A Test for Multiple Binary Endpoints with Continuous Latent Distribution in Clinical Trials

In clinical trials, two or more binary responses obtained by dichotomizing continuous responses are often employed as multiple primary endpoints. Testing procedures for multiple binary variables with latent distribution have not yet been adequately discussed. Based on the association measure among latent variables, we provide a statistic for testing the superiority of at least one binary endpoint. In addition, we propose a testing procedure with a framework in which the trial efficacy is confirmed only when there is superiority of at least one endpoint and non-inferiority of the remaining endpoints. The performance of the proposed procedure is evaluated through simulations.