某院研究者发起的临床研究立项管理实践

Practice of project management for investigator-initiated trials in a hospital

建立完善的研究者发起的临床研究(investigator-initiated trial,IIT)立项与审查管理机制,对保障临床研究的科学性和提高研究质量具有重要作用。自2021年以来,复旦大学附属中山医院在IIT的立项管理方面进行了积极探索,通过实施规范化分级审查管理流程,建立临床研究一体化管理系统,打造临床研究三级培训体系,搭建方法学支撑平台和制定研究方案模板等多项措施,逐步形成规范化分级立项审查管理模式。截至2024年2月,医院依托临床研究一体化管理系统完成快速审查约400次,专家函审超400次,IIT项目的立项效率与审查质量均得到提升;同时,举办了逾40期学术沙龙和论坛,培养了一批临床研究青年骨干,并为30余个临床科室提供数据管理培训,推动了研究方案质量的提升。未来医院应进一步优化信息化系统,扩大培训体系影响力,增强方法学支撑平台能力,并提升临床研究方案撰写能力,以期为高质量临床研究的立项与开展保驾护航,为其他医院的IIT立项管理提供参考。

Establishing a comprehensive mechanism for the initiation and review of investigator-initiated trial(IIT)plays an important role in ensuring the scientific validity of clinical research and improving research quality.Since 2021,Zhongshan Hospital affiliated to Fudan University had actively explored improvements in the project management of IIT.The hospital had established a standardized grading review management process,developed an integrated clinical research management system,established a three-level clinical research training system,built a methodological support platform,and formulated research plan templates,gradually formed a standardized grading project approval review management mode.As of February 2024,the hospital had completed 400 quick reviews and more than 400 expert letter reviews based on the integrated clinical research management system.The efficiency and quality of IIT project approval had been improved.At the same time,over 40 academic salons and forums had been held,cultivating a group of young clinical research talents,providing data management training for more than 30 clinical departments,and promoting the improvement of the quality of research protocol.In the future,hospitals should further optimize their information systems,expand the influence of their training systems,enhance the capabilities of their methodological support platforms,and improve the efficiency of the application of clinical research protocol templates,so as to escort the establishment and implementation of high-quality clinical research projects and provide references for other hospitals′IIT project management.