The use of adaptive population selection designs has become widespread in response to the emergence of numerous targeted therapies. Such designs provide an opportunity to stop the recruitment of patients in a population in midcourse when this population does not benefit from the treatment being tested. Several types of designs have been developed in different settings; however, the procedures for setting thresholds for an interim decision have not yet been established. Therefore, in this article, we propose a novel, simple utility-based approach to guide the construction of an interim decision rule for an adaptive population selection design using survival endpoints. This approach is applicable when there is an available biomarker prior to designing a clinical trial. Our simulation studies, which assumed that only a prespecified population will benefit from a targeted therapy, indicated that the proposed approach assists in setting optimal thresholds for selecting an appropriate population at the interim analysis.

响应于众多靶向疗法的出现，自适应人群选择设计的使用已变得广泛。当该人群无法从所测试的治疗中受益时，这种设计提供了在中途停止招募患者的机会。在不同的环境下开发了几种类型的设计。但是，尚未建立为临时决定设定阈值的程序。因此，在本文中，我们提出了一种新颖的，基于实用程序的简单方法来指导使用生存端点的自适应人群选择设计的临时决策规则的构建。如果在设计临床试验之前有可用的生物标志物，则此方法适用。我们的模拟研究