Article(id=1236334083970757125, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, 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=1667491200000, acceptedDateStr=2022-11-04, onlineDate=1772694615594, onlineDateStr=2026-03-05, pubDate=1690646400000, pubDateStr=2023-07-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694615594, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694615594, creator=13701087609, updateTime=1772694615594, updator=13701087609, issue=Issue{id=1236334083500995077, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='14', pageStart='1385', pageEnd='1488', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=0, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694615483, creator=13701087609, updateTime=1772696065206, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236340164130295845, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236340164130295846, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1406, endPage=1410, ext={EN=ArticleExt(id=1236334084184666630, articleId=1236334083970757125, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Setting of the run-in period and its application in clinical trials, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The run-in period is a specific stage after enrollment and before randomization. It is an important design element of many landmark drug clinical trials and plays an important role in drug development. However, the status quo includes non-standard design of run-in period in research protocols and inadequate reporting of run-in period in results. The author summarize the definition, type, duration, significance, advantages and disadvantages of the run-in period, and list clinical application cases, in order to provide reference for the clinical trial design and the application of the run-in period.

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导入期是受试者入组后与随机分组前的一个特定阶段，是很多具有里程碑意义的药物临床试验的重要设计元素，在药物研发中具有重要作用。然而，目前普遍存在导入期在研究方案中设计不规范、研究结果中报告不充分的问题。本文梳理了导入期的定义、类型、周期长短、意义及优缺点，并列举了临床应用案例，以期为临床研究方案中关于导入期的设计及应用提供借鉴。

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²北京中医药大学中医脑病研究院，北京 100700, bio={"content":"

韩芳，女，主治医师，助理研究员，研究方向：中医药防治神经系统疾病、科研管理。联系电话：(010)87907498，E-mail: hftcmdoctor@mail.ccmu.edu.cn。

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韩芳，女，主治医师，助理研究员，研究方向：中医药防治神经系统疾病、科研管理。联系电话：(010)87907498，E-mail: hftcmdoctor@mail.ccmu.edu.cn。

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