Diabetic macular edema (DME) clinical trial patient populations do not adequately represent those from Black, Asian, and Hispanic heritages, despite a higher prevalence of diabetes in these groups, according to research published in Ophthalmology Retina.
Researchers conducted a cross-sectional retrospective study to examine the racial and ethnic demographic distribution of US-based DME trial participants from January 1, 2002, to December 31, 2021. To evaluate changes in the racial and ethnic makeup of DME trial participants, researchers compared the proportion of participants in each category from Decade 1 (January 1, 2012 to December 31, 2011) to Decade 2 (January 1, 2012 to December 31, 2021).
Of the 43 diabetic macular edema trials analyzed, 28 reported race as a baseline characteristic, while 15 did not. The number of trials reporting race increased from 8 in the first decade to 20 in the second decade. Among the 28 trials that reported race, 6867 participants were White, 1203 participants were Black, 565 participants were Asian, 49 participants were American Indian/Alaska Native, 33 participants were Native Hawaiian/Other Pacific Islander, 35 participants identified as more than one race, and 1365 participants were Hispanic.
With the increase in race reporting spanning the 2 decades, researchers also noted an increase in the proportion of participants with Asian heritage who enrolled (from 2.5% to 8.0%) in diabetic macular edema trials. Additionally, the number of participants with Hispanic backgrounds increased from 13.4% to 19.5%. The proportion of enrolled participants with White ethnicity decreased from 81.9% to 77.1% during the same time period. There were no significant changes in enrollment for all other races.
“Racial reporting in DME clinical trials has increased in the past decade, but differences between the racial/ethnic makeup of the US population and clinical trial participation still exist. Increasing efforts to decrease barriers may partially alleviate these differences and improve outcomes for all patient populations,” the researchers explain.
Study limitations include that the clinical trial screening process may contribute to the underrepresentation of minority patients, and only completed clinical trials were included.