By Deborah Borfitz 

June 18, 2024 | A trailblazing federally qualified health center (FQHC) in Nevada is now in the business of conducting industry-sponsored clinical trials, which may foreshadow more widespread interest among the nation’s roughly 1,400 nonprofit FQHCs enabling access to care for low‐income, racially diverse, and medically underserved populations. Nevada Health Centers (NVHC) will launch a cardiovascular outcomes study for Novartis this month, followed by an Alzheimer’s disease trial for Eli Lilly later this year, according to Chief Integration Officer Sangeeta Wagner, D.O. 

NVHC also recently hosted executives from vaccine maker Moderna for an exploratory meeting at its Carson City office, along with leaders from integrated research organization Javara. As Wagner explains, FQHCs are in an ideal position to deliver what sponsors want—namely, access to a highly diverse and often research-naïve population in the familiar setting of their primary care provider’s office supporting their successful trial participation “from the start to the end.” 

They just can’t do it on their own, which is where Javara comes in. NVHC selected Javara as its partner in early 2023 to bring clinical trial opportunities to patients who might otherwise miss out due to language and literacy barriers, geographic isolation, and financial constraints, says Wagner.  

Javara is providing the missing infrastructure with its clinical trial know-how and understanding of the ins and outs of contracting with biopharmaceutical companies. Two dedicated employees are also now embedded in the Carson City location to help “lift” the program. “I can’t imagine being in this space without them,” Wagner says, adding that she is particularly appreciative of the close-at-hand support when it comes to ensuring regulatory compliance. 

Already Integrated

Most FQHCs already offer an integrated system of care that includes dieticians, behavioral health providers, dentists, pharmacists, and telemedicine, Wagner says. The addition of clinical trials as another service line therefore “doesn’t have to be a foreign concept.” 

Wagner says she was recruited to start the clinical research program in August 2022 by NVHC CEO Walter Davis, who became intrigued with the idea a few years earlier after meeting another physician who had successfully integrated trials into his practice. She is a family medicine doctor who up to then had only ever done academic research as a physician investigator. To gain subject matter expertise, Wagner enrolled in a graduate certificate program on clinical research conduct and management at the University of California, Berkeley.  

It didn’t take long for Wagner to realize NVHC was going to need a mission-aligned collaborator and, after vetting a few integrated research organizations in the country, settled on Javara. To her knowledge, only one other FQHC (North Hudson Community Action Corporation Health Center) had  ever successfully implemented clinical trials. 

This was also a first for Javara, she adds, although it has worked extensively with other types of primary care health centers. Increasingly, industry sponsors have been placing more of their studies in community-based settings rather than big academic medical centers because many patients either don’t live nearby or feel uncomfortable navigating that environment. 

The All of Us Research Program of the National Institutes of Health, which was similarly interested in enrolling a diverse population, used the NVHC’s Carson City location as a host site for recruitment in the fall of 2022, says Wagner. Several hundred people signed up within the Northern Nevada region. 

Only a few months earlier, NextGen Healthcare Partners announced it was teaming up with Circuit Clinical to bolster diversity in clinical trials by extending access to patients of FQHCs whose providers were utilizing its technology solutions. Last year, Neighborhood Healthcare (an FQHC in Escondido, California) also announced that it had teamed up with Altura to launch a Genentech-supported study designed to expand awareness and access to clinical studies of all types among FQHCs. 

Just the Beginning

Among the main barriers for FQHCs getting involved in clinical research are not having a dedicated staff with time and knowledge to conduct trials and the lack of data collection infrastructure, says Wagner. It is essential that the right providers be taking on the research since the patient population has so many unique barriers and disparities and tends to be sicker and have multiple chronic diseases. 

“I am fortunate in my organization because I have dedicated time for this endeavor and to thoughtfully introduce [clinical trials] to other providers within the organization,” she says, on top of the ongoing support from Javara. The rationale is twofold—to provide patients with access to cutting-edge treatments and support for their disease processes as well as provide an additional source of funding to help sustain day-to-day operations of the health center.   

NVHC is open to trials that will help the patients it serves, which would include “most everything” from vaccine trials to studies focused on chronic diseases like diabetes, coronary artery disease, and kidney disease, says Wagner. Transportation services and language interpretation will generally be needed. 

The initial goal is to enroll no more than 20 patients in each of the first two clinical trials with Novartis and Eli Lilly, Wagner continues. It has been smooth sailing thus far in terms of the learning process, dialogue with the sponsors, and site qualification visits.  

The Nevada Primary Care Association has invited Wagner to speak at its annual conference in September about her experience and lessons learned in building research capacity at NVHC, she says, which could expand interest among other FQHCs in the state to follow suit.