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Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.

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Date
1993-03
Authors
Rockhold, FW
Enas, GG
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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 article
Subject
Biomedical and Behavioral Research
Empirical 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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https://hdl.handle.net/10161/11024
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Scholars@Duke

Rockhold

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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