Article(id=1241720035656397270, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241720034091914228, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.06.08, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1683820800000, receivedDateStr=2023-05-12, revisedDate=null, revisedDateStr=null, acceptedDate=1709654400000, acceptedDateStr=2024-03-06, onlineDate=1773978726543, onlineDateStr=2026-03-20, pubDate=1719244800000, pubDateStr=2024-06-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773978726543, onlineIssueDateStr=2026-03-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773978726543, creator=13701087609, updateTime=1773978726543, updator=13701087609, issue=Issue{id=1241720034091914228, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='6', pageStart='401', pageEnd='480', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773978726169, creator=13701087609, updateTime=1773979021315, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241721272128828343, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241720034091914228, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241721272128828344, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241720034091914228, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=436, endPage=441, ext={EN=ArticleExt(id=1241720035887083993, articleId=1241720035656397270, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Analysis of regulatory strategies for remote decentralized clinical trials, columnId=1207314215644270693, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Policy and Management, runingTitle=null, highlight=null, articleAbstract=

Traditional clinical trials are often expensive, relatively inefficient, and may also cause additional burden for trial participants. The use of new technologies and methods in remote decentralized clinical trials (DCT) can help to improve clinical trials efficiency. The application of DCT brings several benefits, but also poses new challenges for the regulation of clinical trials. In this study, the current situation and issues surrounding the use of digital technology in clinical trials were analyzed, as well as the regulatory practices and regulatory scientific research on DCT in Europe and the United States. The proposed regulatory strategies for DCT in China were investigated, taking into account the current development and regulatory considerations of DCT in China.

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传统的临床试验通常费用昂贵，效率相对低下，还可能造成试验受试者的额外负担。远程智能临床试验（DCT）中使用了大量新技术和方法，有助于提高临床试验的效率。DCT的应用带来多项获益，但同时也为临床试验的监管带来新挑战。本研究通过梳理在临床试验中运用数字化技术的现状和问题，分析欧美国家的监管实践和在DCT方面的监管科学研究，结合国内DCT的发展现状和监管考量，探索对我国DCT的监管策略建议。

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孙搏，女，高级工程师，博士，主要从事药品审评、核查/检查等相关工作，E-mail：yssunbo@yjj.sh.gov.cn

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孙搏，女，高级工程师，博士，主要从事药品审评、核查/检查等相关工作，E-mail：yssunbo@yjj.sh.gov.cn

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李刚，男，高级工程师，硕士，主要从事药品审评、核查/检查等相关工作。E-mail：ligang@yjj.sh.gov.cn

"}, bioImg=null, bioContent=

李刚，男，高级工程师，硕士，主要从事药品审评、核查/检查等相关工作。E-mail：ligang@yjj.sh.gov.cn

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