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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/2057

Title: Pairwise non-parametric non-inferiority tests in 3x3 cross-over trials: should we adjust for period?
Authors: DUCHATEAU, Luc
JANSSEN, Paul
Issue Date: 2005
Publisher: JOHN WILEY & SONS LTD
Citation: STATISTICS IN MEDICINE, 24(10). p. 1525-1536
Abstract: Before an active compound can be registered as a drug, it needs to be demonstrated that it does not cause particular unwanted compound specific side effects. Demonstrating non-inferiority of an active drug with placebo with respect to an unwanted side effect is often based on pharmacodynamic 3 x 3 cross-over trials, with the third treatment ann consisting of a positive control. The main comparison then is the pairwise comparison between active drug and placebo. In this paper, two different non-parametric methods with adjustment for period effect are compared with the non-parametric non-adjusted test and the parametric period-adjusted test with respect to size and power. The non-parametric test with period adjustment based on rank alignment has generally the largest power, but its size exceeds the nominal significance level. The non-parametric test with period adjustment based on stratification has low power for trials with a small number of subjects. The non-parametric test without period adjustment is a valid alternative in such cases, but its power decreases substantially in the presence of period effects. In the case of unbalanced designs, however, only the non-parametric test with period adjustment based on stratification can be used. Copyright (c) 2005 John Wiley & Sons, Ltd.
Notes: State Univ Ghent, Fac Vet Med, Dept Physiol Biochem & Biometr, B-9820 Merelbeke, Belgium. Limburgs Univ Ctr, Ctr Stat, B-3590 Diepenbeek, Belgium.Duchateau, L, State Univ Ghent, Fac Vet Med, Dept Physiol Biochem & Biometr, Salisburylaan 133, B-9820 Merelbeke, Belgium.luc.duchateau@UGent.be
URI: http://hdl.handle.net/1942/2057
DOI: 10.1002/sim.2048
ISI #: 000229261700005
ISSN: 0277-6715
Category: A1
Type: Journal Contribution
Validation: ecoom, 2006
Appears in Collections: Research publications

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