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等效性和非劣效性试验中的假设检验——一个概念

Testing of Hypothesis in Equivalence and Non Inferiority Trials-A Concept.

作者信息

Juneja Atul, Aggarwal Abha R, Adhikari Tulsi, Pandey Arvind

机构信息

Scientist 'D', National Institute of Medical Statistics (ICMR) , Ansari Nagar, New Delhi, India .

Scientist 'F', National Institute of Medical Statistics (ICMR) , Ansari Nagar, New Delhi, India .

出版信息

J Clin Diagn Res. 2016 Apr;10(4):LG01-3. doi: 10.7860/JCDR/2016/17748.7547. Epub 2016 Apr 1.

Abstract

Establishing the appropriate hypothesis is one of the important steps for carrying out the statistical tests/analysis. Its understanding is important for interpreting the results of statistical analysis. The current communication attempts to provide the concept of testing of hypothesis in non inferiority and equivalence trials, where the null hypothesis is just reverse of what is set up for conventional superiority trials. It is similarly looked for rejection for establishing the fact the researcher is intending to prove. It is important to mention that equivalence or non inferiority cannot be proved by accepting the null hypothesis of no difference. Hence, establishing the appropriate statistical hypothesis is extremely important to arrive at meaningful conclusion for the set objectives in research.

摘要

建立适当的假设是进行统计检验/分析的重要步骤之一。理解假设对于解释统计分析结果很重要。本文旨在介绍非劣效性和等效性试验中的假设检验概念,在这些试验中,原假设与传统优效性试验中的假设相反。同样,为了证实研究者想要证明的事实,也要寻求对原假设的拒绝。需要指出的是,接受无差异的原假设并不能证明等效性或非劣效性。因此,建立适当的统计假设对于得出针对研究设定目标的有意义结论极为重要。

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