“十四五”期间医院研究者发起的体细胞临床研究建设发展的若干思考  

Some thoughts on the construction and development of somatic cell clinical research initiated by hospital researchers during the“14th Five-Year Plan”

作　　者：向橦 曹烨[2] XIANG Tong;CAO Ye(Department of Experimental Research,Cancer Prevention Center,Sun Yat-sen University,Guangdong Province,Guangzhou510060,China;Department of Clinical Research,Cancer Prevention Center,Sun Yat-sen University,Guangdong Province,Guangzhou510060,China)

机构地区：[1]中山大学肿瘤防治中心实验研究部,广东广州510060 [2]中山大学肿瘤防治中心临床研究部,广东广州510060

出　　处：《中国医药导报》2024年第14期179-181,189,共4页China Medical Herald

基　　金：国家自然科学基金资助项目(82172795)。

摘　　要：本文基于我国《“十四五”生物经济发展规划》和最新《体细胞临床研究工作指引(试行)》指导文件精神,结合国内外医院研究者发起的临床研究现状和发展趋势,分析研究者发起的体细胞临床研究在细胞治疗相关技术产品转化和临床应用中的优劣点,探讨研究者发起的体细胞临床研究未来建设发展。相关医院应对标《体细胞临床研究工作指引(试行)》,结合各自医院相关学科并联合地区特色资源,建立体细胞技术评估与互选体系,建立体细胞制剂生产和检测放行平台、建立临床前和临床中合同研究组织优化平台、建立临床数据化和规范化管理平台,从而共同促进我国研究者发起的体细胞临床研究事业高质量发展。Based on the spirit of guidance document of China’s“14th Five-Year Plan”for the Development of the Bioeconomy and the latest Guidelines for Somatic Cell Clinical Research(Trial),and combined with the current situation and development trend of clinical research initiated by hospital investigators at home and abroad,this paper analyzes the advantages and disadvantages of investigator initiated trial of somatic cell in the transformation of cell therapy-related technology products and clinical application.To explore the future development of investigator initiated trial of somatic cell.Relevant hospitals should standard the Guidelines for Somatic Cell Clinical Research(Trial),establish a somatic cell technology evaluation and mutual selection system,establish a platform for somatic cell preparation production and testing and release,establish a platform for pre-clinical and clinical contract research organization optimization,and establish a platform for clinical data and standardized management by combining the relevant disciplines of their respective hospitals and joint regional characteristic resources,so as to jointly promote the high-quality development of somatic cell clinical research initiated by Chinese researchers.

关 键 词：研究者发起的临床研究 体细胞 规范化管理 高质量发展 

分 类 号：R197[医药卫生—卫生事业管理]