A group-sequential randomized trial design utilizing supplemental trial data.

ABSTRACT: Definitive clinical trials are resource intensive, often requiring a large number of participants over several years. One approach to improve the efficiency of clinical trials is to incorporate historical information into the primary trial analysis. This approach has tremendous potential in the areas of pediatric or rare disease trials, where achieving reasonable power is difficult. In this article, we introduce a novel Bayesian group-sequential trial design based on Multisource Exchangeability Models, which allows for dynamic borrowing of historical information at the interim analyses. Our approach achieves synergy between group sequential and adaptive borrowing methodology to attain improved power and reduced sample size. We explore the frequentist operating characteristics of our design

SUBMITTER: Kotalik A 

PROVIDER: S-EPMC8795487 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature