Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes

What is it about?

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.

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