Photo Credit: Alejandro Franco Garcia
Many barriers exist in the recruitment for diabetic macular edema clinical trials of patients of minority racial and ethnic backgrounds.
At the 2023 annual meeting of the American Academy of Ophthalmology (AAO 2023), Amy Yu, BA, BS, delivered a presentation titled, “Racial and Ethnic Distribution in Diabetic Macular Edema Clinical Trials in the United States, 2002-2021,” which pointed to discrepancies in representation of Hispanic patients in clinical trials for diabetic macular edema (DME) in the past 20 years. The presentation took place November 3 to 6 in San Francisco.
PW interviewed Yu to learn more about her presentation.
“DME is the primary cause of vision loss among patients with diabetic retinopathy,” Yu says. “Among US adults, the prevalence of diabetes is higher among minority groups compared with non-Hispanic Whites. However, non-White racial and ethnic subgroups are often underrepresented in clinical trials. To address this issue, we aimed to provide greater transparency about the demographic of clinical trial participants.”
Race Reporting More Than Doubled Compared With One Decade Prior
Yu and colleagues conducted a cross-sectional retrospective study about clinical trials on DME spanning 20 years, from January 1, 2002, to December 31, 2021. Data were collected from ClinicalTrials.gov and descriptive statistics, ORs, and χ2 tests were compared with 2021 US Census demographic data and 2020 CDC National Diabetes Statistics Report’s diagnosed diabetic patient demographic data.
The researchers note that in the past two decades, there has been a trend of increased racial reporting and minority patient enrollment in DME clinical trials with race reporting more than doubling when compared with the previous decade (87.0% vs 40.0%). “However, Black, Asian, and Hispanic patients remain significantly underrepresented among the DME clinical trial patient population based on the demographics of patients with diabetes,” Yu says.
Of 28 DME trials that included racial data, there were a total of 78.5% White participants, 13.8% Black, 6.5% Asian, 0.6% American Indian/Alaska Native, 0.4% Native Hawaiian/Other Pacific Islander, 0.4% more than one race, and 17.5% Hispanic. The proportion of enrolled Hispanic patients increased from 13.4% to 19.5% (OR=1.56; 95% CI, 1.37-1.78). Compared with the 2021 US Census data, overall Hispanic patients appeared to be underrepresented in the total enrollment of DME clinical trial patients compared with the proportion of Hispanics in the US population (χ2= 10.0; df=1; P=0.002).
Barriers to Clinical Trials Need to Be Addressed
In the future, the study team would like to see DME clinical trials consider enrolling a participant base with demographics more reflective of DME disease burden.
“This would likely include enrolling larger cohorts of patients from underrepresented racial and ethnic backgrounds that experience a greater burden than their White counterparts,” Yu says. “Additionally, there are many barriers in the recruitment of patients of minority racial and ethnic backgrounds, including language barriers, lack of information availability, presence of other medical comorbidities, socioeconomic factors, variable physician enrollment, difficulty in accessing trial sites, and perceived mistrust of the medical system. Increasing efforts to decrease barriers may partially alleviate these differences going forward.”
