中美欧药品监管机构去中心化临床试验指导原则比较研究

Comparison of Decentralized Clinical Trial Guidance in China,US and Europe Drug Regulatory Agencies

近年来,去中心化临床试验(DCT)受到了医药领域业内人士的广泛关注,并得到越来越多的应用。为了规范DCT的应用,中美欧药品监管机构均出台了相应的指导原则和建议文件。本文对比研究了相关指导原则和建议文件,总结了中美欧药品监管机构对DCT各元素的关注重点,分析了中美欧监管规定的异同,以期为我国开展高质量DCT提供借鉴。

In recent years,decentralized clinical trials(DCTs)have garnered widespread attention from professionals in the pharmaceutical field and have witnessed increasing application.To regulate the implementation of DCTs,drug regulatory agencies in China,the United States,and Europe have issued corresponding guidance and recommendation documents.This article provides a comparative study of these guidance and recommendation documents,summarizing the key focus areas of the three regulatory agencies concerning various DCT elements and analyzing the similarities and differences among them.The aim is to offer a reference for conducting high-quality DCTs in China.