我国临床试验中建立独立数据监查委员会的分析与探讨

Analysis and discussion on the establishment of IDMC in clinical trials in China

独立数据监查委员会(IDMC)的设立对于临床研究受试者的安全性、数据的公正性有重要的意义,正成为临床试验中日益常见的部分。目前,我国临床试验中IDMC建立的合理性与规范性、实施的规范性、监管等方面尚面临挑战。本文通过查阅相关文献、法规、指导原则和国家药品监督管理局药品审评中心(CDE)药物临床试验登记与信息公示平台数据,了解其背景、职责、适用范围和各监管部门要求,分析和探讨我国临床试验中建立IDMC的现状与面临的挑战,基于相关法规要求提出建议,为我国临床试验IDMC的建立与监管提供参考。

The establishment of the Independent Data Monitoring Committee(IDMC)is of great significance to the safety of clinical research subjects and the fairness of data,and is becoming an increasingly common part of clinical trials.At present,the rationality and standardization of the establishment of IDMC,the standardization of implementation,and the supervision of IDMC in clinical trials in China are still facing challenges.This article analyzes and discusses the current situation and challenges of establishing IDMC in clinical trials in China by consulting relevant documents,regulations,guiding principles and data of the drug clinical trial registration and information publicity platform of the National Medical Products Administration’s Drug Evaluation Center(CDE)to understand its background,responsibilities,scope of application and requirements of various regulatory departments.Based on the requirements of relevant laws and regulations,suggestions are put forward to provide reference for the establishment and supervision of IDMC in clinical trials in China.