Equitable Breakthroughs in Medicine Development (EQBMED)

Yale School of Medicine, in collaboration with the Morehouse and Vanderbilt schools of medicine and the Research Centers in Minority Institutions (RCMI) Coordination Center program of the National Institutes of Health located at Morehouse School of Medicine, is participating in an initiative aimed at increasing diversity in clinical trials, with grant funding from Pharmaceutical Research and Manufacturers of America (PhRMA).

The COVID-19 pandemic made it clearer than ever that disparities exist between the care and attention that most Americans get and those experienced by underserved and underrepresented communities. Diverse clinical trials are an important way to ensure that all communities receive equitable access to participate in the development of potential new treatments.

This is a pilot program that allows the participating institutions to partner with patients, providers, industry leaders, technical experts, and the community at large to bring clinical trials directly to underrepresented and underserved patients. The participating institutions will work to build and support a network of 10 initial community-based sites.

Clinical trial diversity is an issue of fairness. People who may want to participate in a clinical trial should have information about how to do so and be able to access the trial more easily. Right now, many people, particularly from communities of color and rural communities, may not be asked to participate or may not have easy access, effectively depriving them of the choice.

Barriers to participation can include:

• Limited access to trial sites in historically underrepresented communities.
• Limited diversity among investigators and staff who serve as community leaders for clinical trials.
• The financial and time burden trials can place on patients, especially when there isn’t a site located close to where you live.
• Patient mistrust grounded in experiences with medical bias and historic wrongs.

What makes this effort different is the collaborative approach among health care providers and sites that have historically been less engaged in clinical research, community based organizations and leaders, pharmaceutical companies, subject matter experts, and academic institutions. EQBMED’s partnered approach to sites enablement is aiding in the development of a new model of site sustainability and has also led to an innovative model to measure site clinical trials diversity maturity.

Through EQBMED, sites will have a pipeline of potential studies from the pharmaceutical industry and beyond to support the sites. The intentional focus on mentorship and training opportunities for diverse investigators and staff further differentiates EQBMED from other programs.

Yale School of Medicine is proud to participate, and anticipates great benefits for communities that have been historically left out of research, for medical science, and for society at large.

The Equitable Breakthroughs in Medicine Development (EQBMED) Site Maturity Assessment Model is a holistic, collaborative, site-driven, and formative assessment carried out with potential sites to catalogue their current capabilities and identify opportunities for growth in conducting industry-sponsored clinical trials and enriching diversity of those trials. It is not intended to be evaluative in nature, or to be used to compare sites in the EQBMED program or otherwise benchmark against others.

The completed assessment will:

1. inform the site-specific roadmap for capability building during the Learning Phase (with the support of EQBMED infrastructure partners),
2. serve as a baseline for sites to track progress toward their maturity goals, and
3. create visibility into site capabilities to help trial sponsors assess interest in placing protocols at the site.

Because the EQBMED Learning Phase is focused on increasing representation of Black, Hispanic, and Latino populations, the tool specifies these groups. However, the tool itself is agnostic to the nature of diversity goals and may be tailored for use accordingly. Importantly, this assessment model draws from and synthesizes substantial prior clinical trial diversity initiatives including those led by Yale Center for Clinical Investigation (YCCI), The Clinical Trials Transformation Initiative (CTTI), The National Academy of Medicine, and Multi-Regional Clinical Trials Centers (MRCT).

Citation: Johnson, T., Nunez-Smith, M., Suttiratana, S., Lew, S., Linnander, E. & Curry, L. A. (2024). Equitable Breakthroughs in Medicine Site Maturity Assessment. New Haven, CT: Yale School of Medicine. https://medicine.yale.edu/ycci/researchspectrum/collab/equitable-breakthroughs-medicine-development/