Disparities in Race and Ethnicity Reporting and Representation for Clinical Trials in Stroke: 2010 to 2020.

BACKGROUND

Racial and ethnic minority groups are at a higher stroke risk and have poor poststroke outcomes. The aim of this study was to assess the frequency of race reporting and proportions of race and ethnicity representation in stroke-related clinical trials.

METHODS AND RESULTS

This is a descriptive study of stroke-related clinical trials completed between January 1, 2010 and December 31, 2020, and registered on ClinicalTrials.gov. Trials conducted in the United States, related to stroke and enrolling participants ≥18 years, were considered eligible. Trials were reviewed for availability of published results, data on race and ethnicity distribution, and trial characteristics. Overall, 60.1% of published trials reported race or ethnicity of participants, with a 2.6-fold increase in reporting between 2010 and 2020. White patients represented 65.0% of the participants, followed by 24.8% Black, 2.4% Asian or Pacific Islander, and <1% Native American and multiracial participants; 9.0% were of Hispanic ethnicity. These trends remained consistent throughout the study period, except in 2018, when a higher proportion of Black participants (53.1%) was enrolled compared with White participants (35.8%). Trials with the National Institutes of Health/federal funding had higher enrollment of Black (28.1%) and Hispanic (13.8%) participants compared with other funding sources. Behavioral intervention trials had the most diverse enrollment with equal enrollment of Black and White participants (41.1%) and 14.5% Hispanic participants.

CONCLUSIONS

Despite the increase in race and ethnicity reporting between 2010 and 2020, the representation of racial and ethnic minority groups remains low in stroke trials. Funding initiatives may influence diversity efforts in trial enrollment.