治疗症状类中药新药临床试验疗效指标设计的关键问题  

Key issues in design of efficacy outcome indicators and quality control fordevelopment of new Chinese materia medica which improving symptoms

作　　者：严华美 江云[2] 胡薏慧[1] 汤洁[1] 彭朋[1] 周一辰[1] 史万忠[1] 邵靖渊 张磊[3] 元唯安[1] YAN Huamei;JIANG Yun;HU Yihui;TANG Jie;PENG Peng;ZHOU Yichen;SHI Wanzhong;SHAOJingyuan;ZHANG Lei;YUAN Weian(Clinical Research Unit of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China;Department of Performance Management of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China;Collaborative Innovation Center of Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院临床研究中心,上海200021 [2]上海中医药大学附属曙光医院绩效管理办公室,上海200021 [3]上海中医药大学协同创新中心,上海201203

出　　处：《药物评价研究》2023年第9期1833-1840,共8页Drug Evaluation Research

基　　金：上海市中医药“三年行动计划”项目[ZY(2021-2023)-0211];上海市“科技创新行动计划”生物医药科技支撑专项(20S21902100);上海市教委协同创新中心:中西医结合-中成药临床评价平台项目(A1-U21-205-0103);上海市慢性筋骨病临床医学研究中心项目(20MC1920600);上海市科委2022年度第三批应急科技攻关项目(22YJ1900505);上海市申康中心示范性研究型病房建设项目(SHDC2022CRW010);上海市申康中心医企融合创新协同专项(SHDC2022CRT018)。

摘　　要：《中药注册管理专门规定》颁布后,治疗症状类中药新药研发迎来新机遇,但同时也要清醒认识到治疗症状类中药新药临床试验在指标设计及数据质量方面的新挑战。在以患者为核心新药研发大背景下,充分梳理“症状”概念内涵与外延基础上,全面了解国内外监管机构对“症状”疗效指标设计的最新技术要求,结合中药新药研发的实际情况,最终对形成适合中药新药研发的症状类指标设计的技术要求提供建议,以期为同类中药新药研发提供借鉴。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.

关 键 词：中药新药 新药研发 临床试验 症状 疗效指标设计 疗效评价 

分 类 号：R286[医药卫生—中药学] R969.4[医药卫生—中医学]