摘要
采用文献调研法和归纳分析法对美国癌症临床研究网络的组织形成及运行机制进行研究。结果表明,美国癌症研究中心通过建立国家癌症临床研究网络,使用统一的Information Technology数据管理系统(Medidata RAVE)和研究对象保护系统将既往独立的3 000多个临床试验站点联合起来,进一步提高癌症临床试验的启动速度和执行效率、促进医患的广泛参与、充分利用科技创新。提出我国应增加癌症科研投入、加强癌症研究机构能力建设、加强临床研究的统筹和资源规划、促进研究机构间合作、重视临床研究信息化建设。
Literature research method and the inductive analysis method were used.The results indicate that by establishing the NCTN,NCI combined more than 3,000 independent clinical trial sites together using the unified IT data management system(Medidata RAVE)and the research object protection system,and further improved the start-up speed and execution efficiency of cancer clinical trials,promoted the extensive participation of doctors and patients,and made full use of scientific and technological innovation.The above research conclusion proposes China should increase the investment of cancer research,strengthen the capacity building of cancer research institutions,strengthen the overall and resource planning of clinical research,promote the cooperation between institutions,and attach importance to the information construction of clinical research.
作者
殷环
孙可欣
袁子焰
杨渊
高东平
Yin Huan;Sun Kexin;Yuan Ziyan;Yang Yuan;Gao Dongping(Institute of Medical Information,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100020,China;Cancer Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100021,China)
出处
《科技管理研究》
北大核心
2023年第9期29-35,共7页
Science and Technology Management Research
基金
中国医学科学院中央级公益性科研院所基本科研业务费专项资金项目“医学研究监管制度研究与协同平台功能开发”(2022-ZHCH630-01)。
关键词
临床研究
美国国家癌症临床研究网络
组织机构
运行机制
clinical research
NCI's National Clinical Trials Network
organization structure
operation mechanism
