中国药业2016，Vol.25Issue(24)：7-9,3.
定量检测体外诊断试剂临床试验统计方法常见问题分析
Analysis of Problems of Statistic Analysis Methods Used in Quantitative Testing IVD Clinical Trials
蔡江波1
作者信息
- 1. 江苏省食品药品监督管理局认证审评中心，江苏 南京 210002
- 折叠
摘要
Abstract
Objective To use right statistical analysis methods to evaluate quantitative testing in vitro diagnostic reagent(IVD)clinical tri-al data and get scientific and reasonable conclusion. Methods 4 common statistical analysis methods used in clinical trials and their advantages and disadvantages were introduced,and the problems of statistical analysis were pointed out and analyzed. Results Only 1 statistic analysis method or misuse of statistical analysis method might lead to false trial conclusion. Conclusion Multi-methods of statistical analysis should be adopted in agreement evaluation of 2 testing systems and researchers should be trained professionally.关键词
定量检测/体外诊断试剂/临床试验/统计分析Key words
quantitative testing/in vitro diagnostic reagent/clinical trial/statistical analysis分类
医药卫生引用本文复制引用
蔡江波..定量检测体外诊断试剂临床试验统计方法常见问题分析[J].中国药业,2016,25(24):7-9,3.
