陕西省药物临床试验机构伦理初始审查的现况分析

Analysis of Ethical Initial Review Status of Drug Clinical Trail Institutions in Shaanxi Province

目的研究陕西省医疗机构药物临床试验伦理初始审查的流程,分析初始审查的现状,为加快药物临床试验项目在通过伦理初始审查的速度提出建议。方法根据“药物和医疗器械临床试验机构备案管理信息系统”中陕西省备案的药物临床试验机构,通过检索医院官网、微信公众号并结合电话咨询等方式整理备案机构药物临床试验项目初始审查的流程,分析各医院伦理初始审查的要求、递交文件及获取批件时限。结果陕西省备案的药物临床试验机构共44家。63.6%机构明确发布了伦理审查/申请指南,部分机构对于初始审查递交清单、简版资料及盖章要求等缺少详细的规定;31.8%机构建立了伦理审查管理系统;36.4%机构通过邮箱接收初始审查资料并进行形审;获取伦理批件平均时长5.13~6 d。结论建议进一步完善伦理审查指南,规范初始审查的流程,细化伦理初始审查文件和机构立项文件,搭建信息化管理平台,缩短药物临床试验项目初始审查的时间,提高临床试验启动的速度。

Objective To examine the process of the initial ethical review of drug clinical trials in medical institutions in Shaanxi province,analyze the current situation of initial reviews,and make suggestions to expedite the speed of initial ethical review of drug clinical trial projects.Methods Based on the drug clinical trial institutions in Shaanxi recorded in the"drug and medical device clinical trial institutions for the record management information system".This study involved retrieving information through hospital website,WeChat public accounts,and conducting telephone consultations to usnderstand the process.The analysis focused on the initial review requirements,documents submission,and approval documents.Results A total of 44 drug clinical trial institutions were assessed.63.6%of these institutions had clearly issued ethical review/application guidelines,with some lacking detailed provisions on the initial review submission list,simplified data and seal requirements.31.8%of the institutions had established ethics review management systems.The average time of obtaining ethics approval was from 5.13 to 6 d.Conclusion It is recommended to further improve ethical review guidelines,standardize the initial review process,refine the initial ethical review documents and institutional project approval documents,build an information management platform,reduce the time for initial review of drug clinical trial projects,and improve the speed of clinical trial initiation.