title: Assessing noninferiority in a three-arm trial using the Bayesian approach.
abstract: 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 non-inferiority 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.
authors.affiliation: Department of Quantitative Methods and Information Sciences, Indian Institute of Management, Bangalore. pulak.ghosh@iimb.ernet.in
authors.forename: Pulak
authors.initials: P
authors.lastname: Ghosh
authors.forename: Farouk
authors.initials: F
authors.lastname: Nathoo
authors.forename: Mithat
authors.initials: M
authors.lastname: Gönen
authors.forename: Ram C
authors.initials: RC
authors.lastname: Tiwari
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001499:Bayes Theorem; D018660:Blood Pressure Monitoring, Ambulatory; D003198:Computer Simulation; D006699:Home Care Services; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008962:Models, Theoretical; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design; D013810:Therapeutic Equivalency
chemical_list: D000959:Antihypertensive Agents