【摘要】 目的：以制度建设、组织实施与支撑保障为切入点，评估医院研究者发起的临床研究(IIT)科学性审查现状与不足，为促进医院IIT科学性审查工作提供参考。方法：结合国家IIT管理办法中科学性审查相关内容，采用德尔菲法和层次分析法构建科学性审查评估体系和调查问卷，调查重庆市60所医院，了解科学性审查建设落实情况。结果：样本医院整体平均得分为75.8分，评分为优秀、良好和一般的医院比例分别为41.2%、52.9%、5.9%。参与调研的大部分医院科学性审查制度完善并有组织地开展科学性审查，但部分医院存在科学性审查制度不健全、标准缺失和支撑保障不够等问题。结论：可通过完善科学性审查政策体系、分类制定科学性审查指导意见、建立省级学术委员会或加大科学性审查专家培养、加强医院督导检查等措施，进一步促进科学性审查的实施，提升IIT质量。更多还原

【Abstract】 Objective:To evaluate the current status and deficiencies of scientific review for investigator-initiated trials (IIT) in hospitals from the perspectives of institutional development,organizational implementation,and support mechanisms,and to provide references for improving hospital IIT scientific review practices.Methods:Based on the scientific review requirements specified in national IIT management regulations,the Delphi method and analytic hierarchy process were used to construct a scientific review evaluation system and questionnaire.A survey was conducted in 60 hospitals in Chongqing to assess the implementation status of scientific review systems.Results:The overall average score of the sampled hospitals was 75.8.The proportions of hospitals rated as excellent,good,and average were 41.2%,52.9%,and 5.9%,respectively.Most participating hospitals had relatively complete scientific review systems and organized implementation of scientific review;however,some hospitals exhibited deficiencies such as incomplete systems,lack of standards,and insufficient support mechanisms.Conclusion:Further improvement can be achieved by refining the policy system for scientific review,formulating classified guidance for scientific review,establishing provincial academic committees or strengthening expert training in scientific review,and enhancing hospital supervision and inspection,thereby promoting implementation and improving IIT quality.更多还原