Understanding how the informed consent process influences the decision to participate in an adaptive platform trial: A scoping review

Abstract

Introduction The complex design of adaptive platform trials may be challenging for prospective participants and their families and/or substitute decision makers to understand when approached for informed consent. The purpose of this scoping review is to explore and synthesize literature on how the informed consent process influences the decision to participate in an adaptive platform trial. Methods A scoping review of empirical literature published in English was conducted using MEDLINE, EMBASE and PsychInfo databases (1976–2025). A key term search strategy examined the overarching concepts of informed consent process and adaptive platform trials. Empirical studies whose participants were adults in a health care delivery or clinical research setting were included. The outcome of interest was factors that affect eligible trial participant decisions to participate in adaptive platform trials. Grey literature was further searched to substantiate and complement the peer reviewed literature. Results Of 1085 articles reviewed, four met inclusion criteria. The four papers highlighted challenges in explaining to prospective participants how the randomization ratio may change during the trial and how likely participants are to benefit, as well as the importance of communication outside of the written consent form. Eight grey literature results were included, covering an emerging policy and regulatory discourse, as well as nascent empirical studies examining alternate delivery modalities for consent information. Conclusions Limited data highlight the importance of empirical investigation into how to facilitate informed participation in adaptive platform trials. More research is needed to understand how this trial design may affect enrollment decisions and therefore associated policies and processes needed to support informed participation in this modernized trial design.