我国药物临床试验中心伦理审查的实践瓶颈与路径探析——2020版GCP相关规定的启示

Analysis of the Practical Barrier and Pathway of the Centralized IRB Review of Multi-center Clinical Trials in China:The Implication of GCP 2020 Version

2020版《药物临床试验质量管理规范》未对多中心药物临床试验应采取何种方式进行伦理审查进行要求和规定,通过对我国多中心药物临床试验中心伦理审查历史发展与现状的回顾,发现注册药物临床试验的中心伦理审查在我国并不是一个新鲜事物,而是原来就存在,现在只是考虑如何恢复的问题。借鉴先进国家和地区经验,建议完善建立多中心临床试验中心伦理审查法律法规并制定相关操作指南、逐步确立广泛认可的中心伦理审查模式、加快国内机构伦理委员会注册备案及认证工作、加强必要的软硬件设施建设以及制定相关惩罚措施;从国家层面建立自上而下的、统一的制度设计和监督管理措施,方可在保证审查质量的基础上切实提高多中心临床试验伦理审查效率。

There are no requirements and regulations on the IRB review of multi-center clinical trials in the 2020 version of Good Clinical Practice.In retrospect of the development history and current situation of the centralized IRB review of multi-center clinical trials in China,this paper finds that the centralized IRB review of registered clinical trial of drugs is not a new thing in China,but a problem of reconstruction.Based on the experience of advanced countries and regions,it is suggested that we should perfect the laws,regulations and guidelines for centralized IRB review in multi-center clinical trials,gradually establish a generally accepted mode of centralized IRB review,speed up the registration and certification work of domestic institutional ethics committees,strengthen the construction of necessary software and hardware facilities,and formulate relevant punishment measures from the national level.Only by unified system design,supervision and management measures,can we effectively improve the efficiency of ethical review of multi-center clinical trials with ensurance of review quality.