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There is high similarity between real-world study (RWS) and the clinical practice of traditional Chinese medicine (TCM). RWS can be used as one of the methods to collect the empirical data of human use normatively, and generate high-quality empirical evidence of human use of TCM. From the perspective of the whole life cycle of TCM, RWS can not only help to choose the subject and set up the project, optimize the strategy of TCM research and develop (R&D), shorten the R&D period, guide the pharmacological and toxicological research and clinical trial design, improve the research efficiency, but also continuously explore the clinical value and extend the life cycle of products. In view of the deficiencies in the quality of real-world data and the methodology for using real-world data needing to be standardized, it is necessary to clean up the data to form applicable analysis data, and form the truth through standardized methodological design, well organized implementation, and reasonable statistical analysis. Exploring the safety and effectiveness of TCM with the real-world evidence would support the research and development of new TCM products with human experience.

, authors=Yao LU¹, Hai-nan WANG², authorsList=Yao LU, Hai-nan WANG, authorCompany=null, correspAuthors=Hai-nan WANG, 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=1322127431369076778, articleId=1322127430937063464, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=从中药全生命周期审视真实世界研究的作用, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

真实世界研究接近中医临床诊疗实践，可作为规范收集人用经验数据，形成高质量中药人用经验证据的方法之一。从中药全生命周期审视，真实世界研究不仅有助于选题立项、优化研发策略、缩短研发周期，指导药理毒理研究及临床试验设计、提高研究效率，也可以不断挖掘临床价值、延长产品生命周期。鉴于真实世界数据质量上的缺陷以及利用真实世界数据的方法学有待规范，需要经过数据清理形成可适用的分析数据，并通过规范的方法学设计、严谨的组织实施及合理的统计分析形成真实世界证据，探索用于中药的安全性、有效性评价，来支持已有人用经验的中药新药研发。

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路遥，女，硕士，副研究员，主要从事临床试验管理研究。联系电话：（010）87689782，E-mail：dfluyao@126.com。

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路遥，女，硕士，副研究员，主要从事临床试验管理研究。联系电话：（010）87689782，E-mail：dfluyao@126.com。

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