基于中医医疗与临床科研信息共享系统的临床研究要点

Main Points of TCM Clinical Research Based on TCM Clinical Research Information Sharing System

基于临床实际开展真实世界临床研究是目前临床研究的热点之一。中医几千年的学术发展均基于临床实践,是一门临床医学,真实世界研究是目前最符合中医自身发展规律的研究方法。中医医疗与临床科研信息共享系统(以下简称"共享系统")专门为中医真实世界临床研究设计开发,用于解决真实世界临床研究的方法及技术问题,共享系统已在20余家国家中医临床基地及全国近百家中医医疗机构得到应用。在多年的科研实践中,项目组探索形成基于共享系统开展真实世界临床研究要点,以真实世界中医临床研究范式作为理论指导,科学地设计研究方案,以规范的研究流程作为实施保障,注重质量控制,形成科学数据并进行科学地分析利用。

Real-world study based on clinical practice is one of the focuses in clinical studies. As a clinical medicine, the development of traditional Chinese medicine （TCM） is based on clinical practice. Real-world study meets the development law of TCM. TCM Clinical Research Information Sharing System （hereinafter ＇Sharing System＇ ） is designed specifically for the design and development of clinical research in real world to solve the technical problems in real-world clinical research. Sharing system has been applied in more than 20 national TCM clinical bases and nearly 100 TCM clinical institutions in China. In the years of research and practice, main points of TCM clinical research have been explored based on Sharing System such as taking real-world TCM clinical research paradigm as the theoretical guide, scientifically designing research program, standardizing the research process as the implementation of safeguards, focusing on quality control, forming scientific data and scientifically analyzing and using data.