The industry group Pharmaceutical Research and Manufacturers of America (PhRMA) is hoping to break the mold, investing $10 million to launch 10 community-based trial sites in a new diversity initiative led by three medical schools.
Dubbed Equitable Breakthroughs in Medicine Development, the initiative aims to tackle systemic barriers that communities of color and historically underserved patients face when trying to access clinical trials. The goal is to build sustainable, local clinical trial infrastructure with efforts that address lack of outreach, patient mistrust and lack of available sites.
Participating schools are the Yale School of Medicine, the Morehouse School of Medicine and its Research Centers in the Minority Institutions Coordinating Center and Vanderbilt University Medical Center.
“Clearly, there are other networks out there,” Valerie Montgomery Rice, M.D., president of the Morehouse School of Medicine, said during a July 19 panel. “This is going to be more of a national opportunity … I don't know of any other network that has been as grassroots as we are trying to be.”
The program will step outside academia and the traditional spaces clinical trials are normally conducted, instead going to trusted places in communities—such as a private practice—to set up an infrastructure for trials, Montgomery Rice said, adding that the initiative will hopefully inform major pharmaceutical companies on how to better conduct their trials as well.
Over 18 months, the schools will assess what works and what doesn’t, and then share that knowledge to widely benefit everyone, said Peter Embí, M.D., professor and senior vice president for research and innovation at Vanderbilt.
The program will start in regions in the southeastern and southwestern U.S., areas that currently present the most challenges and have the highest opportunity, said Ramona Sequeira, Takeda’s president of global portfolio division and PhRMA board chair.
The multipronged approach sets the program apart from other diversity initiatives and will be dictated by local needs as well as being trial-agnostic.
The plan is to identify several sites by the end of summer or early fall, said Nancy Brown, M.D., professor and dean at Yale School of Medicine.
“We want to take the time to make sure that we understand the needs of potential sites so that when they get started, they have the maximum chance of succeeding,” Brown said.
Equitable Breakthroughs in Medicine Development will work with trusted community leaders to educate and raise awareness to support participation. The initiative will also provide resources and technical support for the sites and build training opportunities and mentorship for staff to sustain activity.
At every stage, the patient community will be the most important partner, all the leaders reiterated.