推动研究者发起的临床研究立项管理的探索与思考  

Exploration and thinking on promoting investigator-initiated clinical research project management

作　　者：卢伟锋 徐璐[1] 周平 黄红谦[1] 林萍 陈松[1] 郝新宝[1] Lu Weifeng;Xu Lu;Zhou Ping;Huang Hongqian;Lin Ping;Chen Song;Hao Xinbao(Clinical Research Center,The First Affiliated Hospital of Hainan Medical University,Haikou 570102,China)

机构地区：[1]海南医学院第一附属医院临床研究中心,海口570102

出　　处：《中华医学科研管理杂志》2024年第5期429-433,共5页Chinese Journal of Medical Science Research Management

基　　金：海南省卫生健康行业科研项目(22A200246);海南医学院第一附属医院青年培育基金项目(HYYFYPY202306);海南医学院2023年度教育科研项目(HYYB202362)。

摘　　要：目的为探索和思考研究者发起的临床研究(Investigator-Initiated Trial,IIT)项目立项管理模式,对标以注册为目的的临床试验(Industry Sponsored Trial,IST)项目管理,规范研究者发起的临床研究项目立项管理流程,促进医疗卫生机构临床研究管理体系完善,提升临床研究质量管理水平,保护研究参与者权益。方法通过以国家卫生健康委员会临床研究规范管理首批试点地区之一,海南省某医疗卫生机构临床研究管理为例,梳理研究者发起的临床研究管理难点堵点,分析并规范研究者发起的临床研究立项管理。结果医疗机构立项管理是临床研究规范化管理的首要环节和基础保障,科学可行的立项管理是开展有深度、高质量IIT的有力抓手。结论海南省某省级公立医疗机构的案例研究表明,科学可行的立项管理是开展有深度、高质量IIT的有力抓手,充分利用政策优势和临床资源,产出高质量的研究成果,建设高水平的研究型医院。ObjectiveTo explore and think about the project management model of investigator-initiated trial(IIT),and the project management of industry sponsored trial(IST),we should standardize the management process of clinical research projects initiated by researchers,improve the management system of clinical research in medical institutions,improve the quality management level of clinical research,and protect the rights and interests of research participants.MethodsBy taking the clinical research management of a medical and health institution in Hainan province as an example,one of the first pilot areas for the standardized management of clinical research by the National Health Commission,the difficulties in the management of clinical research initiated by researchers were sorted out,to analyze and standardize the management of clinical research project initiated by researchers.ResultsDiscussion Project management was the primary link and basic guarantee of standardized management of clinical research,and scientific and feasible project management was a powerful hand to carry out deep and high-quality IIT.ConclusionsIt can be manifested in a Hainan provincial public medical institution that a feasible project management was the basement in carrying out the profound and high quality IIT.It is advicable to make full use of policy advantages and clinical resources to produce high-quality research results as well as build a high-level research hospital.

关 键 词：研究者发起的临床研究 立项管理 程序优化 

分 类 号：R197.323[医药卫生—卫生事业管理]