FDA“新型冠状病毒肺炎:评价治疗或预防药物和生物制品的主方案”指导原则介绍  

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

作　　者：萧惠来 XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2021年第8期1637-1643,共7页Drug Evaluation Research

摘　　要：正在兴起的主方案临床研究模式有加快药物开发、缩短开发时间等优点,但实施起来也有一定难度。美国食品药品监督管理局(FDA)为了给治疗或预防新型冠状病毒肺炎(COVID-19)药物的主方案申请人排忧解难,于2021年5月发布了"COVID-19:评价治疗或预防药物和生物制品的主方案"技术指导原则,对COVID-19药物主方案设计、实施和统计学提出了许多建议。详细介绍FDA的该指导原则,希望对我国开展这方面的研究工作及其监管有益,也对结合国情制定类似的指导原则有启示。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.

关 键 词：美国食品药品管理局 新型冠状病毒肺炎 药物 主方案 指导原则 

分 类 号：R951[医药卫生—药学]