Article(id=1322125573200138684, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, 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=1629907200000, acceptedDateStr=2021-08-26, onlineDate=1793148900555, onlineDateStr=2026-10-28, pubDate=1638201600000, pubDateStr=2021-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793148900555, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793148900555, creator=13701087609, updateTime=1793148900555, updator=13701087609, issue=Issue{id=1322125552731927464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='22', pageStart='2017', pageEnd='2120', issueExtLink='null', onlineDate='null', pubDate='1638201600000', pubDateStr='2021-11-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793148895675, creator='13701087609', updateTime=1793149501548, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128094022971944, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128094022971945, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2083, endPage=2090, ext={EN=ArticleExt(id=1322125573393076669, articleId=1322125573200138684, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Overview and applications of master protocol in clinical trials, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Master protocol is a novel and more efficient design for clinical trial research than the traditional clinical trials. Usually a master protocol includes several sub-protocols which could investigate treatment effects of a single drug on several diseases or multiple drugs targeting a single disorder. This review compared master protocol with traditional trials in terms of the research design principle, application, and procedure flow as well as advantages and limitations. We also presented some examples of ongoing applications of master protocol designs including treatment of COVID-19 related illness. Finally, we discussed about potential implementation of master protocol in China especially under the COVID-19 pandemic with an evaluation on the relevant opportunities and challenges.

, authors=Yuan-ming MAO^{1, 3}, Jin-qi ZHAN², Rong-rong WANG³, Qiu-tang XIE¹, Ying-ying DAI¹, Shu-wei LIU¹, Jin-yu ZHOU⁴, Hong-jia ZHU⁵, Jing MA⁶, authorsList=Yuan-ming MAO, Jin-qi ZHAN, Rong-rong WANG, Qiu-tang XIE, Ying-ying DAI, Shu-wei LIU, Jin-yu ZHOU, Hong-jia ZHU, Jing MA, authorCompany=null, correspAuthors=Jing MA, 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=1322125573653123518, articleId=1322125573200138684, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=临床医学试验主方案概述及其应用, columnId=1236331741447778310, journalTitle=中国新药杂志, columnName=药物临床试验规范与进展专栏, runingTitle=null, highlight=null, articleAbstract=

主方案（master protocol）试验设计是一种旨在突破传统临床试验壁垒，提高药物研发效率的新型临床试验模式。一个主设计方案下含有多个子方案，使同时针对一种药物对于多种疾病疗效或多个药物对于一种疾病疗效的临床试验成为现实。本文综述了主方案的设计理念、应用现状与流程细节，总结了主方案相较于传统试验设计的优势，并讨论了以2019新型冠状病毒肺炎（COVID-19）疫情作为契机，在我国推行主方案应用的机遇与挑战。

, authors=毛元铭^{1, 3}, 詹瑨祺², 王榕榕³, 谢秋堂¹, 戴英莹¹, 刘姝玮¹, 周瑾瑜⁴, 朱鸿嘉⁵, 马晶⁶, authorsList=毛元铭, 詹瑨祺, 王榕榕, 谢秋堂, 戴英莹, 刘姝玮, 周瑾瑜, 朱鸿嘉, 马晶, authorCompany=null, correspAuthors=马晶, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=f5qX4j6EWteKvo/HF+skLg==, magXml=qNBpmTrzZIFSNoxAtl8ndA==, pdfUrl=null, pdf=xTVXN9F7xn2v3B8R8eXtvQ==, pdfFileSize=1532168, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=VFRhSINQ7PjcJh29CzB7pQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322125574496178642, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125573200138684, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=mym927@126.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322125574638784981, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125573200138684, authorId=1322125574496178642, language=EN, stringName=Yuan-ming MAO, firstName=Yuan-ming, middleName=null, lastName=MAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^{1, 3}, address=¹Columbia University Mailman School of Public Health, New York 10032, United States
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³中美健康峰会，马萨诸塞州　02142，美国, bio={"content":"

毛元铭，女，硕士研究生，主要从事分子流行病学研究。E-mail：mym927@126.com。

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毛元铭，女，硕士研究生，主要从事分子流行病学研究。E-mail：mym927@126.com。

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