我国研究者发起的临床研究管理现况分析

Analysis of the current status of management in Investigator-Initiated Trials in China

目的了解近10年我国研究者发起的临床研究(IIT)管理存在的问题和建议,为医疗机构探索IIT规范管理提供依据。方法采用文献分析法对IIT管理文章发表年份、地区、管理内容及其存在问题和建议等方面进行整理和分析。结果58篇文献来自12个地区,发文量排名前3的地区分别是上海市、北京市和广东省。IIT管理内容有10项,包括管理现况、伦理管理、过程管理、信息化管理、合同管理、立项管理、人类遗传资源管理、研究者管理、多中心管理和方法学体系管理,分别总结了每一项管理内容存在的问题和建议。结论我国IIT监管体系尚不完善,给管理部门带来巨大难度。医疗机构应从IIT管理的各个环节着手,明确管理要点和风险点,针对性采取措施,积极推进高质量IIT研究。

ed and analyzed by Bibliometric analysis.Results58 studies were included in the analysis from 12 regions,and the top three regions were Shanghai,Beijing,and Guangdong Province.There were 10 items of IIT management,including management status,ethical management,process management,information management,contract management,approval management,human genetic resource management,researcher management,multi-center management,and methodology system management.The problems and suggestions of each item of IIT management were summarized respectively.ConclusionsThe imperfect supervision system of IIT has brought great difficulties to the management department.Medical institutions should clarify management points and risk points from the item of IIT management and take targeted measures to actively promote high-quality IIT research.