Adapt to survive and thrive: the time is now for adaptive platform trials for preterm birth

Abstract

In this Viewpoint, we discuss the challenges facing perinatal clinical researchers, many of which are unique to this field, and how traditional two-arm randomised trials using frequentist analysis might no longer be fit for purpose for perinatology. We propose a solution: the adoption of adaptive platform trials (APTs) with Bayesian methodology to address perinatal research questions to improve outcomes of preterm birth. APTs use a master protocol as a foundation to efficiently assess multiple interventions simultaneously for a particular disease. APTs can study these interventions in a perpetual manner, with interventions allowed to enter or leave the platform on the basis of preplanned decision algorithms. In this Viewpoint, we outline the ways in which APTs can overcome some of the issues facing perinatal clinical research, and the challenges and essential requirements for the design and implementation of perinatal APTs that should be considered.

Trial registration: ClinicalTrials.gov NCT06461429.