PhRMA Joins Top Academic Leaders to Announce New Community-Based Initiative to Enhance Clinical Trial Diversity

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First-of-its-kind initiative seeks to build trust and address systemic barriers to participation in the development of innovative medicines

WASHINGTON, D.C. (July 19, 2022) –The Pharmaceutical Research and Manufacturers of America (PhRMA) today joined Yale School of Medicine, Morehouse School of Medicine, the Research Centers in Minority Institutions Coordinating Center at Morehouse School of Medicine and Vanderbilt University Medical Center to announce a new initiative to enhance diversity in clinical trials, the Equitable Breakthroughs in Medicine Development.

Funded by a grant from PhRMA and led by some of the nation’s top medical schools, the initiative will pilot a network of sustainable, connected, community-based trial sites that brings together diverse communities, clinical trial sponsors, patients, providers, health partners, community organizations and academic institutions. The initiative follows more than two years of PhRMA-led stakeholder engagement to assess barriers to clinical trial participation and identify tangible actions and goals that can make a difference.

“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.”

“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 first-of-its-kind collaboration will seek to address systemic barriers underserved patients often face when it comes to clinical trials, including a lack of outreach, patient mistrust and a lack of available sites in historically underserved communities. 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 and sustainable long term.
Build training opportunities and mentorship for investigators and staff.
Create a comprehensive, collaborative network of sustainable, connected, community-based sites supporting clinical trial diversity in underserved communities.

“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.”

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