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Equitable Breakthroughs in Medicine Development (EQBMED)

Aerial photograph of Yale School of Medicine and Yale New Haven Hospital, New Haven, CT

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.

What is the EQBMED Site Maturity Assessment Model?

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/


Resources

PhRMA's Equity Initiative

Enhancing clinical trial diversity is a highly complex challenge that requires a community-based, multi-stakeholder approach.

Learn more about PhRMA’s efforts to address the systemic barriers that can deter underserved communities from participating in clinical trials, so that people who want to participate, can.

Program Leadership

Yale School of Medicine

  • Professor of Laboratory Medicine, of Biomedical Engineering, of Medicine (Hematology) and of Pediatrics; Deputy Dean for Research, (Clinical and Translational); Director, Clinical Immunology Laboratory, Laboratory Medicine; Chair, Laboratory Medicine; Chief, Laboratory Medicine

  • Robert L. McNeil, Jr. Professor of Translational Research and Professor of Psychiatry, of Neuroscience, and of Psychology; Co-Director, Yale Center for Clinical Investigation; Chair, Psychiatry; Physician-in-Chief of Psychiatry, Yale New Haven Hospital; Director: NIAAA Center for the Translational Neuroscience of Alcoholism; Director, Clinical Neuroscience Division, VA National Center for PTSD

  • Associate Dean for Health Equity Research and C.N.H. Long Professor of Internal Medicine (General Medicine), of Epidemiology (Chronic Disease) and of Public Health (Social And Behavioral Sciences) & Professor of Internal Medicine (General Medicine); Affiliated Faculty, Yale Institute for Global Health; Founding Director, Equity Research and Innovation Center (ERIC), Yale School of Medicine; Director, Center for Research Engagement (CRE); Director, Center for Community Engagement and Health Equity; Deputy Director for Health Equity Research and Workforce Development, Yale Center for Clinical Investigation (YCCI); Director, Pozen-Commonwealth Fund Fellowship in Health Equity Leadership

  • Robert W. Berliner Professor of Medicine (Cardiology); Chief, Cardiovascular Medicine; Chief, Cardiovascular Medicine, Yale New Haven Hospital; Physician-in-Chief, Heart and Vascular Center, Yale New Haven Health System; Deputy Director, Clinical Trials Innovation, Yale Center for Clinical Investigation (YCCI); Co-Chair, Clinical and Translational Research Oversight Committee; President’s contingency planning committee, Clinical Practice/Clinical Research Subcommittee

  • Professor of Pediatrics (Emergency Medicine) and of Emergency Medicine; Chief Health Information Officer, Yale School of Medicine & Yale New Haven Health, Yale School of Medicine; Vice Chair of Clinical Systems, Biomedical Informatics & Data Science

Morehouse School of Medicine

RCMI Coordination Center at Morehouse School of Medicine

Vanderbilt University Medical Center