Kawasaki Yohei, Shimokawa Asanao, Yamada Hiroshi, Miyaoka Etsuo
a Department of Drug Evaluation and Informatics , School of Pharmaceutical Sciences, University of Shizuoka , Suruga-ku , Shizuoka , Japan.
b Department of Mathematics , Tokyo University of Science , Shinjuku-ku , Tokyo , Japan.
J Biopharm Stat. 2016;26(4):781-9. doi: 10.1080/10543406.2015.1074919. Epub 2015 Aug 31.
In clinical trials, it is often necessary to perform an equivalence study. The equivalence study requires actively denoting equivalence between two different drugs or treatments. Since it is not possible to assert equivalence that is not rejected by a superiority test, statistical methods known as equivalency tests have been suggested. These methods for equivalency tests are based on the frequency framework; however, there are few such methods in the Bayesian framework. Hence, this article proposes a new index that suggests the equivalency of binomial proportions, which is constructed based on the Bayesian framework. In this study, we provide two methods for calculating the index and compare the probabilities that have been calculated by these two calculation methods. Moreover, we apply this index to the results of actual clinical trials to demonstrate the utility of the index.
在临床试验中,常常需要进行等效性研究。等效性研究要求明确指出两种不同药物或治疗方法之间的等效性。由于无法断言未被优效性检验拒绝的等效性,因此有人提出了称为等效性检验的统计方法。这些等效性检验方法基于频率框架;然而,在贝叶斯框架下这类方法很少。因此,本文提出了一种基于贝叶斯框架构建的、用于表明二项比例等效性的新指标。在本研究中,我们提供了两种计算该指标的方法,并比较了这两种计算方法所计算出的概率。此外,我们将该指标应用于实际临床试验的结果,以证明该指标的实用性。