Race and Ethnicity Reporting in Acute Stroke Clinical Trials

Introduction: Stroke affects up to 9.4 million Americans, disproportionately affecting black Americans with a prevalence nearly 2 times higher than non-Hispanic white Americans. Despite this, clinical trials have historically underrepresented black and minority individuals. This study aims to evaluate the representation of racial/ethnic minorities in acute stroke trials.

Methods: The ClinicalTrials.gov database was searched on March 29, 2022, using “stroke” to identify all trials related to stroke. Trials with an intervention aimed at minimizing brain tissue damage at or immediately following ischemic or hemorrhagic stroke were included. Trial status, locations, and race/ethnicity data were extracted directly from the database or associated publications on PubMed.

Results: Out of 114 trials (15 conducted in the US only, 23 in the US and abroad, and 76 exclusively abroad), race/ethnicity data reporting varied: 93% in US-only trials, 56.5% in US and abroad trials, and 14.5% in exclusively abroad trials. In US-only trials, 18% of participants identified as Black, 8% as Hispanic, and 1.6% as Asian. Compared to the US population, Black participants were overrepresented, while Hispanic and Asian participants were underrepresented. Compared to the demographic makeup of US stroke cases, Black participants were appropriately represented, but Hispanic and Asian participants were still underrepresented. In US and abroad trials, 23.49% identified as Asian, 7.21% as Hispanic, and 3.79% as Black. In exclusively abroad trials, 43.38% identified as Asian, 0.03% as Hispanic and 0.58% as Black.

Conclusion : Our study revealed disparities in race/ethnicity reporting and representation. High disclosure of race/ethnicity data in the US is likely due to NIH guidelines, clinicaltrials.gov mandates, and journal mandates, while lower disclosure abroad may be due to demographic and regulatory differences. These findings underscore the importance of improved data reporting and greater inclusivity to ensure equitable representation in stroke trials.