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Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes #MMPMID25844122
Hamasaki T; Asakura K; Evans SR; Sugimoto T; Sozu T
Stat Biopharm Res 2015[]; 7 (1): 36-54 PMID25844122show ga
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, i.e., 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.