治疗类风湿关节炎中药新药的临床评价核心问题

类风湿关节炎(RA)是最常见的风湿性疾病之一,治疗RA的中药已经成为新药研发的热点,但是其临床评价中还存在很多需要注意的核心问题。参考国内外相关法规与文献,并结合作者多年来从事中药新药临床研究的实践经验,对治疗RA中药新药的临床评价中在研发目标、设计类型、诊断标准与目标人群、基础治疗、试验周期、有效性评价、安全性评价及试验结束后医疗措施等方面存在的核心问题进行分析与探讨,并提出了解决办法。

Clincal evaluation of Chinese materia medica new drug for treatment of rheumatoid arthritis

Rheumatoid arthritis (RA) is one of the most common rheumatic diseases, Chinese materia medica (CMM) new drugs for treatment of RA has become a hot point in the research and development of new drugs, but there are still a lot of problems in the clinical evaluation. This article intends to address the position in the main topics of clinical development of new Chinese medicinal products in the treatment of RA based on the domestic and international regulations, literature, as well as the author's practical experience. The elaboration includes possible claims, clinical study design, selection of patients, endpoints, safety observation, as well as other significant points.