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Initiative will train 250 new clinical investigators and work within communities to build capacity to serve underrepresented patient populations.

PRINCETON, N.J.--(BUSINESS WIRE)-- The Bristol Myers Squibb Foundation and National Medical Fellowships today announced that they have entered into a partnership aimed at improving diversity in clinical trials. Leveraging $100 million of the previously announced commitment from Bristol Myers Squibb and the Bristol Myers Squibb Foundation to diversity and inclusion, the partnership will develop a program to extend the reach of clinical trials into underserved patient populations in urban and rural U.S. communities. This program will train and develop 250 new clinical investigators who are racially and ethnically diverse or who have a demonstrated commitment to increasing diversity in clinical trials, and it will expose 250 promising, underrepresented minority medical students across the country to clinical research career pathways. Additionally, the program will assist program investigators in building capacity and standing up new clinical trials sites in communities with diverse and heavily burdened patient populations.

The need for diversity in clinical trials

“Clinical research is necessary to generate evidence demonstrating the efficacy and safety of new treatments,” said Robert Winn, M.D., Director, Massey Cancer Center, Virginia Commonwealth University, who is serving as chair of the national advisory committee of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program. “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. 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.”

In fact, aggregated data on the racial and ethnic participation in clinical trials published by the FDA show that in general 80% of patients taking part in clinical trials are white. Black Americans represent 13%1 of the US population but only reflect about 7%2 of participants in clinical trials.

John Damonti, president of the Bristol Myers Squibb Foundation added, “Science demonstrates that we must diversify clinical trials in order to improve health outcomes and advance health equity. We are pleased to partner with National Medical Fellowships so that this effort will benefit from their decades of experience and unmatched expertise. 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.”

“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, M.D., Chairperson, National Medical Fellowships Board of Directors. “National Medical Fellowships has a vision to promote equity of access to quality healthcare for all groups in American society. 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.”

About the program

The goal of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program is to increase diversity of patients enrolled in clinical trials, and ultimately enhance the development of therapeutics for all populations. The program will collaborate with communities to facilitate an approach to clinical and translational research that is community-informed, designed and conducted. It will provide the sponsorship, support and tools that emerging investigators need to conduct clinical trials that will yield the development of new treatments that are effective in all populations.

How to apply

Applications will open in January 2021. Eligible candidates will hold the degree of MD, MD/PhD, DO or DO/PhD and have an interest in clinical research in the areas of cancer (hematology and oncology), cardiovascular disease and immunologic disorders. In addition, they will reflect the NIH definition of Early Stage Investigator and the NIH definition of underrepresented populations in the U.S. Biomedical, Clinical Behavioral and Social Sciences Research Enterprise, or have a demonstrated commitment to increasing diversity in clinical trials. To learn more about eligibility and program details, please email DCTCDPinfo@nmfonline.org.

About the Bristol Myers Squibb Foundation

The Bristol Myers Squibb Foundation is committed to improving the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and addressing unmet medical need.

National Medical Fellowships

Seeking to empower and support aspiring physicians and health professionals underrepresented in medicine to contribute to the health of our nation, National Medical Fellowships’ mission is to provide scholarships and support for underrepresented minority students in medicine and the health professions.

Founded in 1946, NMF was one of America’s first diversity organizations. Today, as we come together to celebrate our diversity with joy and new purpose, NMF remains the only national organization solely dedicated to providing scholarships to medical and health professions students in all groups underrepresented in healthcare.

NMF is supported by a national network of Alumni who serve tens of millions of patients annually. Their experience inspires us and gives voice to our mission.

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1 https://www.census.gov/newsroom/releases/archives/2010_census/cb11-cn125.html
2 https://www.fda.gov/media/143592/download

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BRISTOL MYERS SQUIBB FOUNDATION
MEDIA: media@bms.com

Source: Bristol Myers Squibb

There's a Stunning Lack of Diversity in Clinical Trials. Can Philanthropy Move the Needle?

Calls for equity in our healthcare system are growing louder every day—from the need to boost access to care, to the push for more doctors of color. For years, there has also been a stunning lack of diversity in clinical trials, an area of medicine with a low profile but a tremendous impact. 

One big pharmaceutical company’s foundation is now tackling this issue, which has proven stubbornly resistant to change. The Bristol Myers Squibb Foundation, in partnership with National Medical Fellowships, just announced a new push to improve diversity in clinical trials. 

The Diversity in Clinical Trials Career Development Program will train 250 new clinical investigators who are racially and ethnically diverse or have shown a commitment to diversity in medical trials. The program also seeks to introduce minority medical students to clinical research career pathways and increase the number of clinical trials located in communities of color and underserved areas of the country. 

The program is part of a five-year, $300 million commitment on the part of global pharmaceutical giant Bristol Myers Squibb and its foundation to “accelerate and expand health equity, and diversity and inclusion efforts.” Out of that pledge, $100 million will support the clinical trials initiative.

A moral and scientific imperative

Today, close to 80% of participants in clinical research trials are white, according to the Food and Drug Administration; only 7% are Black. This homogeneity is consistent across many areas of medical research: A 2019 report published in JAMA Oncology found that Black and Hispanic people were severely underrepresented in cancer clinical trials, for example, and STAT reported that Hispanics make up just 0.54% of participants in genome-wide association studies. 

This issue isn’t new. The National Institutes of Health Revitalization Act, passed by Congress in 1993, required the NIH to include more women and people of color in research studies. It was partially successful: The participation of women in clinical trials has increased significantly, but racial diversity continues to lag. 

Diversity in clinical trials isn’t a simple issue of fairness. We now know that individual factors, including race and ethnicity, can and do influence how a person responds to illness and treatment. As researchers put it in a recent report, “To ensure that medical discoveries, new treatments and interventions are applicable to all populations for whom they are intended, appropriately representative clinical trial diversity is a moral, scientific and medical imperative.”

Bristol Myers Squibb Foundation (BMSF) President John Damonti agrees: “We now know that medical treatments don’t work the same way for everyone, and we need to understand that if we are going to provide the best possible care.” 

Barriers to diversity

Diversity in medical trials has been hard to achieve for reasons that range from the historical to the practical. Even when researchers try to diversify their trials, many people of color are reluctant to participate. This mistrust is entirely understandable, given shameful abuses like the Tuskegee experiment, the exploitation of Henrietta Lacks and the forced sterilization of many Blacks, Indigenous people, immigrants and people with disabilities conducted throughout the U.S. into the 20th century.

Damonti points out that the location of clinical trials can also present a barrier. “Many clinical trials are conducted at large urban academic centers,” he says. “These are excellent institutions, but they are not always conducive or welcoming to minority patients, and they’re not necessarily where they get their regular care. Transportation can also be a barrier. And, of course, very few clinical trials are located in rural areas.”

Damonti hopes that BMSF’s partnership with National Medical Fellowships (NMF) will help break down these barriers. NMF, which was founded in 1946, provides scholarships and support to minority students in healthcare. 

“For 70 years, NMF has been a leader in the support of underrepresented minorities in medical schools,” Damonti said. “That is their sweet spot. They have an enormous network of medical students and medical professionals who live in and are able to connect to diverse communities across the country.”  

Perhaps unsurprising, main funders in this space include other pharmaceutical companies and their foundations. Amgen has supported clinical trial diversity, and more recently, Novartis US Foundation made a $25 million commitment to health equity with a focus on making trials more diverse.

Damonti believes BMSF’s approach will be more effective than past efforts. He points out that BMSF has been around for 21 years, and has developed a track record of healthcare philanthropy around the world. This new initiative actually grew out of the foundation’s work treating HIV/AIDS patients in Africa in the 1990s.

“We learned then that to reach people, it couldn’t be done out of New York City,” he said. “To build trust, we had to have staff on the ground who were from the communities where we were working. We’ve seen it through the years of clinical trials: Patients are more likely to participate through the course of a trial and be consistent in their participation if they trust the people treating them. And we’re creating a cadre of professionals that will be continuing this work over the long term.”

“A stake in the ground on health equity”

BMSF was already planning to launch an initiative to improve diversity in clinical trials when the layered crises of 2020 hit—and made the need even more urgent. “We were planning to train a smaller number of investigators,” Damonti said. “Then COVID-19 hit and George Floyd was killed. The company decided they wanted to put a stake in the ground on the issue of health equity. At the foundation, we said, ‘If we really want to move the needle on health equity, let’s make this program more significant.’ And the company agreed.”   

Will BMSF’s approach succeed where other efforts have failed? Damonti himself is hopeful, but waiting to be convinced. The upstream strategy of backing the very people who will be conducting clinical trials is a strategic one, but also takes time and requires a leap of faith.

“Training these investigators is important,” he said. “But if in five years, I tell you, ‘We’ve trained 250 investigators, here they are,’ and they haven’t been able to increase the diversity of clinical trials, then we won’t have achieved our goals.” 

By Connie Matthiessen, Inside Philanthropy 

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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.”

By Nicole DeFeudis, Associate Editor, Endpoints News

View Source Version on Endpoints News at: https://endpts.com/bristol-myers-squibb-foundation-launches-program-to-tackle-diversity-problem-in-clinical-trials/

BMS Earmarks $100M of its $300M Equity Pledge for Diverse Clinical Trial Investigators

The Bristol Myers Squibb Foundation has been tackling health inequities around the world for 20 years, but nowhere has it come more quickly and sharply into focus than in the U.S. this year.

The COVID-19 pandemic disproportionately marginalizing communities, vaccine trials that couldn’t recruit enough people of color, the murder of George Floyd in May and the resurgence of the Black Lives Matter movement all at once shone a spotlight on the chronic problem in the U.S.

To help fight that problem, BMS in August pledged $300 million over the next five years, and this week, it earmarked $100 million of that sum for the Foundation and its partner National Medical Fellowships to build a program to train 250 new clinical investigators from racially and ethnically diverse backgrounds.

RELATED: Bristol Myers Squibb takes on racial inequality with $300M pledge to up diversity, improve healthcare access

The 250-person clinical trial investigators program will begin accepting applications in January, with candidates for the two-year program chosen by September. The first year is dedicated to training, while the second will pair them as mentors to minority medical students.

“What’s going to be successful for us is not that we’ve been able to train 250 diverse investigators—it really is putting in the metrics and the measurement to understand, 'What have these 250 diverse investigators done at the community level to increase patient participation in trials?'” John Damonti, president of the Bristol Myers Squibb Foundation, said.

“We all know that people have really strong empathy and support and can have a more open dialogue and trust with people who look like them, and that’s what we really need to try to get at,” he added.

The foundation also received an additional $50 million of the original allotment to spend in the U.S. on ongoing and new efforts. Already, $14 million has been allocated this year to new initiatives, including a program in Chicago with health education outreach in barber shops and beauty salons and another program that will be deployed in big cities to better diagnose prostate cancer in African-American men, Damonti said.

RELATED: J&J, following BMS, pledges $100M to address racism and health inequities

BMS isn’t alone in the industry in working to tackle inequities. Johnson & Johnson this week pledged $100 million over the next five years, earmarked to help communities and people of color, and made a commitment to increasing internal hiring of Black executives by 50%.

And earlier this year, Gilead Sciences teamed with Morehouse School of Medicine to sponsor research around demographic disparities in health. Roche’s Genentech, meanwhile, ran a survey that found wide-ranging disparities in healthcare experiences among Black, Latinx and other disadvantaged groups and is using that data to inform its efforts.

“People have come to the awareness this year that not only are these profound issues, but we need to do something about it. It’s not just Bristol Myers Squibb’s $300 million commitment, but also Microsoft and J.P. Morgan Chase and others,” Damonti said. "It’s heartening for me having worked on these issues with the Bristol Myers Squibb Foundation for 20 years to see it now as a part of, 'How do we think about who we are as a company, and what do we look like as a company?'”

By Beth Synder Bulik, Senior Editor, Fierce Pharma 

View Source Version on Fierce Pharma at: https://www.fiercepharma.com/marketing/bms-earmarks-100-million-its-300-million-equity-pledge-for-diverse-clinical-trial

Bristol Myers Squibb Foundation and National Medical Fellowships Launch Program to Help Increase Diversity and Inclusion

The Bristol Myers Squibb Foundation and National Medical Fellowships have announced that they have entered into a partnership aimed at improving diversity in clinical trials. Leveraging $100 million of the previously announced commitment from Bristol Myers Squibb and the Bristol Myers Squibb Foundation to diversity and inclusion, the partnership will develop a program to extend the reach of clinical trials into underserved patient populations in urban and rural U.S. communities, training and developing 250 new clinical investigators who are racially and ethnically diverse or who have a demonstrated commitment to increasing diversity in clinical trials.

“Clinical research is necessary to generate evidence demonstrating the efficacy and safety of new treatments,” said Robert Winn, MD, Director, Massey Cancer Center, Virginia Commonwealth University, who is serving as chair of the national advisory committee of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program. “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. 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.”

View Source Version on Applied Clinical Trials at: https://www.appliedclinicaltrialsonline.com/view/bristol-myers-squibb-foundation-and-national-medical-fellowships-launch-program-to-help-increase-diversity-and-inclusion