CAJ | 학술논문

本文介绍了3种特殊检验的基本概念和所需样本含量估计方法,即非劣效性检验(主要目的为检验试验药的疗效在临床上不比阳性对照药差)、等效性检验(主要目的为检验两种药物的疗效在临床上是否等效)和优效性检验(主要目的为检验试验药的疗效在临床上优于对照药).本文还通过具体的实例,详细介绍了进行前述3种特殊检验所对应的试验研究之前所需要的样本含量的计算公式和用SAS实现计算的方法.
본문개소료3충특수검험적기본개념화소수양본함량고계방법,즉비렬효성검험(주요목적위검험시험약적료효재림상상불비양성대조약차)、등효성검험(주요목적위검험량충약물적료효재림상상시부등효)화우효성검험(주요목적위검험시험약적료효재림상상우우대조약).본문환통과구체적실례,상세개소료진행전술3충특수검험소대응적시험연구지전소수요적양본함량적계산공식화용SAS실현계산적방법.
This article introduces definitions of three special tests,namely,non-inferiority test (to verify that the efficacy of the experimental drug is clinically not inferior to that of the positive control drug),equivalence test (to verify that the efficacy of the experimental drug is equivalent to that of the control drug) and superiority test (to verify that the efficacy of the experimental drug is superior to that of the control drug),and methods of sample size estimation under the three different conditions.By specific examples,the article introduces formulas of sample size estimation for the three special tests,and their SAS realization in detail.