A review of ophthalmology clinical trials resulting in FDA-approved drugs has found the majority failed to represent the USA’s ethnic makeup.
Led by Dr Sean Berkowitz from Vanderbilt University Medical Center, the study of 31 clinical trials found that Black, Hispanic, Latinx and other non-white participants were underrepresented among the more than 18,000 participants in 12 of 13 drugs trials. The prevalence of eye conditions among ethnic groups was also not reflected in the enrolment profiles of drug trials for those conditions, with a decrease in Black participants in diabetic retinopathy (DR) drug trials over the 20-year period. Sex distribution was also unrepresentative of the country’s population in the trials of 10 drugs.
Based on these trends, researchers concluded that the enrolment incidence ratio is likely to worsen by 2050, with overrepresentation of white participants vs underrepresentation of Black and Hispanic or Latinx participants in trials of drugs for age-related macular degeneration (1.08 vs 0.04 vs 0.77), DR (1.83 vs 0.87 vs 0.59), and open-angle glaucoma (1.62 vs 0.90 vs 0.37).
