Predictive Approach in Group Sequential Design for Time-to-Event Endpoint

• Activity Number: 128
• Type: Contributed
• Date/Time: Monday, August 4, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Soumi Lahiri*+ and Satrajit Roy Choudhury
• Companies: Novartis and Novartis
• Keywords: Time to event endpoint ; Interim analysis ; Bayesian ; Predictive probability

Abstract

Group sequential designs are nowadays becoming the gold standard for long-term confirmatory trials. Often clinical trials have one or more interim look to access early efficacy or futility information. Several methods have been developed to assess efficacy and safety of the study drug during interim. We propose a Bayesian prediction based method for quantitative monitoring of clinical trials. Proposed methodology is focused on predictive probability and provides flexibility in the decision-making, thus a very useful tool for Data Monitoring Committee. Monitoring tools will be discussed for time-to-event endpoint with numerical example.