Crossover Designs With Two Binary Endpoints

ABSTRACT

We propose a crossover design for simultaneous significance testing of two binary endpoints, in which the AB/BA crossover design is carried out for each endpoint. An asymptotic α-level test is obtained by applying the intersection-union principle to the marginal Mainland–Gart tests. Power approximations and sample size calculation are derived and implemented in R programs. An adaptive design with sample size reestimation is also presented. We demonstrate the numerical accuracy of the proposed design through an extensive simulation study. Supplementary materials for this article are available online.