數據與安全監(jiān)查委員會（Data and Safety Monitoring Board，DSMB）在國際范圍內廣泛應用于大規(guī)模、多中心臨床試驗及政府資助項目，它在全程保護受試者安全、提升臨床研究質量與水平方面起著十分重要的作用。雖然DSMB在歐美發(fā)達國家運用經驗較成熟，但在我國目前尚處于起步階段。該文通過回顧DSMB的起源和工作流程，比較模式及國際現行各指導原則，分析其應用現狀、發(fā)展趨勢和存在的問題，提出根據各國國情及不同臨床研究特點，除了對累積數據進行期中分析以動態(tài)評估干預措施的安全性有效性外，采取擴大監(jiān)查范圍、豐富監(jiān)查模式、建立專業(yè)的技術隊伍、制定符合各類臨床研究特點的DSMB操作規(guī)程、重視并建立DSMB保險和賠償機制等策略，不僅是在國際范圍內推進和完善數據與安全監(jiān)查工作的有效途徑，也是提高我國臨床研究技術與國際先進水平接軌亟待解決的問題。

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.