超说明书用药IIT的伦理管理及实践*甄红1,2刘墨池1,2王旭东1,2张峻1,2许锋1,2,3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。关键词：超说明书用药，临床研究，伦理审查中图分类号：R-05文献标识码：A文章编号：1002-0772(2024)06-0019-04DOI：10.12014/j.issn.1002-0772.2024.06.05EthicalManagementandPracticeofIITwithOff-labelDrugUseZHENHong1,2,LIUMochi1,2,WANGXudong1,2,ZHANGJun1,2,XUFeng1,2,3．1.InstitutionalReviewBoard,ShanghaiNinthPeoplesHospital,ShanghaiJiaoTongUniversitySchoolofMedicine,Shanghai200011,China;2.CenterforSpecialtyStrategyResearchofShanghaiJiaoTongUniversityChinaHospitalDevelopmentInstitute,Shanghai200011,China;3.DisciplinePlanningDepartment,ShanghaiNinthPeoplesHospital,ShanghaiJiaoTongUniver-sitySchoolofMedicineShanghai200011,ChinaAbstract：Tostandardizethemanagementofinvestigator-initiatedtrials(IITs)involvingoff-labeldruguse,theauthorsusetheactualsituationoftheirhospitalasanexample.Bystrengtheningdiscipline-specificexpertconsultation,integratingthemanagementofthePharmacyandTherapeuticsCommitteeandtheMedicalAffairsOffice,andrefininginternalmanagementprocesses,theauthorsenhancetheconductofIITsinvolvingoff-labeldruguse.ConsideringthechallengesinlegislationandregulationfacedduringthemanagementofIITswithoff-labeldruguse,theauthorsprovidemanagementrecommendations.Emphasisisplacedonresearchers'ethicalawareness,strictsupervision,andmanagementofIITsinvolvingoff-labeldruguse,improvinginternalmanagementprocessesofmedicalinstitutions,ensuringinformedconsent,andsafeguardingtherightsofparticipants.Additionally,res...
