Assessing the similarity of dose response and target doses in two non-overlapping subgroups
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Date
2016
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Abstract
We consider two problems that are attracting increasing attention in clinical dose
finding studies. First, we assess the similarity of two non-linear regression models
for two non-overlapping subgroups of patients over a restricted covariate space. To
this end, we derive a confidence interval for the maximum difference between the two
given models. If this confidence interval excludes the equivalence margins, similarity
of dose response can be claimed. Second, we address the problem of demonstrating
the similarity of two target doses for two non-overlapping subgroups, using again a
confidence interval based approach. We illustrate the proposed methods with a real
case study and investigate their operating characteristics (coverage probabilities, Type
I error rates, power) via simulation.
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Keywords
equivalence testing, subgroup analyses, target dose estimation, multiregional trial