The Analysis of Safety Data of Drug Trials

Cleophas, Ton J.; Zwinderman, Aeilko H.; Cleophas, Toine F.

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

Ton J. Cleophas MD, PhD, Associate-Professor^5,6,
Aeilko H. Zwinderman Math D, PhD, Professor⁷ &
Toine F. Cleophas D Techn⁸

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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.

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Authors and Affiliations

European Interuniversity College of Pharmaceutical Medicine Lyon, France
Ton J. Cleophas MD, PhD, Associate-Professor (President American College of Angiology, Co-Chair Module Statistics Applied to Clinical Trials, Internist-clinical pharmacologist)
Department Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands
Ton J. Cleophas MD, PhD, Associate-Professor (President American College of Angiology, Co-Chair Module Statistics Applied to Clinical Trials, Internist-clinical pharmacologist)
Department Biostatistics and Epidemiology, Academic Medical Center Amsterdam, The Netherlands
Aeilko H. Zwinderman Math D, PhD, Professor (Co-Chair Module Statistics Applied to Clinical Trials, Professor of Statistics)
Technical University, Delft, The Netherlands
Toine F. Cleophas D Techn

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Ton J. Cleophas MD, PhD, Associate-Professor
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Aeilko H. Zwinderman Math D, PhD, Professor
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Toine F. Cleophas D Techn
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Cleophas, T.J., Zwinderman, A.H., Cleophas, T.F. (2006). The Analysis of Safety Data of Drug Trials. In: Statistics Applied to Clinical Trials. Springer, Dordrecht. https://doi.org/10.1007/978-1-4020-4650-6_3

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DOI: https://doi.org/10.1007/978-1-4020-4650-6_3
Publisher Name: Springer, Dordrecht
Print ISBN: 978-1-4020-4229-4
Online ISBN: 978-1-4020-4650-6
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)

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