Article(id=1322246467029414531, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, 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=1607270400000, acceptedDateStr=2020-12-07, onlineDate=1793177723891, onlineDateStr=2026-10-28, pubDate=1624982400000, pubDateStr=2021-06-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177723891, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177723891, creator=13701087609, updateTime=1793177723891, updator=13701087609, issue=Issue{id=1322246421869346895, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='12', pageStart='1057', pageEnd='1152', issueExtLink='null', onlineDate='null', pubDate='1624982400000', pubDateStr='2021-06-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177713123, creator='13701087609', updateTime=1793178158604, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248290402414824, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248290402414825, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1132, endPage=1136, ext={EN=ArticleExt(id=1322246467197186692, articleId=1322246467029414531, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=An initiative to establish coordinated and consistent causality assessment criteria for adverse drug reaction in clinical trials, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Establishment of causality between drug exposure and adverse event, namely adverse drug reaction (ADR) assessment, is a crucial procedure in drug safety evaluation. While various causality assessment tools for ADR have been published, the poor agreement among them hinders the collection, analysis and interchange of drug safety data, and causes confusion for ADR research as well. The correlation of safety information throughout the whole process of clinical trials is important, so it is well-advised to maintain causality assessment criteria as coherent and consistent in both pre-marketing and post-marketing stages. Furthermore, the application of the WHO-UMC and ICH causality assessment system may promote ADR causality assessment standardization. Since joining the ICH, China has developed a series of regulations and guidelines on ADR monitoring and evaluation. However, these documents remain unclear towards the operating instructions for ADR assessment, especially in the early pre-marketing stages. Accordingly, we suggest that coordinated and consistent causality assessment criteria and relevant operating instructions be developed to improve the data sharing and continuity of drug safety monitoring in China.

, authors=Qian HUANG¹, Ze-huai WEN^{2, 3}, authorsList=Qian HUANG, Ze-huai WEN, authorCompany=null, correspAuthors=Ze-huai WEN, 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=1322246467440456325, articleId=1322246467029414531, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=倡议建立协调统一的药物不良反应因果关系评价标准, columnId=1236331163573342670, journalTitle=中国新药杂志, columnName=药物安全与合理应用, runingTitle=null, highlight=null, articleAbstract=

评价个体的不良事件（adverse event，AE）与药物的因果关系，即药物不良反应（adverse drug reaction，ADR）因果关系判断是药物安全性评价的关键。在上市前及上市后的不同研究阶段，ADR判断、监测和评价虽各有侧重，但保持ADR因果关系评价标准在整个研发过程中的连贯性、协调性甚为重要。现行的个体ADR因果关系评价方法多样，不同方法判断结论的差异阻碍了药物安全性数据的汇总、分析和交流，也对ADR研究造成困扰。推广及应用WHO乌普萨拉监测中心（WHO-UMC）和国际人用药品注册技术协调会（ICH）的ADR因果关系评价标准和方法，将有力促进ADR因果关系判断的标准化。我国自加入ICH后，逐步建立起与国际接轨的试验及数据传输标准，但有关ADR监测与评价的法规对于ADR因果关系判断的操作说明仍较模糊，尚无文件明确说明上市前ADR因果关系评价的操作细节。因此，我们倡议制订覆盖药品研发全周期、统一协调、包含操作说明的ADR因果关系判定标准，以进一步改善我国药物安全性监测的连续性和数据共享。

, authors=黄仟¹, 温泽淮^{2, 3}, authorsList=黄仟, 温泽淮, authorCompany=null, correspAuthors=温泽淮, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=xRpywqAvFpyknehzXHqJxA==, magXml=CeVZY7B1kTnSIM94CmbPRw==, pdfUrl=null, pdf=+IY16x8CQhDav7hwXEdboA==, pdfFileSize=944387, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=KYyfst6tR2VH2Zj/SOfgoQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322246467939578512, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246467029414531, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=huangqian_2018@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322246468027658898, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246467029414531, authorId=1322246467939578512, language=EN, stringName=Qian HUANG, firstName=Qian, middleName=null, lastName=HUANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou 510120, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322246468094767763, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322246467029414531, authorId=1322246467939578512, language=CN, stringName=黄仟, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹广州中医药大学第二临床医学院，广州　510120, bio={"content":"

黄仟，女，博士研究生，研究方向：临床流行病学方法应用。联系电话：（020）81887233-35837，E-mail：huangqian_2018@163.com。

"}, bioImg=null, bioContent=

黄仟，女，博士研究生，研究方向：临床流行病学方法应用。联系电话：（020）81887233-35837，E-mail：huangqian_2018@163.com。

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