|HospitalManagementForum|Jan.2024Vol.41No.0168Research/TeachingManagement临床试验过程中妊娠事件分析及应对策略AnalysisofPregnancyEventsduringClinicalTrialsandCountermeasures□顾海鹰GUHai-ying沈敏敏SHENMin-min蒋凤琴JIANGFeng-qin王沛WANGPei摘要Abstract目的针对临床试验过程中出现的妊娠事件进行分析，增加对受试者权益和安全的保护。方法分析本院临床试验机构发生的2例妊娠事件，结合文献和实际工作经验，提出对策和建议。结果通过改善试验方案设计、给受试者购买保险、加强受试者知情和宣教、加强伦理启动前审查及跟踪审查，降低妊娠相关风险、保护受试者的权益和安全。结论通过增加对临床试验过程中妊娠事件的预防和管理措施，减少妊娠事件对试验各方带来的风险，增加对受试者权益和安全保护。ObjectiveToanalyzethepregnancyeventsintheprocessofclinicaltrials,andtoincreasetheprotectionoftherightsandsafetyofsubjects.MethodsTwocasesofpregnancyeventsoccurredintheclinicaltrialinstitutionofourhospitalwereanalyzed,combinedwithliteratureandpracticalworkexperience,countermeasuresandsuggestionswereputforward.ResultsPregnancy-relatedriskscanbereducedandtherightsandsafetyofthesubjectscanbeprotectedbyimprovingthedesignofthetrialprotocol,purchasinginsuranceforthesubjects,strengtheningtheawarenessandeducationofthesubjects,strengtheningtheethicalreviewbeforeinitiationandfollow-upreview.ConclusionByincreasingthepreventionandmanagementmeasuresofpregnancyeventsintheprocessofclinicaltrials,therisksofpregnancyeventstoallpartiesinthetrialcouldbereduced,andtheprotectionoftherightsandsafetyofthesubjectscouldbeincreased.关键词Keywords：临床试验Clinicaltrials；妊娠事件Pregnancyevents；应对策略Countermeasures作者单位：浙江中医药大学第五临床医学院/湖州市中心医院TheFifthClinicalMedicalCollegeofZhejiangChineseMedicalUniversity/HuzhouCentralHospitalEmail:guhaiying1984@126.com通讯作者：顾海鹰中图分类号：R197.3；文献标识码：ADOI:10.3969/j.issn.1671-9069.2024.01.017临床试验以人体(患者或健康受试者)为对象的试验，意在发现或验证某种试验药物的临床医学、药理学以及其他药效学作用、不良反应，或者试验药物吸收、分布、代谢和排泄情况，以确定药物的疗...
