Medicine and Health Sciences Commons^™

Randomised Trials At The Level Of The Individual, Jay J H. Park, Nathan Ford, Denis Xavier, Per Ashorn, Rebecca F. Grais, Zulfiqar Ahmed Bhutta, Herman Goossens, Kristian Thorlund, Maria Eugenia Socias, Edward J. Mills

Centre of Excellence in Women and Child Health

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 …