類風濕關節(jié)炎(RA)是最常見的風濕性疾病之一,治療RA的中藥已經(jīng)成為新藥研發(fā)的熱點,但是其臨床評價中還存在很多需要注意的核心問題。參考國內(nèi)外相關法規(guī)與文獻,并結合作者多年來從事中藥新藥臨床研究的實踐經(jīng)驗,對治療RA中藥新藥的臨床評價中在研發(fā)目標、設計類型、診斷標準與目標人群、基礎治療、試驗周期、有效性評價、安全性評價及試驗結束后醫(yī)療措施等方面存在的核心問題進行分析與探討,并提出了解決辦法。

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.