A Bayesian non-inferiority test for two independent binomial proportions

作者：Kawasaki Yohei^*; Miyaoka Etsuo

来源：Pharmaceutical Statistics, 2013, 12(4): 201-206.

DOI：10.1002/pst.1571

• independent binomial proportions
• Bayesian inference
• non-inferiority
• empirical Bayes method
• exact probability

In drug development, non-inferiority tests are often employed to determine the difference between two independent binomial proportions. Many test statistics for non-inferiority are based on the frequentist framework. However, research on non-inferiority in the Bayesian framework is limited. In this paper, we suggest a new Bayesian index =P((1)%26gt;(2)-(0)|X-1,X-2), where X-1 and X-2 denote binomial random variables for trials n(1) and n(2), and parameters (1) and (2), respectively, and the non-inferiority margin is (0)%26gt;0. We show two calculation methods for , an approximate method that uses normal approximation and an exact method that uses an exact posterior PDF. We compare the approximate probability with the exact probability for . Finally, we present the results of actual clinical trials to show the utility of index .

• 出版日期2013-7