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

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

Author information

1
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.
2
Department of Biostatistics and the Center for Biostatistics in AIDS Research, Harvard School of Public Health, USA.
3
Department of Mathematical Sciences, Hirosaki University Graduate School of Science and Technology, Japan.
4
Department of Biostatistics, Kyoto University School of Public Health, Japan.

Abstract

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.

KEYWORDS:

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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