《中藥注冊管理專門規(guī)定》頒布后，治療癥狀類中藥新藥研發(fā)迎來新機遇，但同時也要清醒認識到治療癥狀類中藥新藥臨床試驗在指標設計及數(shù)據(jù)質量方面的新挑戰(zhàn)。在以患者為核心新藥研發(fā)大背景下，充分梳理“癥狀”概念內(nèi)涵與外延基礎上，全面了解國內(nèi)外監(jiān)管機構對“癥狀”療效指標設計的最新技術要求，結合中藥新藥研發(fā)的實際情況，最終對形成適合中藥新藥研發(fā)的癥狀類指標設計的技術要求提供建議，以期為同類中藥新藥研發(fā)提供借鑒。

After announcement of the Special Provisions on the Administration of Traditional Chinese Medicine Registration, opportunities have enhanced for the development of new Chinese materia medica which improving symptoms, but at the same time, new challenges of clinical trial in efficacy outcome indicator design and quality control have occured as well. In the context of patient-focused drug development, thoroughly understand the connotation and extension of "symptoms", comprehensively understand the latest technical requirements of domestic and foreign regulatory agencies for the design of efficacy indicators, effectively integrate the actual development situation of new Chinese materia medica, finally provide suggestions about technical requirements and expect to provide reference for the development of similar new Chinese matria medica.

R286，R969.4

上海市中醫(yī)藥“三年行動計劃”項目［ZY（2021-2023）-0211］；上海市“科技創(chuàng)新行動計劃”生物醫(yī)藥科技支撐專項（20S21902100）；上海市教委協(xié)同創(chuàng)新中心：中西醫(yī)結合-中成藥臨床評價平臺項目（A1-U21-205-0103）；上海市慢性筋骨病臨床醫(yī)學研究中心項目（20MC1920600）；上海市科委2022年度第三批應急科技攻關項目（22YJ1900505）；上海市申康中心示范性研究型病房建設項目（SHDC2022CRW010）；上海市申康中心醫(yī)企融合創(chuàng)新協(xié)同專項（SHDC2022CRT018）