Model selection versus model averaging in dose finding studies
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Date
2015
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Abstract
Phase II dose finding studies in clinical drug development are typically
conducted to adequately characterize the dose response relationship of a new
drug. An important decision is then on the choice of a suitable dose response
function to support dose selection for the subsequent Phase III studies. In
this paper we compare different approaches for model selection and model
averaging using mathematical properties as well as simulations. Accordingly,
we review and illustrate asymptotic properties of model selection criteria and
investigate their behavior when changing the sample size but keeping the
effect size constant. In a large scale simulation study we investigate how
the various approaches perform in realistically chosen settings. Finally, the
different methods are illustrated with a recently conducted Phase II dosefinding
study in patients with chronic obstructive pulmonary disease.
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Keywords
model selection, simulation study, clinical trials, model averaging