Studies have shown that different races and ethnicities can have varying responses to medication, and yet, 80% of clinical trial participants are white.
Dr. Annellys Hernandez, assistant professor at the Herbert Wertheim College of Medicine, is one of 52 physicians chosen nationwide to participate in a new program focused on addressing this disparity.
The Diversity in Clinical Trials Career Development Program is a $100 million, 5-year initiative launched by the Bristol Myers Squibb Foundation (BMSF) to train a diverse group of community-oriented physicians in clinical research and minority recruitment.
“The goal is to make clinical trials more inclusive of minorities and diverse populations,” said Hernandez, who has spent most of her young career working with underserved populations. When she first joined FIU, she worked as a physician making household visits to patients enrolled in the college of medicine’s Green Family Foundation NeighborhoodHELP program. Hernandez is currently part of a team of FIU hospitalists at Jackson Memorial Hospital, one of the largest safety-net hospitals in the country.
“To have sound research, you need trial participants who mirror your population,” she said. Factors determining racial differences in response to medications are complex. But pharmacogenetic research, the study of how genes affect the body’s response to certain medications, has “uncovered significant differences among racial and ethnic groups in the metabolism; clinical effectiveness; and side effect profiles of therapeutically important drugs,” according to the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA).
For example, in 2007, the FDA issued a warning that the anti-epileptic drug carbamazepine could increase the risk of potentially life-threatening skin reactions in some Asian populations.
Pfizer, one of the world’s largest pharmaceutical companies most recently known for its COVID-19 vaccine, notes the importance of diversity in clinical trials on its webpage: “African Americans sometimes need a different dosage — or a different drug altogether — for certain asthma, blood pressure, and heart conditions than white, Asian, or Hispanic patients with the same diagnoses. For this reason, the diversity in clinical trial populations can be critical to public health and well-being through the increased representation of the populations who experience a condition.”
The FDA has instituted policies to increase minority participation in clinical trials, but recruitment remains a challenge. What’s different about this new program is that it looks to make a generational shift in who leads clinical trial research to ensure that previously ignored patient populations are included.
As part of her training, Hernandez will be paired with two local clinical researchers and mentors, Dr. Marco Ruiz of the Miami Cancer Institute, part of Baptist Health South Florida, and Dr. Paulo Chaves of the college of medicine’s Benjamin Leon Jr. Family Center for Geriatric Research & Education.
The training kicks off in November with a six-day intensive educational workshop on clinical research. The program will pick up 40% of Hernandez’s salary so she can devote that time to research. The rest, she will continue to dedicate to teaching medical students and caring for South Florida’s underserved communities.