Article(id=1322624503725801792, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.19.005, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1783872000000, receivedDateStr=2026-07-13, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793267854863, onlineDateStr=2026-10-29, pubDate=1791993600000, pubDateStr=2026-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793267854863, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793267854863, creator=13701087609, updateTime=1793267854863, updator=13701087609, issue=Issue{id=1322624482217415197, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='19', pageStart='2017', pageEnd='2128', issueExtLink='null', onlineDate='null', pubDate='1791993600000', pubDateStr='2026-10-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1793267849735, creator='13701087609', updateTime=1793268229475, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322626075042100008, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322626075046294313, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2055, endPage=2060, ext={EN=ArticleExt(id=1322624503914545473, articleId=1322624503725801792, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Reflections on the management of investigational products in the light of the revised Good Clinical Practice, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To explore the current application status, implementation considerations, and practical measures for a new model of delivering investigational drugs directly to trial participants (direct-to-subject, DTS) in the context of the revised Good Clinical Practice (GCP) and ICH E6 (R3), with the aim of providing a reference for optimizing its management quality.
Methods: Through a literature review, this study compared regulatory policy differences, current implementation status, and common models for the direct-to-subject model between domestic and international settings, and analyze the key considerations for its implementation.
Results: The direct-to-subject model has been adopted both domestically and internationally, but there is a lack of unified implementation guidelines. Its use may be considered when appropriate. Effective implementation can be ensured by strengthening the following aspects: clarification of responsibilities, ethical review, informed consent, risk assessment, qualification verification, training, information system development, risk management, privacy protection, and investigator oversight.
Conclusion: The model aligns with the “patient-centered” philosophy but is still in its exploratory phase. When planning to adopt this approach, its feasibility should be fully demonstrated in the protocol, with enhanced emphasis on ethical review, training, and risk control, while clearly defining the responsibilities of all parties to safeguard participants’ rights and ensure data reliability.
, authors=Hui-zhen JIN
1, Chen-mei MAO
1, Ya-ru ZOU
1, Ji-yin ZHOU
2, *, authorsList=Hui-zhen JIN, Chen-mei MAO, Ya-ru ZOU, Ji-yin ZHOU, authorCompany=null, correspAuthors=Ji-yin ZHOU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322624504212341058, articleId=1322624503725801792, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=新版《药物临床试验质量管理规范》背景下试验用药品管理的思考, columnId=1322624486113915175, journalTitle=中国新药杂志, columnName=·2026年版《药物临床试验质量管理规范》解读专题, runingTitle=null, highlight=null, articleAbstract=
目的： 探讨在新版《药物临床试验质量管理规范》及ICH E6（R3）背景下试验用药品直达试验参与者这一新型试验用药品供应模式的应用现状、实施考量与落实措施，为优化其管理质量提供参考。
方法： 通过文献分析，比较国内外试验用药品直达试验参与者模式应用的监管政策差异、实施现状及常见模式，分析实施的主要考量点。
结果： 试验用药品直达试验参与者模式在国内外已有所应用，但缺乏统一的实施细则，在适当情况下可考虑使用，通过强化职责划分、伦理审查、知情同意、风险评估、资质审核、培训、信息化建设、风险管理、隐私保护及研究者监管等方面保障有效实施。
结论： 试验用药品直达试验参与者模式符合“以患者为中心”理念，但尚处于探索阶段。计划使用时应在方案中充分论证其可行性，加强伦理审查、培训与风险管控，明确各方职责，从而保障参与者权益与数据可靠性。
, authors=金慧臻
1, 毛晨梅
1, 邹亚茹
1, 周吉银
2, *, authorsList=金慧臻, 毛晨梅, 邹亚茹, 周吉银, authorCompany=null, correspAuthors=周吉银, authorNote=
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金慧臻，男，副主任药师，主要从事临床试验项目管理工作。E-mail：522941840@qq.com。
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金慧臻，男，副主任药师，主要从事临床试验项目管理工作。E-mail：522941840@qq.com。
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