The Analysis of Safety Data of Drug Trials

Ton J. Cleophas, Aeilko H. Zwinderman and Toine F. Cleophas
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Ton J. Cleophas: European Interuniversity College of Pharmaceutical Medicine Lyon, Dept Medicine Albert Schweitzer Hospital Dordrecht
Aeilko H. Zwinderman: Dept Statistics Academic Hospital Leiden
Toine F. Cleophas: Technical University

Chapter Chapter 3 in Statistics Applied to Clinical Trials, 2000, pp 29-34 from Springer

Abstract: 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.

Keywords: Contingency Table; Drug Trial; Survival Fraction; Left Group; Discordant Pair (search for similar items in EconPapers)
Date: 2000
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-94-015-9508-7_3

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DOI: 10.1007/978-94-015-9508-7_3

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