Drift Parameter Based Sample Size Determination in Multi-Stage Bayesian Randomized Clinical Trials.

Abstract

Sample size determination in Bayesian randomized phase II trial design often relies on computationally intensive search methods, presenting challenges in terms of feasibility and efficiency. We propose a novel approach that greatly reduces the computing time of sample size calculations for Bayesian trial designs. Our approach innovatively connects group sequential design with Bayesian trial design and leverages the proportional relationship between sample size and the squared drift parameter. This results in a faster algorithm. By employing regression analysis, our method can accurately pinpoint the required sample size with significantly reduced computational burden. Through theoretical justification and extensive numerical evaluations, we validate our approach and illustrate its efficiency across a wide range of common trial scenarios, including binary endpoint with Beta-Binomial model, normal endpoint, binary/ordinal endpoint under Bayesian generalized linear model, and survival endpoints under Bayesian piecewise exponential models. To facilitate the use of our methods, we create an R package named "BayesSize" on GitHub.