ABSTRACT
Master protocol is a novel and more efficient design for clinical trial research than the traditional clinical trials. Usually a master protocol includes several sub-protocols which could investigate treatment effects of a single drug on several diseases or multiple drugs targeting a single disorder. This review compared master protocol with traditional trials in terms of the research design principle, application, and procedure flow as well as advantages and limitations. We also presented some examples of ongoing applications of master protocol designs including treatment of COVID-19 related illness. Finally, we discussed about potential implementation of master protocol in China especially under the COVID-19 pandemic with an evaluation on the relevant opportunities and challenges. © 2021, Chinese Journal of New Drugs Co. Ltd. All right reserved.