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
Aeilko H. Zwinderman: Academic Medical Center Amsterdam, Department Biostatistics and Epidemiology
Toine F. Cleophas: Technical University

Chapter Chapter 3 in Statistics Applied to Clinical Trials, 2006, pp 41-58 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: Safety Data; Drug Trial; Proportional Data; Left Group; Pocket Calculator (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_3

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DOI: 10.1007/978-1-4020-4650-6_3

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