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Assessing noninferiority in a three‐arm trial using the Bayesian approach
Author(s) -
Ghosh Pulak,
Nathoo, Farouk,
Gönen Mithat,
Tiwari Ram C.
Publication year - 2011
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4244
Subject(s) - bayesian probability , parametric statistics , computer science , placebo , statistical hypothesis testing , clinical trial , statistics , machine learning , medicine , artificial intelligence , mathematics , alternative medicine , pathology
Non‐inferiority trials, which aim to demonstrate that a test product is not worse than a competitor by more than a pre‐specified small amount, are of great importance to the pharmaceutical community. As a result, methodology for designing and analyzing such trials is required, and developing new methods for such analysis is an important area of statistical research. The three‐arm trial consists of a placebo, a reference and an experimental treatment, and simultaneously tests the superiority of the reference over the placebo along with comparing this reference to an experimental treatment. In this paper, we consider the analysis of noninferiority trials using Bayesian methods which incorporate both parametric as well as semi‐parametric models. The resulting testing approach is both flexible and robust. The benefit of the proposed Bayesian methods is assessed via simulation, based on a study examining home‐based blood pressure interventions. Copyright © 2011 John Wiley & Sons, Ltd.