Global health funders want to make sure the clinical studies they support are as informative and efficient as possible. While global health trial protocols go through standard ethical and regulatory reviews, there have been no documented standards and business processes for funders to perform scientific reviews of the final protocols they fund.
A maturity model is a tool for growing capabilities in a new area by performing a self-assessment in an existing area. This maturity model is designed to help funders create and maintain a process for conducting their own scientific design reviews of the protocols they fund. This is needed to identify flaws in trial designs that can cause uninformative outcomes if not fixed before the trial starts. The model includes 11 process areas where funders can set their own priorities, achieve increasing levels of maturity over time, and predict and prepare for forthcoming challenges.
Publication: https://www.preprints.org/manuscript/202304.0147/v1
Citation: Dolley S, Norman T, McNair D, Hartman D. A maturity model for the scientific review of clinical trial designs and their informativeness. Trials. 2024 Apr 19;25(1):271.
