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

Frank Bretz, Kathrin Möllenhoff, Holger Dette, Wei Liu, Matthias Trampisch

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)722-738
Number of pages17
JournalStatistics in Medicine
Volume37
Issue number5
DOIs
Publication statusPublished - 28 Feb 2018
Externally publishedYes

Bibliographical note

Copyright © 2017 John Wiley & Sons, Ltd.

Keywords

  • Clinical Trials, Phase II as Topic/methods
  • Computer Simulation
  • Confidence Intervals
  • Data Interpretation, Statistical
  • Dose-Response Relationship, Drug
  • Humans
  • Linear Models

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