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Ajay E. Kuriyan, Theo Bowe, Rebecca Russ Soares, Charles Huang, Rishi P Singh, M. Ali Ali Khan, Basil K Williams, Jayanth Sridhar, Allen Chiang, Michael Cohen, Michael Klufas, Omesh P Gupta, Yoshihiro Yonekawa, David Xu; Racial and Gender Disparities in Enrollment and Participation in Diabetic Macular Edema Clinical Trials in the United States. Invest. Ophthalmol. Vis. Sci. 2022;63(7):2505 – F0231.
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© ARVO (1962-2015); The Authors (2016-present)
Numerous studies have raised concerns that clinical trial cohorts are frequently demographically different from the population undergoing treatment post FDA approval. Our study describes the racial and ethnic composition of the cohorts of diabetic macular edema(DME) clinical trials and compares this to the racial and ethnic composition of patients undergoing treatment for DME from the (Intelligent Research in Sight) IRIS ® Registry.
This is a retrospective cohort study comparing the racial/ethnicity and gender composition of patients undergoing treatment for DME from the (Intelligent Research in Sight) IRIS ® Registry and participants in Diabetic Retinopathy Clinical Research (DRCR) Retina Network clinical trials and industry sponsored trials that met the following inclusion criteria: conducted in the United States of America, Phase III completed, data reported between Jan 1, 2000, and Jan 1, 2020, and demographic information reported with results.
Twenty-two clinical trials met our inclusion criteria. Seventeen were part of the DRCR and five were industry-sponsored trials. Compared to the enrollment fraction of 4.94% among Whites, lower enrollment fractions were found in Black patients (3.99%, odds ratio [OR] 0.816,confidence interval [CI] 0.786-0.867, P< 0.001) and in Hispanic patients (2.81%, OR 0.579, CI 0.541-0.620, P<0.001). Men were more likely to enroll in the clinical trials compared to women (enrollment fraction, 4.11% vs 3.64%, respectively, OR 1.22, CI 1.074-1.172, P < 0.001).
DME clinical trials have a higher relative proportion of White and male subjects when compared to the population undergoing treatment for DME. Further efforts should consider measures to encourage clinical trial recruitment that is reflective of the DME population undergoing treatment to ensure generalizability of clinical trial results.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.
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