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

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.