Issues in regulatory guidelines for data monitoring committees.
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As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute.
SubjectClinical Trials Data Monitoring Committees
Clinical Trials as Topic
Guidelines as Topic
Research Support as Topic
United States Food and Drug Administration
Published Version (Please cite this version)10.1191/1740774504cn019xx
Publication InfoCaliff, Robert M; DeMets, David Leon; Dixon, Dennis; Ellenberg, S; Fleming, T; Held, P; ... Whitley, R (2004). Issues in regulatory guidelines for data monitoring committees. Clin Trials, 1(2). pp. 162-169. 10.1191/1740774504cn019xx. Retrieved from http://hdl.handle.net/10161/11006.
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Donald F. Fortin, M.D. Professor of Cardiology, in the School of Medicine
Robert Califf, MD MACC, is the Donald F. Fortin, MD, Professor of Cardiology. He is also Professor of Medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the Commissioner of Food and Drugs in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational
Professor of Biostatistics & Bioinformatics
Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. In addition his role of full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute, Frank is also Managing Partner of HunterRock
Alphabetical list of authors with Scholars@Duke profiles.