Futility Analysis Approaches in Clinical Equivalence Trials

• Activity Number: 517
• Type: Contributed
• Date/Time: Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Christine K. Gause*+
• Companies: Merck Research Laboratories
• Keywords: equivalence ; futility ; group sequential

Abstract

In many studies with an active comparator, a formal demonstration of non-inferiority is the goal, and a variety of methods exist for demonstration of non-inferiority using synthesis approaches. These methods rely on an assumption that the active comparator effect is the same in the current trial as in previous historic trials. We investigate synthesis approaches applied to the clinical equivalence setting, with incorporation of an interim futility analysis to potentially stop a trial if it is unlikely that the experimental drug is equivalent to the active comparator. Both group sequential spending functions and Bayesian approaches to equivalence testing that incorporate prior information for the active comparator will be considered. A simulation study is conducted to compare the approaches under a variety of conditions for a trial with a binary outcome.