Article(id=1292126505962857403, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.03.023, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1764777600000, receivedDateStr=2025-12-04, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996565570, onlineDateStr=2026-08-06, pubDate=1771257600000, pubDateStr=2026-02-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996565570, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996565570, creator=13701087609, updateTime=1785996565570, updator=13701087609, issue=Issue{id=1292126460546929080, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='3', pageStart='301', pageEnd='450', issueExtLink='null', onlineDate='null', pubDate='1771257600000', pubDateStr='2026-02-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996554742, creator='13701087609', updateTime=1786014541627, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201903060963536, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201903060963537, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=445, endPage=450, ext={EN=ArticleExt(id=1292126506139018172, articleId=1292126505962857403, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Quality evaluation and improvement strategies of investigator-initiated trials in an infectious disease hospital, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
Objective This study aimed to evaluate analyze the current quality status of investigator-initiated trials (IITs) conducted in a hospital, analyze key influencing factors, explore targeted improvement measures, and provide references for enhancing the design level of IITs.
Methods IITs registered in the Medical Research Registration and Filing Information System by the hospital from January 2020 to April 2025 were selected as the research objects. The research compliance, scientificity, and value were assessed, and then followed by statistical analysis.
Results Among the 124 IITs, 76% were initiated by investigators with associate senior titles or above. The median scores of the standardization and scientificity dimensions were both 8 points, while the median score of the research value dimension was 6 points. The total scores of interventional studies and observational studies were 23 and 21, respectively (P<0.01), and the total scores of multi-center studies and single-center studies were 23 and 20, respectively (P<0.001). Except for the correlation between funding support and the scientificity score, which the difference was not statistially signifccant (P>0.05), funding support showed a significant positive correlation with both the research compliance and research value dimensions (correlation coefficients ranging from 0.300 to 0.346, all P<0.001); disciplinary strength, and investigator title were significantly positively correlated with all three dimensions of research quality (correlation coefficients ranging from 0.213 to 0.380, P<0.01, P<0.001) and disciplinary strength had the greatest impact on research value.
Conclusions Medical institutions still need to strengthen the standardization and scientificity of IITs, and there is great room for improvement in research value. Disciplinary strength, investigator background, and funding support are key factors affecting the research quality. From the perspective of institutional management, the quality of IITs can be effectively improved by constructing a systematical management system that integrates scientific review, methodological support and resource guarantee.
, authors=Xin FENG, Han-xi ZHANG, Mei-ling CHEN, Yan LI, Chao-ying HU, authorsList=Xin FENG, Han-xi ZHANG, Mei-ling CHEN, Yan LI, Chao-ying HU, authorCompany=null, correspAuthors=Chao-ying HU, 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=1292126506373899197, articleId=1292126505962857403, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=某医疗机构研究者发起的临床研究质量评价与改进策略分析, 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=
目的 评价某医疗机构研究者发起的临床研究（IIT）质量现状，分析关键影响因素，探索针对性改进措施，为提升IIT设计水平提供参考。
方法 选取该医院2020年1月至2025年4月在医学研究登记备案信息系统中完成备案的IIT为研究对象，从研究的规范性、科学性、研究价值3个维度开展质量评价，并进行统计学处理。
结果 124项IIT中，76%由副高及以上职称研究者发起；规范性与科学性维度中位数均为8分，研究价值维度中位数为6分；干预性研究和观察性研究的总分分别为23和21分（P<0.01），多中心研究和单中心研究的总分分别为23和20分（P<0.001）；除经费支持与科学性评分的相关性在统计学上差异无统计学意义（P>0.05），经费支持与研究的规范性和研究价值均呈显著正相关（研究系数为0.300~0.346，均P<0.001），学科实力、研究者职称与研究质量的3个维度均呈显著正相关（研究系数为0.213~0.380，P<0.01，P<0.001），其中学科实力对研究价值影响最大。
结论 医疗机构IIT在规范性和科学性方面仍需强化，研究价值提升空间较大，学科实力、研究者背景和经费支持是影响研究质量的关键因素。从机构管理角度，通过构建涵盖科学性审查、方法学支持与资源保障的管理体系，可有效提高IIT研究设计的质量。
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冯鑫（1979-），女，高级工程师，主要从事临床研究质量评价及管理方面的工作和研究
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