Abstract

The test treatment in confirmatory clinical trials is often assessed using multiple primary endpoints. We considered that trial efficacy is confirmed only when there is superiority of at least one endpoint and non-inferiority of the remaining endpoints. Some researchers proposed testing procedures for multiple primary endpoints that are continuous variables. However, there has not yet been discussion of the case in which a trial has multiple binary endpoints in the above framework. In this study, we consider a testing procedure for multiple primary endpoints that are binary, and evaluate the performance of the proposed method through simulations.

中文翻译：

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具有多个二进制端点的临床试验中的测试程序

摘要

验证性临床试验中的测试治疗通常使用多个主要终点进行评估。我们认为，只有在至少一个终点具有优势且其余终点具有非劣效性时，才能确认试验疗效。一些研究人员提出了针对连续变量的多个主要终点的测试程序。然而，在上述框架中尚未讨论试验具有多个二元终点的情况。在这项研究中，我们考虑了一个针对多个二进制主要端点的测试程序，并通过模拟评估所提出方法的性能。