Bristol Myers Squibb Foundation launches program to tackle diversity problem in clinical trials
Over the last several months, the pandemic has amplified calls for more diverse clinical trials.
While minority populations are contracting Covid-19 at higher rates than white Americans, they are notably underrepresented in clinical trials. Black Americans make up 13% of the US population, but only 7% of participants in clinical trials, according to the FDA. And they’re being infected with Covid-19 at a 2.6 times higher rate than white Americans.
“The importance of diversity in the clinical trials for the vaccines is just another spotlight on an issue that’s been going on for decades,” John Damonti, president of the Bristol Myers Squibb Foundation, told Endpoints News.
On Tuesday, the foundation launched a new program with the nonprofit organization National Medical Fellowships and backed it with $100 million to help clinical trials reach underserved populations. The program consists of three parts: a training component for 250 new clinical investigators, fellowships for 250 minority medical students, and an infrastructure fund to help investigators build new clinical trial sites.
The new sites, he said, would ideally go “in clinical trial deserts where … the disease burden is high but clinical trials don’t exist in those sites, or even look to building out in urban centers through safety net hospitals and others.”
Principal investigators will mentor the new clinical investigators who will mentor the medical students, who will work in federally qualified health centers, safety net hospitals and other medical centers in their communities.
“At the end of the day, even if you have 250 diverse clinical investigators, if they’re not actively working in the communities to build those relationships and build that trust, the program will not be as successful as it potentially could be,” Damonti said.
The money comes from a $300 million commitment that Bristol Myers Squibb and its foundation made back in August for health equity, diversity and inclusion efforts. National Medical Fellowships will help with implementation, such as managing components of the application process and an independent advisory board.
Applications will open in January for clinical investigators, and Damonti expects the first class to begin sometime in September.
“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,” said Robert Winn, director of the Virginia Commonwealth University Massey Cancer Center and chair of the national advisory committee of the Bristol Myers Squibb Foundation’s new program.
Black Americans made up 20% of participants in the NIAID-funded ACTT-1 trial of remdesivir, according to a New England Journal of Medicine piece. And Latinx and Native Americans, who are at a 2.8 times higher risk of infection than white Americans, made up 23% and 0.7% of the ACTT-1 participants, respectively.
The issue isn’t unique to the pandemic. Out of 230 trials leading to FDA oncology OKs in the last decade or so, Black and Latinx participants were “underrepresented… relative to their proportion among the US cancer population,” according to a piece published in JAMA last year.
“The real outcome, and the impact of this program is going to be measured by the role that these individuals can play in terms of attracting diverse patient populations into clinical trials. That’s what this program has been created to do,” Damonti said. “We just want to make sure that the end of the day it’s the patient that gets into the trial.”
A previous version of this article stated that the Bristol Myers Squibb Foundation made a $300 million commitment in August for health equity efforts. The piece has been updated to clarify that the biotech also participated in the commitment.