Carlos Orantes, Alcanza CEO
40+ years after the modern clinical research era began, patient recruitment remains as one of the biggest challenges, which makes inclusive research even more challenging. Alcanza recognizes this as a longstanding issue that won’t be solved through short-term tactics. It requires a commitment to a long-term vision with incremental milestones to achieve meaningful progress in representative trial participation.
Public awareness of clinical trials has come a long way in the last decade, but clinical trial sites can’t make meaningful progress without looking to the broader health system for collaboration, partnership and community investment opportunities. Physicians can play a major role in reducing the barriers to participation by introducing research opportunities to their patients — across a variety of healthcare settings, including family practices, specialty practices, community health centers and others.
Alcanza’s sites have pioneered some of the partnership strategies that many researchers are pursuing at scale today. Starting with community health centers – also known as federally qualified health centers (FQHCs), this blog series highlights research opportunities and some of the strategies we’re forging in local communities we serve to build trust and long-term relationships. Our ultimate goal is to expand clinical trial participation into diverse communities, as well as other traditionally underrepresented demographic sub-groups.
Since their inception in the 1960’s, Community Health Centers or Federally Qualified Health Centers (FQHCs) integrate medical, dental, behavioral, and other health care services for at-risk and underserved patient populations, including the underinsured and uninsured. These health centers are incentivized to treat Medicare and Medicaid patients, and many of the 1 in 12 people who rely on FQHCs for care live below the federal poverty level, according to HRSA.
FQHCs serve diverse patient populations who are often research naïve. They provide an important connection for expanding clinical trial access to underserved populations and creating DCT models. Building on the partnership model between teaching hospitals and FQHCs that moves the continuity clinic out of the hospital and into the FQHC, there are extensive opportunities to bring research into the more than 14,000 FQHCs nationwide, or extend care through clinical trial collaborations at nearby clinical trial sites.
Research partnerships don’t happen overnight. By extension, it’s important for site leaders to find trusted medical authorities in local communities and start small with collaboration goals. While serving as CEO of Accel Research Sites in 2017, I had the opportunity to forge relationships with community practices near sites located in central Florida and Birmingham, Alabama.
One of these physicians — Dr. Rowell Ashford II of Cahaba Medical Care-OBGYN is an FQHC success story. He initially volunteered as an exploratory partner/principal investigator for Accel to boost patient recruitment in areas of obstetrics and gynecology and women’s health. Since 2018, Cahaba Medical Care has served as an “embedded” clinical site in a FQHC practice. (Embedded sites are physician practices who are typically more specialty-driven, serve as a strong referral network for Accel studies and support research in a broader context.)
In this model, Accel provides infrastructure support that ranges from staff resources to recruitment, logistics and compliance. Accel has provided Dr. Ashford and Cahaba Medical Care with centralized services to conduct studies inside the facility. This includes a full time and well-trained Clinical Research Coordinators, Site Managers and several centralized functions such as business development, contracts, budgets, patient recruitment, and regulatory resources. These resources and services enable flexible enrollment of clinical trials out of a well-established practice without having to fully staff a research unit.
Accel’s recruitment performance has benefitted from the FQHC’s diversified database comprised of patients and referring physicians from 18 associated clinics.
Since 2018, Cahaba Medical Care has consistently enrolled a diverse representation of patients in studies for uterine fibroids, hot flashes, STD prevention, endometriosis, birth control, post-menopausal, and other biospecimen collection studies related to women’s health. Current enrolling studies include treatments related to dyspareunia, and endometriosis.
As a second-generation physician, taking on new challenges runs in the family. His father, (also Dr. Rowell Ashford) is best known for and now recognized in Alabama’s Healthcare Hall of Fame for integrating Birmingham’s medical community in the early 1970’s, while providing quality medical services to poverty-stricken communities.
Alcanza is building on this model to expand our reach and scale clinical research opportunities to patient populations who need access to the innovation medicine within our industry’s burgeoning pipeline. The future of clinical research success relies on collaboration and partnerships like the ones we’re building with FQHCs, and we welcome discussions with any institution or practice interested in clinical research.
Research partnerships take all shapes and sizes. Don’t miss our next blog topic as we explore embedded site strategies.
