电子化临床试验的发展及未来  

Development of the electronic clinical trials and its future

作　　者：陈君超[1] 郑青山[1] 何迎春[1] 吕映华[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4期377-380,396,共5页Chinese Journal of New Drugs

基　　金：上海市中医药发展办公室资助项目(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：随着电子数据采集技术的成熟和应用,电子化临床试验已成为当前医药研发领域革新的关键。电子化临床试验的全面实现,不仅提高了临床研究速度和研究质量,也节约了研发时间和费用成本,比以往传统的纸质临床试验更快、更准确、更灵活、更有效率。本文分3个层面对电子化临床试验展开论述,介绍早期电子化临床试验的背景及其雏形,总结当前电子化临床试验的发展情况,并概括目前各种电子化系统的应用及其特色,期望能为临床试验相关人员提供参考。The growth of electronic clinical trial has been accelerated by widely applied electronic technology of data capture. Thus, it has recently become a hot topic in the global pharmaceutical industry. The full implementation of electronic clinical trials not only improves the quality and speed of clinical research, but also can save the time and costs during drug development. Compared with paper-based clinical trial, it is more effective, flexible and controllable. Hoping to provide a reference for personnel related to clinical trials, we in this article described the process of electronic clinical trials in following three phases. Firstly, the background of the early electronic clinical trials and its characteristics were introduced. Secondly, the current status of electronic clinical trials was summarized and various clinical research electronic tools were reviewed. Finally, the future of the electronic clinical trials was proposed based on current trends.

关 键 词：电子化临床试验 电子化数据采集 电子化临床研究 

分 类 号：R969.4[医药卫生—药理学]