Article(id=1321425858829603466, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.17.009, 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=1758124800000, acceptedDateStr=2025-09-18, onlineDate=1792982075649, onlineDateStr=2026-10-26, pubDate=1789401600000, pubDateStr=2026-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982075649, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982075649, creator=13701087609, updateTime=1792982075649, updator=13701087609, issue=Issue{id=1321425847911830056, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='17', pageStart='1793', pageEnd='1904', issueExtLink='null', onlineDate='null', pubDate='1789401600000', pubDateStr='2026-09-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982073047, creator='13701087609', updateTime=1792982858328, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429141673586821, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429141673586822, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1849, endPage=1853, ext={EN=ArticleExt(id=1321425859026735755, articleId=1321425858829603466, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Exploration on the current status of protocol violations in pediatric drug clinical trials and corresponding countermeasures, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To analyze the current situation and causes of protocol violations in pediatric drug clinical trials, develop strategies to prevent and reduce them, and provide a reference for standardized implementation of pediatric drug clinical trials.
Methods: Cases of protocol violations in pediatric drug clinical trials at a Grade Ⅲ Level A specialized women and children's hospital from January 2022 to June 2025 were collected. A retrospective analysis of the types of protocol violations, responsible entities, and specific causes was performed, and targeted improvement measures were formulated accordingly.
Results: Across 24 pediatric drug clinical trials, a total of 186 occurrences of protocol violations were recorded. The primary types included sample-related violations, visit-related violations, medication-related violations, and examination/test-related violations. When classified by the responsible entity and ranked by frequency of occurrence, the order was: subjects/guardians, investigators, clinical research coordinators, sponsors, and other factors.
Conclusion: Throughout the entire process of pediatric drug clinical trials, continuous summary and optimization work should be carried out, and corresponding strategies should be formulated for each responsible entity to effectively reduce the incidence of protocol violations, thereby providing practical reference for improving the quality of pediatric clinical trials.
, authors=Zhuo-er ZHU, Ying-yan YAN, Chao-hui YE, authorsList=Zhuo-er ZHU, Ying-yan YAN, Chao-hui YE, authorCompany=null, correspAuthors=null, 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=1321425859349697164, articleId=1321425858829603466, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=儿童药物临床试验方案违背现状及对策探讨, 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=
目的： 剖析儿童药物临床试验中方案违背的现状及成因，构建预防与减少方案违背的应对策略，为儿童药物临床试验的规范开展提供参考依据。
方法： 收集某三甲专科妇儿医院2022年1月—2025年6月儿科药物临床试验中方案违背案例，回顾性分析方案违背的类型、责任主体及具体诱因，并据此制定针对性的改进措施。
结果： 24项儿童药物临床试验共发生186例次方案违背，主要类型包括样本相关违背、访视相关违背、药物相关违背、检查检验相关违背等；责任主体按发生频次依次为受试者及监护人、研究者、临床试验协调员、申办方及其他因素。
结论： 儿童药物临床试验需在试验全流程中持续开展总结与优化工作，针对各责任主体制定对应策略有效降低方案违背发生率，为提升儿童类临床试验质量提供实践借鉴。
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朱卓儿，女，硕士，主管药师，研究方向：药物临床试验。E-mail: zhuzhuoer@163.com。
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