| Literature DB >> 27935199 |
Björn Bornkamp1, David Ohlssen2, Baldur P Magnusson1, Heinz Schmidli1.
Abstract
In many clinical trials, biological, pharmacological, or clinical information is used to define candidate subgroups of patients that might have a differential treatment effect. Once the trial results are available, interest will focus on subgroups with an increased treatment effect. Estimating a treatment effect for these groups, together with an adequate uncertainty statement is challenging, owing to the resulting "random high" / selection bias. In this paper, we will investigate Bayesian model averaging to address this problem. The general motivation for the use of model averaging is to realize that subgroup selection can be viewed as model selection, so that methods to deal with model selection uncertainty, such as model averaging, can be used also in this setting. Simulations are used to evaluate the performance of the proposed approach. We illustrate it on an example early-phase clinical trial.Entities:
Keywords: Bayesian inference; exploratory study; proof of concept trial; shrinkage; subgroup analysis
Mesh:
Year: 2016 PMID: 27935199 DOI: 10.1002/pst.1796
Source DB: PubMed Journal: Pharm Stat ISSN: 1539-1604 Impact factor: 1.894