Bias Due to Conflicts of Interests, some Guidelines

Ton J. Cleophas, Aeilko H. Zwinderman and Toine F. Cleophas
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Ton J. Cleophas: European Interuniversity College of Pharmaceutical Medicine Lyon
Aeilko H. Zwinderman: Academic Medical Center Amsterdam, Department Biostatistics and Epidemiology
Toine F. Cleophas: Technical University

Chapter Chapter 31 in Statistics Applied to Clinical Trials, 2006, pp 345-351 from Springer

Abstract: Abstract The controlled clinical trial, the gold standard for drug development, is in jeopardy. The pharmaceutical industry rapidly expands its commend over clinical trials. Scientific rigor requires independence and objectivity. Safeguarding such criteria is hard with industrial sponsors, benefiting from favorable results, virtually completely in control. The recent Good Clinical Practice Criteria adopted by the European Community1 were not helpful, and even confirmed the right of the pharmaceutical industry to keep everything under control. Except for the requirement that the trial protocol should be approved by an external protocol review board, little further external monitoring of the trial is required in Europe today. The present paper was written to review flawed procedures jeopardizing the credibility of current clinical trials, and to look for possible solutions to the dilemma between sponsored industry and scientific independence.

Keywords: Pharmaceutical Industry; Scientific Rigor; Current Clinical Trial; Independent Monitoring; Europe Today (search for similar items in EconPapers)
Date: 2006
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-1-4020-4650-6_31

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DOI: 10.1007/978-1-4020-4650-6_31

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