“Jennifer Pinal, a co-author on this study and a current Latinx medical student from the community we serve, and I were inspired to do this study from our own observations on the Inland Empire of Southern California,” Vivienne S. Hau, MD, PhD, explains. “We serve a population that is predominantly Latinx, and we see more severe cases of diabetic retinopathy and less enrollment in early clinical trials due to failure to meet inclusion criteria for HbA1c.”
For a study presented at the American Society of Retina Specialists 2023 Annual Meeting, Dr. Hau and colleagues aimed to determine whether racial and ethnic disparities exist on a national scale in recruitment for clinical trials related to diabetic retinopathy as a way to start improving healthcare access. “In addition, we wanted to see how our field was doing in the recruitment of various racial and ethnic minorities in clinical trials, even though there are federal mandates for inclusion,” says Dr. Hau. “For us to target areas for improvement, we need to first understand the current situation.”
Dr. Hau and colleagues examined US-based trials that were registered on ClinicalTrials.gov from January 2012 through January 2022. Trials included in the study were categorized as complete with available results.
Few Sites Recruit Racial & Ethnic Minorities
The search identified 96 US-based trials (N=13,016); 80 trials (n=7,731) were included for qualitative analysis. Dr. Hau and colleagues also identified 31 diabetes-related trials (n=2,677), which were stratified by the following race and ethnicity categories: Black, American Indian and Alaska Native (AIAN), and Native Hawaiian or Other Pacific Islander (NHPI). The lack of available data on race limited the number of trials included to 21, which comprised a total of 20 Black, 9 AIAN, 5 NHPI, and 13 Hispanic participants.
“We hypothesized that most participants from racial and ethnic minority groups would be centered in areas where the population is reflective of these groups but would overall still be under-represented compared with the greater US population,” Dr. Hau says. “What we actually found is that only a small number of sites who reported data are carrying the weight of recruiting these groups.”
The results indicate “that we, as a field, need to do a better job of recruiting and reporting for all races and ethnicities in our retina clinical trials,” she continues. “We found that, in some trials, it may seem like we are doing a decent job of recruiting certain races or ethnicities, but that is mainly due to the efforts of a small handful of clinical trial sites.”
There were many sites in areas with more diverse communities that were not recruiting well despite their “ideal geographic location,” Dr. Hau notes. “This means there is potential for the field to understand and target barriers to recruitment while leveraging the experience of successful primary investigators to create new trial sites or build up current ones.”
Mentoring upcoming investigators represents another “ideal” strategy, according to Dr. Hau, but she acknowledges that racial and ethnic minorities are under-represented in ophthalmology, especially in clinical trials. “Through mentorship efforts to increase diversity in the field and leadership training to share this subset of the field, we can begin to address the issue of access to clinical trials for both the investigators and the communities that need treatment.”