超说明书用药IIT的伦理管理及实践  

Ethical Management and Practice of IIT with Off- label Drug Use

作　　者：甄红 刘墨池 王旭东[1,2] 张峻[1,2] 许锋[1,2,3] ZHEN Hong;LIU Mochi;WANG Xudong;ZHANG Jun;XU Feng(Institutional Review Board,Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine,Shanghai 200011,China;Center for Specialty Strategy Research of Shanghai Jiao Tong University China Hospital Development Institute,Shanghai 200011,China;Discipline Planning Department,Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine Shanghai 200011,China)

机构地区：[1]上海交通大学医学院附属第九人民医院伦理委员会,上海200011 [2]上海交通大学中国医院发展研究院学科建设研究所,上海200011 [3]上海交通大学医学院附属第九人民医院学科规划处,上海200011

出　　处：《医学与哲学》2024年第6期19-22,共4页Medicine and Philosophy

基　　金：2023年上海交通大学中国医院发展研究院医院管理项目(CHDI-2023-B-11);2023年上海交通大学医学院科技创新项目-人文社科课题(WK2318)。

摘　　要：为规范研究者发起的超说明书用药临床研究管理,作者以所在医院实际情况为例,通过强化学科专家论证,结合药事委员会和医务处管理,完善医院内部管理流程,规范超说明书用药IIT的开展。结合超说明书用药IIT管理过程中所面临的关于立法、监管等方面存在的问题,提出管理建议。强化研究者对超说明书用药IIT的伦理意识、严格监督和管理,完善医疗机构内部管理流程,切实做好知情同意,保障受试者权益,同时鼓励研究者与药企开展实质性的超说明书用药IIT合作,合理平摊风险,以期为医疗机构的超说明书用药IIT管理提供建议,优化超说明书用药的管理现状。To standardize the management of investigator-initiated trials(IITs)involving off-label drug use,the authors use the actual situation of their hospital as an example.By strengthening discipline-specific expert consultation,integrating the management of the Pharmacy and Therapeutics Committee and the Medical Affairs Office,and refining internal management processes,the authors enhance the conduct of IITs involving off-label drug use.Considering the challenges in legislation and regulation faced during the management of IITs with off-label drug use,the authors provide management recommendations.Emphasis is placed on researchers'ethical awareness,strict supervision,and management of IITs involving off-label drug use,improving internal management processes of medical institutions,ensuring informed consent,and safeguarding the rights of participants.Additionally,researchers are encouraged to engage in substantive collaborations with pharmaceutical companies for IITs involving off-label drug use,sharing risks reasonably.The aim is to provide suggestions for the management of IITs with off-label drug use in medical institutions and optimize the current management status of off-label drug use.

关 键 词：超说明书用药 临床研究 伦理审查 

分 类 号：R-05[医药卫生]