Evidence map›Paper›PMID 31544265›Full record

ArticleBiometrical journal. Biometrische Zeitschrift2020

A multiple comparison procedure for dose-finding trials with subpopulations.

Marius Thomas, Björn Bornkamp, Martin Posch, Franz König

Abstract readComparative Study
In one paragraph

Article in Biometrical journal. Biometrische Zeitschrift, 2020. 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. A multiple comparison procedure for dose-finding trials with subpopulations.Biometrical journal. Biometrische Zeitschrift · 2020
    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

4 authors.

Marius ThomasNovartis Pharma AG, Novartis Campus, Basel, Switzerland.ORCID 0000-0003-2790-829X
Björn BornkampNovartis Pharma AG, Novartis Campus, Basel, Switzerland.
Martin PoschSection of Medical Statistics, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-8499-8573
Franz KönigSection of Medical Statistics, Medical University of Vienna, Vienna, Austria.ORCID 0000-0002-6893-3304

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Identifying subgroups of patients with an enhanced response to a new treatment has become an area of increased interest in the last few years. When there is knowledge about possible subpopulations with an enhanced treatment effect before the start of a trial it might be beneficial to set up a testing strategy, which tests for a significant treatment effect not only in the full population, but also in these prespecified subpopulations. In this paper, we present a parametric multiple testing approach for tests in multiple populations for dose-finding trials. Our approach is based on the MCP-Mod methodology, which uses multiple comparison procedures (MCPs) to test for a dose-response signal, while considering multiple possible candidate dose-response shapes. Our proposed methods allow for heteroscedastic error variances between populations and control the family-wise error rate over tests in multiple populations and for multiple candidate models. We show in simulations that the proposed multipopulation testing approaches can increase the power to detect a significant dose-response signal over the standard single-population MCP-Mod, when the specified subpopulation has an enhanced treatment effect.

Indexed as

Clinical Trials as TopicBiometryDose-Response Relationship, DrugHumansMCP-Modmultiple testingsubgroup analysestargeted therapies

Identifiers

PMID31544265
PMCPMC6973002

What OpenQuestion holds

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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.