[关键词]
[摘要]
美国癌症研究中心通过建立国家癌症临床研究网络，将既往独立的三千多个临床试验站点联合起来，使用统一的IT数据管理系统（Medidata RAVE）和研究对象保护系统，进一步提高癌症临床试验的启动速度和执行效率、促进患者和医生的广泛参与、充分利用科技创新。采用文献调研法、归纳分析法，系统分析美国国家癌症临床医学研究网络组织结构及运行机制的特点和经验，为我国癌症临床研究能力建设提供参考。
[Key word]
[Abstract]
The National Cancer Institute had launched NCI’s national Clinical Trials network to improve the speed and efficiency of the design, launch, and conduct of clinical trials，make optimal use of scientific innovations，foster expanded participation of both patients and physicians by using a unified IT data management system (Medidata RAVE) and research object protection system to unite over 3,000 clinical trials sites. Literature research method and the inductive analysis method were used to analyze the NCI’s national Clinical Trials network 's characteristics and experience on organization structure and operation mechanism, to provide reference for the improvement of capacity on China’s cancer clinical research.
[中图分类号]
G311; G321
[基金项目]
中国医学科学院中央级公益性科研院所基本科研业务费“医学研究监管制度研究与协同平台功能开发”,编号：2022-ZHCH630-01
