中国临床药理学与治疗学2009，Vol.14Issue(7)：721-725,5.
临床试验随机化的质量保证
Quality assurance of randomization in clinical trials
刘玉秀1
作者信息
- 1. 南京军区南京总医院,南京,210002,江苏
- 折叠
摘要
Abstract
Randomization is one of the effective procedures avoiding selection bias in randomized con-trolled clinical trials. Quality assurance of the random-ization is crucial to improve the quality of clinical tri-als . Successful implementation of randomization de-pends on two interrelated aspects. The first is the gen-eration of unpredictable random allocation sequence which prevent researchers, clinicians, and patients from predicting. The second is allocation concealment which conceals the upcoming allocation sequence from researchers and participants. Based on introducing the concept of randomization, the techniques of generating random sequence and allocation concealment used in clinical trials are reviewed and described. Meanwhile, the contents and requirements reporting randomization are provided, hoping to improve the quality of reporting randomized controlled clinical trials in China.关键词
临床试验/随机化/随机分配/分配隐蔽/质量保证Key words
clinical trial/ randomization/ random allocation/ allocation concealment/ quality assurance分类
医药卫生引用本文复制引用
刘玉秀..临床试验随机化的质量保证[J].中国临床药理学与治疗学,2009,14(7):721-725,5.
