The PATIENTS Program at the University of Maryland School of Pharmacy is collaborating with partners in West Baltimore to improve the inclusion of African Americans and minority populations in COVID-19 vaccine research.
The one-year, $1 million collaboration, titled “COMmunity Mistrust and Institutional Trustworthiness to Advance Health EQuity Research” (COMMIT-EQ), is supported by the Food and Drug Administration (FDA), the governmental regulatory body that oversees the regulation of testing, vaccines, and treatment approval.
The initial clinical trials of COVID-19 vaccine research, which have produced the vaccines made by Pfizer and BioNTech, Moderna, Johnson & Johnson, and Novavax, initially struggled to include enough African Americans in their samples. UMSOP and the FDA, through COMMIT-EQ, seek to better understand this challenge and ameliorate it for future COVID-19 vaccine development to better ensure vaccines are safe and effective for all communities.
“When you start a clinical trial and put out advertisements, sometimes it may not have as many members of every single community represented,” says Joey Mattingly, PharmD, MBA, PhD, associate professor in the Department of Pharmaceutical Health Services Research (PHSR) and a co-principal investigator of COMMIT-EQ. “It’s important to have diverse participation in clinical trials, so we can evaluate the safety and efficacy of vaccines or drug products that come out of that research.”
In addition to Mattingly, other principal investigators on the project include Claudia Baquet, MD, PhD, MPH, affiliate professor of PHSR, C. Daniel Mullins, PhD, professor of PHSR and executive director of the PATIENTS Program, and Franklin Lance, DMin, pastor at Mount Lebanon Baptist Church.
“The focus of this research on COVID-19 clinical trials, vaccines, and variant research requires ongoing guidance from communities most affected by inequities in health,” Baquet says. “I look forward to the valuable and powerful input from the community participants in guiding the solutions to assuring equity and justice in research and health care.”
COMMIT-EQ has three main aims. First, it will build off Baquet’s previous research to determine the reasons that people, in particular African Americans, may not want to participate in clinical trials. Second, COMMIT-EQ will develop a set of community guidelines for vaccine research. Third, the project will create a toolkit for clinical investigators that will include best practices on recruitment, bioethics, and considerations for working with minority populations.
“My interest in this research builds around my previous work advancing the triple aim of health care,” Mattingly says. “We try to improve the quality of patient experiences, improve patient health, and lower costs.”
To achieve its research goals, COMMIT-EQ will take a multi-faceted approach. Focus groups, primarily with African American stakeholders in West Baltimore, will allow investigators to hear directly from community members. An expert consensus method will bring experts in the field together to develop guidelines.
Although just a one-year project, Mattingly says the researchers hope to have a lasting effect on the FDA, Baltimore, and future research in this area.
“This grant focuses primarily on COVID-19 vaccines, but we anticipate it could have broader implications because we’re hoping the results or recommendations could apply to all types of clinical trials,” Mattingly says.