Evidence map›Paper›PMID 36453057›Full record

ArticleStatistical methods in medical research2023

The population-wise error rate for clinical trials with overlapping populations.

Werner Brannath, Charlie Hillner, Kornelius Rohmeyer

Open access · hybridAbstract read
In one paragraph

Article in Statistical methods in medical research, 2023. 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
2.0field-weighted citation impact, top 12% of its field
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, 8 citations in OpenAlex.

  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 at 2 institutions in 1 country.

Werner BrannathUniversity of Bremen, Institute for Statistics and Competence Center for Clinical Trials, Bremen, Germany.ORCID 0000-0002-8622-3904
Charlie HillnerUniversity of Bremen, Institute for Statistics and Competence Center for Clinical Trials, Bremen, Germany.ORCID 0000-0001-9496-5169
Kornelius RohmeyerUniversity of Oldenburg, Institute of Mathematics, Oldenburg, Germany.
University of Bremen · DECarl von Ossietzky Universität Oldenburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We introduce a new multiple type I error criterion for clinical trials with multiple, overlapping populations. Such trials are of interest in precision medicine where the goal is to develop treatments that are targeted to specific sub-populations defined by genetic and/or clinical biomarkers. The new criterion is based on the observation that not all type I errors are relevant to all patients in the overall population. If disjoint sub-populations are considered, no multiplicity adjustment appears necessary, since a claim in one sub-population does not affect patients in the other ones. For intersecting sub-populations we suggest to control the average multiple type I error rate, i.e. the probability that a randomly selected patient will be exposed to an inefficient treatment. We call this the population-wise error rate, exemplify it by a number of examples and illustrate how to control it with an adjustment of critical boundaries or adjusted

Indexed as

Clinical Trials as TopicData Interpretation, StatisticalHumansProbabilityResearch DesignEnrichment designsfamily-wise error ratemultiple testingplatform trialspopulation-wise error rateumbrella trials

Identifiers

PMID36453057
PMCPMC9896298
OpenAlexW4310568488

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.