How to deal with multiple treatment or dose groups in randomized clinical trials?

Publikation: Beitrag in Fachzeitschrift › Übersichtsarbeit › Forschung › Peer-Review

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  • L. A. Hothorn

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OriginalspracheEnglisch
Seiten (von - bis)137-154
Seitenumfang18
FachzeitschriftFundamental and Clinical Pharmacology
Jahrgang21
Ausgabenummer2
PublikationsstatusVeröffentlicht - 7 Feb. 2007

Abstract

Multiplicity adjustment in general is currently a controversial topic. This review focuses on the proof of efficacy in randomized clinical trials. The ICH guidelines mandate control of the familywise error rate. Confidence intervals are clinically more appropriate than P-values or yes/no decisions. Therefore, simultaneous confidence intervals are proposed for several designs and aims in clinical trials. The computation of simultaneous confidence intervals for the difference or the ratio is demonstrated by means of real data examples using the R-packages multcomp and mratios. A special problem is the evaluation of dose-finding trials with and without the assumption that the effects increase with increasing doses. Simultaneous intervals are presented not only for one-way layouts and normal distributed endpoints, but also for higher way layouts, generalized linear models, and mixed models. Under importance ordering, the conditional testing of all hypotheses at level α will be shown using the intersection-union test principle. Other multiplicity issues (i.e. multiple endpoints, multiple analyses, and subgroup analyses) are discussed.

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How to deal with multiple treatment or dose groups in randomized clinical trials? / Hothorn, L. A.
in: Fundamental and Clinical Pharmacology, Jahrgang 21, Nr. 2, 07.02.2007, S. 137-154.

Publikation: Beitrag in Fachzeitschrift › Übersichtsarbeit › Forschung › Peer-Review

Hothorn LA. How to deal with multiple treatment or dose groups in randomized clinical trials? Fundamental and Clinical Pharmacology. 2007 Feb 7;21(2):137-154. doi: 10.1111/j.1472-8206.2007.00469.x
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