A flexible multi-metric Bayesian framework for decision-making in Phase II multi-arm multi-stage studies.

ABSTRACT: We propose a multi-metric flexible Bayesian framework to support efficient interim decision-making in multi-arm multi-stage phase II clinical trials. Multi-arm multi-stage phase II studies increase the efficiency of drug development, but early decisions regarding the futility or desirability of a given arm carry considerable risk since sample sizes are often low and follow-up periods may be short. Further, since intermediate outcomes based on biomarkers of treatment response are rarely perfect surrogates for the primary outcome and different trial stakeholders may have different levels of risk tolerance, a single hypothesis test is insufficient for comprehensively summarizing the state of the collected evidence. We present a Bayesian framework comprised of multiple metrics based on point e

SUBMITTER: Dufault SM 

PROVIDER: S-EPMC7617374 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature