Federally Qualified Health Centers (FQHCs) – usually a part of local health departments or community centers – are meant to serve communities most affected by health disparities, but they often miss the mark when it comes to enrolling Black patients in clinical research trials. A recent Journal of the American Medical Association (JAMA) study explored this discrepancy, highlighting how increased on-site physician and specialist involvement directly correlates to the centers’ clinical trial participation; a numbers game that is detrimental to medical outcomes within the Black community.
According to the National Institutes of Health (NIH), Black people experience higher rates of diabetes, diabetes-related complications, and death. They are also diagnosed with high blood pressure at a younger age than their white counterparts. Despite the correlation between hypertension and diabetes, they also face significantly higher risks of developing type 2 diabetes compared to their white counterparts, regardless of blood pressure levels.
And while they experience higher rates of cardiovascular disease (CVD) and cardiometabolic diseases like hypertension (high blood pressure) and type 2 diabetes (T2D), underserved populations lack meaningful representation in CVD clinical trials.
Disparities in hypertension and diabetes are closely tied to broader issues of being medically underserved, including limited access to consistent, preventive healthcare. Many people affected by these chronic conditions rely on FQHCs, often due to a lack of insurance or other barriers.
FQHCs, also described as safety net providers, are medical centers that provide services to patients regardless of their ability to pay. They deliver essential healthcare services to underserved and vulnerable community members, including those who are underinsured, uninsured, or with limited access to care. These community-based centers are funded by the Health Resources and Services Administration (HRSA) and can be found throughout the country.
The JAMA study reviewed databases from 2013 to 2023 to examine how FQHCs engaged in adult hypertension and type 2 diabetes clinical trials.
Researchers found four levels of engagement, ranging from Level 1, where centers were informed of the clinical trials but did not participate, to Level 2 engagement, which included centers that were involved in recruitment and participation in the early trial phases. Levels 3 and 4 indicated centers that were either sponsors (initiators) of the trial or leads in the trial, respectively. Study authors grouped level 3 and 4 data due to limited data (low numbers).
The study also analyzed how the centers’ involvement in clinical trials varied by location, patient demographics (including age, sex, race, ethnicity), insurance coverage, and specific diagnoses. The goal was to better understand how involved these safety net providers were in clinical trials and the factors that drove their involvement.
The review by JAMA found that the more physicians and specialists at the sites correlated with higher levels of clinical trial engagement. Essentially, the more people associated with a center, the higher the chance that the center would be enrolled in and care for clinical trial participants. Understanding these patterns is important in addressing medical issues in underserved communities. Given an FQHC’s proximity to these populations, not engaging in clinical trials is a missed opportunity to improve healthcare outcomes for Black patients.
Dr. Monique Gary, a breast cancer surgeon and advocate, noted that federally qualified health centers are the backbone of community care, especially at the primary care level.
“What is not surprising is the basic and foundational understanding that engaging with health centers, community, and advocates are all essential components of successful trial enrollment, and truly a successful clinical trial pipeline. Nothing about us, without us,” Gary emphasized.
“And when all stakeholders are represented, from the level of trial design through execution, and iterative evaluation of barriers at every level, with solutions presented at the table, then we will truly see advancement in trial execution,” she continued. “This is a model that can and should be reproduced to create sustainable pathways to trial diversity.”
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