Governance of adaptive platform trials

Abstract

Adaptive Clinical Trials (ACT) differ from conventional clinical trials because they permit continual modifications to key components of trial design during the trial. ACTs have grown in prevalence in recent years, with Adaptive Platform Trials (APTs), in particular, having demonstrated their significant scientific, clinical, and public health utility in relation to the COVID-19 pandemic. There has been a steady increase in the number of regulations and guidelines aimed at guiding the conduct of clinical trials. However, despite the potential of APTs to expedite the testing of new interventions in emergency situations, there is a relative dearth of published literature on why and how such trials should be governed. This work attempts to address this knowledge gap.