Impact of Borrowing Historical Information in Group Sequential Trials

• Activity Number: 591
• Type: Topic Contributed
• Date/Time: Wednesday, August 7, 2013 : 2:00 PM to 3:50 PM
• Sponsor: Section on Bayesian Statistical Science
• Author(s): Soumi Lahiri*+
• Companies: GlaxoSmithKline
• Keywords: Group sequential design ; Prediction ; Historical information ; Operating characteristics

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 information regarding effect size and provides flexibility in the decision-making, thus a very useful tool for Data Monitoring Committee. Monitoring tools will be discussed for different endpoints (e.g., binary, continuous and time-to-event) with numerical examples.

Additionally, use of Bayesian method allows utilization of historical information as "prior"; but, there is a risk associated with the operating characteristic of the study design. Multiple sources of historical information may conflict with other and result in inflation of the Type I error. Simulation based approach will be used to access the overall impact of different level of borrowing information on the proposed methodology.