Article(id=1242141949856129974, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1242141088937485147, articleNumber=null, orderNo=null, doi=10.3981/j.issn.1000-7857.2024.05.00477, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1713283200000, receivedDateStr=2024-04-17, revisedDate=1720281600000, revisedDateStr=2024-07-07, acceptedDate=null, acceptedDateStr=null, onlineDate=1734105600000, onlineDateStr=2024-12-14, pubDate=1731427200000, pubDateStr=2024-11-13, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1734105600000, onlineIssueDateStr=2024-12-14, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1774079318725, creator=sys-migrate, updateTime=1774079318725, updator=sys-migrate, issue=Issue{id=1242141088937485147, tenantId=1146029695717560320, journalId=1146031591421210625, year='2024', volume='42', issue='21', pageStart='1', pageEnd='188', issueExtLink='null', onlineDate='null', pubDate='1731427200000', pubDateStr='2024-11-13', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=null, issueType=-1, specialIssue=null, createTime=1774079113466, creator='sys-migrate', updateTime=1774079113466, updator='sys-migrate', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=163, endPage=169, ext={EN=ArticleExt(id=1242141956806094986, articleId=1242141949856129974, tenantId=1146029695717560320, journalId=1146031591421210625, language=EN, title=Ethical considerations of real world research and its consideration in the clinical practice of traditional Chinese medicine, columnId=1242141098387252106, journalTitle=Science & Technology Review, columnName=Exclusive: The paradigm and application of clinical research in traditional Chinese medicine, runingTitle=null, highlight=null, articleAbstract=Evidence generated from real world data can be used to support drug development，therefoere the real world study of traditional Chinese medicine (TCM) has ushered in a good opportunity for development.However it faces new ethical risks and challenges.The article analyzes the common ethical issues involved in real world study, such as population selection, study duration, implementation scenarios, personnel, and research data.It outlines the choice and elements of informed consent models and further explores the challenges and solutions that TCM real world study may encounter in human experience, data governance, and research design.The analysis demonstrates that domestic regulations related to real world study are becoming more refined and aligned with international standards.Researchers need to dynamically learn relevant requirements, scientifically design clinical studies, and implement ethical requirements to ultimately form reliable, trustworthy, and usable real-world evidence., authors=LI Ruoqi^1,2, DUAN Wenhui², WANG Dong², XUE Yiming², WANG Peichen², ZI Mingjie^2,3,4, authorsList=LI Ruoqi, DUAN Wenhui, WANG Dong, XUE Yiming, WANG Peichen, ZI Mingjie, authorCompany=1. Graduate School, Bejing University of Chinese Medicine, Beijing 100029, China;
2. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;
3. NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China;
4. National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China, correspAuthors=null, 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=1242141955812044928, articleId=1242141949856129974, tenantId=1146029695717560320, journalId=1146031591421210625, language=CN, title=真实世界研究的伦理考虑及在中医临床中的思考, columnId=1242141097774883713, journalTitle=科技导报, columnName=专题：中医临床研究的范式与应用, runingTitle=null, highlight=null, articleAbstract=分析了真实世界研究在人群选择、研究期限、实施场景、实施人员、研究数据等方面涉及的共性伦理问题，概述了知情同意模式的选择和撰写要素，并进一步探讨中医真实世界研究在人用经验、数据治理、研究设计中可能遇到的挑战和解决办法。分析说明，国内真实世界研究相关规范趋于完善和细化，也将逐渐与国际接轨，需要研究者动态学习相关要求，科学设计临床研究，落实伦理要求，才能最终形成可靠、可信、可利用的真实世界证据。, authors=李若琪^1,2, 段文慧², 王东², 薛一鸣², 王培琛², 訾明杰^2,3,4, authorsList=李若琪, 段文慧, 王东, 薛一鸣, 王培琛, 訾明杰, authorCompany=1. 北京中医药大学研究生院, 北京 100029;
2. 中国中医科学院西苑医院, 北京 100091;
3. 中药临床研究与评价重点实验室, 北京 100091;
4. 国家中医心血管病临床医学研究中心, 北京 100091, correspAuthors=null, authorNote=李若琪，硕士研究生，研究方向为中西医结合临床，电子信箱：15070361670@163.com；訾明杰（通信作者），主任医师，研究方向为医学伦理学、临床研究方法学，电子信箱：drzimingjie@126.com, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=Rm8Ox0tkAPx04fbj0+jahw==, pdfFileSize=1042328, 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=中国中医科学院创新工程项目（CI2021A00703）；中国中医科学院科技创新工程创新团队项目（CI2021B003）)}, authors=null, keywords=[Keyword(id=1242141954004299899, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242141949856129974, language=CN, orderNo=1, keyword=真实世界研究), Keyword(id=1242141954083991677, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242141949856129974, language=CN, orderNo=1, 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