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

• Hamasaki, Toshimitsu

• Asakura, Koko

• Evans, Scott R

• Sugimoto, Tomoyuki

• Sozu, Takashi

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.

Journal

• Statistics in biopharmaceutical research

  Statistics in biopharmaceutical research 7 (1), 36-54, 2015-03-18

  Taylor & Francis Group

Keywords

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

Details

• CRID: 1050845760743597440
• NII Article ID: 120005619770
• ISSN: 19466315
• HANDLE: 2433/198576
• Text Lang: en
• Article Type: journal article
• Data Source:
  • IRDB
  • CiNii Articles