Article(id=1322246382535164713, 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=1603900800000, acceptedDateStr=2020-10-29, onlineDate=1793177703746, onlineDateStr=2026-10-28, pubDate=1623686400000, pubDateStr=2021-06-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177703746, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177703746, creator=13701087609, updateTime=1793177703746, 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=980, endPage=983, ext={EN=ArticleExt(id=1322246382690353962, articleId=1322246382535164713, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=US FDA “Real-World Evidence Program”: the enlightenment to China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

This article aims to provide reference for China to use real-world evidence (RWE) in drug approval and regulatory decision-making system. The main content of “Real-World Evidence Program” issued by US FDA was summarized by literature research method, and the construction of related systems in China were analyzed. To promote the application of real-world research for drug regulatory decisions, China should publish guidelines related to real-world research, promote the construction of data standards and shared database, extensively introduce the demonstration projects as well as strengthen the guidance for real-world research of enterprises. And at the same time, the relationship between stakeholders should be paid attention to deal with.

, authors=Li DONG^{1, 2}, Gui-yu LIAN^{1, 2}, Chuang WANG^{1, 2}, Xian-qin HUANG¹, Yu-wen CHEN^{1, 2}, Zhe HUANG^{1, 2}, authorsList=Li DONG, Gui-yu LIAN, Chuang WANG, Xian-qin HUANG, 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=1322246382900069163, articleId=1322246382535164713, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=美国FDA《真实世界证据计划框架》及对我国的启示, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

本文旨在为我国使用真实世界证据（RWE）用于药品审批和监管决策制度的建立提供参考。采用文献研究法对美国FDA发布的《真实世界证据计划框架》的主要内容进行概述，并对我国相关制度建设进行了分析。为促进利用真实世界研究用于药品监管决策，中国应该发布真实世界研究相关指南或指导原则，应促进数据标准建设和加强共享数据库建设，应广泛介绍示范项目并加强对企业真实世界研究的指导，同时要注意处理利益相关者关系。

, authors=董丽^{1, 2}, 连桂玉^{1, 2}, 王闯^{1, 2}, 黄先琴¹, 陈玉文^{1, 2}, 黄哲^{1, 2}, authorsList=董丽, 连桂玉, 王闯, 黄先琴, 陈玉文, 黄哲, authorCompany=null, correspAuthors=陈玉文, 黄哲, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=uN9NpuWbh5pi24+7rIYw1Q==, magXml=AUZZk0KRFcJDzcjy/d1osQ==, pdfUrl=null, pdf=+BnCbV2KuiQPX66fQjXMcw==, pdfFileSize=865494, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=y5+hAvKUP3NgfFPg+NypQQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322246383294333747, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246382535164713, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=sydongli@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322246383374025526, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246382535164713, authorId=1322246383294333747, language=EN, stringName=Li DONG, firstName=Li, middleName=null, lastName=DONG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^{1, 2}, address=¹Shenyang Pharmaceutical University School of Business Administration, Shenyang 110016, China
²Shenyang Pharmaceutical University Institute of Pharmaceutical Regulatory Science, Shenyang 110016, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322246383449522999, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246382535164713, authorId=1322246383294333747, language=CN, stringName=董丽, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^{1, 2}, address=¹沈阳药科大学　工商管理学院，沈阳　110016
²沈阳药科大学　药品监管科学研究院，沈阳　110016, bio={"content":"

董丽，女，博士，副教授，硕士研究生导师，研究方向：药事管理。E-mail：sydongli@163.com。

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董丽，女，博士，副教授，硕士研究生导师，研究方向：药事管理。E-mail：sydongli@163.com。

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