A 20-year study reveals that clinical trials related to diabetic macular edema (DME) do not adequately represent individuals of Black, Asian, and Hispanic race/ethnicity, even though diabetes disproportionately affects these patient populations.
Study Design
In this retrospective, cross-sectional study, the ethnic and racial demographics of patients enrolled in clinical trials for DME from 2002–2021 were analyzed. Forty-three studies from the ClinicalTrials.gov database were included. Racial/ethnic distributions and trends were analyzed and compared against data from the 2021 US Census.
Outcomes
Despite diabetes disproportionately affecting Black, Asian, and Hispanic individuals, patients of these racial/ethnic groups were consistently underrepresented in the DME clinical trials. The frequency of race reporting improved over time, increasing from 40% of trials in the first 10 years of the study period to 87% of trials in the second 10 years (p = 0.0032). Improved representation was seen among Hispanic and Asian populations in DME trials, though these groups were still underrepresented compared to overall diabetes prevalence; the proportion of Black patients in DME trials did not significantly change.
Limitations
This study does not explore the reasons for disparity in racial or ethnic representation, such as study design or inclusion/exclusion criteria that may inadvertently exclude minority patients. There are also ongoing DME studies that were not part of this analysis, since only completed clinical trials were included. Also, data reporting was not consistent among the included trials.
Clinical Significance
This study illustrates the disparity that exists between overall population demographics and study-related demographic distribution of patients being treated for DME. Black and Hispanic patients with diabetes often experience worse disease, both systemically and related to the eye, so realizing that the clinical trials on which we base our treatment patterns are not representative of these most-affected populations is important. Examining the reasons for this disparity may lead to more equitable clinical trials in the future and findings that are more applicable for all patients.
Financial Disclosures: Dr. Jessica Randolph discloses financial relationships with Apellis Pharmaceuticals (Lecture Fees); Astellas, Genentech (Consultant/Advisor).