样本量估计与检验效能分析(三)(英文)

Estimation of sample size and testing power(Part 3)

本文介绍了结果为二值变量的单因素两水平设计的3种特殊检验(即非劣效性检验、等效性检验和优效性检验)的基本概念和样本含量估计方法。非劣效性试验是指主要研究目的为显示试验药的疗效在临床上不比阳性对照药差的试验;等效性试验是指主要研究目的为显示两种药物的疗效在临床上是否等效的试验;优效性试验是指主要研究目的为显示试验药的疗效优于对照药的试验。通过实例,本文介绍了所需样本含量的计算公式和SAS实现方法。

This article introduces the definition and sample size estimation of three special tests （namely, non-inferiority test, equivalence test and superiority test） for qualitative data with the design of one factor with two levels having a binary response variable. Non-inferiority test refers to the research design of which the objective is to verify that the efficacy of the experimental drug is not clinically inferior to that of the positive control drug. Equivalence test refers to the research design of which the objective is to verify that the experimental drug and the control drug have clinically equivalent efficacy. Superiority test refers to the research design of which the objective is to verify that the efficacy of the experimental drug is clinically superior to that of the control drug. By specific examples, this article introduces formulas of sample size estimation for the three special tests, and their SAS realization in detail,