临床试验暂停和提前终止的技术管理要求探讨

临床试验暂停和提前终止是临床试验动态管理中的重要程序。本文结合欧美临床试验暂停和提前终止的管理要求,分析了临床试验暂停和提前终止的定义,概述了欧美临床试验暂停、提前终止的程序要求,并列举了美国食品药品监督管理局(FDA)发起暂停和提前终止新药临床试验的主要考虑,并探讨了暂停和提前终止新药临床试验的热点问题。对于实施默示许可制的我国来说,借鉴欧美临床试验暂停和提前终止管理要求的先进相关经验,将在提高审评效率同时有效地控制风险。

Discussion of the suspension and early termination management requirements of clinical trials

The suspension and early termination has become key procedures in dynamic management of clinical trials. This paper analyzes the definition of suspension and early termination, summarizes the suspension and early termination management requirements of clinical trials in Europe and the United States, lists the main considerations for Food and Drug Administration(FDA) to initiate suspension and early termination of clinical trials, and discusses the issues of suspension and early termination of clinical trials. For implementation of implied licensing of our country, learning the advanced experience of suspension and early termination will improve the efficiency of the medical review and control risk effectively.