Abstract
In this chapter, we provide methods for power and sample size calculation for clinical trials with multiple co-primary binary endpoints. On the basis of three association measures among the multiple binary endpoints, we discuss five methods for power and sample size calculation: the asymptotic normal method with and without a continuity correction, the arcsine method with and without a continuity correction, and the Fisher’s exact method. We evaluate the behavior of the sample size and empirical power associated with the methods. We also provide numerical examples to illustrate the methods.
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