Article(id=1291704908818969351, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.20.024, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1753977600000, receivedDateStr=2025-08-01, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896048979, onlineDateStr=2026-08-05, pubDate=1761580800000, pubDateStr=2025-10-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896048979, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896048979, creator=13701087609, updateTime=1785896048979, updator=13701087609, issue=Issue{id=1291704786705993936, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='20', pageStart='2851', pageEnd='3000', issueExtLink='null', onlineDate='null', pubDate='1761580800000', pubDateStr='2025-10-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896019864, creator='13701087609', updateTime=1785896741492, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707813508702571, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707813508702572, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2993, endPage=3000, ext={EN=ArticleExt(id=1291704909431337736, articleId=1291704908818969351, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis of success and failure in dry eye drug development, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=

Dry eye disease causes eye discomfort in patients due to lack of tears or instability of the tear film and has a prevalence of 30%-50% in Asia. Conventional therapies suffer from limited efficacy and frequent drug administration, leading to continued active research and development of new drugs. This research explores the development process of 12 new dry eye drugs from 2003 to 2023, and analyzes the key successes and failures of these drugs in the context of U.S. Food and Drug Administration(FDA) guidelines. The study found that the core strategies of successful drugs included flexible adjustment of phase Ⅲ endpoints, strict adherence to one of the three FDA efficacy targets, and consistency between phase Ⅱ and phase Ⅲ trial designs. Failure cases were mostly due to deficiencies in the design of phase Ⅱ trials, such as overestimation of the efficacy of the drug due to small samples and lack of a placebo control, which led to an insufficient sample size for phase Ⅲ trials, and also due to the failure of the drug because of failure of endpoints to be adjusted in a timely manner. Dry eye drug development should be based on rigorous phase Ⅱ clinical trials, prioritize objective endpoint indicators such as the Schirmer test in phase Ⅲ studies, and set up an run-in period to reduce the placebo effect, as well as to meet the FDA's requirements on sample size and endpoint indicators, so as to effectively reduce the risk of research and development and improve the success rate of drug marketing.

, authors=Jin-wen WANG¹, Xia CHEN², authorsList=Jin-wen WANG, Xia CHEN, authorCompany=null, correspAuthors=Xia CHEN, 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=1291704909804630793, articleId=1291704908818969351, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=干眼药物研发成败案例分析, columnId=1291704889869103713, journalTitle=中国临床药理学杂志, columnName=临床试验管理专栏, runingTitle=null, highlight=null, articleAbstract=

干眼症由于缺乏泪液或泪膜不稳定引起患者眼部不适，在亚洲患病率高达30%~50%。传统疗法存在疗效局限和频繁给药等问题，导致新药研发持续活跃。本研究通过探索2003至2023年12种干眼新药研发过程，结合美国食品药品监督局（FDA）指导原则剖析研发成败关键。研究发现成功药物核心策略包括灵活调整Ⅲ期终点，严格遵循FDA三项疗效指标之一，并保持Ⅱ期与Ⅲ期试验设计的一致性等；失败案例多因Ⅱ期设计缺陷导致，例如小样本、缺乏安慰剂对照造成疗效高估，进而引发Ⅲ期样本量不足，也有药物因终点未及时调整而失败。干眼症药物研发须以严格的Ⅱ期临床试验为基础，在Ⅲ期研究中优先选择Schirmer试验等客观终点指标，并设置导入期以降低安慰剂效应，同时满足FDA对样本量和终点指标等要求，从而有效降低研发风险，提高药物上市成功率。

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王瑾雯（2001－） ，女，硕士研究生，主要从事药物临床试验方向的相关研究

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王瑾雯（2001－） ，女，硕士研究生，主要从事药物临床试验方向的相关研究

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