建立数据监查委员会对多中心临床试验的价值

The Importance of Data Monitoring Committees for Multi-Centre Clinical Trials

随着我国多中心临床试验数量日益增多,为保护受试者的安全与研究数据的完整性,防止多中心临床试验过程发生偏倚,往往需要对临床试验进行独立和持续的监测。因此,有必要建立与之对应的数据监查委员会(Data Monitoring Committee,DMC)来负责这些任务。本文主要通过介绍DMC的组成、独立性、利益冲突、会议形式、审查研究进展、数据质量、安全性与有效性结果、在期中分析中的作用以及对试验数据的评价,探讨在多中心临床试验建立DMC的意义和价值。

With the increasing of multi-center clinical trials in China,independent and continuous monitoring of clinical trials is often required to protect the safety of subjects and the integrity of research data and prevent bias in the process of multi-center clinical trials.Therefore,it is necessary to set up a corresponding Data Monitoring Committee(DMC)to take charge of these tasks.This paper discusses the significance and value of DMC established in multi-center clinical trials by introducing the composition,independence,conflict of interest,meeting format,review of research progress,data quality,safety,effectiveness results,effect in interim analysis,and evaluation of trial data.