Skip to Content

Racial/Ethnic Disparities Identified in Ophthalmology Trials

TUESDAY, April 27, 2021 -- 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.

Abstract/Full Text (subscription or payment may be required)

Editorial (subscription or payment may be required)

© 2021 HealthDay. All rights reserved.

Read this next

Prevalence of Cognitive Impairment Up in Normal-Tension Glaucoma

WEDNESDAY, March 31, 2021 -- Normal-tension glaucoma (NTG) is associated with an increased prevalence of cognitive impairment, according to a study published online March 29 in...

2008 to 2017 Saw Drop in Serious Vision Impairment in U.S. Seniors

MONDAY, March 22, 2021 -- The prevalence of serious vision impairment among older Americans declined significantly between 2008 and 2017, according to a study published online...

Incidence of Scleritis Down in the United Kingdom

WEDNESDAY, March 17, 2021 -- From 1997 to 2018, there was a decrease in the incidence of scleritis in the United Kingdom, according to a study published online March 16 in...

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.