In ophthalmology clinical trials that led to drug approvals by the U.S. Food and Drug Administration, representation by Black, Hispanic or Latinx, and other non-White participants was less than expected in relation to disease burden and racial/ethnic distribution, according to a study.
Researchers used data from clinical trials of drugs for neovascular age-related macular degeneration (AMD), open-angle glaucoma (OAG), and expanded indications for diabetic retinopathy (DR) occurring from 2000 to 2020 to evaluate racial/ethnic representation.
A total of 18,410 participants across 31 trials for 13 medications were identified. Less than expected distribution in regard to the race/ethnicity and sex of participant was noted in trials for 12 drugs and 10 drugs, respectively.
Enrollment of Asians and Hispanic or Latinx participants for AMD, Asian participants for DR, and Black and Hispanic or Latinx participants for OAG increased from 2011-2020 compared with from 2000-2010. A decrease in Black participants was found in DR trials.
According to the authors, “the enrollment incidence ratio is expected to worsen by 2050, with overrepresentation of white participants vs underrepresentation of Black and Hispanic or Latinx participants in trials of drugs for AMD.”
Berkowitz ST, Groth SL, Gangaputra S, et al. Racial/ethnic disparities in ophthalmology clinical trials resulting in US Food and Drug Administration Drug approvals From 2000 to 2020. JAMA Ophthalmol. 2021; DOI:10.1001/jamaophthalmol.2021.0857