我国药物临床试验机构立项审查的现况分析  

Analysis of project approval status of drug clinical trial institutions in China

作　　者：候磊 董恒进[1] HOU Lei;DONG Heng-jin(School of Public Health,Zhejiang University,Hangzhou 310012,China.)

机构地区：[1]浙江大学医学院公共卫生学院,杭州310012

出　　处：《中国处方药》2023年第3期45-48,共4页Journal of China Prescription Drug

摘　　要：目的研究我国药物临床试验机构立项管理的流程,分析立项审查现状,为加快药物临床试验在机构立项速度提出建议。方法根据中国医院药物临床试验2021年年度报告,选出承接药物临床试验数量前30名的试验机构,通过医院官网、机构微信公众号检索并结合电话及实地调研等方式梳理每家机构立项管理流程,分析各机构立项要求、立项文件和立项时间。结果其中84%的机构发布立项审查指南,但部分机构立项文件格式要求、立项审查形式和审查时间等缺少清晰明确规定,同一机构内立项审查与伦理审查的文件重复率较高。结论建议进一步完善机构的立项审查指南,规范立项审查流程,细分立项审查和伦理审查文件,搭建联合立项审查电子化平台,减少临床试验立项审查等待时间,加快临床试验启动。Objective To study current status review process of drug clinical trial institutions in China,understand the status of project approval,and put forward suggestions for speeding up the project approval of drug clinical trials in institutions.Methods According to the 2021 annual report of drug clinical trials in Chinese hospitals,the top 30 drug clinical trials institutions were selected,and the review approval process of each institution was sorted out to analyze requirements and documents through the hospital official website,Wechat official account,telephone consultation and field investigation.Results Among them,84%of the institutions had clear guidelines for initiation review,however,the requirements for the format of project approval documents,the form of project approval review and the review time are still not clearly defined,and the document repetition rate of project approval review and ethical review in the same institution is relatively high.Conclusion We need detailed project approval review guidelines for drug clinical trial institutions in China,standardize the project approval review process,further subdivide the project approval review and ethical review documents,build an electronic platform for joint project approval,speed up the project approval review and launch of clinical trials,and create a better environment for drug research and development in China.

关 键 词：药物临床试验机构 立项审查管理 立项审查现状 

分 类 号：R95[医药卫生—药学]