—Black and Hispanic or Latinx participants are underrepresented in clinical trials for ophthalmology drugs, according to a study published online April 22 in JAMA Ophthalmology.
Sean T. Berkowitz, from the Vanderbilt University School of Medicine in Nashville, Tennessee, and colleagues examined racial/ethnic representation, trends, and disparities for participants in clinical trials leading to U.S. Food and Drug Administration ophthalmology drug approvals for neovascular age-related macular degeneration (AMD), open-angle glaucoma (OAG), and expanded indications for diabetic retinopathy (DR) from Jan. 1, 2000, to Dec. 31, 2020. Thirty-one clinical trials were identified for 13 medications with 18,410 participants.
The researchers found that for most approvals, the distribution of trial participants was different from the expected trial distribution with respect to race/ethnicity (12 drugs) and sex (10 drugs). Trials conducted in 2011 to 2020 versus 2000 to 2010 showed increases in enrollment of Asian and Hispanic or Latinx participants for AMD (odds ratios, 2.30 and 1.74, respectively); Asian participants for DR (odds ratio, 2.21); and Black and Hispanic or Latinx participants for OAG (odds ratios, 1.60 and 10.31, respectively). In DR trials, there was a decrease in Black participants (odds ratio, 0.58). Based on these trends, by 2050, the enrollment incidence ratio is expected to worsen with overrepresentation of Whites and underrepresentation of Black and Hispanic or Latinx participants in trials of drugs for AMD, DR, and OAG.
“Diverse, representative enrollment in pivotal clinical trials is vital to sufficiently power subgroup analyses and ensure equity and validity of trial results,” the authors write.
One author disclosed receiving grants from Alcon.