Evidence map›Paper›PMID 40922064›Full record

ArticleStatistics in medicine2025

Testing for Similarity of Dose Response in Multiregional Clinical Trials.

Holger Dette, Lukas Koletzko, Frank Bretz

Abstract read
In one paragraph

Article in Statistics in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Holger DetteDepartment of Mathematics, Ruhr-Universität Bochum, Bochum, Germany.ORCID https://orcid.org/0000-0001-7048-474X
Lukas KoletzkoDepartment of Mathematics, Ruhr-Universität Bochum, Bochum, Germany.ORCID https://orcid.org/0009-0006-6435-2074
Frank BretzStatistical Methodology, Novartis Pharma AG, Basel, Switzerland.ORCID https://orcid.org/0000-0002-2008-8340

Funding

Deutsche Forschungsgemeinschaft 499552394-SFB 1597European Union 825575Innovative Health Initiative Joint Undertaking 101165912
6 · The paper itself

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.

Indexed as

Clinical Trials as TopicDose-Response Relationship, DrugMulticenter Studies as TopicComputer SimulationHumansModels, Statisticalconstrained bootstrapequivalence testing of curvessubgroup analysis

Identifiers

PMID40922064
PMCPMC12417559

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.