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The Analysis of Safety Data of Drug Trials

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

As discussed in chapter 1 the primary object of clinical trials of new drugs is generally to demonstrate efficacy rather than safety. However, a trial in human beings not at the same time adequately addressing safety is unethical, and the assessment of safety variables is an important element of the trial.

Suggested Citation

  • Ton J. Cleophas & Aeilko H. Zwinderman & Toine F. Cleophas, 2006. "The Analysis of Safety Data of Drug Trials," Springer Books, in: Statistics Applied to Clinical Trials, chapter 0, pages 41-58, Springer.
    • Handle: RePEc:spr:sprchp:978-1-4020-4650-6_3
    DOI: 10.1007/978-1-4020-4650-6_3
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