A new $100-million program aims to improve the diversity of participants in U.S. clinical trials with the ultimate goal of achieving better health outcomes and parity in care for underserved patient populations.
The initiative seeks to extend the reach of clinical studies to underserved populations in the nation’s urban and rural communities, and promote treatment development for all patient groups, the Bristol Myers Squibb Foundation and National Medical Fellowships announced in a press release.
Funding will come from a recently announced $300-million investment by the foundation and Bristol Myers Squibb to accelerate health equity and diversity inclusion efforts, with a focus on clinical trials. These trials largely seek to determine whether a device, procedure, or pharmaceutical therapy works and is safe in humans.
The initiative — called the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program — will train 250 new clinical investigators who are ethnic minorities or have demonstrated a commitment to heightening diversity in clinical trials. In the process, 250 medical students will also gain exposure to clinical research careers.
The program is designed to help investigators develop clinical trial sites in U.S. communities with diverse and disproportionately burdened patient populations. Researchers will work alongside these communities to design and conduct clinical studies.
“Clinical research is necessary to generate evidence demonstrating the efficacy and safety of new treatments,” said Robert Winn, MD, chair of the program’s national advisory committee.
“While the patient response to medical therapies may differ across racial and ethnic subgroups, clinical trials often fail to represent the demographic diversity of the populations that these products aim to serve,” he added. “I am proud to serve as an advisor to this program, which will support improvements toward diverse representation in clinical research, and promote health equity.”
Data published by the U.S. Food and Drug Administration show that, in general, 80% of U.S. trial participants are white. Blacks comprise 13% of the nation’s population, and represent 7% of the participants in clinical trials.
“Diversity has a role to play in the entire lifecycle of therapeutic development, from the trial design and community engagement, to therapeutic efficacy and adoption,” said Sandra Nichols, MD, chair of the National Medical Fellowship’s board.
“National Medical Fellowships has a vision to promote equity of access to quality healthcare for all groups in American society,” added Nichols. “Advancing diversity in clinical trials is a critically important component of this effort, and our partnership with the Bristol Myers Squibb Foundation is consistent with our mission.”
The program will rely heavily on the experience of established clinicians who are racial or ethnic minorities, said John Damonti, president of the foundation.
“We are pleased to partner with National Medical Fellowships so that this effort will benefit from their decades of experience and unmatched expertise,” he said. “Together, we will tap the often overlooked but powerful resource of racially and ethnically diverse physicians or other physicians who have a demonstrated commitment to increasing diversity in clinical trials, working in academic medical centers, community-based practices, and Federally Qualified Health Centers.”
“These physicians are established in their communities, and no one is in a better position to build trusting relationships with patients than they are,” he added.
Fellowship applications will open in January. Candidates must be early-stage investigators, and have interest in clinical research in cancer, cardiovascular disease, and immunologic disorders. They must be medical doctors or doctors of osteopathic medicine, and be members of an underrepresented U.S. population. Non-minority applicants must have a track record of promoting diversity in clinical trials.
For more about eligibility and program details, send an email to [email protected].