Introduction Across 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. Objective To 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. Methods In 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. Results U.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. Conclusion Results 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.<Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="left" colname="c1" colnum="1" /> <colspec align="left" colname="c2" colnum="2" /> <tbody> <row> <entry nameend="c2" namest="c1"> 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. </entry> </row> </tbody> </tgroup> </Table>

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

期刊论文
发表日期：

2025年12月20日

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

摘要

Introduction

Across 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.

Objective

To 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.

Methods

In 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.

Results

U.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.

Conclusion

Results 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.