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.
关键词
去中心化临床试验/指导原则/建议文件/中美欧/监管
Key words
decentralized clinical trial/guidance/recommendation documents/China,US and Europe/regulation
维普
万方数据