我国临床研究支撑保障体系健全路径探索

Improvement Path of the Clinical Research Support System in China

目的为完善我国临床研究支撑保障体系提供参考。方法分析我国临床研究工作的实际情况、实践经验和存在的主要问题,从人才教育及培养、医师薪酬及晋升制度、资源协调及机构内部质量管理方面提出建议,并针对信息化平台、培训体系、区域伦理委员会建设及管理体系专职化提出构想。结果与结论我国在临床研究管理理念、伦理委员会构架和功能、研究者教育和培训、研究者职业发展通道等各方面仍面临诸多问题。未来需要在加强人才教育培养力度、改革医师薪酬与晋升制度、提升临床试验机构内部质量、转变临床试验机构管理模式等方面进行顶层设计,提供制度保障,从而激励广大临床科研工作者以更饱满的热情真抓实干,进一步夯实临床研究基础,持续推进临床研究质量的提升。

Objective To provide a reference for the improvement of the clinical research support system in China.Methods The actual situation,practical experience and main problems of clinical research work in China were analyzed to put forward suggestions on talent education and training,physician′s salary and promotion system,resource coordination and internal quality management,and put forward ideas on the construction of information platform,training system and regional ethics committees,and the professionalization of management system.Results and Conclusion Clinical research in China still faces many problems in terms of management philosophy,the structure and function of the ethics committee,the protection of the rights of subjects,the education and training of researchers,and the career development path of researchers.In the future,it is necessary to carry out top-level design and institutional guarantees in terms of talent education and training,the reform of the physician′s salary and promotion system,the internal quality improvement of clinical trial institutions,and the transformation of the management model of clinical trial institutions,so as to motivate clinical researchers to devote themselves to work with greater enthusiasm and more practical actions,further consolidate the foundation of clinical research,and continuously promote the quality improvement of clinical research.