Evidence map›Paper›PMID 41422346›Full record

ArticleClinical rheumatology2026

Underrepresentation of Black participants in systemic sclerosis clinical trials: the U.S.A. and southeast region.

Mara Hartoyo, Natalie Goulett, Danyelle M Dawes, Andrea D Maderal

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Article in Clinical rheumatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Mara HartoyoUniversity of Miami Miller School of Medicine, Miami, FL, USA. mah1196@med.miami.edu.ORCID http://orcid.org/0000-0003-3314-0096
Natalie GoulettDepartment of Biostatistics, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, USA.
Danyelle M DawesDr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.
Andrea D MaderalDr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAcross the U.S.A., health disparities have contributed to a higher prevalence and more severe disease course in Black patients with systemic sclerosis compared to other racial groups. Lack of inclusivity in systemic sclerosis clinical trials may exacerbate these disparities in health outcomes.

objectiveTo estimate the underrepresentation of Black patients with systemic sclerosis in clinical trials, with a focus on characterizing the underrepresentation in the U.S. southeastern region, where Black individuals comprise larger portions of state populations.

methodsIn this cross-sectional study, the proportion of Black patients with systemic sclerosis enrolled in U.S. clinical trials versus those in the U.S. general population were compared using one sample z-tests. The number of unrepresented Black patients with systemic sclerosis in the U.S. southeastern region was estimated using published prevalence data.

resultsU.S. systemic sclerosis clinical trials are not representative of the estimated number of Black patients in the U.S.A. (z =  - 7.72, p < 0.001), leaving an estimated 50% of Black patients with systemic sclerosis in the U.S.A. unrepresented. In the U.S. southeastern region specifically, we estimated an astounding 69% are unrepresented in systemic sclerosis clinical trials.

conclusionResults of systemic sclerosis clinical trials are not applicable to the U.S. southeastern territory, limiting investigation of the geographic and sociodemographic factors influencing disease progression in Black individuals in this region. Representative clinical trial enrollment is crucial for equitable advancement of medical treatment. Key Points • Black patients with systemic sclerosis are underrepresented in U.S. clinical trials • When analyzing the U.S. southeastern region specifically, an astounding 69% of Black patients with systemic sclerosis are unrepresented, limiting investigation into the geographic and sociodemographic factors affecting health outcomes in this region.

Indexed as

Black or African AmericanClinical Trials as TopicScleroderma, SystemicCross-Sectional StudiesFemaleHumansMaleMiddle AgedPatient SelectionSoutheastern United StatesUnited StatesClinical trialsDiversityInclusionSystemic sclerosis

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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.