Key role and practical analysis of the Data Monitoring Committee in the clinical trial of"Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA"
DONG Nai-jia
DU Ya-wei
WU Sheng-xian
Abstract：Objective:To explore how to establish a data monitoring committee(DMC)in clinical trials and how the committee should fulfill its duties,with a view to providing reference for the establishment of DMC in clinical research in China.Methods:Taking"Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA"as an example,introduction and analysis were conducted mainly focusing on the purpose of establishing DMC,the preparation work of the clinical trial,and the guidance of subsequent decision-making based on the results of the interim analysis in the implementation process of the study.Conclusion:The establishment of DMC can not only protect the safety and interests of the subjects,but also ensure the scientific validity of the clinical trial and improve its integrity and reliability.
Keywords：Data Monitoring CommitteeData and Safety Monitoring Boardinterim analysiscaseclinical trial
Publication Date：2025-07-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1526-1530 )