Comparison of Decentralized Clinical Trial Guidance in China,US and Europe Drug Regulatory Agencies
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.
decentralized clinical trialguidancerecommendation documentsChina,US and Europeregulation
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维普
