Group-Sequential Strategies for Clinical Trials When Comparing Two Interventions Using Multiple Co-Primary Endpoints

• Activity Number: 526
• Type: Topic Contributed
• Date/Time: Wednesday, August 12, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Toshimitsu Hamasaki* and Koko Asakura and Scott R. Evans
• Companies: National Cerebral and Cardiovascular Center and National Cerebral and Cardiovascular Center and Harvard University
• Keywords: Adaptive Type I error allocation ; Average sample number ; Co-Primary Endpoints ; Conjunctive power ; Maximum sample size

Abstract

We discuss the decision-making frameworks for clinical trials with multiple co-primary endpoints in a group-sequential setting. "Co-primary" means that the trial is designed to evaluate if an intervention is superior to the control on ALL of the endpoints. The decision-making frameworks are flexible accounting for a varying number of analyses, equally or unequally spaced increments of information, and fixed or adaptive Type I error allocation. The frameworks provide efficiency potentially resulting in 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.