|
|||||
|
|
| 大样本多中心随机对照试验中的药品管理 | |
| 引用本文： | 戴国华,张伯礼,郭治昕,商洪才,张俊华,姚晨,文天才,赵敏,张军平.大样本多中心随机对照试验中的药品管理[J].中国循证医学杂志,2006,6(8):609-612. |
| 作者姓名： | 戴国华 张伯礼 郭治昕 商洪才 张俊华 姚晨 文天才 赵敏 张军平 |
| 作者单位： | 1. 天津天士力研究院,天津,300402 2. 天津中医药大学,天津,300193 3. 北京大学第一医院医学统计室,北京,100034 4. 中国中医科学院临床评价中心,北京,100026 |
| 基金项目： | 国家科技攻关计划项目(编号:2004BA716B01)~~ |
| 摘 要： | 药品管理对随机对照试验的研究结果是否真实可靠非常重要。药品管理主要涉及到盲法设计,研究用药的准备与包装,标签制作与贴签装箱,研究用药的运送、发放、回收。利用中心随机化系统在药品管理方面的优势,可以确保大样本多中心随机对照试验的顺利实施。 |
| 关 键 词： | 随机对照试验 药品管理 |
| 收稿时间： | 11 21 2005 12:00AM |
| 修稿时间： | 05 10 2006 12:00AM |
Drug Administration in Large-scale Randomized Controlled Multi-center Clinical Trials |
|
| DAI Guo-hua,ZHANG Bo-li,GUO Zhi-xi,SHANG Hong-cai,ZHANG Jun-hua,YAO Chen,WEN Tian-cai,ZHAO Min,ZHANG Jun-ping.Drug Administration in Large-scale Randomized Controlled Multi-center Clinical Trials[J].Chinese Journal of Evidence-based Medicine,2006,6(8):609-612. | |
| Authors: | DAI Guo-hua ZHANG Bo-li GUO Zhi-xi SHANG Hong-cai ZHANG Jun-hua YAO Chen WEN Tian-cai ZHAO Min ZHANG Jun-ping |
| Institution: | 1.Tianjin Tasly Institute, Tianjin 300402, China; 2. Tianjin University of Traditional Chinese Medicine,Tianjin 300193, China ;3.Peking University First Hospital, Beijing 100034, China; 4.China Academy of Chinese Medical Sciences, Beijing 100026, China |
| Abstract: | Drug administration is an extremely important aspect in the design and conduct of randomized controlled trials, which can influence the reliability and quality of the trials' results. This topic covers issues such as blinding, preparation, packaging, labeling, shipping, dispensing and returning of test articles. Good drug administration procedures should ensure the smooth implementation of large- scale multi-center randomized controlled trials and increase their reliability and usefulness. |
| Keywords: | Randomized controlled trial Drug administration |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |