Bayesian sample size determination in basket trials borrowing information between subsets.

ABSTRACT: Basket trials are increasingly used for the simultaneous evaluation of a new treatment in various patient subgroups under one overarching protocol. We propose a Bayesian approach to sample size determination in basket trials that permit borrowing of information between commensurate subsets. Specifically, we consider a randomized basket trial design where patients are randomly assigned to the new treatment or control within each trial subset ("subtrial" for short). Closed-form sample size formulae are derived to ensure that each subtrial has a specified chance of correctly deciding whether the new treatment is superior to or not better than the control by some clinically relevant difference. Given prespecified levels of pairwise (in)commensurability, the subtrial sample sizes are solved sim

SUBMITTER: Zheng H 

PROVIDER: S-EPMC11616727 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature