challenge, for both patient and clinician, of 'sitting with' rather than 'fixing' an ill person; (c) Feeling bombarded by despair acknowledged the intense emotions that the clinicians brings to the clinical encounter; (d) Reconstructing the clinical encounter as a shared journey reconstructed the time-constrained clinical encounter as a single step on a shared journey towards healing, rather than fixing. Films portraying qualitative research findings can stimulate a pro-active and dialectic form of knowing. Research-based qualitative films can make qualitative findings accessible and can be a useful resource in clinical training. Our research presents, for the first time, specific learning themes for clinical education.

  19. Clinical nursing and midwifery research: grey literature in African countries.

    PubMed

    Sun, C; Dohrn, J; Omoni, G; Malata, A; Klopper, H; Larson, E

    2016-03-01

    This study reviewed grey literature to assess clinical nursing and midwifery research conducted in southern and eastern African countries over the past decade. The shortage of published nursing research from African countries severely limits the ability of practicing nurses and midwives to base clinical decisions on solid evidence. However, little is known regarding unpublished or unindexed clinical research ('grey literature'), a potentially rich source of information. Identifying these sources may reveal resources to assist nurses in providing evidence-based care. This scoping review of grey literature on clinical nursing and midwifery research in southern and eastern African countries helped to identify gaps in research and assess whether these gaps differ from published research. Systematic searches of grey literature were performed. Research was included if it was conducted by nurses in 1 of 25 southern or eastern African countries, between 2004 and 2014 and included patient outcomes. Data were extracted on location, institution, research topic, institutional connections and author information. Chi-square tests were performed to compare differences between indexed and non-indexed literature. We found 262 studies by 287 authors from 17 southern and eastern African countries covering 13 topics. Although all topics were also found in indexed literature and there were statistically significant differences between the number of times, fewer topics were covered in grey literature vs. indexed. Patient satisfaction and experience and traditional health practices were more likely to be published, whereas chronic disease, assault and paediatric-related research were less often published. Generally, there is a paucity of clinical nursing research in this region. This could reflect the shortage of nurses prepared to conduct research in this region. Nurses may find additional resources for evidence in the grey literature. A complete understanding of the state of nursing

  20. Characteristics desired in clinical data warehouse for biomedical research.

    PubMed

    Shin, Soo-Yong; Kim, Woo Sung; Lee, Jae-Ho

    2014-04-01

    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. 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. 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. 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.

  1. 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

  2. Time-lapse microscopy and image analysis in basic and clinical embryo development research.

    PubMed

    Wong, C; Chen, A A; Behr, B; Shen, S

    2013-02-01

    Mammalian preimplantation embryo development is a complex process in which the exact timing and sequence of events are as essential as the accurate execution of the events themselves. Time-lapse microscopy (TLM) is an ideal tool to study this process since the ability to capture images over time provides a combination of morphological, dynamic and quantitative information about developmental events. Here, we systematically review the application of TLM in basic and clinical embryo research. We identified all relevant preimplantation embryo TLM studies published in English up to May 2012 using PubMed and Google Scholar. We then analysed the technical challenges involved in embryo TLM studies and how these challenges may be overcome with technological innovations. Finally, we reviewed the different types of TLM embryo studies, with a special focus on how TLM can benefit clinical assisted reproduction. Although new parameters predictive of embryo development potential may be discovered and used clinically to potentially increase the success rate of IVF, adopting TLM to routine clinical practice will require innovations in both optics and image analysis. Combined with such innovations, TLM may provide embryologists and clinicians with an important tool for making critical decisions in assisted reproduction. In this review, we perform a literature search of all published early embryo development studies that used time-lapse microscopy (TLM). From the literature, we discuss the benefits of TLM over traditional time-point analysis, as well as the technical difficulties and solutions involved in implementing TLM for embryo studies. We further discuss research that has successfully derived non-invasive markers that may increase the success rate of assisted reproductive technologies, primarily IVF. Most notably, we extend our discussion to highlight important considerations for the practical use of TLM in research and clinical settings.

  3. Clinical Research Priorities in Adult Congenital Heart Disease

    PubMed Central

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

    2014-01-01

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

  4. The PRIME curriculum. Clinical research training during residency.

    PubMed

    Kohlwes, R J; Shunk, R L; Avins, A; Garber, J; Bent, S; Shlipak, M G

    2006-05-01

    The Primary Medical Education (PRIME) program is an outpatient-based, internal medicine residency track nested within the University of California, San Francisco (UCSF) categorical medicine program. Primary Medical Education is based at the San Francisco Veteran's Affairs Medical Center (VAMC), 1 of 3 teaching hospitals at UCSF. The program accepts 8 UCSF medicine residents annually, who differentiate into PRIME after internship. In 2000, we implemented a novel research methods curriculum with the dual purposes of teaching basic epidemiology skills and providing mentored opportunities for clinical research projects during residency. Single academic internal medicine program. The PRIME curriculum utilizes didactic lecture, frequent journal clubs, work-in-progress sessions, and active mentoring to enable residents to "try out" a clinical research project during residency. Among 32 residents in 4 years, 22 residents have produced 20 papers in peer-reviewed journals, 1 paper under review, and 2 book chapters. Their clinical evaluations are equivalent to other UCSF medicine residents. While learning skills in evidence-based medicine, residents can conduct high-quality research. Utilizing a collaboration of General Internal Medicine researchers and educators, our curriculum affords residents the opportunity to "try-out" clinical research as a potential future career choice.

  5. Clinical research priorities in adult congenital heart disease.

    PubMed

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

    2014-02-15

    Adult congenital heart disease (ACHD) clinicians are hampered by the paucity of data to inform clinical decision-making. The objective of this study was to identify priorities for clinical research in ACHD. A list of 45 research questions was developed by the Alliance for Adult Research in Congenital Cardiology (AARCC), compiled into a survey, and administered to ACHD providers. Patient input was sought via the Adult Congenital Heart Association at community meetings and online forums. The 25 top questions were sent to ACHD providers worldwide via an online survey. Each question was ranked based on perceived priority and weighted based on time spent in ACHD care. The top 10 topics identified are presented and discussed. The final online survey yielded 139 responses. Top priority questions related to tetralogy of Fallot (timing of pulmonary valve replacement and criteria for primary prevention ICDs), patients with systemic right ventricles (determining the optimal echocardiographic techniques for measuring right ventricular function, and indications for tricuspid valve replacement and primary prevention ICDs), and single ventricle/Fontan patients (role of pulmonary vasodilators, optimal anticoagulation, medical therapy for preservation of ventricular function, treatment for protein losing enteropathy). In addition, establishing criteria to refer ACHD patients for cardiac transplantation was deemed a priority. The ACHD field is in need of prospective research to address fundamental clinical questions. It is hoped that this methodical consultation process will inform researchers and funding organizations about clinical research topics deemed to be of high priority. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  6. 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

  7. Evolution of Clinical Proteomics and its Role in Medicine | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    NCI's Office of Cancer Clinical Proteomics Research authored a review of the current state of clinical proteomics in the peer-reviewed Journal of Proteome Research. The review highlights outcomes from the CPTC program and also provides a thorough overview of the different technologies that have pushed the field forward. Additionally, the review provides a vision for moving the field forward through linking advances in genomic and proteomic analysis to develop new, molecularly targeted interventions.

  8. Strengthening clinical cancer research in the United Kingdom

    PubMed Central

    Stead, M; Cameron, D; Lester, N; Parmar, M; Haward, R; Kaplan, R; Maughan, T; Wilson, R; Campbell, H; Hamilton, R; Stewart, D; O'Toole, L; Kerr, D; Potts, V; Moser, R; Darbyshire, J; Selby, P

    2011-01-01

    Background: In 1999, 270 000 cases of cancer were registered in the United Kingdom, placing a large burden on the NHS. Cancer outcome data in 1999 suggested that UK survival rates were poorer than most other European countries. In the same year, a Department of Health review noted that clinical trials accrual was poor (<3.5% of incident cases) and hypothesised that increasing research activity might improve outcomes and reduce the variability of outcomes across England. Thus, the National Cancer Research Network (NCRN) was established to increase participation in cancer clinical research. Methods: The NCRN was established in 2001 to provide a robust infrastructure for cancer clinical research and improvements in patient care. Remit of NCRN is to coordinate, support and deliver cancer clinical research through the provision of research support staff across England. The NCRN works closely with similar networks in Scotland, Wales and the Northern Ireland. A key aim of NCRN is to improve the speed of research and this was also assessed by comparing the speed of study delivery of a subset of cancer studies opening before and after NCRN was established. Results: Patient recruitment increased through NCRN, with almost 32 000 (12% of annual incident cases) cancer patients being recruited each year. Study delivery has improved, with more studies meeting the recruitment target – 74% compared with 39% before NCRN was established. Conclusion: The coordinated approach to cancer clinical research has demonstrated increased accrual, wide participation and successful trial delivery, which should lead to improved outcomes and care. PMID:21364584

  9. 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

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

    PubMed

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

    2014-08-14

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

  11. [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. Copyright © 2013 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

    Wadlund, Jill; Platt, Leslie A

    2002-01-01

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

  14. 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

  15. Group-based trajectory modeling in clinical research.

    PubMed

    Nagin, Daniel S; Odgers, Candice L

    2010-01-01

    Group-based trajectory models are increasingly being applied in clinical research to map the developmental course of symptoms and assess heterogeneity in response to clinical interventions. In this review, we provide a nontechnical overview of group-based trajectory and growth mixture modeling alongside a sampling of how these models have been applied in clinical research. We discuss the challenges associated with the application of both types of group-based models and propose a set of preliminary guidelines for applied researchers to follow when reporting model results. Future directions in group-based modeling applications are discussed, including the use of trajectory models to facilitate causal inference when random assignment to treatment condition is not possible.

  16. Clinical cancer research: the past, present and the future.

    PubMed

    DeVita, Vincent T; Eggermont, Alexander M M; Hellman, Samuel; Kerr, David J

    2014-11-01

    In the past decade, we have witnessed unprecedented changes and some remarkable advances that have enabled true personalized medicine. Nevertheless, many challenges in clinical cancer research remain and need to be overcome if we are to witness similar progress in the next decade. Such hurdles include, but are not limited to, clinical development and testing of multiple agents in combination, design of clinical trials to best accommodate the ever increasing knowledge of heterogeneity of the disease, regulatory challenges relating to drug development and trial design, and funding for basic research. With this in mind, we asked four leading cancer researchers from around the world, and who have been associated with the journal since its launch in November 2004 what, in their opinion, we have learnt over the past 10 years and how we should progress in the next 10 years.

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

    PubMed

    Hey, Spencer Phillips

    2015-07-01

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

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

    PubMed

    Callister, Lynn Clark

    2011-01-01

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

  19. Discovering the Sky.

    ERIC Educational Resources Information Center

    Weedman, Daniel W.

    1997-01-01

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

  20. Clinical health research in India: is there a way forward?

    PubMed

    Sayed, Suhail I; Dutta, Sourav; Mateen, Sayyad; Kazi, Rehan; Jagade, Mohan

    2011-04-01

    A vibrant health research industry is an indispensible asset for societal development. Health research focus and output in India is sadly not at par with the magnitude and distribution of the prevalent disease burden. In the current scenario of the ever evolving Indian public health sector, the balancing of research efforts between different competing fields, especially when resources are meagre, is a delicate one and quite typical of the problems anticipated in developing countries. To progress, the nation's clinical health research needs good quality, authentic and relevant research in the varied aspect of public health. Rhetoric or theoretical concepts alone cannot move the health status and research forward in this country. Evidence and evidence based medicine have revitalised the academic aspects of the public health sector. But, its up to the Indian policy makers, administrators and medical professionals to assure that the vast research opportunity this country offers is exploited to its maximum potential.

  1. 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.…

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  3. A review of clinical decision making: models and current research.

    PubMed

    Banning, Maggi

    2008-01-01

    The aim of this paper was to review the current literature clinical decision-making models and the educational application of models to clinical practice. This was achieved by exploring the function and related research of the three available models of clinical decision making: information-processing model, the intuitive-humanist model and the clinical decision-making model. Clinical decision making is a unique process that involves the interplay between knowledge of pre-existing pathological conditions, explicit patient information, nursing care and experiential learning. Historically, two models of clinical decision making are recognized from the literature; the information-processing model and the intuitive-humanist model. The usefulness and application of both models has been examined in relation the provision of nursing care and care related outcomes. More recently a third model of clinical decision making has been proposed. This new multidimensional model contains elements of the information-processing model but also examines patient specific elements that are necessary for cue and pattern recognition. Literature review. Evaluation of the literature generated from MEDLINE, CINAHL, OVID, PUBMED and EBESCO systems and the Internet from 1980 to November 2005. The characteristics of the three models of decision making were identified and the related research discussed. Three approaches to clinical decision making were identified, each having its own attributes and uses. The most recent addition to the clinical decision making is a theoretical, multidimensional model which was developed through an evaluation of current literature and the assessment of a limited number of research studies that focused on the clinical decision-making skills of inexperienced nurses in pseudoclinical settings. The components of this model and the relative merits to clinical practice are discussed. It is proposed that clinical decision making improves as the nurse gains experience of

  4. An interdisciplinary approach to research management in anesthesia: the integrated clinical research team model.

    PubMed

    Gasior, Izabela; Solari, Jessica; Young, Vanessa; Bode, Justine; Herdes, Rachel E; Chung, Michelle

    2012-01-01

    The Anesthesia Clinical Research Unit (ACRU) at Boston Children's Hospital developed the integrated clinical research team model in 2009 as a framework to support the high ethical standards and team-based approach in pediatric anesthesia research which was already established within the department. The foundation of the model is built on interdisciplinary collaboration, communication, and integrity in the field of clinical research. Above all, the work of the ACRU is focused on the patients, families and community as a whole. In order to uphold these standards, each member of the ACRU has a clearly-defined role while still promoting the core fundamentals of teamwork and continuity of care. This department-wide, team-based approach to clinical research has proven to be effective in its resourcefulness and productivity in running numerous large projects concurrently within the department.

  5. Dementia Caregiver Intervention Research: In Search of Clinical Significance

    PubMed Central

    Schulz, Richard; O’Brien, Alison; Czaja, Sara; Ory, Marcia; Norris, Rachel; Martire, Lynn M.; Belle, Steven H.; Burgio, Lou; Gitlin, Laura; Coon, David; Burns, Robert; Gallagher-Thompson, Dolores; Stevens, Alan

    2008-01-01

    Purpose We reviewed intervention studies that reported dementia caregiver outcomes published since 1996, including psychosocial interventions for caregivers and environmental and pharmacological interventions for care recipients. Our goal was to focus on issues of clinical significance in caregiver intervention research in order to move the field toward a greater emphasis on achieving reliable and clinically meaningful outcomes. Design and Methods MEDLINE, PsycINFO, and Cumulative Index to Nursing & Allied Health databases from 1996 through 2001 were searched to identify articles and book chapters mapping to two medical subject headings: caregivers and either dementia or Alzheimer’s disease. Articles were evaluated on two dimensions, outcomes in four domains thought to be important to the individual or society and the magnitude of reported effects for these outcomes in order to determine if they were large enough to be clinically meaningful. Results Although many studies have reported small to moderate statistically significant effects on a broad range of outcomes, only a small proportion of these studies achieved clinically meaningful outcomes. Nevertheless, caregiving intervention studies have increasingly shown promise of affecting important public health outcomes in areas such as service utilization, including delayed institutionalization; psychiatric symptomatology, including the successful treatment of major and minor depression; and providing services that are highly valued by caregivers. Implications Assessment of clinical significance in addition to statistical significance is needed in this research area. Specific recommendations on design, measurement, and conceptual issues are made to enhance the clinical significance of future research. PMID:12351794

  6. 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.

  7. Veterinary clinical research database for homeopathy: placebo-controlled trials.

    PubMed

    Clausen, J; Albrecht, H; Mathie, R T

    2013-04-01

    Veterinary homeopathy has led a somewhat shadowy existence since its first introduction. Only in the last three decades has the number of clinical trials increased considerably. This literature is generally not well perceived, which may be partly a consequence of the diffuse and somewhat inaccessible nature of some of the relevant research publications. The Veterinary Clinical Research Database for Homeopathy (VetCR) was launched in 2006 to provide information on existing clinical research in veterinary homeopathy and to facilitate the preparation of systematic reviews. The aim of the present report is to provide an overview of this first database on clinical research in veterinary homeopathy, with a special focus on its content of placebo controlled clinical trials and summarising what is known about placebo effects in animals. In April 2012, the VetCR database contained 302 data records. Among these, 203 controlled trials were identified: 146 randomised and 57 non-randomised. In 97 of those 203 trials, the homeopathic medical intervention was compared to placebo. A program of formal systematic reviews of peer-reviewed randomised controlled trials in veterinary homeopathy is now underway; detailed findings from the program's data extraction and appraisal approach, including the assessment of trial quality (risk of bias), will be reported in due course. Copyright © 2012 Elsevier Ltd. All rights reserved.

  8. Evolving Research Data Sharing Networks to Clinical App Sharing Networks

    PubMed Central

    Wagholikar, Kavishwar B.; Jain, Rahul; Oliveira, Eliel; Mandel, Joshua; Klann, Jeffery; Colas, Ricardo; Patil, Prasad; Yadav, Kuladip; Mandl, Kenneth D.; Carton, Thomas; Murphy, Shawn N.

    2017-01-01

    Research networks for data sharing are growing into a large platform for pragmatic clinical trials to generate quality evidence for shared medical decision-making. Institutions partnering in the networks have made large investments in developing the infrastructure for sharing data. We investigate whether institutions partnering on Patient-Centered Outcomes Research Institute’s (PCORI) network can share clinical apps. At two different sites, we imported patient data in PCORI’s clinical data model (CDM) format into i2b2 repositories, and adapted the SMART-on-FHIR cell to perform CDM-to-FHIR translation, serving demographics, laboratory results and diagnoses. We performed manual validations and tested the platform using four apps from the SMART app gallery. Our study demonstrates an approach to extend the research infrastructure to allow the partnering institutions to run shared clinical apps, and highlights the involved challenges. Our results, tooling and publically accessible data service can potentially transform research networks into clinical app sharing networks and pave the way towards a learning health system. PMID:28815145

  9. Evolving Research Data Sharing Networks to Clinical App Sharing Networks.

    PubMed

    Wagholikar, Kavishwar B; Jain, Rahul; Oliveira, Eliel; Mandel, Joshua; Klann, Jeffery; Colas, Ricardo; Patil, Prasad; Yadav, Kuladip; Mandl, Kenneth D; Carton, Thomas; Murphy, Shawn N

    2017-01-01

    Research networks for data sharing are growing into a large platform for pragmatic clinical trials to generate quality evidence for shared medical decision-making. Institutions partnering in the networks have made large investments in developing the infrastructure for sharing data. We investigate whether institutions partnering on Patient-Centered Outcomes Research Institute's (PCORI) network can share clinical apps. At two different sites, we imported patient data in PCORI's clinical data model (CDM) format into i2b2 repositories, and adapted the SMART-on-FHIR cell to perform CDM-to-FHIR translation, serving demographics, laboratory results and diagnoses. We performed manual validations and tested the platform using four apps from the SMART app gallery. Our study demonstrates an approach to extend the research infrastructure to allow the partnering institutions to run shared clinical apps, and highlights the involved challenges. Our results, tooling and publically accessible data service can potentially transform research networks into clinical app sharing networks and pave the way towards a learning health system.

  10. Clinical research potential in Victorian hospitals: the Victorian clinician researcher needs analysis survey.

    PubMed

    Hiscock, H; Ledgerwood, K; Danchin, M; Ekinci, E; Johnson, E; Wilson, A

    2014-05-01

    The 2012 McKeon Review highlighted the role of clinician researchers in patient based research and the need to foster this capacity. While anecdotal evidence suggests that clinician researchers are under threat and underfunded, Australian data on barriers and enablers of clinician-led research are scant. To describe (i) characteristics of clinician researchers; (ii) for research-active clinicians: areas of research, barriers/enablers of research and factors associated with funding success; and (iii) for research-inactive clinicians: enablers of future research. An online survey distributed through the Bio21 Cluster to clinicians (doctors, nurses, allied health professionals) in 15 Victorian hospitals between November 2011 and January 2012. Seven hundred and seventy of 1027 (75%) of respondents were research-active and were more likely to be male, medical doctors, aged 45-54 years, to work full-time and have a higher degree (all P < 0.01). Of clinicians with a higher degree, 28% were research-inactive. Clinicians identified protected research time (50%), designated research space (42%), clinical trial coordinators (35%), institutional funding (34%) and mentoring (33%) as critical enablers of research. Research-inactive clinicians identified protected research time as the key enabler of future research. To realise recommendations in the McKeon Review, hospitals and research bodies will need to protect research time and provide space and funding. Engaging research-inactive clinicians will build research capacity. © 2014 The Authors; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

  11. Applying community-based participatory research principles and approaches in clinical trials: forging a new model for cancer clinical research.

    PubMed

    Seifer, Sarena D; Michaels, Margo; Collins, Stacy

    2010-01-01

    Although an estimated 20% of adult cancer patients are medically eligible for a cancer treatment clinical trial (CCT), adult trial participation in the U.S. remains under 3%.- Participation rates are even lower among ethnic and racial minorities and the medically underserved, who tend to have higher cancer mortality rates than the population as a whole.- Given persistent cancer health disparities in these populations, cancer clinical trial participation is increasingly an issue of social justice. Community-based participatory research (CBPR) approaches have been repeatedly recommended as a key strategy for increasing and diversifying cancer clinical trial participation and enhancing their relevance and quality. In 2006, Community-Campus Partnership for Health (CCPH) and the Education Network to Advance Cancer Clinical Trials (ENACCT) received funding from the Agency for Healthcare Research and Quality and the National Cancer Institute (NCI), along with industry and nonprofit partners, to develop the first set of national recommendations to employ CBPR approaches in multisite, phase III cancer clinical trials. The Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy final report, developed through a national advisory committee, two stakeholder meetings and a public vetting process, makes more than fifty detailed recommendations to engage communities in specific and meaningful ways throughout the cancer clinical trial process.1 The report is the first to provide specific guidance as to how and why clinical trials should involve communities affected by cancer-from trial design to implementation to dissemination of results. This paper describes the background and rationale for the initiative, the process used to develop and disseminate the report, and the challenges and opportunities for implementing the report's community-based approaches to cancer clinical research.

  12. Regulatory environment for clinical research: Recent past and expected future

    PubMed Central

    Bhave, Amita; Menon, Suresh

    2017-01-01

    In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest. PMID:28194332

  13. Regulatory environment for clinical research: Recent past and expected future.

    PubMed

    Bhave, Amita; Menon, Suresh

    2017-01-01

    In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest.

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

    PubMed

    Straight, Timothy M

    2009-01-01

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

  15. American Society of Clinical Oncology policy statement: oversight of clinical research.

    PubMed

    2003-06-15

    Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public

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

    PubMed

    Varawalla, Nermeen

    2007-06-01

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

  17. Conducting multiple-site clinical trials in medical rehabilitation research.

    PubMed

    Fuhrer, Marcus J

    2005-11-01

    This article examines the distinctive opportunities and challenges of multiple-site clinical trials, as distinguished from trials conducted by a single program. Among the topics discussed are: the role of clinical trials generally in medical rehabilitation research; definitions of "clinical trials" and "multiple site"; the distinction between exploratory and capstone trials; the potential advantages and disadvantages of multiple-site trials; planning issues in terms of sampling designs, the choice of outcome measures, approaches to dealing with intervention fidelity, organizational structures, authorship, and the conduct of collateral studies; and implementation issues in terms of pilot-testing procedures, handling emerging issues, and optimizing communication.

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

    PubMed

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

    2014-07-01

    The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs. Copyright © 2014. Published by Elsevier Inc.

  19. Television: A Medium for Discovering Diversity?

    ERIC Educational Resources Information Center

    Selva, Marta; Sola, Anna

    1995-01-01

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

  20. New volcanoes discovered in southeast Australia

    NASA Astrophysics Data System (ADS)

    Wendel, JoAnna

    2014-07-01

    Scientists have discovered three new active volcanoes in the Newer Volcanics Province (NVP) in southeast Australia. Researchers from Monash University in Melbourne describe in the Australian Journal of Earth Sciences how they used a combination of satellite photographs, detailed topography models from NASA, the distribution of magnetic minerals in the rocks, and site visits to analyze the region.

  1. Statistical power and effect sizes of clinical neuropsychology research.

    PubMed

    Bezeau, S; Graves, R

    2001-06-01

    Cohen, in a now classic paper on statistical power, reviewed articles in the 1960 issue of one psychology journal and determined that the majority of studies had less than a 50-50 chance of detecting an effect that truly exists in the population, and thus of obtaining statistically significant results. Such low statistical power, Cohen concluded, was largely due to inadequate sample sizes. Subsequent reviews of research published in other experimental psychology journals found similar results. We provide a statistical power analysis of clinical neuropsychological research by reviewing a representative sample of 66 articles from the Journal of Clinical and Experimental Neuropsychology, the Journal of the International Neuropsychology Society, and Neuropsychology. The results show inadequate power, similar to that for experimental research, when Cohen's criterion for effect size is used. However, the results are encouraging in also showing that the field of clinical neuropsychology deals with larger effect sizes than are usually observed in experimental psychology and that the reviewed clinical neuropsychology research does have adequate power to detect these larger effect sizes. This review also reveals a prevailing failure to heed Cohen's recommendations that researchers should routinely report a priori power analyses, effect sizes and confidence intervals, and conduct fewer statistical tests.

  2. Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research.

    PubMed

    Lazarus, Gerald S; Kirsner, Robert S; Zenilman, Jonathan; Valle, M Frances; Margolis, David J; Cullum, Nicky; Driver, Vickie R; Gould, Lisa; Lindsay, Ellie; Tunis, Sean; Marston, William; Bass, Eric; Ennis, William; Davidson, Jeffrey; Bowden, Jeremy

    2016-09-01

    The present status of clinical leg ulcer healing research was reviewed by 25 experts over 2 days on September 28 and 29, 2015. Multiple clinical effectiveness reviews were presented suggesting that published clinical wound healing research often does not meet present (2015) evidence based standards. Specific areas requiring remediation were highlighted and approaches to overcoming existing challenges were proposed. Participants using anonymous voting technology developed an action plan to resolve perceived deficiencies. Statements were accepted if 75% of participants agreed. Older patients with a high frequency of comorbid conditions posed particular difficulties in designing clinical research protocols and better diagnostic categorization is necessary A standardized model template for collecting information about diagnosis and evaluation of the effect of interventions on healing of all types of leg ulcers was considered a high priority. Such a model template could be modified depending on the specific etiology of the leg ulcers. Generally agreed on quantifiable standards to establish degree of morbidity was considered a high priority. There was universal agreement that sources of funding and conflicts of interest needed to be disclosed in presentations and all publications. All clinical research studies should be registered with appropriate authorities. There was substantial enthusiasm for a clinical research network with quality standards for membership and an advisory research core available to investigators. Such a network should be funded and actively managed to insure long-term viability. The governance of such an entity needs to be established by the wound care community. The present trend to integrate patients into the clinical research process was endorsed and there was enthusiasm to develop patient advocacy for wound healing research.

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

    ERIC Educational Resources Information Center

    Nicholson, Scott

    2003-01-01

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

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

    PubMed

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

    2013-01-01

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

  5. Ethics of clinical research with mentally ill persons.

    PubMed

    Helmchen, Hanfried

    2012-08-01

    This article describes ethical, legal and professional components of the two core requirements of clinical research: informed consent and risk-benefit relationships. It deals particularly with the ethically relevant reasons, criteria, procedures and validity of (1) the informed consent process, (2) the relationship between benefits and risks, and as a requirement of its assessment: (3) standards and (quasi quantitative) criteria of benefits and risks and/or burdens of a research intervention. These requirements will be discussed with specific reference to research interventions in mentally ill patients, and particularly in those who are incompetent to consent. (4) The analysis concludes by demanding a strong adherence to the ethical rules of clinical research in order to protect participants and preserve the trust of both the patients and the public and (5) yields in a set of recommendations.

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

    PubMed Central

    Lee, Laura N.; Yessis, Jennifer L.; Wesley, Robert; Alfano, Sandra; Alexander, Steven R.; Kassis, Sylvia Baedorf; Cola, Philip; Dozier, Ann; Ford, Dan E.; Harris, Paul A.; Kim, Emmelyn; Lee, Simon Craddock; O'Riordan, Gerri; Roth, Mary‐Tara; Schuff, Kathryn; Wasser, June; Henderson, David K.; Coller, Barry S.

    2014-01-01

    Abstract Background Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants’ experiences. To address this, we developed and deployed a survey at 15 NIH‐supported clinical research centers to assess participant‐centered outcomes; we report responses from 4,961 participants. Methods Survey questions addressed core aspects of the research participants’ experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. Results Respondents broadly represented the research population in sex, race, and ethnicity. Seventy‐three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R 2 = 0.80–0.96). White participants trusted researchers more (88%) than did nonwhite participants collectively (80%; p < 0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). Conclusions Our survey demonstrates that a majority of participants at NIH‐supported clinical research centers rate their research experience very positively and that participant‐centered outcome measures identify actionable items for improvement of participant's experiences, research protections, and the conduct of clinical investigation. PMID:24842076

  7. The way forward for clinical research in Cameroon: first scientific and research day in Douala, 2014.

    PubMed

    Dzudie, Anastase; Aminde, Leopold; Ngowe Ngowe, Marcelin; Takah, Noah; Luma, Henry Namme; Doualla, Marie Solange; Mapoure, Yacouba; Mbatchou, Hugo; Njamen, Theophile Nana; Priso, Eugene Belley; Kengne, Andre Pascal; Sliwa-Hahnle, Karen; Nkwescheu, Armand S; Sone, Albert Mouelle

    2014-01-01

    There is a huge need for health research to support contextually relevant health service and policy solutions to better the health of populations in sub-Saharan Africa. This need contrasts with the very timid engagement of healthcare practitioners in research in the region.It is against this background that the Douala General Hospital (a tertiary-care hospital in Cameroon), under the stewardship of its chief executive officer, organised the first annual scientific and research day in October 2014. This maiden event saw the participation of local research leaders and the eminent director of the South African Hatter Institute for Cardiovascular Research in Africa, who co-chaired the event. The aim was to educate students, clinicians and junior researchers on the importance of clinical research and evidence-based medicine around the leading theme of the event: action for clinical research and good medical practice.Several abstracts were presented, covering various aspects of medicine, including cardiology, rheumatology, paediatrics, pulmonology, HIV medicine, and obstetrics and gynaecology, together with key lectures on cardiac disease and pregnancy, and plenary sessions on research methodology, scientific writing and publishing. It is hoped that this event will enhance clinical research and the dissemination of research findings to improve evidence-based clinical practice in the country.

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

    PubMed

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

    2009-01-01

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

  9. Global Health and Emergency Care: Defining Clinical Research Priorities.

    PubMed

    Hansoti, Bhakti; Aluisio, Adam R; Barry, Meagan A; Davey, Kevin; Lentz, Brian A; Modi, Payal; Newberry, Jennifer A; Patel, Melissa H; Smith, Tricia A; Vinograd, Alexandra M; Levine, Adam C

    2017-06-01

    Despite recent strides in the development of global emergency medicine (EM), the field continues to lag in applying a scientific approach to identifying critical knowledge gaps and advancing evidence-based solutions to clinical and public health problems seen in emergency departments (EDs) worldwide. Here, progress on the global EM research agenda created at the 2013 Academic Emergency Medicine Global Health and Emergency Care Consensus Conference is evaluated and critical areas for future development in emergency care research internationally are identified. A retrospective review of all studies compiled in the Global Emergency Medicine Literature Review (GEMLR) database from 2013 through 2015 was conducted. Articles were categorized and analyzed using descriptive quantitative measures and structured data matrices. The Global Emergency Medicine Think Tank Clinical Research Working Group at the Society for Academic Emergency Medicine 2016 Annual Meeting then further conceptualized and defined global EM research priorities utilizing consensus-based decision making. Research trends in global EM research published between 2013 and 2015 show a predominance of observational studies relative to interventional or descriptive studies, with the majority of research conducted in the inpatient setting in comparison to the ED or prehospital setting. Studies on communicable diseases and injury were the most prevalent, with a relative dearth of research on chronic noncommunicable diseases. The Global Emergency Medicine Think Tank Clinical Research Working Group identified conceptual frameworks to define high-impact research priorities, including the traditional approach of using global burden of disease to define priorities and the impact of EM on individual clinical care and public health opportunities. EM research is also described through a population lens approach, including gender, pediatrics, and migrant and refugee health. Despite recent strides in global EM research and

  10. [Clinical research training in dentistry: analysis of the current status].

    PubMed

    Sosa Martínez, J; Deister Mateos, E

    1990-06-01

    The collegiate and university realms--which include lectures, students, clinical and scientific sessions--is open to growth. Furthermore, it has opened gates for new currents of thought and planted hopes for the growth and development of professors who, apart from mastering their specialty, may be familiar with didactics and directly or indirectly engage in full-time research, so that their lecturing and promotions may partially depend on the number and quality of their published works, preferably on scientific research.

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

    PubMed

    Ross, Joseph S

    2016-09-20

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

  12. Bulls and bears: the stock market and clinical pathology research.

    PubMed

    Khong, T Y

    2009-09-01

    To analyse the level of funded research in clinical pathology in a recent bear and bull market to act as a predictor for future funding during the current global financial crisis. The level of funding for research published in three clinical pathology journals in 2005 and 2008 to coincide with the bear market of March 2000 to October 2002 and with the subsequent bull market to October 2007 was determined using a Medline query. Other parameters examined were the type of article, affiliation of the first author and the pathology subspecialty. Approximately 30% of publications were funded and did not differ between the 2 years studied. Original research papers were more likely to be funded than case reports or reviews. Research from university departments of pathology was more likely to be funded than from hospital pathology departments but there were more publications from hospital pathology departments. The proportion of research in the different subspecialties that was funded did not differ significantly between each other and between 2005 and 2008. Based on data from the previous bear market, which was the longest and deepest of the post 1950 era, and the subsequent bull market, which led to the all-time high in the Dow Jones Industrial Index, funding for clinical pathology research does not seem to be affected by bull or bear markets.

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

    PubMed

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

    2015-06-01

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

  14. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

    PubMed

    Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

    2015-06-01

    Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p < .05). Participants who had participated in a long-term trial-training course earned higher importance scores for "CRN four-subthemes role responsibilities" (p <.05) and lower difficulty scores for "subject protection", "research coordination and management" (p <.005) than their short-term course peers. "Recognition of overall responsibilities" and "receiving trial training" were the significant predictors of difficulty in performing CRN role responsibilities, explaining 21.9% of the total variance. To further promote CRN as a professional career in Taiwan, the findings of this study recommend identifying the core competences of CRNs and adding CRN-related study materials into the advanced nursing curriculum. Long-term and systematic educational training may help CRNs understand the importance of their role responsibilities, better recognize their professional role, and reflect these

  15. Discovering electrophysiology in photobiology

    PubMed Central

    Volkov, Vadim

    2014-01-01

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

  16. Medical ethics, clinical research, and special aspects in nuclear medicine.

    PubMed

    Corrao, S; Arnone, G; Arnone, S; Baldari, S

    2004-09-01

    Medical ethics is the science of survival. It studies the working out of judgments on right or wrong referred to the human being as a biological entity interacting with the whole ecosystem. Medical ethics in clinical research raises numerous moral and technical issues. Methodological aspects are essential for carrying out the aim of clinical research. Medical ethics documents are inspired by the Nuremberg Code and culminate in the recently updated Helsinki Declaration of 1964. In Italy 2 ministerial decrees in 1997 and 1998 laid the basis for the work of a medical ethics committee. They acknowledge the European Good Clinical Practice Guidelines and set professional needs within ethical committees. In clinical research the use of ionising radiation merits special consideration. In the recent past, serious human rights abuses in radiation experiments of the 1950s and 1960s have been found. As regards research in this field we can refer to the publication of the International Commission on Radiological Protection (ICRP) and to the report of the World Health Organisation (WHO). Legislative decree no. 187 of May 26, 2000, which transposed the 97/43/ EURATOM Directive represents the most comprehensive and recent normative reference to clinical research using ionising radiation. However, law no. 39 of March 1, 2002 is important for the partial modifications of previous decrees (art. 108 of L.D. no. 230 of March 17, 1995 and, art. 4 and attachment III of L.D. no. 187 of May 26). In this paper medical ethics, research, methodological issues and aspects of ionizing radiation are discussed.

  17. Hard paternalism, fairness and clinical research: why not?

    PubMed

    Edwards, Sarah J L; Wilson, James

    2012-02-01

    Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons. First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for regulators to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize.

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  20. Data management in clinical research: Synthesizing stakeholder perspectives.

    PubMed

    Johnson, Stephen B; Farach, Frank J; Pelphrey, Kevin; Rozenblit, Leon

    2016-04-01

    This study assesses data management needs in clinical research from the perspectives of researchers, software analysts and developers. This is a mixed-methods study that employs sublanguage analysis in an innovative manner to link the assessments. We performed content analysis using sublanguage theory on transcribed interviews conducted with researchers at four universities. A business analyst independently extracted potential software features from the transcriptions, which were translated into the sublanguage. This common sublanguage was then used to create survey questions for researchers, analysts and developers about the desirability and difficulty of features. Results were synthesized using the common sublanguage to compare stakeholder perceptions with the original content analysis. Individual researchers exhibited significant diversity of perspectives that did not correlate by role or site. Researchers had mixed feelings about their technologies, and sought improvements in integration, interoperability and interaction as well as engaging with study participants. Researchers and analysts agreed that data integration has higher desirability and mobile technology has lower desirability but disagreed on the desirability of data validation rules. Developers agreed that data integration and validation are the most difficult to implement. Researchers perceive tasks related to study execution, analysis and quality control as highly strategic, in contrast with tactical tasks related to data manipulation. Researchers have only partial technologic support for analysis and quality control, and poor support for study execution. Software for data integration and validation appears critical to support clinical research, but may be expensive to implement. Features to support study workflow, collaboration and engagement have been underappreciated, but may prove to be easy successes. Software developers should consider the strategic goals of researchers with regard to the

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

    PubMed

    Barisoni, Laura; Hodgin, Jeffrey B

    2017-08-30

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

  2. Managing the interface between medical schools, hospitals, and clinical research.

    PubMed

    Gallin, J I; Smits, H L

    1997-02-26

    To review how academic health centers are coping with the changing environment of health care delivery with special emphasis on the impact of the changing health care system on clinical research. In response to Health and Human Services Secretary Donna Shalala's 1995 mandated review of the National Institutes of Health (NIH) Warren Grant Magnuson Clinical Center, an NIH review team visited 30 health facilities and government-owned organizations throughout the country. The review team determined what strategies are used by academic health centers to survive and thrive in the changing health care marketplace. The findings have implications for the NIH Clinical Center as well as academic health centers. Management strategies in successful academic health centers include streamlined governance structures whereby small groups of highly empowered group leaders allow institutions to move quickly and decisively; an active strategic planning process; close integration of hospital and medical school management; heavy investment in information systems; and new structures for patient care delivery. Successful centers are initiating discussions with third-party payers and are implementing new initiatives, such as establishing their own managed care organizations, purchasing physician practices, or owning hospitals. Other approaches include establishing revenue-generating centers for clinical research and new relations with industry. Attention to the infrastructure required to support the training and conduct of clinical research is essential for the future vitality of medical schools.

  3. Clinical research and industrial sponsoring: avenues towards transparency and credibility.

    PubMed

    Hildebrandt, M; Ludwig, W-D

    2003-12-01

    Clinical research is intended to serve the patient, in the pursuit of a deepened understanding of physiological interactions and their changes in disease, and of potentially beneficial implications for the patient. The impetus to perform clinical research is shaped by various intentions, such as the desire to provide cure or relief, striving for personal and professional success, public attention, financial considerations, or simply scientific curiosity. A similarly wide range of diverging interests must be assumed to impinge on diagnostic and therapeutic decisions in clinical work. How are we to perform clinical research and therapy with the patients' benefit in mind, in view of such a complex motivational status, and how are we to perceive the peculiar interests of those influencing clinical work, including ourselves? In this review, we attempt to elucidate the complex pathways of interaction between physicians and industrial sponsors. Special attention will be paid to the following topics: the pharmaceutical market, public interests, legal and ethical issues, conflicts of interest, and the potential impact of industry-sponsored drug trials on medical information and subsequent therapeutic decisions. We will conclude with recommendations for an acceptable position in the tension between cooperation and corruptibility, a position that grants priority to the patient's needs rather than third party interests. Copyright 2003 S. Karger GmbH, Freiburg

  4. Korea University Joins the International Efforts in Clinical Proteogenomics Cancer Research | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The National Cancer Institute's (NCI) Office of Cancer Clinical Proteomics Research, part of the National Institutes of Health, and Korea University (KU) located in The Republic of Korea have signed a Memorandum of Understanding (MOU) in clinical proteogenomics cancer research. The MOU between NCI and KU represents the twenty-ninth institution and eleventh country to join the continued effort of the International Cancer Proteogenome Consortium (ICPC), an effort catalyzed through the vision of the 47th Vice President of the United States Joseph R. Biden, Jr. and the Cancer Moonshot.

  5. Advancing Proteomics Research 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.

  6. [Clinical research and prisoners: coercion and grounds to participate].

    PubMed

    García-Guerrero, Julio; Vera-Remartínez, Enrique J

    2012-01-01

    To assess the coercion perceived, the quality of the information, and the reasons that lead prisoners to participate in clinical research. Descriptive and multicenter study. Information was gathered on the social, demographic and penitentiary characteristics, perceived coercion, kind of information received and reasons that lead prisoners to take part in research. Both univariate and bivariate analyses were performed. Quantitative variables are expressed as mean or median, and qualitative ones as absolute numbers or percentages. Comparison between means is performed by a Student T-test, and between medians by a Mann-Whitney U-test. The research was approved by an accredited Ethical Research Committee. The sample comprises 110 prisoners from 11 different prisons, mean age 41.8 (40.4-43.2) years. Of these 105 were men and 8 non-Spanish. 83 prisoners (75.5%) opined they received high quality information about the clinical research; although, only 73 (66.4%) understood it completely. 104 (94.5%) felt no coercion and to 92.5% said they were guaranteed an anonymity. The reasons to be included in the research were: benefits for science (67.3%); benefit for future patients (65.5%); altruism (65.5%); possibility of improvement in the own illness (70%). Bivariate analyses showed no differences that depended on the length of the sentence or educational level. Spanish prisoners take part in clinical researches freely. The information provided on the research should be improved and be made more understandable. Altruism and benefits for the science are the principal reasons for participating in research.

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

    Cancer.gov

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

  8. Clinical pharmacology research strategy for dissolvable tobacco products.

    PubMed

    Mishina, Elena V; Hoffman, Allison C

    2014-03-01

    Dissolvable tobacco products (DTPs) are relatively new to the market. Some researchers and manufacturers describe them as finely ground tobacco that has been compressed into sticks, strips, and orbs that dissolve or disintegrate in the mouth and do not require spitting. While the pharmacokinetic profiles of nicotine and other tobacco-associated compounds and pharmacological effects of these products are complex, their clinical pharmacology has not been systematically evaluated. We reviewed the scientific literature regarding the known pharmacokinetic (PK) characteristics and pharmacodynamic (PD) effects of DTPs with the purpose of identifying research gaps and informing future studies. To evaluate current knowledge of the pharmacological properties of DTPs; to assess their similarities and differences with other tobacco products, especially smokeless tobacco products, and Food and Drug Administration-approved nicotine replacement therapies; to identify gaps in existing information; and to propose a strategy for future clinical pharmacology studies of DTPs. We reviewed the peer-reviewed literature and generated research questions for future clinical pharmacology studies. Data on the PK and PD of DTPs are sparse and inconsistent. The results of existing studies are limited and inconclusive, and their interpretation is complicated by methodological and/or study design issues. This review identifies a need for larger, comprehensive, and prospectively designed studies that include PK/PD measurements and data analyses. We propose a research agenda for future DTP studies related to the clinical pharmacology of nicotine, its metabolites, tobacco-specific nitrosamines, and other toxic compounds.

  9. The integration of similar clinical research data collection instruments.

    PubMed

    Cohen, Dorothy B; Frawley, Sandra J; Shifman, Mark A; Miller, Perry L; Brandt, Cynthia

    2003-01-01

    We devised an algorithm for integrating similar clinical research data collection instruments to create a common measurement instrument. We tested this algorithm using questions from several similar surveys. We encountered differing levels of granularity among questions and responses across surveys resulting in either the loss of granularity or data. This algorithm may make survey integration more systematic and efficient.

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

    ERIC Educational Resources Information Center

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

    2002-01-01

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

  11. A pragmatic analysis of vulnerability in clinical research.

    PubMed

    Wendler, David

    2017-09-01

    Identifying which subjects are vulnerable, and implementing safeguards to protect them, is widely regarded as essential to clinical research. Commentators have endorsed a number of responses to these challenges and have thereby made significant progress in understanding vulnerability in clinical research. At the same time, this literature points to a central contradiction which calls into question its potential to protect vulnerable subjects in practice. Specifically, analysis suggests that all human subjects are vulnerable and vulnerability in clinical research is comparative and context dependent, in the sense that individuals are vulnerable relative to others and in some contexts only. Yet, if everyone is vulnerable, there seems to be no point in citing the vulnerability of some individuals. Moreover, the conclusion that everyone is vulnerable seems inconsistent with the claims that vulnerability is comparative and context dependent, raising concern over whether it will be possible to develop a comprehensive account of vulnerability that is internally consistent. The solution to this dilemma lies in recognition of the fact that the practical significance of claims regarding vulnerability depends on the context in which they are used. The claims that appear to lead to the central contradiction are in fact accurate conclusions that follow from different uses of the term 'vulnerability'. The present manuscript describes this 'pragmatic' approach to vulnerability in clinical research and considers its implications for ensuring that subjects receive appropriate protection. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  12. Forgiveness: Theory, Research, and Clinical Implications for Adolescent Offenders.

    ERIC Educational Resources Information Center

    Pelayo, Stephanie L.

    This paper reviews the literature on the subject of forgiveness and suggests clinical implications for the treatment of adolescent offenders. Although research has been done in the areas of forgiveness, no studies have been conducted with adolescent offenders. This dearth of information points to a gap in understanding the role of forgiveness in…

  13. Contact Us | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    For more information, please contact: Office of Cancer Clinical Proteomics Research Center for Strategic Scientific Initiatives Office of the Director National Cancer Institute 31 Center Drive, MS 2580 Bethesda, MD 20892-2580 Phone: (240) 781-3370 Email: cancer.proteomics@mail.nih.gov

  14. Biospecimen Solicitation - Office of Cancer Clinical Proteomics Research

    Cancer.gov

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

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

    Cancer.gov

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

  16. Tumor Cold Ischemia | Office of Cancer Clinical Proteomics Research

    Cancer.gov

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

  17. Close range photogrammetry--a clinical dental research tool.

    PubMed

    Chadwick, R G

    1992-08-01

    Photogrammetry is the art, science and technology of obtaining reliable information about physical objects through processes of recording and interpreting photographic images. This review outlines the principles of the technique and summarizes the various methodologies and applications in clinical dental research.

  18. The intensive care medicine clinical research agenda in paediatrics.

    PubMed

    Peters, Mark J; Argent, Andrew; Festa, Marino; Leteurtre, Stéphane; Piva, Jefferson; Thompson, Ann; Willson, Douglas; Tissières, Pierre; Tucci, Marisa; Lacroix, Jacques

    2017-03-17

    Intensive Care Medicine set us the task of outlining a global clinical research agenda for paediatric intensive care (PIC). In line with the clinical focus of this journal, we have limited this to research that may directly influence patient care. Clinician researchers from PIC research networks of varying degrees of formality from around the world were invited to answer two main questions: (1) What have been the major recent advances in paediatric critical care research? (2) What are the top 10 studies for the next 10 years? (1) Inclusive databases are well established in many countries. These registries allow detailed observational studies and feasibility testing of clinical trial protocols. Recent trials are larger and more valuable, and (2) most common interventions in PIC are not evidenced-based. Clinical studies for the next 10 years should address this deficit, including: ventilation techniques and interfaces; fluid, transfusion and feeding strategies; optimal targets for vital signs; multiple organ failure definitions, mechanisms and treatments; trauma, prevention and treatment; improving safety; comfort of the patient and their family; appropriate care in the face of medical complexity; defining post-PICU outcomes; and improving knowledge generation and adoption, with novel trial design and implementation strategies. The group specifically highlighted the need for research in resource-limited environments wherein mortality remains often tenfold higher than in well-resourced settings. Paediatric intensive care research has never been healthier, but many gaps in knowledge remain. We need to close these urgently. The impact of new knowledge will be greatest in resource-limited environments.

  19. Common Data Elements for Clinical Research in Friedreich Ataxia

    PubMed Central

    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

    2012-01-01

    Background 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 ataxia, a neurological disorder that involves multiple organ systems. Methods To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: 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 Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment. Results 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. Conclusions 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 and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia. PMID:23239403

  20. Plant Biofilm Inhibitors to Discover Biofilm Genes

    DTIC Science & Technology

    2011-04-08

    REPORT Final Report for Plant Biofilm Inhibitors to Discover Biofilm Genes 14. ABSTRACT 16. SECURITY CLASSIFICATION OF: To control biofilms , we have...synthesized the natural biofilm inhibitor (5Z)-4-bromo-5-(bromomethylene) -3-butyl-2(5H)-furanone from the red alga Delisea pulchra and determined that...Research Office P.O. Box 12211 Research Triangle Park, NC 27709-2211 15. SUBJECT TERMS biofilms , biofilm inhibitors Thomas K. Wood Texas Engineering