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作 者:刘真[1] 呼君瑜 田玉翠[1] 鞠蕊 代荫梅[1] LIU Zhen;HU Junyu;TIAN Yucui;JU Rui;DAI Yinmei(GCP Office,Beijing Maternal and Child Health Care Hospital,Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing 100026,China)
机构地区:[1]首都医科大学附属北京妇产医院,北京妇幼保健院,药物临床试验办公室,北京100026
出 处:《中国药学杂志》2025年第1期100-104,共5页Chinese Pharmaceutical Journal
基 金:第二批北京市研究型病房示范建设单位资助项目资助(BCRW202109)。
摘 要:目的在缺乏研究者发起的临床研究(investigator-initiated trials,IIT)管理规范的情况下,探讨基于风险防控的IIT立项管理。方法通过文献调查结合工作实践,分析IIT立项审核发现的问题及其潜在风险,梳理《医疗卫生机构开展研究者发起的临床研究管理办法》颁布后的立项审核流程,总结立项审核要点,分析基于风险防控的立项审核的意义。结果IIT项目立项阶段在项目的研究设计、受试者保护、研究团队及研究经费4个方面存在诸多风险。基于风险防控实施合规性审查、同行专家评议和专家技术委员会的层级化立项审核;针对科学性、可行性审核要点和研究经费能否保障的重点审核,有助于IIT项目尽早识别潜在风险并予以防范。结论基于风险防控的立项管理对IIT项目潜在的风险起到了规避效应,有助于项目实施。IIT项目的中心化管理、数据管理平台建设和项目研究经费的多渠道保障对潜在风险的防范值得进一步探索。OBJECTIVE To explore investigator-initiated trial(IIT)approval management with a focus on risk prevention and control in the absence of guidelines for IIT approval management.METHODS Through a combination of literature review and practical experiences,this study analyzed the challenges encountered in the approval process and explored its potential risks,outlined the approval process following the promulgation of the management regulations,summarized its key aspects,and assessed the significance of the approval process with a focus on risk prevention and control.RESULTS There exist inherent risks in areas such as research design,participant protection,research team dynamics,and research funding.The authors advocate for the implementation of compliance review,peer expert evaluation,and a hierarchical approval review by expert technical committee,emphasizing scrutiny of scientific validity,feasibility,and funding adequacy.CONCLUSION The proactive identification and prevention of potential risks are highlighted as crucial benefits of the approval management.Centralized management of IIT projects,development of data management platforms,and diversification of funding channels to enhance risk mitigation should be further explored.
关 键 词:研究者发起的临床研究 风险防控 立项管理 数据质量 科研管理
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