Introduction of FDA's COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance

ABSTRACT

The emerging master protocol clinical research model has the advantages of accelerating drug development and shortening the development time, but it is also difficult. To solve the difficulties of sponsors of master protocols of drugs for the treatment or prevention of COVID-19, American Food and Drug Administration (FDA) issued COVID-19 Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance in May 2021. It has put forward many suggestions on the design, conduct, and statistics of the master rotocols of COVID-19 drugs. This paper introduces the FDA's guidance in detail. It is hoped that it will be helpful for China to carry out the research and supervision in this field, and also enlighten us to formulate similar guidance according to the national conditions. © 2021 Drug Evaluation Research. All Rights Reserved.