正在興起的主方案臨床研究模式有加快藥物開(kāi)發(fā)、縮短開(kāi)發(fā)時(shí)間等優(yōu)點(diǎn)，但實(shí)施起來(lái)也有一定難度。美國(guó)食品藥品監(jiān)督管理局（FDA）為了給治療或預(yù)防新型冠狀病毒肺炎（COVID-19）藥物的主方案申請(qǐng)人排憂解難，于2021年5月發(fā)布了“COVID-19：評(píng)價(jià)治療或預(yù)防藥物和生物制品的主方案”技術(shù)指導(dǎo)原則，對(duì)COVID-19藥物主方案設(shè)計(jì)、實(shí)施和統(tǒng)計(jì)學(xué)提出了許多建議。詳細(xì)介紹FDA的該指導(dǎo)原則，希望對(duì)我國(guó)開(kāi)展這方面的研究工作及其監(jiān)管有益，也對(duì)結(jié)合國(guó)情制定類似的指導(dǎo)原則有啟示。

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.