Sample size re-estimation in Phase 2 Dose-Finding: Conditional power vs. Bayesian predictive power
Abstract
Unblinded sample size re-estimation (SSR) is often planned in a clinical trial when there is large uncertainty about the true treatment effect. For Proof-of Concept (PoC) in a Phase II dose finding study, contrast test can be adopted to leverage information from all treatment groups. In this article, we propose two-stage SSR designs using frequentist conditional power and Bayesian posterior predictive power for both single and multiple contrast tests. The Bayesian SSR can be implemented under a wide range of prior settings to incorporate different prior knowledge. Taking the adaptivity into account, all type I errors of final analysis in this paper are rigorously protected. Simulation studies are carried out to demonstrate the advantages of unblinded SSR in multi-arm trials.
Cite
@article{arxiv.2012.14589,
title = {Sample size re-estimation in Phase 2 Dose-Finding: Conditional power vs. Bayesian predictive power},
author = {Qingyang Liu and Guanyu Hu and Binqi Ye and Susan Wang and Yaoshi Wu},
journal= {arXiv preprint arXiv:2012.14589},
year = {2022}
}