We discuss the decision-making frameworks for clinical trials with multiple co-primary endpoints in a group-sequential setting. The decision-making frameworks can account for flexibilities, such as a varying number of analyses, equally or unequally spaced increments of information, and fixed or adaptive Type I error allocation among endpoints. The frameworks can provide efficiency, that is, potentially fewer trial participants, than the fixed sample size designs. We investigate the operating characteristics of the decision-making frameworks and provide guidance on constructing efficient group-sequential strategies in clinical trials with multiple co-primary endpoints.

我们讨论了在群序环境中具有多个共同主要终点的临床试验的决策框架。决策框架可以考虑灵活性，例如变化数量的分析，等距或不等距的信息增量以及端点之间固定或自适应的I类错误分配。与固定样本数量的设计相比，这些框架可以提供更高的效率，即潜在的试验参与者更少。我们调查决策框架的运作特征，并为在具有多个共同主要终点的临床试验中构建有效的群体顺序策略提供指导。