研究型医院高质量发展对研究者发起的临床研究管理的要求与分析  

The requirements and analysis on the management of investigator-initiated trials for the high-quality development of research-oriented hospitals

作　　者：李饶尧 江映萍 胡俊 邓艳红[1,2] LI Rao-yao;JIANG Ying-ping;HU Jun;DENG Yan-hong(the Clinical Research Center,The Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou 510655,China;Biomedical Innovation Center,The Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou 510655,China;Department of Human Resources,The Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou 510655,China)

机构地区：[1]中山大学附属第六医院临床研究中心,广州510655 [2]广州市黄埔区中六生物医学创新研究院,广州510655 [3]中山大学附属第六医院人才科,广州510655

出　　处：《中国新药杂志》2025年第3期286-291,共6页Chinese Journal of New Drugs

基　　金：广东省消化系统疾病临床医学研究中心项目(2020B1111170004)。

摘　　要：研究者发起的临床研究(investigator initiated trial,IIT)是研究型医院建设链条中的核心环节之一。在越来越多的政策引导下,研究型医院建设整体转向高质量发展体系是必然的要求,对IIT全过程管理也将提出更高的要求。本文结合广州市某三甲综合医院的相关探索措施,对标《医疗卫生机构开展研究者发起的临床研究管理办法(试行)》进行解读并提出建议,为医疗卫生机构提升IIT项目管理策略提供参考。The management of investigator initiated trial(IIT)is the central part in the construction chain of research-oriented hospitals.Under the guidance of more and more policies,it is an inevitable requirement for the construction of research-oriented hospitals to shift towards a high-quality development system as a whole,and higher standards will be put forward for the whole-process management of IIT.Based on the relevant exploration measures of a third-grade class-A hospital in Guangzhou,this paper interprets and makes suggestions to the IIT management measures issued by the National Health Commission,so as to provide reference to promote the development of IIT project management strategy in medical and health institutions.

关 键 词：研究者发起的临床研究 研究型医院 高质量发展 组织和管理 对策探讨 

分 类 号：R969[医药卫生—药理学]