CRF physician asked for national training program to increase diversity in clinical trials | News from the FIU
Studies have shown that different races and ethnicities can have varying responses to drugs, yet 80% of clinical trial participants are white.
Dr. Annellys Hernandez, assistant professor at Herbert Wertheim College of Medicine, is one of 52 physicians nationally selected to participate in a new program focused on addressing this disparity.
The Career Development Program for Diversity in Clinical Trials is a 5-year, $ 100 million initiative launched by the Bristol Myers Squibb Foundation (BMSF) to train a diverse group of community physicians in clinical research and recruiting minorities.
âThe goal is to make clinical trials more inclusive for minorities and diverse populations,â said Hernandez, who has spent most of his young career working with underserved populations. When she first joined the CRF, she worked as a physician, making home visits to patients enrolled in the School of Medicine’s Green Family Foundation NeighborhoodHELP program. Hernandez is currently part of a team of CRF hospitalists at Jackson Memorial Hospital, one of the largest safety net hospitals in the country.
âTo have solid research, you need trial participants who reflect your population,â she said. The factors determining racial differences in response to drugs are complex. But pharmacogenetic research, the study of how genes affect the body’s response to certain drugs, has “discovered significant differences between racial and ethnic groups in metabolism; clinical efficacy; and side effect profiles of therapeutically important drugs, âaccording to the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research.
For example, in 2007, the FDA issued a warning that the antiepileptic drug carbamazepine could increase the risk of life-threatening skin reactions in certain Asian populations.
Pfizer, one of the largest pharmaceutical companies in the world most recently known for its COVID-19 vaccine, notes the importance of diversity in clinical trials on its webpage: âAfrican Americans sometimes need a dosage different – or a completely different drug – for certain asthma, blood pressure, and heart problems than white, Asian, or Hispanic patients with the same diagnoses. For this reason, the diversity of clinical trial populations can be critical to public health and well-being through increased representation of populations with disease. “
The FDA has policies in place to increase minority participation in clinical trials, but recruitment remains a challenge. What is different about this new program is that it seeks to effect a generational change in who directs seeking clinical trials to ensure 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, which is part of Baptist Health South Florida, and Dr. Paulo Chaves of the Benjamin Leon Jr. family of the Medical School. Geriatric Research and Education Center.
The training starts in November with an intensive six-day educational workshop on clinical research. The program will receive 40% of Hernandez’s salary so that she can devote that time to research. The rest, she will continue to devote to teaching medical students and caring for underserved communities in South Florida.