Work

Testing for Similarity of Dose Response in Multiregional Clinical Trials

Year: 2025

Type: article

Abstract: This article addresses the problem of determining whether the dose response relationships between subgroups and the full population in a multiregional trial are similar. Similarity is assessed in terms of the maximal deviation between the dose response curves. We consider a parametric framework and develop two powerful bootstrap tests: one for assessing the similarity between the dose response curves of a single subgroup and that of the full population, and another for comparing the dose response curves of multiple subgroups with that of the full population. We prove the validity of these tests, investigate their finite sample properties through a simulation study and illustrate the methodology with a case study.

Source: Statistics in Medicine

DOI: 10.1002/sim.70255

Authors: Holger Dette, Lukas Koletzko, Frank Bretz

Institutions: Ruhr University Bochum, Novartis (Switzerland), Medical University of Vienna

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $5,450