Research published in JAMA Ophthalmology sought to determine how racial and ethnic demographic characteristics in randomized clinical trials (RCTs) for diabetic macular edema (DME) and retinal vein occlusion (RVO) across the U.S. compared to the U.S. Census data.
Tell me about the study.
Researchers conducted a cross-sectional retrospective analysis of racial and ethnic distribution data reported among completed RCTs from 2004 to 2020 to the same data reported in the 2010 U.S. Census. A total of 23 trials—15 DME and 8 RVO—included race and ethnicity information.
What demographic groups were included?
Demographics among the 9,924 participants included American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (0.4%); Black (9.6%); Hispanic (10.1%); and White (80.4%).
How did this compare to census data?
The census reported that 1.1% of the U.S. population (308,745,538 in total) self-reported as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander; 4.8% self-reported as Asian; 12.6% as Black or African-American; 16.3% as Hispanic; and 63.7% as White. (via)
What did they find in the trials?
Asian participants were underrepresented in 10 trials, overrepresented in 4, and neither in 2 trials. Black participants were underrepresented in 9 trials, overrepresented in 2, and neither in 11. Hispanic participants were underrepresented in 15 trials, overrepresented in 2, and neither in 5; and White participants were underrepresented in 2 trials, overrepresented in 14, and neither in 7. (via)
Any limitations to the study?
The populations from RCTs were compared to the U.S. Census’s reported corresponding demographics instead of comparisons to disease- or treatment-specific databases. Further, the authors stated that reporting of ethnicity and race are not consistent and are heterogeneously collected and reported—if at all—in trials.
Take home?
Study authors noted a discernible discrepancy between ethnic and racial demographic data among DME and RVO RCTs and the U.S. Census data. They expressed the need for more efforts to recruit underrepresented minorities to improve external validity in trial findings. (via)