计量资料非劣效临床试验样本量及把握度的计算与SAS程序实现  

SAS programming for sample size and power calculation of measurement data in non-inferior trials

作　　者：文世梅[1] 陈云飞[1] 刘华[1] 

机构地区：[1]上海中医药大学附属岳阳中西医结合医院药物临床试验机构,上海200437

出　　处：《中国临床药理学与治疗学》2013年第1期51-54,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：上海高校青年教师培养资助计划(ZZszy12046)

摘　　要：目的:利用SAS简易快速对计量资料非劣效临床试验进行样本量及把握度的计算。方法:比较公式及SAS编程两种计算方法,同时给出反推把握度的SAS宏程序。结果:公式和SAS程序两种计算方法的结果一致,利用SAS程序可以直接给出结果,无需要再进行查表获得相关参数,更简单、快捷。结论:利用本文提供的程序可以更好地帮助研究者理解与运用此程序进行样本量和把握度的估算,为此类新药临床试验服务。AIM： To calculate sample size and power of measurement data in non-inferior trials using SAS programming. METHODS： Two calculation method, formula and SAS programming, were compared based on examples and the SAS macro for power was given as well. RE SULTS：The calculation results of SAS program ming was consistent with the formula, and SAS programming can directly give the resuit was more convenient without looking-up table to obtain the relevant parameters. CONCLUSION. It is helpful for investigator to have a better understanding at this programming to calculate sample size and power provided in this paper.

关 键 词：计量资料 非劣效性试验 样本量 把握度 SAS程序 

分 类 号：R96[医药卫生—药理学]