美欧监管机构对远程智能临床试验探索的进展  

Exploratory Progress of US&EU Regulatory Authorities on Remote Decentralized Clinical Trial

作　　者：马润镒 苏娴 王海学[1] 王涛[1] MA Run-yi;SU Xian;WANG Hai-xue;WANG Tao(Center for Drug Evaluation National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2020年第11期102-109,共8页China Food & Drug Administration Magazine

摘　　要：近年来,以患者为中心的远程智能临床试验受到各界关注。美欧监管机构及其协作组织,以各国既有国情和法规环境为基础,积极地对这一新兴的临床试验模式开展了广泛且深入的探究,并在监管要求方面达成了一定的共识。此外,新冠肺炎疫情期间,大量的临床试验以前期共识为基础进行了应急性的远程智能化实践。所积累的经验,将为后续远程智能临床试验在各国的实施以及各国监管要求的成熟奠定基础。本文总结了美欧监管机构及其协作组织探索远程智能临床试验实施与监管要求的进展,为形成我国远程智能临床试验监管考虑提供参考。In recent years,patient-centered remote decentralized clinical trials have attracted attention from all stakeholders.Based on the existing national conditions and regulatory environment of each country,the U.S.and European regulatory authorities and their cooperative organizations have carried out extensive and in-depth exploration of this emerging clinical trial model,and have formed certain consensus on regulatory requirements.In addition,during the COVID-19 pandemic,many clinical trials were conducted as emergency remote decentralized practice based on the previous consensus.The accumulated experience will lay the foundation for the implementation of subsequent remote decentralized clinical trials in many countries and the maturity of national regulatory requirements.This article summarizes the progress of the U.S.and European regulatory agencies and their collaborative organizations in exploring the implementation and regulatory requirements of remote decentralized clinical trials,in order to provide reference for the supervision of the remote intelligent clinical trial in china.

关 键 词：远程智能临床试验 以患者为中心 美国食品药品监督管理局 临床试验转型倡议 欧盟委员会 创新医药倡议 

分 类 号：R95[医药卫生—药学]