Analysis of the current situation, advantages and difficulties of standardized management of Investigator Initiated Clinical Trials
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目的 分析研究者发起的临床研究(IIT)规范化管理的现状、优势和难点。 方法 总结归纳国内外临床研究管理要求和政策规定、国内外临床研究发展情况、中国临床研究管理发展的成绩和优势、研究者发起的临床研究规范化管理的主要问题和难点，并汇总了一些医疗机构在IIT管理方面的经验和模式。 结果 中国临床医学论文发表数量较多且在全球排名靠前，但高质量论文数量有待进一步提升。国内关于IIT的管理要求正在逐步完善，为医疗机构落实IIT全生命周期的规范化管理提供了依据，并且取得了一定成效，但在管理部门划分、管理标准统一、全流程管理和质量管理、科学性审查、高风险项目管理及注册备案等方面仍存在一些管理难点。 结论 借鉴国内医疗机构的优秀经验，通过落实主责部门、建立统一监查标准、落实全生命周期管理等方式，解决IIT管理的难点，提升IIT的管理质量和效率。 Objective To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT). Methods This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management. Results While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration. Conclusions Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.
Objective To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT). Methods This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management. Results While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration. Conclusions Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.
Investigator-Initiated Clinical Trials(IIT)Standardized managementScientific reviewSupervision and inspection
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