Group-Sequential Clinical Trials for Comparing Two Interventions Using Two Time-to-Event Outcomes

• Activity Number: 548
• Type: Contributed
• Date/Time: Wednesday, August 3, 2016 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Toshimitsu Hamasaki* and Tomoyuki Sugimoto and Koko Asakura and Scott Evans
• Companies: National Cerebral and Cardiovascular Center and Hirosaki University and National Cerebral and Cardiovascular Center and Harvard
• Keywords: Alpha-level allocation ; Bivariate time-to-event outcomes ; Group-sequential designs ; Multiple co-primary endpoints ; Multiple primary endpoints

Abstract

In this presentation, we discuss methods for group-sequential clinical trials when comparing two interventions using two time-to-event outcomes. We consider two inferential goals, i.e., to evaluate if a test intervention is superior to a control intervention on: (1) both outcomes (multiple co-primary endpoints) or (2) on at least one outcome (multiple primary endpoints). One complex issue in these trials is how to allocate alpha to each interim analysis to control the Type I rate, as the amount of information for the two endpoints may vary at a particular interim time-point of the trial. We consider several strategies for allocating alpha and evaluate the behavior of Type I error rate. We provide an example to illustrate the aspect of the methods.