Article(id=1322246399882809794, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1603209600000, acceptedDateStr=2020-10-21, onlineDate=1793177707882, onlineDateStr=2026-10-28, pubDate=1623686400000, pubDateStr=2021-06-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177707882, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177707882, creator=13701087609, updateTime=1793177707882, updator=13701087609, issue=Issue{id=1322246381633389353, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='11', pageStart='961', pageEnd='1056', issueExtLink='null', onlineDate='null', pubDate='1623686400000', pubDateStr='2021-06-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177703531, creator='13701087609', updateTime=1793178125547, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248152208486593, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248152212680898, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=976, endPage=979, ext={EN=ArticleExt(id=1322246400331600323, articleId=1322246399882809794, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The enlightenment to the establishment of real-world data applicability evaluation standard in China from “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” of US FDA, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

This paper is expected to provide reference for China to establish appropriate standards to evaluate the adaptability of real-world data, and facilitate the establishment of related systems for medical device approval and supervision. Finding appraised standard to evaluate the suitability of real-world data by analyzing the series of factors in the “Use of Real-world Evidence to Support Regulatory Decision-Making for Medical Devices”, in order to turn real-world data (RWD) into a truly practical real-word evidence (RWE). The adaptability assessment of China's RWD can be carried out from 2 aspects such as relevance and reliability. In the aspect of RWD relevance assessment, evaluation criteria can be designed from 5 aspects: data source and selection, data validity, regulatory requirements, ethical issues as well as operability. In the aspect of real world data reliability assessment, evaluation criteria can be designed from 3 aspects: management process standardization, data standardization and quality control.

, authors=Xiao-liang YUAN^{1, 2}, Li DONG^{1, 2}, Ling-quan MENG^{1, 2}, Yu-wen CHEN^{1, 2}, Zhe HUANG^{1, 2}, authorsList=Xiao-liang YUAN, Li DONG, Ling-quan MENG, Yu-wen CHEN, Zhe HUANG, authorCompany=null, correspAuthors=Yu-wen CHEN, Zhe HUANG, 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=1322246400780390852, articleId=1322246399882809794, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=美国FDA《使用真实世界证据支持医疗器械的监管决策指南》对我国真实世界数据适用性评估标准建立的启示, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

本文旨在为我国制定合适标准来评估真实世界数据（RWD）适应性，助力医疗器械审批和监管决策相关制度建立提供参考。通过深入剖析美国FDA《使用真实世界证据支持医疗器械的监管决策指南》中对RWD适用性评估的系列要素，寻求评估RWD适应性，使RWD转化为真实可用的真实世界证据（RWE）的相关标准。我国RWD适应性评估可以从相关性和可靠性2个层面进行，RWD相关性评估可从数据来源及选取范围、数据有效性、监管要求、伦理问题和可操作性5个方面设计评估标准。在RWD可靠性方面可从管理流程规范性、数据标准化、数据质量控制三方面设计评估标准。

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²沈阳药科大学　药品监管科学研究院，沈阳　110016, bio={"content":"

袁小量，女，副教授，博士，研究方向：药事管理。E-mail：yxl19840806@163.com。

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袁小量，女，副教授，博士，研究方向：药事管理。E-mail：yxl19840806@163.com。

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