WALTHAM, Mass. — Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and the National Minority Quality Forum (NMQF), an independent not-for-profit research and education organization, today announced a collaboration to help bring clinical research to historically underserved patient populations through NMQF’s Alliance for Representative Clinical Trials (ARC). The collaboration supports biopharmaceutical and biotech customers in meeting regulatory expectations to enroll and retain patients in clinical trials who more fully reflect real-world populations experiencing the disease or health condition being studied, including U.S. Food and Drug Administration requirements around diversity action plans.
The work reflects Thermo Fisher and NMQF’s shared commitment to health equity and building sustainable solutions to engage groups and communities in the United States that have suffered past structural and systemic inequity and/or have been denied access to clinical research for promising new medicines. These include African Americans, Asian Americans, Hispanics/Latinos and Native Americans, as well as other ethnicities, veterans, people with disabilities, LGBTQ+ individuals, religious groups, and those with challenged socioeconomic backgrounds and geographic groups with disparate access to health care.
Participation in clinical trials provides patients with early access to cutting-edge medicines under close medical supervision, while offering treatment options to patients facing a variety of disease diagnoses. ARC is a multi-sponsor public/private program focused on increasing clinical research participation within communities of color and other populations that have been historically underrepresented in clinical trials. Since NMQF’s recently renamed Center for Clinical and Social Research launched ARC in 2022, the program has established clinical research sites in 11 states, including California, Florida, Georgia, Louisiana, Maryland, Mississippi, New Jersey, New York, North Carolina, Pennsylvania and Virginia.
The ARC program includes the PI Institute, which trains community clinicians to become clinical trial principal investigators. MyClinical, a for-profit affiliate of the ARC program, is an investigative research network of PI Institute graduates designed to empower independent community clinicians and federal qualified health clinics to facilitate industry-sponsored clinical trials.
Thermo Fisher’s clinical research business and NMQF will help build the capacity of community health clinics to participate in clinical trials. The collaboration will integrate ARC clinics into the clinical research process through comprehensive training and ongoing participation as investigator sites in clinical trials. Participating clinics include federally qualified health centers and private community-based/non-academic health care practices.
“To better serve our biopharma customers and drive greater health equity and access to potentially life-changing therapies, we are working to build clinical trials that reflect the diverse populations in society,” said Michel Lagarde, executive vice president and chief operating officer at Thermo Fisher Scientific. “Helping to train clinicians with NMQF addresses the need to expand and sustain a pipeline of experienced clinical research providers, and underscores Thermo Fisher’s mission to enable our customers to make the world healthier, cleaner and safer.”
Thermo Fisher’s clinical research business provides customized support, training and mentorship through its SiteCoach program to community clinicians in the PI Institute and the MyClinical investigative site network. This support helps expand access to trials and accelerate the development of novel medicines by providing advanced training to staff members at community clinics and practices who are new to clinical research.
The SiteCoach program includes practical, self-paced modules to help investigator sites better understand, recognize and address the barriers that often prevent populations from accessing clinical trials. Building this level of in-depth capacity – with experienced site clinical resources and establishing connectivity with industry clinical trial sponsors – is a critical success factor for investigator sites.
The MyClinical network utilizes community clinicians, who have developed trust in, and have personal knowledge of, the neighborhood residents they serve. These clinicians can support trial recruitment and planning by ensuring enrollment criteria and trial logistics do not create additional barriers. This can help simplify the research site-selection process for trial sponsors seeking to ensure their studies represent historically underserved patients who disproportionately experience disease.
“Diversifying clinical trials demands an enduring commitment and shared responsibility among the various stakeholders within the health care ecosystem,” said Salvatore Alesci, M.D. Ph.D., senior vice president of NMQF’s Center for Clinical and Social Research. “ARC sets the stage. ARC isn’t just a platform. It’s a catalyst set to disrupt the traditional approach to clinical research that does not reflect the increased diversity and complexity of the U.S. and global population. Ultimately, ARC’s aim is to bring clinical trials to communities that are historically underserved yet stand to gain enormously. Together with Thermo Fisher, we are prepared to help democratize clinical research and deliver equitable health care for all.”