美国FDA对于研究者药物临床试验现场检查的关注点和发现问题分析

Analysis of the concerns and problems found by the U.S.FDA bioresearch monitoring program in clinical investigator inspection

我国医药创新能力显著提高,境内外同步申报成为国内制药企业创新药申报的新策略,临床试验也面临接受更多美国FDA生物研究监测项目(bioresearch monitoring program,BIMO)研究者现场检查的现状。本研究结合BIMO检查的实践经验,探讨BIMO检查的流程、检查重点和常见问题并剖析问题发生的原因,以期为国内临床试验机构、研究者以及申办方应对BIMO检查提供参考。

The innovation ability of Chinese pharmaceutical industry has been significantly improved.Simultaneous declaration at home and abroad has become a new strategy for domestic enterprises to declare innovative drugs.Investigators are also facing more on-site inspections by U.S.FDA bioresearch monitoring program(BIMO).Based on the practical experience of BIMO inspection,this study discussed the process,key points and common problems of BIMO inspection,and analyzed the causes of the problems,in order to assist GCP centers,investigators and sponsors to deal with BIMO inspection.