Article(id=1322246382795215212, 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=1606579200000, acceptedDateStr=2020-11-29, onlineDate=1793177703807, onlineDateStr=2026-10-28, pubDate=1623686400000, pubDateStr=2021-06-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177703807, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177703807, creator=13701087609, updateTime=1793177703807, 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=971, endPage=975, ext={EN=ArticleExt(id=1322246383004930413, articleId=1322246382795215212, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=A comparative study of real-world evidence and randomized controlled trial evidence, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Results from large-sample double-blind randomized controlled trial (RCT) have always represented the highest level of evidence-based medicine clinical evidence, but it cannot solve all the clinical research problems, thus real-world evidence (RWE) based on the perspective of real-world research (RWS) has developed rapidly. This paper aims to provide reference for the further application and development of RWE by comparing the differences between RWE and randomized controlled trial evidence in data source, internal and external effectiveness, evidence level, application scope, experiment design, implementation elements and implementation cost.

, authors=Yu ZHANG1, 2, Yi QU1, 2, Li DONG1, 2, Ling-quan MENG1, 2, Zhe HUANG1, 2, Yu-wen CHEN1, 2, authorsList=Yu ZHANG, Yi QU, Li DONG, Ling-quan MENG, Zhe HUANG, Yu-wen CHEN, authorCompany=null, correspAuthors=Zhe HUANG, Yu-wen CHEN, 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=1322246383248200046, articleId=1322246382795215212, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=真实世界证据与随机对照试验证据比较研究, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

大样本双盲的随机对照试验(RCT)结果历来代表循证医学临床证据的最高等级,但它无法解决所有的临床研究问题,因此基于真实世界研究(RWS)视角下的真实世界证据(RWE)得到了迅速发展。本文通过对比生成真实世界证据与随机对照试验证据在数据来源、内外部有效性、证据等级、应用范围、试验设计、实施要素、实施成本中的差异,旨在为真实世界证据的进一步应用发展提供参考。

, authors=张喻1, 2, 曲艺1, 2, 董丽1, 2, 孟令全1, 2, 黄哲1, 2, 陈玉文1, 2, authorsList=张喻, 曲艺, 董丽, 孟令全, 黄哲, 陈玉文, authorCompany=null, correspAuthors=黄哲, 陈玉文, authorNote=

张喻,男,硕士研究生,研究方向:药事管理。E-mail:。

, correspAuthorsNote=
陈玉文,男,教授,博士生导师,研究方向:药事管理。联系电话:(024)23986552,E-mail:。
黄哲,女,教授,博士生导师,研究方向:药事管理。E-mail:。
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张喻,男,硕士研究生,研究方向:药事管理。E-mail:。

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张喻,男,硕士研究生,研究方向:药事管理。E-mail:。

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真实世界证据与随机对照试验证据比较研究
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张喻 1, 2 , 曲艺 1, 2 , 董丽 1, 2 , 孟令全 1, 2 , 黄哲 1, 2 , 陈玉文 1, 2
中国新药杂志 | 新药述评与论坛 2021,30(11): 971-975
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中国新药杂志 |新药述评与论坛 2021 , 30 (11) : 971 -975
真实世界证据与随机对照试验证据比较研究
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张喻1, 2 , 曲艺1, 2, 董丽1, 2, 孟令全1, 2, 黄哲1, 2 , 陈玉文1, 2
作者信息
  • 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
通讯作者:
陈玉文,男,教授,博士生导师,研究方向:药事管理。联系电话:(024)23986552,E-mail:。
黄哲,女,教授,博士生导师,研究方向:药事管理。E-mail:。
作者简介:

张喻,男,硕士研究生,研究方向:药事管理。E-mail:。

A comparative study of real-world evidence and randomized controlled trial evidence
Yu ZHANG1, 2 , Yi QU1, 2, Li DONG1, 2, Ling-quan MENG1, 2, Zhe HUANG1, 2 , Yu-wen CHEN1, 2
Affiliations
  • 1Shenyang Pharmaceutical University School of Business Administration, Shenyang 110016, China
  • 2Shenyang Pharmaceutical University Shenyang Pharmaceutical University/Institute of Pharmaceutical Regulatory Sciences, Shenyang 110016, China
出版时间: 2021-06-15
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大样本双盲的随机对照试验(RCT)结果历来代表循证医学临床证据的最高等级,但它无法解决所有的临床研究问题,因此基于真实世界研究(RWS)视角下的真实世界证据(RWE)得到了迅速发展。本文通过对比生成真实世界证据与随机对照试验证据在数据来源、内外部有效性、证据等级、应用范围、试验设计、实施要素、实施成本中的差异,旨在为真实世界证据的进一步应用发展提供参考。

真实世界数据  /  真实世界证据  /  随机对照试验证据

Results from large-sample double-blind randomized controlled trial (RCT) have always represented the highest level of evidence-based medicine clinical evidence, but it cannot solve all the clinical research problems, thus real-world evidence (RWE) based on the perspective of real-world research (RWS) has developed rapidly. This paper aims to provide reference for the further application and development of RWE by comparing the differences between RWE and randomized controlled trial evidence in data source, internal and external effectiveness, evidence level, application scope, experiment design, implementation elements and implementation cost.

real world data  /  real world evidence  /  randomized controlled trial evidence
张喻, 曲艺, 董丽, 孟令全, 黄哲, 陈玉文. 真实世界证据与随机对照试验证据比较研究. 中国新药杂志, 2021 , 30 (11) : 971 -975 .
Yu ZHANG, Yi QU, Li DONG, Ling-quan MENG, Zhe HUANG, Yu-wen CHEN. A comparative study of real-world evidence and randomized controlled trial evidence[J]. Chinese Journal of New Drugs, 2021 , 30 (11) : 971 -975 .
  • 国家药品监督管理局药品监管科学研究基地-沈阳药科大学药品监管科学研究院专项基金资助项目(2020jgkx005)
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2021年第30卷第11期
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  • 首发时间:2026-10-28
  • 出版时间:2021-06-15
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  • 录用日期:2020-11-29
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国家药品监督管理局药品监管科学研究基地-沈阳药科大学药品监管科学研究院专项基金资助项目(2020jgkx005)
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    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

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陈玉文,男,教授,博士生导师,研究方向:药事管理。联系电话:(024)23986552,E-mail:。
黄哲,女,教授,博士生导师,研究方向:药事管理。E-mail:。
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2种不同金属材料的力学参数
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属数
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genus
种数
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species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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