临床研究数据与安全监查国际发展现状与思考

Current status and considerations of clinical research data and safety monitoring

数据与安全监查委员会(Data and Safety Monitoring Board,DSMB)在国际范围内广泛应用于大规模、多中心临床试验及政府资助项目,它在全程保护受试者安全、提升临床研究质量与水平方面起着十分重要的作用。虽然DSMB在欧美发达国家运用经验较成熟,但在我国目前尚处于起步阶段。该文通过回顾DSMB的起源和工作流程,比较模式及国际现行各指导原则,分析其应用现状、发展趋势和存在的问题,提出根据各国国情及不同临床研究特点,除了对累积数据进行期中分析以动态评估干预措施的安全性有效性外,采取扩大监查范围、丰富监查模式、建立专业的技术队伍、制定符合各类临床研究特点的DSMB操作规程、重视并建立DSMB保险和赔偿机制等策略,不仅是在国际范围内推进和完善数据与安全监查工作的有效途径,也是提高我国临床研究技术与国际先进水平接轨亟待解决的问题。

The Data and Safety Monitoring Board (DSMB) is widely used worldwide in large scale, multicenter clinical trials and government-funded projects. It plays an important role in the protection of whole-course subject safety and improving the quality of clinical research. Although the developed countries have more experience in DSMB practice, it's still in its initial stage in China. By revision of the origin and workflow of DSMB and comparison of the models and the current guiding principles, the application status, development tendency and existing problems in different countries, along with making interim analysis on cumulative data to dynamically assess the efficacy and safety of the intervention, the authors propose that DSMB should expand the monitor scope, enrich monitor approaches, establish professional expert group, formulate operating instruction to satisfy the different clinical researches, and make a point of setting up DSMB insurance and indemnity mechanism according to different country's conditions and clinical research characteristics. This will not only enhance the data and safety monitor practice, but also improve the clinical research level in China to meet international standards.