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Crossover Studies with Binary Responses

In: Statistics Applied to Clinical Trials

Author

Listed:
  • Ton J. Cleophas

    (European Interuniversity College of Pharmaceutical Medicine Lyon
    Albert Schweitzer Hospital, Department Medicine)

  • Aeilko H. Zwinderman

    (European Interuniversity College of Pharmaceutical Medicine Lyon
    Academic Medical Center Amsterdam, Department Biostatistics and Epidemiology)

  • Toine F. Cleophas

    (Technical University)

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.

Suggested Citation

  • Ton J. Cleophas & Aeilko H. Zwinderman & Toine F. Cleophas, 2002. "Crossover Studies with Binary Responses," Springer Books, in: Statistics Applied to Clinical Trials, edition 0, chapter 0, pages 143-150, Springer.
    • Handle: RePEc:spr:sprchp:978-94-010-0337-7_13
    DOI: 10.1007/978-94-010-0337-7_13
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