Randomised trials at the level of the individual.

Auteurs: Park JJH Ford N Xavier D Ashorn P Grais RF Bhutta ZA Goossens H Thorlund K Socias ME Mills EJ
Référence de l'article: The Lancet. Global health 2021 May ; 9(5); e691-e700. doi: 10.1016/S2214-109X(20)30540-4. Epub 2021 04 18
Essai clinique
eng

Abstract

In global health research, short-term, small-scale clinical trials with fixed, two-arm trial designs that generally do not allow for major changes throughout the trial are the most common study design. Building on the introductory paper of this Series, this paper discusses data-driven approaches to clinical trial research across several adaptive trial designs, as well as the master protocol framework that can help to harmonise clinical trial research efforts in global health research. We provide a general framework for more efficient trial research, and we discuss the importance of considering different study designs in the planning stage with statistical simulations. We conclude this second Series paper by discussing the methodological and operational complexity of adaptive trial designs and master protocols and the current funding challenges that could limit uptake of these approaches in global health research.

Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.