Press Release

Increasing Clinical Trial Diversity Through a Community-Based Approach

For Immediate Release

February 14, 2024

Equitable Breakthroughs in Medicine Development is a first-of-its-kind, community-based collaboration
supported by grant funding from PhRMA

WASHINGTON, DC – Today, Yale School of Medicine, Morehouse School of Medicine (MSM), the Research Centers in Minority Institutions (RCMI) Coordinating Center at Morehouse School of Medicine, and Vanderbilt University Medical Center launched Equitable Breakthroughs in Medicine Development, an innovative collaboration to increase diversity in clinical trials and address systemic barriers to participation by communities of color. Equitable Breakthroughs in Medicine Development will help underrepresented patients be more involved in the research and development of potential life-saving medical treatments. Funded by a grant from the Pharmaceutical Research and Manufacturers of America (PhRMA), Equitable Breakthroughs in Medicine Development will work over the next 18 months to bring together diverse communities, patients, providers, health partners, community organizations and academic institutions, along with individual clinical trial sponsors, to pilot a network of sustainable, connected, community-based trial sites.

While the COVID-19 pandemic has brought significantly more awareness to the lack of diversity in clinical trials, the work to make meaningful change is not new. Patient and community organizations, academia, the U.S. Food and Drug Administration (FDA) and the biopharmaceutical industry have been working with underrepresented communities to break down barriers to participation in clinical trials for decades. Equitable Breakthroughs in Medicine Development is different because it will bring pharmaceutical companies, academic institutions and providers together with community groups and leaders to help ameliorate health disparities with a specific focus on mentorship for staff at clinical trial sites, sustainable support for local community-based sites and partnership with communities of color that have historically been underrepresented.

The goal is to build a sustainable, community-based infrastructure that tears down the systemic barriers underserved patients often face when it comes to clinical trials, including a lack of outreach, a lack of available sites in underserved communities, and patient mistrust. At every stage of this work, the patient community will be the most important partner.

Equitable Breakthroughs in Medicine Development’s community-based trial sites will:

  • Partner with trusted messengers and community leaders to raise education, awareness, and support for clinical trial participation.
  • Provide the resources and technical support for local sites to be successful, sustainable, and thrive.
  • Build training opportunities and mentorship for investigators and staff.

“Addressing health inequities—including increasing the participation of diverse populations in clinical
trials —is a priority of Yale School of Medicine,” said Nancy J. Brown, MD, Jean and David W. Wallace
Dean of Medicine and C.N.H. Long Professor of Internal Medicine at Yale School of Medicine. “We
have made inroads in this area over the past decade and are eager to partner with our colleagues to
continue to find ways to have an impact on the health of communities of color.”

“Morehouse School of Medicine and the RCMI Consortium are committed to increasing diversity and
inclusion in clinical trials as we lead the creation and advancement of global health equity,”
said Elizabeth Ofili, MD, MPH, FACC, Professor of Medicine and Principal Investigator of the RCMI
Coordinating Center at Morehouse School of Medicine “While this level of comprehensive
collaboration is a first-of-its-kind initiative, it’s important to recognize that MSM and others have been
working tirelessly on this issue for decades. We are honored and excited to be partnering with the
community systems, providers, and the patients they serve, who are and always have been committed
to inclusive clinical trials and medicine development. Their questions, feedback, insight, participation,
and leadership will be crucial to creating and maintaining a sustainable proof of concept.”

“To ensure that clinical trial results are relevant and applicable across diverse populations, we must find
new ways to ethically and effectively improve participation by people from diverse backgrounds,” said
Peter Embí, MD, MS, FACP, FACMI, FIAHSI, Professor of Biomedical Informatics and Medicine, Chair of
Biomedical Informatics, and Senior Vice-President for Research and Innovation at Vanderbilt
University Medical Center. “At VUMC, we are focused on advancing personalized health care for
everyone and enabling equitable participation in clinical trials is essential to that mission. As a physician,
researcher, and proud member of the Hispanic-American community, I recognize that we face many
challenges in overcoming disparities in clinical trials and health care, and I am excited to partner with my
colleagues on this critically important initiative. Through our collaboration, I’m confident that we will
learn and implement new ways to overcome systemic barriers and improve the pace of ethical research
for those who have been historically under-represented.”

“Our goal is to make sure all people, regardless of geography, socioeconomics, race, ethnicity, or gender
identity, who want to participate in a clinical trial have the opportunity to do so,” said Ramona
Sequeira, President of Takeda’s Global Portfolio Division and Chair of the PhRMA Board of Directors.
“Equitable Breakthroughs in Medicine Development will help make this goal a reality by meaningfully
addressing local, long-standing barriers to clinical trial participation. Through this initiative, we’ll
continue to work to earn the trust of vulnerable and underserved communities through a community
centered network of locally based trial sites. By enabling clinical-trial sponsors to reach more diverse
and representative populations, we aspire to positively impact clinical trial diversity and health equity.”
“This new initiative builds on the industry’s continued effort and commitment to working toward more
equitable access to clinical trials, so they better reflect the patients intended to be served,” said Stephen
J. Ubl, President and Chief Executive Officer of PhRMA. “Supported by a grant from PhRMA, the
initiative will be a sustained effort in partnership with community leaders to provide pilot sites with the
resources they need to break down barriers and build successful, trusted clinical trial sites.”

Equitable Breakthroughs in Medicine Development’s initial pilot sites will begin opening this summer in
the Southeast and Southwest and will serve as an anchor from which further engagement and work in
communities will grow, including mentorship and training opportunities for a diverse clinical trial
workforce, as well as ongoing engagement and dialogue with the patient community on the benefits of
being a part of clinical trials.

Stay updated on our progress and learn more about Equitable Breakthroughs in Medicine Development
at PhRMA.org/Equity.

The Learning Phase includes:

  • Connecting Clinical Trial Sponsors: Bringing sponsors and local EQBMED-selected sites together to work as partners.
  • Sharing Key Learnings: Sharing important lessons learned from these partnerships.
  • Building Robust Infrastructure: Creating a strong support system that continues to support the growth and aspirations of local sites.