Article(id=1291704931455619424, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.18.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1749744000000, receivedDateStr=2025-06-13, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896054376, onlineDateStr=2026-08-05, pubDate=1758988800000, pubDateStr=2025-09-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896054376, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896054376, creator=13701087609, updateTime=1785896054376, updator=13701087609, issue=Issue{id=1291704811443999077, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='18', pageStart='2551', pageEnd='2700', issueExtLink='null', onlineDate='null', pubDate='1758988800000', pubDateStr='2025-09-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896025763, creator='13701087609', updateTime=1785896871490, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708358743053253, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708358743053254, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2697, endPage=2700, ext={EN=ArticleExt(id=1291704931615002977, articleId=1291704931455619424, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=General statistical considerations in the design of confirmatory clinical trials for antiviral drugs in uncomplicated influenza patients, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

The purpose of this article is to discuss the general statistical considerations of confirmatory clinical trial design of antiviral drugs for uncomplicated influenza patients, including estimands, sample size, bias control measures and statistical analysis methods, with reference to the Food and Drug Administration (FDA) biostatistics review report on baloxavir marboxil, the guidance of clinical trial technology for influenza treatment and prevention drugs, ICH E9R1 and statistical guidances issued by National Medical Products Administration (NMPA), in order to provide reference for clinical trial design of antiviral drugs in uncomplicated influenza patients.

, authors=Ming-li HENG, Feng-yu SUN, Chen-bo ZHANG, authorsList=Ming-li HENG, Feng-yu SUN, Chen-bo ZHANG, authorCompany=null, correspAuthors=Ming-li HENG, 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=1291704932181234018, articleId=1291704931455619424, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=流感抗病毒药物确证性临床试验的统计学考虑, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

本文旨在参考美国食品药品监督管理局（FDA）关于玛巴洛沙韦生物统计学审评报告，并结合国家药品监督管理局（NMPA）发布的《流行性感冒治疗和预防药物临床试验技术指导原则》、国际人用药品注册技术协调会《临床试验的统计学原则》指导原则的增补——临床试验中的估计目标与敏感性分析（ICH E9R1）以及统计学相关指导原则，探讨单纯性流感抗病毒治疗药物临床试验设计的相关统计学考虑，包括估计目标、样本量、偏倚控制措施和统计分析方法等，以期为无并发症的单纯性流感患者抗病毒治疗药物确证性临床试验设计提供参考。

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衡明莉（1980-），女，副研究员，主要从事生物统计学审评工作

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衡明莉（1980-），女，副研究员，主要从事生物统计学审评工作

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