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Bias Due to Conflicts of Interests, some Guidelines

In: Statistics Applied to Clinical Trials

Author

Listed:
  • Ton J. Cleophas

    (European Interuniversity College of Pharmaceutical Medicine Lyon
    Albert Schweitzer Hospital, Department Medicine)

  • Aeilko H. Zwinderman

    (Academic Medical Center Amsterdam, Department Biostatistics and Epidemiology)

  • Toine F. Cleophas

    (Technical University)

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.

Suggested Citation

  • Ton J. Cleophas & Aeilko H. Zwinderman & Toine F. Cleophas, 2006. "Bias Due to Conflicts of Interests, some Guidelines," Springer Books, in: Statistics Applied to Clinical Trials, chapter 0, pages 345-351, Springer.
    • Handle: RePEc:spr:sprchp:978-1-4020-4650-6_31
    DOI: 10.1007/978-1-4020-4650-6_31
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