基于实践经验对中药新药临床研究的思考  

Reflection on clinical research of new traditional Chinese medicine based on practical experience

作　　者：雷翔 高春升[1] 田逸群 欧阳绘天 崔天红 LEI Xiang;GAO Chun-sheng;TIAN Yi-qun;OU-YANG Hui-tian;CUI Tian-hong(Beijing Qihuang Clinical Research Center,Beijing 100055,China)

机构地区：[1]北京岐黄药品临床研究中心,北京100055

出　　处：《中国新药杂志》2020年第16期1825-1828,共4页Chinese Journal of New Drugs

摘　　要：中药新药研发与临床研究是对科学性与操作性具有较高要求,受到政策法规、疾病研究进展、科学技术创新与发展深度影响的领域,需要“政产学研用”的系统协作。合同研究组织作为药物研究生态链中的一环,在新药研发,特别是临床研究中发挥着重要作用。本文从致力于中医药临床研究的合同研究组织近20年的实践经验出发,对取得成功的经验与案例及遇到的挑战与困难进行讨论,以期能够抛砖引玉,有益于促进中药新药研发与临床研究的健康发展。The research and development and clinical research of TCM new drugs have high requirements for scientificity and operability,and are deeply affected by policies and regulations,disease research progress,and scientific and technological innovation and development.Therefore,the systematic cooperation of“government,industry,university,research and application”is needed.As a link in the ecological chain of drug research,contract research organizations play an important role in the development of new drugs,especially in clinical research.Based on the 20-year practice experience of contract research organizations devoted to TCM clinical research,this paper discusses the successful experiences and cases,challenges and difficulties encountered.It is expected to promote the development of new traditional Chinese medicine research.

关 键 词：中药新药 临床研究 合同研究组织 

分 类 号：R95[医药卫生—药学]