Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials.
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SubjectClinical Laboratory Techniques
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Practice Guidelines as Topic
Published Version (Please cite this version)10.1371/journal.pmed.1000067
Publication InfoCleland, N; Cox, J; Denny, Thomas Norton; Hural, J; Needham, Leila K; Ozaki, Dan; ... Tarragona-Fiol, T (2009). Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials. PLoS Med, 6(5). pp. e1000067. 10.1371/journal.pmed.1000067. Retrieved from https://hdl.handle.net/10161/14736.
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Professor in Medicine
Thomas N. Denny, MSc, M.Phil, is the Chief Operating Officer of the Duke Human Vaccine Institute (DHVI) and the Center for HIV/AIDS Vaccine Immunology (CHAVI), and a Professor of Medicine in the Department of Medicine at Duke University Medical Center. He is also an Affiliate Member of the Duke Global Health Institute. He has recently been appointed to the Duke University Fuqua School of Business Health Sector Advisory Council. Previously, he was an Associate Professor of Pathology, Laboratory M
Research Professor of Immunology
Ongoing Applied Activities •I direct a Global Quality Assurance Program, which I developed and pioneered here at Duke University, to oversee compliance with Good Clinical Laboratory Practice Guidelines in three HIV vaccine trial networks (CHAVI, CAVD, Duke HVTN, EQAPOL, Duke VTEU) involving domestic and international laboratory sites. •I also direct a Global Proficiency Testing Program for laboratories testing for neutralizing antibody function in individuals infected
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Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov. Alexander, Karen; Califf, Robert; Kong, David; Kramer, Judith; Tasneem, Asba; Chiswell, Karen; Starr, Aijing Z (Journal of the American Heart Association, 2013-09-26)Cardiovascular medicine is widely regarded as a vanguard for evidence-based drug and technology development. Our goal was to describe the cardiovascular clinical research portfolio from ClinicalTrials.gov.We identified 40 ...
Development of a clinical trials version of the Impact of Weight on Quality of Life-Lite questionnaire (IWQOL-Lite Clinical Trials Version): results from two qualitative studies. Kolotkin, Ronette; Ervin, CM; Meincke, HH; Højbjerre, L; Fehnel, SE (Clinical obesity, 2017-10)Existing measures of health-related quality of life and patient functioning in obesity, such as the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, lack the developmental rigour required by the Food ...
Description of Common Clinical Presentations and Associated Short-Term Physical Therapy Clinical Outcomes in Patients With Neck Pain. Bishop, Mark D; Brennan, Gerard P; George, Steven Z; Harman, JS; Horn, Maggie Elizabeth (Arch Phys Med Rehabil, 2015-10)OBJECTIVE: To determine the effect of clinical presentations of neck pain on short-term physical therapy outcomes. DESIGN: Retrospective analysis of pair-matched groups from a clinical cohort. SETTING: Thirteen outpatient ...