Racial and ethnic minorities may be underrepresented in retinal clinical trials

Racial and ethnic representation in studies of retinal vascular disease do not match distribution within the US population according to US Census data.

Study design

The authors performed a cross-sectional retrospective analysis of racial and ethnic demographic characteristics reported in US-based randomized clinical trials (RCTs) of diabetic macular edema (DME) and retinal vein occlusion (RVO) from 2004 through 2020 compared with the same demographic data as reported in the 2010 US Census. After selecting for completed US-based RCTs that included race and ethnicity information, 15 DME and 8 RVO trials were available for analysis. Demographic groups included American Indian or Alaska Native, Asian, Black, Hispanic, Native Hawaiian or Other Pacific Islander, and White participants.

Outcomes

Asian participants were underrepresented in 10 of the 23 trials, Black participants were underrepresented in 9 trials, and Hispanic participants were underrepresented in 15 trials. In contrast, White participants were overrepresented in 14 of the 23 trials.

Limitations

RCT populations in this article were compared to corresponding demographic characteristics as reported in the US Census instead of to treatment- or disease-specific databases. Moreover, race and ethnicity reporting are inconsistently and heterogeneously gathered and reported in clinical trials, if reported at all.

Clinical significance

These findings reveal a discrepancy between racial and ethnic composition of patients enrolled in RCTs for DME and RVO compared to the general population. Specifically, there appears to be underrepresentation of certain racial and ethnic minorities in retinal vascular disease clinical trials.

Financial Disclosures: Dr. Shriji Patel discloses financial relationships with Alcon Laboratories (Grant Support); Genentech (Advisory Board); Eyepoint (Advisory Board).