数据安全监察委员会在IIT中的实践与思考  

Practice and Thinking of Data and Safety Monitoring Board in IIT Research

作　　者：沈昊[1] 孙鲁宁[1] 汪秀琴[1] 赵俊[1] Shen Hao;Sun Luning;Wang Xiuqin;Zhao Jun(The First Affiliated Hospital with Nanjing Medical University,Nanjing,Jiangsu,210009,China;不详)

机构地区：[1]南京医科大学第一附属医院,江苏南京210009

出　　处：《中国医院管理》2023年第7期68-70,共3页Chinese Hospital Management

基　　金：“重大新药创制”科技重大专项基金(2018ZX09734007)。

摘　　要：目的 通过研究分析数据安全监察委员会(Data and Safety Monitoring Board,DSMB)在高风险研究者发起的临床研究(Investigator Initiated Trial,IIT)中的实践应用,探讨DSMB建立的必要性和可行性,为IIT的风险管理提出对策建议。方法 通过文献综述分析DSMB在IIT中的应用现状,结合医院DSMB实操案例,重点介绍DSMB的建立、职能、运行管理等实践过程。结果 医院为高风险IIT建立DSMB,可以通过对累积数据的分析结果针对研究设计和实施、数据管理、质量控制等提出修改或变更建议,提高研究质量,特别是通过定期分析受试者的安全性与有效性数据,为受试者保护提供建议,必要时提前终止研究,保护受试者的安全,从而保障临床科研的安全开展。结论 为高风险IIT建立DSMB十分必要和紧迫,临床科研管理部门需重视IIT风险评估,设置严格的管理体系,以推动临床研究工作的开展和能力提升。Objective Through research and analysis of the practical application of Data and Safety Monitoring Board(DSMB) in Investigator Initiated Trial(IIT),it explores the necessity and feasibility of DSMB establishment,for IIT research risk management and propose countermeasures.Method Through literature review and analysis of the application status of DSMB in IIT research,combined with the case of DSMB practice in hospitals,it focuses on introducing the establishment,function,operation and management of DSMB and other practical processes.Result A DSMB for high-risk IIT research is established to make recommendations for revisions or changes in research design and implementation,data management and quality control,through the analysis of cumulative data results to improve the quality of the study,especially by regularly analyzing data on the safety and efficacy of subjects,providing advice on subject protection and.If necessary,early termination of the study to protect the safety of subjects,thus ensuring the safe conduct of clinical research.Conclusion It is very necessary and urgent to establish a DSMB for high-risk IIT research.The clinical research management department needs to pay attention to the risk assessment of IIT research and set up a strict management system to promote the development of clinical research and the improvement of capacity.

关 键 词：数据安全监察委员会 研究者发起的临床研究 风险管理 

分 类 号：R197.323.6[医药卫生—卫生事业管理]