符合中医药特点的中药新药评价思路探讨

目的：探讨中药新药区别于化学药新药的评价思路。方法：以真实世界证据为工具，以整体证据评价为方法，以电子化的患者报告结局为技术支持，创新中药新药评价思路。结果：1)提出中药新药质量控制中的质量一致性评价思路。在单一角度对中药新药质量一致性无法评价的前提下，采用整体证据方法这种多角度的审评观念，用真实世界证据评价多批次药品的疗效一致性，适当放宽中药新药质量一致性的要求，使中药新药的疗效一致性评价作为质量一致性评价的有力补充。2)提出中药新药临床疗效评价思路。在传统临床试验的评价基础上，以患者为中心进行临床试验设计，创建电子化的患者报告结局，关注患者生活质量改善，形成临床疗效的支持性证据。结论：鼓励采用新工具、新方法、新技术、新思路，在中药新药评价中充分体现中药临床疗效评价方法的开创性，创新中药新药评价思路。

Discussion on the Evaluation of New Traditional Chinese Medicine in Line with the Characteristics of TCM

Objective: To discuss the evaluation of new traditional Chinese medicines (TCM) which differ from new chemical drugs. Methods: The evaluation idea of new TCM was innovated by using the tool of the realworld evidence (RWE), the method of overall evidence evaluation, and the technical support of the electronic patient-reported outcome (PRO). Results: 1) This article put forward the idea of quality consistency evaluation in the quality control of new TCM. Under the premise of unsatisfactory evaluation of the quality consistency of new TCM in a single angle, the multi-angle review concept of the overall evidence method was used to evaluate the consistency of the efficacy of multiple batches of drugs with RWE, and to appropriately relax the requirements on consistency of the quality of new TCM. It was required to make the consistency evaluation of the efficacy of new TCM as a powerful supplement to the quality consistency evaluation. 2) The idea of clinical efficacy evaluation of new TCM was proposed. Based on the evaluation of traditional clinical trials, the patient-focused clinical trial design was conduted to create electronic PRO, focus on improving the life quality of patients and form supporting evidence for clinical efficacy. Conclusion: To encourage the use of new tools, new methods, new technologies, new ideas, fully embody the pioneering nature of TCM clinical efficacy evaluation methods in the evaluation of new TCM, and innovate the evaluation ideas of new TCM.