医院管理论坛|2024年1月第41卷第1期|71科教管理药物生物等效性临床试验中方案偏离的分析与改进AnalysisandImprovementonProtocolDeviationinBioequivalenceTrials□陈莹蓉CHENYing-rong叶丽冰YELi-bing田孟丽TIANMeng-li杨水新YANGShui-xin摘要Abstract目的研究药物生物等效性临床试验实施中发生方案偏离的原因，并探讨解决对策，为提高临床试验质量提供依据。方法以方案偏离的年度分布、发生率和类别为评价指标，分析造成方案偏离现象的原因，并提出解决对策。结果2018年1月至2022年12月湖州市中心医院共开展生物等效性试验项目27个，发生方案偏离项目23个，共计229例次。发生方案偏离的类别主要为血样采集过程(59.40%)、违反试验流程(33.17%)和生物样本管理(7.43%)。结论建议组建职业化的临床试验人才队伍，建立完善的质量管理体系；研究人员应持续学习和培训，严格遵循GCP原则及试验方案，减少方案偏离的发生。ObjectiveTostudythecausesofprotocoldeviationintheimplementationofdrugbioequivalenceclinicaltrials,andtoexplorethecountermeasures,soastoprovideabasisforimprovingthequalityofclinicaltrials.MethodsBasedontheannualdistribution,incidenceandcategoriesofprotocoldeviation,thecausesofthedeviationwereanalyzed,andthecountermeasureswereproposed.ResultsFromJanuary2018toDecember2022,atotalof27bioequivalencetrialprojectswerecarriedoutinHuzhouCentralHospital,and23protocoldeviationsoccurred,withatotalof229cases.Themaincategoriesofprotocoldeviationwerebloodsamplecollectionprocess(59.40%),violationoftrialprocedures(33.17%)andbiologicalsamplemanagement(7.43%).ConclusionItissuggestedtoestablishaprofessionalclinicaltrialtalentteamandestablishathoroughqualitymanagementsystem.Researchersshouldcontinuetolearnandtrain,andstrictlyfollowtheprinciplesofGCPandthetrialprotocoltoreducetheoccurrenceofprotocoldeviation..关键词Keywords：药物临床实验Clinicaltrialsofdrugs；生物等效性试验Bioequivalencetrials；方案偏离Protocoldeviation作者单位：湖州市中心医院HuzhouCentralHospitalEmail:phase1@163.com通讯作者：杨水新基金项目：湖州市科技计划公益性应用研究项目，编号：2021GZ71中图分类号：R197.3；文献标识码：ADOI:10.3969/j.issn.1671-9069.2024.01.018临床试验是评价药...
