临床试验的随机化分配与组间均衡性

Randomization and Baseline Characteristics in a Randomized Controlled Trial

为提高临床试验及其报告的质量,作者结合国内外随机对照试验的原则与自己的实践经验,系统地阐述了临床试验的随机化的概念、随机化分配方法的分类及具体操作方法,同时也就组间均衡性做了论述,介绍了组间均衡性的要求以及组间不均衡的处理方法。从中药临床试验研究的实际情况出发,提出中药临床试验质量的提高需要临床研究人员和医学刊物编辑共同努力。

This paper introduced randomization methods in clinical trials, including the conception, classification and procedure of randomization, as well as the balance between groups. It recommended the guideline for reporting of randomization and baseline characteristics in a randomized controlled clinical trial. The methods for dealing with unbalance between groups were also brought forward. According to the situation of clinical trials of traditional Chinese medicine (TCM), it is suggested that endeavor of clinical researchers and editors of academic journals should be needed for improving the quality of reporting of randomized controlled trials of TCM. 