Article(id=1322626735166832743, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, 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=1590508800000, acceptedDateStr=2020-05-27, onlineDate=1793268386880, onlineDateStr=2026-10-29, pubDate=1610640000000, pubDateStr=2021-01-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268386880, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268386880, creator=13701087609, updateTime=1793268386880, updator=13701087609, issue=Issue{id=1322626690153562922, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='1', pageStart='1', pageEnd='93', issueExtLink='null', onlineDate='null', pubDate='1610640000000', pubDateStr='2021-01-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268376148, creator='13701087609', updateTime=1793269030229, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322629433626837820, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322629433626837821, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=35, endPage=37, ext={EN=ArticleExt(id=1322626735330410600, articleId=1322626735166832743, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Countermeasures for drug clinical trial management under major public health emergencies, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The management strategies for drug clinical trials under major public health emergencies were discussed from the perspectives of measures taken for epidemic prevention and control as well as clinical trial quality assurance. Facing major public health emergencies, clinical trial institutions should take preventive and control measures in accordance with relevant regulations. It was necessary for ethics committees, investigators and sponsors to take use of any approaches to minimize the impact on trial quality. A major public health emergency is the challenge to emergency response capability for drug clinical trial institutions. Relevant practitioners need to promote cooperation among all parties by transforming their thinking modes so as to improve comprehensive management skills.

, authors=Peng PENG, Wei-an YUAN, Yi-hui HU, Jie TANG, authorsList=Peng PENG, Wei-an YUAN, Yi-hui HU, Jie TANG, authorCompany=null, correspAuthors=Wei-an YUAN, 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=1322626735552708713, articleId=1322626735166832743, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=重大突发公共卫生事件下药物临床试验管理对策, columnId=1236331161786569054, journalTitle=中国新药杂志, columnName=重大新药创制专项巡礼, runingTitle=null, highlight=null, articleAbstract=

本文拟通过针对疫情防控所采取的措施及临床试验质量保证的角度，探讨重大突发公共卫生事件下药物临床试验的管理对策。面对重大突发公共卫生事件，临床试验机构应根据相关规定采取防控措施，伦理委员会、研究者、申办者也要尽可能利用各种渠道减少对试验质量的影响。重大突发公共卫生事件是对药物临床试验机构应急能力的挑战。相关从业人员需转换思维模式，推进各方合作，全面提升管理能力。

, authors=彭朋, 元唯安, 胡薏慧, 汤洁, authorsList=彭朋, 元唯安, 胡薏慧, 汤洁, authorCompany=null, correspAuthors=元唯安, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=BemZ0IBsYNCnyXl4X2tVXw==, magXml=ILmhSTJvKzCoDkrmr+O7fQ==, pdfUrl=null, pdf=oK03B6y1/SkhP6p8wIOYmw==, pdfFileSize=721552, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=GbKkK8M4O8LQd5aClXH72w==, mapNumber=null, fund=null)}, authors=[Author(id=1322626735959556206, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322626735166832743, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=harryp_2007@hotmail.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322626736068608112, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322626735166832743, authorId=1322626735959556206, language=EN, stringName=Peng PENG, firstName=Peng, middleName=null, lastName=PENG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=National Drug Clinical Trial Institution, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322626736156688497, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322626735166832743, authorId=1322626735959556206, language=CN, stringName=彭朋, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=上海中医药大学附属曙光医院国家药物临床试验机构，上海　201203, bio={"content":"

彭朋，男，硕士，主管药师，主要从事药物临床试验质量控制研究。联系电话：（021）20256052，E-mail：harryp_2007@hotmail.com。

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彭朋，男，硕士，主管药师，主要从事药物临床试验质量控制研究。联系电话：（021）20256052，E-mail：harryp_2007@hotmail.com。

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