构建中医药特色真实世界临床研究新模式的实践与思考

Practice and thinking on constructing a new and unique schema of real world clinical research of Traditional Chinese Medicine

结合国内外真实世界临床研究与人工智能技术等的研究进展,围绕开展高质量真实世界中医药临床研究的理念、方法与技术等问题,论述了真实世界研究范式转化、以临床问题为导向的研究模式建立、真实世界数据质量和高质量因果证据方法学等挑战及对策,以期从中医临床诊疗的本体视角充分认识真实世界中医药研究的长期性与对中医药高质量发展的重要性。

Based on the research progress in real-world clinical study and artificial intelligence technology domestically and internationally,aiming at the issues of the concepts,methods,and technologies for conducting high-quality TCM real world clinical research,this article focuses on the challenges and solutions for the transformation of real world research paradigms,the establishment of clinical problem-oriented research models,the quality of real world data,and the methodology of inferring highquality causal evidences.With a view to fully understanding the importance and difficulty of real world TCM research for the high-quality development of TCM from the ontological perspective of TCM clinical diagnosis and treatment,it is expected to provide reference for establishing a new real-world research system with TCM characteristics and creating a new model of TCM clinical research.