近十年国内药品临床综合评价研究的现状分析与建议

Current Situation and Suggestion of Comprehensive Clinical Evaluation of Medical Products in China in Recent Ten Years

通过分析2013年至2023年国内药品临床综合评价研究的现状,发现目前药品临床综合评价研究中存在着“四多四少”现象,即开展药品临床综合评价的研究多,给出综合评价意见的相对少;研究资料来源于公开信息的多,来源于真实世界数据的少;可供选择的同类对照药品多,事先设定对照药品的研究少;研究开展过程中步骤多,严格实施质量控制的研究少。基于此,从提高药品临床综合评价的质量、加强药品临床综合评价结果的转化与传播、提高药品临床综合评价的规范性三个方面提出建议;并针对中成药临床综合评价研究的现状,从提升原始研究证据、突出中成药特色和优势两个方面提出思考,以期促进药品临床综合评价结果更好地转化和应用。

Through analyzing the current situation of clinical comprehensive evaluation researches of domestic medical products from 2013 to 2023,it is found that there is a phenomenon of“four more,four less”.Specifically,there is a greater emphasis on conducting research on drug clinical comprehensive evaluation,but fewer comprehen⁃sive evaluation opinions provided;more research data come from publicly available information,but fewer derived from real world;more options for similar reference drugs,but less pre-defined research on reference drugs;the re⁃search process involves more steps,yet there are fewer studies strictly implementing quality control.Based on this,suggestions are proposed in three aspects:improving the quality of clinical comprehensive evaluation of medical products,enhancing the transformation and dissemination of results,and improving the standardization of clinical comprehensive evaluation of medical products.Regarding the current state of clinical comprehensive evaluation re⁃search on Chinese patent medicine,reflections are presented on elevating original research evidence and highlighting the characteristics and advantages of Chinese patent medicine,so as to promote better transformation and application of the results of clinical comprehensive evaluation of medical products.