远程智能临床试验及数字化技术应用的探讨  

A Discussion on Remote Decentralized Clinical Trial and Application of Digital Technologies in Clinical Trials

作　　者：王海学[1] 王涛[1] 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110-116,共7页China Food & Drug Administration Magazine

摘　　要：2020年,我国经历前所未有的新冠肺炎疫情。随着新冠肺炎疫情发生,远程智能临床试验及数字化技术应用成为热点。目前,国内尚无具体细化的相关法规文件要求。本文基于疫情期间工作调研及新版GCP,阐述了新冠肺炎疫情对传统临床试验的影响,从监管科学角度分析并探讨远程智能临床试验及数字化技术要求。远程智能临床试验及数字化技术的应用,应以GCP中保护受试者安全和保障数据完整性等要求为基础,为受试者和试验各参与方提供便利,最终提高临床试验效能。In 2020,China experienced an unprecedented COVID-19 pandemic.With the outbreak of the pandemic,the application of remote decentralized clinical trials and digital technology has become a hotspot.At present,there are no specific detailed requirements of relevant regulations and documents.Based on the work during the pandemic and the new version of GCP,this paper describes the impact of the COVID-19 pandemic on traditional clinical trials,and analyzes and discusses the requirements of remote decentralized clinical trials and digital technology from the perspective of regulation and science.The application of remote decentralized clinical trial and digital technology should be based on the requirements of GCP to protect the safety of subjects and data integrity,so as to provide convenience for subjects and participants,and ultimately improve the efficiency of clinical trials.

关 键 词：临床试验 数字化技术 远程智能 新冠肺炎 药物临床试验质量管理规范 

分 类 号：R95[医药卫生—药学]