基于共享系统的真实世界中医临床研究范式初步实施方案的设计

Preliminary Embodiment Design of Real-World TCM Clinical Research Paradigm Based on Sharing System

中医医疗与临床科研信息共享系统已在国家中医临床基地为主的医疗机构得到应用,为真实世界中医临床研究范式的实践提供了技术平台。该范式中的临床研究需要结合具体临床问题,进行基于临床实际数据的实施方案设计。实施方案设计的核心是确定研究相关的特征数据及提取方法。结合国内外观察性研究的方法学要求及中医临床研究的需求,结合基地建设中真实世界临床研究的实施经验,提出了基于共享系统的真实世界中医临床研究范式实施方案设计及管理细则。

Traditional Chinese medicine（ TCM） Clinical Research Information Sharing System（ Sharing System）has been applied in TCM clinical bases and TCM institutions in China.Sharing System has provided a technology platform for the real-world TCM clinical research paradigm.The embodiment design should be implemented based on actual clinical data and specific clinical problems in clinical studies in the paradigm.The core of embodiment design is to determine characteristic data and extraction method related to research.The embodiment design and management rules of real-world TCM clinical research paradigm based on Sharing System were raised in this article according to methodological requirements of observational studies at home and abroad,needs of TCM clinical research,and implementation experience of real-world clinical studies in base construction.