Collaboration Aims to Address Clinical Trial Patient Diversity Shortcomings

Ramona Sequeira

Ramona Sequeira, Chair, PhRMA Board of Directors

Addressing “clinical trial diversity is an issue of fairness and the first step in achieving health equity,” Dr. Valerie Montgomery Rice, MD, FACOG, president and CEO of the Morehouse School of Medicine (MSM), told attendees at a July 19 press event announcing a new collaboration aimed at fostering greater participation in clinical trials among more diverse populations of volunteers.

Along with MSM, the Yale School of Medicine and Vanderbilt University Medical Center have launched “Equitable Breakthroughs in Medicine Development,” an “historic” collaboration designed to increase diversity in clinical trials and address systemic barriers to participation in them by communities of color, Rice said.

Equitable Breakthroughs in Medicine Development will help underrepresented patients be more involved in the research and development of potentially life-saving medical treatments. Funded by a grant from the Pharmaceutical Research and Manufacturers of America (PhRMA), the collaboration will work over the next 18 months to bring together diverse communities of 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 in the southwest and southeast United States.

“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 group said in a press announcement.

“We need to understand the needs of the local communities [and maintain] a partnership mindset,” said Dr. Nancy Brown, MD, the Jean and David W. Wallace Dean of Medicine and C.N.H. Long Professor of Internal Medicine at Yale School of Medicine.

Ramona Sequeira, president of the Global Portfolio Division for Takeda and chair of the PhRMA Board of Directors, said the group would work to be an “effective catalyst, [in part] by leading with humility, listening, [and recognizing] we don’t have all the answers.”

While progress has been made in promoting clinical trial diversity, Sequeira said, “we need to come together to make substantial change.”

Clinical trial inequities represent “real barriers for real patients,” said Stephen Ubl, president and CEO of PhRMA, adding, “clinical trials haven’t always reflected the patients [the experimental drugs and treatments] are intended to serve.”

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.

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 thriving.
  • Build training opportunities and mentorships for clinical trial investigators and their staff.

Author: Michael Causey