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Stat Biopharm Res. 2015;7(1):36-54.

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

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Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Japan ; Department of Innovative Clinical Trials and Data Science, Osaka University Graduate School of Medicine, Japan.
Department of Biostatistics and the Center for Biostatistics in AIDS Research, Harvard School of Public Health, USA.
Department of Mathematical Sciences, Hirosaki University Graduate School of Science and Technology, Japan.
Department of Biostatistics, Kyoto University School of Public Health, Japan.


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.


Adaptive Type I error allocation; Average sample number; Hierarchical testing procedure; Maximum sample size; equally or unequally spaced increments of information

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