Abstract
Purpose :
Diabetic macular edema (DME), the leading cause of vision loss among patients with diabetes mellitus, disproportionately affects Black and Hispanic patients. Currently, non-White racial and ethnic subgroups are frequently underrepresented in clinical trials, limiting the application of results to the most pertinent patient populations. Thus, we aimed to characterize the trajectory of racial reporting as well as changes and disparities in racial and ethnic distribution among participants of DME clinical trials.
Methods :
This was a cross-sectional retrospective study reviewing the racial and ethnic demographic distribution of patients enrolled in US-based clinical trials for DME from 2002 to 2021. Clinical trials were screened from ClinicalTrials.gov for DME, US trial location, study completion, and greater than 50 patient enrollment. Descriptive statistics and χ2 tests were used for data analysis and comparison with the 2021 US Census demographic data. Proportions and odds ratios were also reported.
Results :
Of 43 trials on DME, 28 (65.1%) reported at least one race as a baseline characteristic and 15 (34.9%) did not report race. There was an increase in race reporting from January 2002 to December 2011 (8 [40.0%] trials) vs. January 2012 to December 2021 (20 [87.0%] trials) (OR= 10.00; 95% CI: 2.21, 45.16). In the 28 DME trials that included racial data, there were a total of 6867 White participants (78.5%), 1203 Black (13.8%), 565 Asian (6.5%), 49 American Indian/Alaska Native (0.6%), 33 Native Hawaiian/Other Pacific Islander (0.4%), 35 more than one race (0.4%), and 1365 Hispanic (17.5%). Across the two decades, the proportion of Asian patients enrolled increased from 2.4% to 8.0% (OR=3.47; 95% CI: 2.64, 4.56) (Figure 1). Similarly, the proportion of enrolled Hispanic patients increased from 13.4% to 19.5% (OR=1.56; 95% CI: 1.37, 1.78) (Figure 1). Compared to the 2021 US Census data, overall Hispanic patients appear to be underrepresented in the total enrollment of DME clinical trial patients compared to the proportion of Hispanics in the US population (χ2= 10.0; df=1; p=0.002).
Conclusions :
In the past two decades, there has been a trend of increased racial reporting in DME clinical trials. While enrollment of Asian and Hispanic patients has increased, the Hispanic population remains significantly underrepresented among the DME clinical trial patient population according to US Census data.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.