Issues in regulatory guidelines for data monitoring committees.
Abstract
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.
Type
Journal articleSubject
Clinical Trials Data Monitoring CommitteesClinical Trials as Topic
Guidelines as Topic
Humans
Research Support as Topic
United States
United States Food and Drug Administration
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https://hdl.handle.net/10161/11006Published Version (Please cite this version)
10.1191/1740774504cn019xxPublication Info
(2004). Issues in regulatory guidelines for data monitoring committees. Clin Trials, 1(2). pp. 162-169. 10.1191/1740774504cn019xx. Retrieved from https://hdl.handle.net/10161/11006.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Robert M. Califf
Adjunct Professor of Medicine
Robert Califf, MD MACC, is an Adjunct 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
research at Duke University. He also served as direc
This author no longer has a Scholars@Duke profile, so the information shown here reflects
their Duke status at the time this item was deposited.
Frank Wesley Rockhold
Professor of Biostatistics & Bioinformatics
Frank is a full time Professor of Biostatistics and Bioinformatics and Faculty Director
for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics
at Virginia Commonwealth University, and Strategic Consultant at Hunter Rockhold,
Inc. His 40+-year career includes senior research positions at Lilly, Merck, and
GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President
of Global Clinical Safety and Pharmacovigilance. He h
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