摘要
就近年应用逐渐增多的非劣性 /等效性试验中涉及的一些关键统计学问题进行详细介绍 ,其中包括设计过程中的非劣性 /等效性界值的确定、样本含量的估计方法和统计推断过程中的检验假设建立、检验统计量计算以及可信区间计算方法。结合 7个有针对性的应用实例有助于对相关事项的理解和在非劣性 /等效性试验时进行参照。
The main statistical problems associated with noninferiority/equivalence trials included sample size,hypothesis testing and confidence interval.Based on principles and requirements of ICH(International Conference on Harmonization) and information published in literatures,the choice of noninferiority/equivalence margin,sample size determination,form of null and alternative hypothesis,hypothesis testing,and confidence interval were introduced in this paper.Examples were given to corresponding problem,in an attempt to help understanding.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2003年第5期371-376,共6页
Chinese Journal of New Drugs
关键词
临床试验
非劣性
等效性
优效性
非劣性/等效性界值
样本含量
假设检验
可信区间
clinical trial
noninferiority
equivalence
superiority
noninferiority/equivalence margin
sample size
hypothesis testing
confidence interval
