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

作　　者：张晓方[1] 于冰 龚瑛 张晓琴 王莉 周佳卉 武阳丰[1] ZHANG Xiao-fang;YU Bing;GONG Ying;ZHANG Xiao-qin;WANG Li;ZHOU Jia-hui;WU Yang-feng(Clinical Research Institute,Institute of Advanced Clinical Medicine,Peking Univerisiy,Peking University Health Science-China National Biotech Group Clinical and Regulatory Sciences Joint Laboratory;China Association of Enterprises with Foreign Investment R&D-based Pharmaceutical Association Committee;Pfizer(China)Research&Development Co.,Ltd;Bayer Healthcare Co.,Ltd.;Lilly China Drug Development&Medical Affairs Center;China-Japan Friendship Hospital)

机构地区：[1]北京大学临床医学高等研究院临床研究所,北大医学-中国生物临床与监管科学联合实验室 [2]中国外商投资企业协会药品研制和开发工作委员会 [3]辉瑞(中国)研究开发有限公司 [4]拜耳医药保健有限公司 [5]礼来中国药物发展及医学事务中心 [6]中日友好医院

出　　处：《中国食品药品监管》2024年第8期90-99,共10页China Food & Drug Administration Magazine

摘　　要：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.

关 键 词：去中心化临床试验 指导原则 建议文件 中美欧 监管 

分 类 号：R95[医药卫生—药学]