Abstract:
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We consider group-sequential strategies in clinical trials with multiple co-primary endpoints with the decision-making frameworks for: (1) accepting the null hypothesis (stopping for futility only) and (2) rejecting or accepting the null hypothesis (stopping for either efficacy or futility), based on stopping boundaries using group-sequential methodology, where the trial is designed to evaluate if the intervention is superior to the control on all of the endpoints. We investigate operating characteristics of the group-sequential strategies for (1) and (2) in terms of overall power, the Type I error rate, and sample sizes with the number of analyses, the correlation between the two endpoints, the effect sizes, and the boundary combinations. An example is used to illustrate the group-sequential strategies. We conclude by providing guidance on constructing efficient group-sequential strategies in clinical trials with multiple co-primary endpoints.
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