Crossover Studies with Binary Responses

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: European Interuniversity College of Pharmaceutical Medicine Lyon
Toine F. Cleophas: Technical University

Chapter Chapter 13 in Statistics Applied to Clinical Trials, 2002, pp 143-150 from Springer

Abstract: Summary The two-period crossover trial has the evident advantage that by the use of within-patients comparisons, the usually larger between-patient variability is not used as a measuring stick to compare treatments. However, a prerequisite is that the order of the treatments does not substantially influence the outcome of the treatment. Crossover studies with a binary response (such as yes/no or present/absent), although widely used for initial screening of new compounds, have not previously been studied for such order effects. In the present paper we use a mathematical model based on standard statistical tests to study to what extent such order effects, here identical to carryover effects, may reduce the power of detecting a treatment effect. We come to the conclusion that in spite of large carryover effects the crossover study with a binary response remains a powerful method and that testing for carryover effects makes sense only if the null hypothesis of no treatment effect cannot be rejected.

Keywords: Crossover Study; Carryover Effect; Crossover Trial; Binary Response; Testing Treatment Effect (search for similar items in EconPapers)
Date: 2002
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-94-010-0337-7_13

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DOI: 10.1007/978-94-010-0337-7_13

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