Response adaptive randomisation in clinical trials: Current practice, gaps and future directions.

ABSTRACT: Introduction: Adaptive designs (ADs) offer clinical trials flexibility to modify design aspects based on accumulating interim data. Response adaptive randomisation (RAR) adjusts treatment allocation according to interim results, favouring promising treatments. Despite scientific appeal, RAR adoption lags behind other ADs. Understanding methods and applications could provide insights and resources and reveal future research needs. This study examines RAR application, trial results and achieved benefits, reporting gaps, statistical tools and concerns, while highlighting examples of effective practices. Methods: RAR trials with comparative efficacy, effectiveness or safety objectives, classified at least phase I/II, were identified via statistical literature, trial registries, s

SUBMITTER: Wilson I 

PROVIDER: S-EPMC12460923 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature