Racial, gender disparities exist in enrollment of DME clinical trials
NEW YORK — There are racial and gender disparities in the enrollment of participants in clinical trials for diabetic macular edema, according to a poster presented at the American Society of Retina Specialists annual meeting.
In a retrospective cohort study, Theodore S. Bowe, MD, and colleagues analyzed the data of Diabetic Retinopathy Clinical Research Network clinical trials and industry-sponsored phase 3 trials on DME conducted in the U.S. between 2000 and 2020.
They found that white and male participants were relatively overrepresented in all trials. Overall, white participants made up 75.8% of trials as compared with 13.1% of Black or African American participants and 11.9% of Hispanic participants; 57.1% of participants were male. These percentages were not consistent with the reference sample size of patients with DME undergoing treatment from published IRIS Registry data.
“[Diabetes mellitus] broadly, and DME specifically, are not equally prevalent by race in the USA, with Black and Hispanic patients facing a greater burden of disease as compared to white and Asian patients. Numerous studies have raised concerns that clinical trial cohorts are frequently demographically different from the population undergoing treatment post-FDA approval,” the authors wrote.
The findings of this study confirm that clinical trials do not draw a representative sample of the patient population being treated for DME. To ensure generalizability of clinical trial results, enrollment criteria should be modified to ensure that clinical trial populations are reflective of the DME population undergoing treatment, the authors wrote.
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Bowe TS, et al. Racial disparities in enrollment and participation in diabetic macular edema clinical trials in the United States. Presented at: American Society of Retina Specialists annual meeting; July 13-16, 2022; New York.
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