Fixed and Adaptive Parallel Subgroup-Specific Design for Survival Outcomes: Power and Sample Size.

ABSTRACT: Biomarker-guided clinical trial designs, which focus on testing the effectiveness of a biomarker-guided approach to treatment in improving patient health, have drawn considerable attention in the era of stratified medicine with many different designs being proposed in the literature. However, planning such trials to ensure they have sufficient power to test the relevant hypotheses can be challenging and the literature often lacks guidance in this regard. In this study, we focus on the parallel subgroup-specific design, which allows the evaluation of separate treatment effects in the biomarker-positive subgroup and biomarker-negative subgroup simultaneously. We also explore an adaptive version of the design, where an interim analysis is undertaken based on a fixed percentage of target event

SUBMITTER: Antoniou M 

PROVIDER: S-EPMC5748631 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature