Publications

Assessing the similarity of dose response and target doses in two non-overlapping subgroups

Bretz, F. and Möllenhoff, K. and Dette, H. and Liu, W. and Trampisch, M.

STATISTICS IN MEDICINE
Volume: 37 Pages: 722-738
DOI: 10.1002/sim.7546
Published: 2018

Abstract
We consider 2 problems of increasing importance in clinical dose finding studies. First, we assess the similarity of 2 non-linear regression models for 2 non-overlapping subgroups of patients over a restricted covariate space. To this end, we derive a confidence interval for the maximum difference between the 2 given models. If this confidence interval excludes the pre-specified equivalence margin, similarity of dose response can be claimed. Second, we address the problem of demonstrating the similarity of 2 target doses for 2 non-overlapping subgroups, using again an approach based on a confidence interval. We illustrate the proposed methods with a real case study and investigate their operating characteristics (coverage probabilities, Type I error rates, power) via simulation. Copyright © 2017 John Wiley & Sons, Ltd.

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