电子化临床试验中的新技术  

Current new technologies in e-clinical trials

作　　者：陈君超[1] 郑青山[1] 黄继汉[1] 李禄金[1] 许羚[1] 杨娟[1] 刘红霞[1] 

机构地区：[1]上海中医药大学药物临床研究中心,上海201203

出　　处：《中国新药杂志》2014年第23期2758-2761,2766,共5页Chinese Journal of New Drugs

基　　金：上海市中医药发展办公室项目资助(ZYSNXD-CC-LCPJ);创新药物研究开发技术平台建设(2012ZX09303-003;2012ZX09303009-001);上海市中医药事业发展三年行动计划项目

摘　　要：随着电子化数据采集技术的普遍应用,临床试验电子化趋势日益明显,从试验设计到实施的各个环节正经历一场全新变革。本文概览了上述环节过程中的热门技术与方法,包括交互式响应技术、便携式电子设备、电子化文档管理和项目申报、可视化数据管理、自动化数据处理、基于风险的临床监查、物联网技术与智能标签、云技术及云服务、模型化模拟化技术以及适应性试验设计,并分别介绍了其在临床试验中的应用概况,以期对国内电子化临床试验技术方法的成熟与未来发展提供新视角和帮助。As the existing electronic data capture technology as the basis of electronic clinical trial has been widely applied, more new technologies and methods are expand to optimize clinical trial design and operation. These new technologies include the interactive response technology, portable electronic devices, electronic trial master file, data visualized management, automatic data processing, risk-based monitoring, internet of things tech- nology, cloud technology, modeling and simulation technology, as well as adaptive design. In this paper, we overviewed the hot technologies and introduced the present status of their application in the clinical trials, in order to provide the future vision of electronic clinical trial technology and promote the development of domestic e-clinical trials.

关 键 词：临床试验 电子化临床试验 电子化数据采集 

分 类 号：R95[医药卫生—药学]