人用经验在中药新药研发中具有独特价值，但在实际应用中，高质量临床人用经验数据的收集与证据转化仍需进一步探索。基于中医药临床诊疗实践解构人用经验从个案累计到形成数据，再到转化为证据的过程，并从临床数据质量不高、科研与成果转化的衔接不充分、临床科研支撑条件不足、数据治理与临床证据评价方法缺如等方面分析当前人用经验在向中药新药审批证据转化中面临的现实挑战与原因。同时，结合目前研究进展，从人用经验形成过程出发，对人用经验数据质量把控、中医药临床科研体系建设、证据等级评价完善等方面提出对策与建议，推动人用经验向能支持注册审评的高质量证据转化，加快中药新药研发进程。

Human experience has a unique value in the development of new traditional Chinese medicines, but the collection of highquality clinical data of application experience in human and the transformation of evidence in practical applications still need to be further explored. Based on the clinical practice of Chinese medicine, this paper deconstructs the process of application experience in human from the accumulation of individual cases to the formation of data, and then transformed into evidence, and analyses the challenges and reasons for the transformation of application experience in human into evidence for the approval of new traditional Chinese medicines in terms of the poor quality of clinical data, the insufficient connection between scientific research and the transformation of results, inadequate support conditions for clinical scientific research, and the lack of methods for data governance and evaluation of clinical evidence. At the same time, in light of the current research progress, from the perspective of the formation process of application experience in human, we put forward countermeasures and suggestions on the quality control on data of application experience in human, the construction of clinical research system of traditional Chinese medicines, and the improvement of evidence evaluation, so as to promote the transformation of application experience in human into high-quality evidence to support the registration and review, and to accelerate the process of new traditional Chinese medicines.

R944

中药上市后临床再评价技术体系研究（2025YFC3507905）；国家中医药管理局中医药标准化资助项目（GZY-FJS-2020-206）