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Activity Number: 320
Type: Topic Contributed
Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
Sponsor: Section on Bayesian Statistical Science
Abstract #312163 View Presentation
Title: Bayesian Subgroup Analysis in Drug Development
Author(s): David Ohlssen *+
Companies: Novartis
Keywords: clinical trials ; subgroup analysis ; Bayesian methods ; shrinkage estimation ; drug development ; hierarchical modeling
Abstract:

In a pharmaceutical drug development setting, possible interactions between the treatment and particular baseline clinical or demographic factors are often of interest. However, the subgroup analysis required to investigate such associations remains controversial. Concerns with classical hypothesis testing approaches to the problem include low power, multiple testing, and the possibility of data dredging. As an alternative to hypothesis testing, the use of shrinkage estimation techniques shall be explored in the context of an exploratory post-hoc subgroup analysis. A range of models that have been suggested in the literature will be reviewed. Building on this, we propose a general modeling strategy, considering various options for shrinkage of the effect estimates. This is then applied to a case-study, where evidence was available from seven phase II/III clinical trials examining a novel therapy. Emphasis is placed on hierarchical modeling techniques, adopted within a Bayesian framework using freely available software.


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