Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.
Abstract
The characteristics of data monitoring and the need for the use of data monitoring
committees in clinical trials sponsored by the pharmaceutical industry differ from
those of trials sponsored by government. Data monitoring is a continuous process in
industry trials due to the regulatory requirements and the need to more thoroughly
evaluate safety of new compounds. As part of this process, interim analyses are employed
to make decisions about treatment effects. In some cases, such analyses may require
the use of an external data monitoring committee to assist in the data review, analysis
and decision making. A number of examples of interim analyses, with and without data
monitoring committees, are discussed. Issues surrounding the need for external data
monitoring committees and recommendations are presented. In particular the issues
of sponsor participation in the data monitoring committee and controls of the decision
making process are considered.
Type
Journal articleSubject
Biomedical and Behavioral ResearchEmpirical Approach
Clinical Trials Data Monitoring Committees
Clinical Trials as Topic
Drug Industry
Ethics
Government Regulation
Humans
Internationality
Research Design
Research Subjects
Risk Assessment
United States
United States Food and Drug Administration
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Show full item recordScholars@Duke
Frank Wesley Rockhold
Professor of Biostatistics & Bioinformatics
Frank is a fulltime 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 HunterRockhold, 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 has

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