Designing dose finding studies with an active control for exponential families
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Date
2014-10-26
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Abstract
In a recent paper Dette et al. (2014) introduced optimal design problems for dose
finding studies with an active control. These authors concentrated on regression models
with normal distributed errors (with known variance) and the problem of determining
optimal designs for estimating the smallest dose, which achieves the same treatment
effect as the active control. This paper discusses the problem of designing activecontrolled
dose finding studies from a broader perspective. In particular, we consider a
general class of optimality criteria and models arising from an exponential family, which
are frequently used analyzing count data. We investigate under which circumstances
optimal designs for dose finding studies including a placebo can be used to obtain
optimal designs for studies with an active control. Optimal designs are constructed for
several situations and the differences arising from different distributional assumptions
are investigated in detail. In particular, our results are applicable for constructing
optimal experimental designs to analyze active-controlled dose finding studies with
discrete data, and we illustrate the efficiency of the new optimal designs with two
recent examples from our consulting projects.
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Keywords
optimal designs, active control, dose estimation, dose response