Background: Despite the higher rates of diabetes among the Black, Indigenous, and People of Color (BIPOC) population, there is a significant underrepresentation of this population in diabetes-related clinical trials which compromises the generalizability of results and further exacerbates health disparities.

Objective: To identify barriers and solutions to BIPOC enrollment in diabetes-related clinical trials.

Methods: We reviewed 18 diabetes-related clinical trials at Retina Associates LLC in Kansas City and interviewed recruiting physicians from practices across the US. Results: Fewer BIPOC population (15.6%) and women (40%) were enrolled in the analyzed trials. Men were 1.6 times more likely to be screened despite having a 20% higher screen fail rate than women. The fail rate was lower among Caucasian participants than among Hispanic participants (29.6% vs 37.5%). Based on zip codes, the fail rate was 1.25 times higher for those with an estimated average household income below $70,000 compared to those with an income above $100,000. The interviewed physicians valued a potential clinical trial patient’s ability to understand, commitment to health, reliability, and overall interest. They stressed the immense difficulty of time and travel commitments that clinical trials can pose for patients and agreed that increasing diversity in the staff could prove to be beneficial, especially regarding the language barrier many patients face.

Conclusions: Several recommendations from the reviewed trials and interviews to improve BIPOC enrollment. Clinical trial sponsors should provide Informed Consent Forms (ICFs) in multiple languages. There needs to be a level of diversity when hiring healthcare providers and study coordinators. Clinical trials should be designed to be less burdensome and include geographic locations with a higher population percentage of minorities, as well as locations within the neighborhoods where these populations receive their healthcare care.


L.H.Cooper: None. L.Ainley: None. H.Stevens: None. K.Quinn: None. B.A.Cooper: Advisory Panel; Genentech, Inc., Speaker's Bureau; Regeneron, Optomed.

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