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Evaluation of Safety Data from Controlled Clinical Trials: The Clinical Principles Explained

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Abstract

A comprehensive discussion is presented of the principles underlying the evaluation of safety data from controlled clinical trials. Emphasis is placed on clinical concepts rather than statistical methodology. The essential elements of safety analysis, the critical concepts involved, and trial design issues that affect the interpretation of safety data are explained. Particular attention is paid to the importance of exposure data, the estimation of adverse event frequencies in longer-term trials, evaluation of laboratory data, and the assessment of risk factors.

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Authors and Affiliations

  1. International Clinical Safety Department, Amgen Inc, 1, Amgen Center Drive, Thousand Oaks, California, 91320-1799, USA

    John E. Gait MD, Sandy Smith PhD & Sherri L. Brown MD

Authors
  1. John E. Gait MD
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  2. Sandy Smith PhD
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  3. Sherri L. Brown MD
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Corresponding author

Correspondence to John E. Gait MD.

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Gait, J.E., Smith, S. & Brown, S.L. Evaluation of Safety Data from Controlled Clinical Trials: The Clinical Principles Explained. Ther Innov Regul Sci 34, 273–287 (2000). https://doi.org/10.1177/009286150003400135

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  • DOI: https://doi.org/10.1177/009286150003400135

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