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Yale School of Medicine collaboration to further clinical trial diversity

April 24, 2024

Combining their capacity and experience in making strides in reducing health disparities, Yale School of Medicine, Morehouse School of Medicine, the Research Centers in Minority Institutions Coordinating Center (RCMI-CC) at Morehouse School of Medicine, and Vanderbilt University Medical Center have come together to lead a national initiative to diversify participation in clinical trials. This initiative, Equitable Breakthroughs in Medicine Development (EQBMED), is a collaborative effort that aims to connect with sites across the US to increase awareness of the benefits of diverse participation in clinical trials, addressing misinformation and historical mistrust, and ensuring trials are easily accessible.

As network partners, Yale School of Medicine, Morehouse School of Medicine, RCMI-CC, and Vanderbilt University Medical Center are coordinating with fourteen long-established community, faith, and professional organizations that will contribute their distinct expertise and deep experience to ultimately improve the health of communities of color through medical research.

“Yale School of Medicine has been working to increase diversity within clinical trials through groundbreaking community partnerships and initiatives for more than a decade, which has been the foundation of much of our EQBMED work,” said Nancy J. Brown, MD, the Jean and David W. Wallace Dean of Yale School of Medicine. “We are honored this tremendous group of professional societies and community and faith-based organizations have agreed to partner with us in establishing a new infrastructure that will positively impact clinical trial diversity.”

EQBMED is supported by a grant from Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA convened thousands of stakeholders, including community leaders, in the development of the grant, which supports EQBMED’s efforts to identify key learnings around clinical trial diversity and establish 10 clinical trial learning phase sites in underserved communities that are sustainable and scalable.

“This is the next positive step in building and supporting a strong network of community-based clinical trial sites that can lead to institutional change and better health equity. Community partnership is foundational to EQBMED’s approach to improving access to clinical trials,” said Stephen J. Ubl, President, and Chief Executive Officer of PhRMA. “Through EQBMED’s partnership with trusted community leaders, the initiative will raise awareness and support that will lead to participation in local sites.”

EQBMED builds on efforts underway at each of the network partners to address inequitable access in clinical research, much of which is conducted through Clinical and Translational Science Awards (CTSA), funded through the National Center for Advancing Translational Sciences (NCATS). The RCMI sites are funded by the National Institutes on Minority Health and Health Disparities (NIMHD), both at the National Institutes of Health (NIH).

These network partnerships unite five CTSA grants and three RCMI-CC sites, each bringing their unique strengths and resources to the table, all in aid of the shared objectives between EQMBED and NIMHD/NCATS: to address burdens and roadblocks in research and optimize systems to improve efficiency as well as health outcomes for underserved communities. The involved CTSAs are the Yale CTSA, Morehouse School of Medicine, a partner in the Georgia Clinical and Translational Science Alliance; the Vanderbilt Institute for Clinical and Translational Research; the South Carolina Clinical and Translational Science Institute (supporting the Florence Medical University of South Carolina EQBMED clinical site); and the University of Texas Medical Branch CTSA (supporting the Texas Southern University EQBMED clinical site). The RCMI-CC sites include Morehouse School of Medicine (network partner), Meharry School of Medicine (EQBMED clinical site), and Texas Southern University (EQBMED clinical site).

EQBMED is founded upon a collaborative approach to working with local community-facing practices and trusted messengers to address critical barriers facing communities of color and rural residents as participants, and health care providers as trial sites. Some of these barriers can include limited access to trials in communities historically underrepresented in research; the financial and time burden trials can place on patients, patient mistrust grounded in experiences with medical bias; simply not being asked to participate; limited diversity among investigators and staff who serve as community leaders for clinical trials; the financial and time burden faced by smaller community-based trials sites and health care providers, along with challenges of being selected for participation as sites without lengthy history of participation as a prior site.

"Our collaboration with these esteemed partners is critical to enhancing clinical trial diversity beyond metrics," said Marcella Nunez-Smith, MD, MHS, associate dean for Health Equity Research, and C.N.H Long Professor of Internal Medicine, Public Health, and Management at Yale University. "This collection of organizations is unique: their various focus areas are brought together under one concentrated effort in furthering clinical trial diversity. With the collective knowledge, valued trust, and deep community ties of our partners, we are creating an accessible landscape for medical research, and ultimately driving more equitable breakthroughs in healthcare."

EQBMED recently announced the selection of the first four learning phase sites, each aligned with one of EQBMED’s network partners. Those sites are located in areas where minority and rural communities have limited access to clinical research opportunities, and whose health concerns have been historically underrepresented in clinical research. “Backed by a rich history, this diverse mix of clinical trial sites saves lives by giving their patients – the Atlanta, Florence, Galveston, and Nashville communities – an opportunity to advance the science of lifesaving medicines as well as benefit from this extraordinary work,” said Priscilla Pemu, MD, MS, FACP, Associate Dean for Clinical Research and Professor of Medicine at Morehouse School of Medicine. “EQBMED is making real progress towards equitable access to clinical trials and enhancing these sites with needed resources.”

The EQBMED network partners are paired with a local clinical trial site, serving as collaborators and peer mentors to help the site and community meet its clinical goals and site aspiration, building on the past and present work of the Network Partners. Yale will be working with Medical University of South Carolina’s site in Florence, South Carolina; Morehouse School of Medicine will be working with Grady Health System in Atlanta, Georgia; RCMI-CC and Texas Southern University in Houston and University of Texas Medical Branch (UTMB) in Galveston, Texas; and Vanderbilt University Medical Center and Meharry Medical College in Nashville, Tennessee. “A critical element of EQBMED is meeting the community and sites where they are in their clinical research journey,” said Tesheia Harris, MBA, MHS, chief strategy officer at Yale Center for Clinical Investigation (YCCI) at Yale School of Medicine (formerly Tesheia Johnson). “This goal led us to develop a tailored approach to site readiness, through a site maturity assessment model, enabling each site through a bidirectional mapping process to identify its current capabilities, as well as aspirations to co-develop a roadmap for the site to achieve its goal.”

The maturity model enables not only the matching of sites with trials based on current capabilities but also with EQBMED infrastructure resources, such as funding for dedicated personnel and enhanced technology capabilities. The model also aids in establishing partnerships’ needs and goals, enabling a pairing of potential collaborators, including the community and faith-based partners launched with this announcement. Finally, the model enables tracking progress at each site over time, toward reaching the definition of success agreed upon by the community, trial sites, and EQBMED, while maintaining the necessary scientific standards and metrics for quality in clinical trial research. Partnering with each site through this tailored approach is just one way EQBMED is focused on fostering sustainable partnerships with community-based organizations and leaders.

EQBMED’s fourteen professional, community, and faith partners are national and international leaders, with local-level engagement. The partners bring invaluable insights and capabilities to the table, further enriching its efforts to dismantle barriers to medical research, access, and participation. EQBMED has collaborated with each partner to develop a collaborative scope with dedicated funding which will be led by the professional society, community organization, or faith-based partner. “These collaborations are essential in furthering EQBMED's goal of advancing equity and access to innovative clinical trials,” said Tesheia Harris. “Through our combined commitment to fostering diversity in clinical trials, we can continue to forge a path toward a more inclusive landscape for medical research. We find ourselves at an exciting juncture, having deliberately pursued our objectives to cultivate significant bonds with both our sites and communities.”

Community and faith-based organizations will partner with EQBMED to develop strategies to more effectively engage and incorporate community perspectives in clinical trials. The groups will hold listening sessions, and develop tested tools, models, and messages to support community engagement and participation. “Successfully addressing the many challenges to diversifying clinical trial participation requires the efforts and talents of a diverse group of partners,” said Peter Embí, MD, MS, Professor and Chair of the Department of Biomedical Informatics and Senior Vice-President for Research and Innovation at Vanderbilt University Medical Center. “Each community leadership and professional organization brings their own particular expertise to EQBMED, and each will be critical to developing and delivering on a comprehensive strategy to increase diversity at each of our sites.”

Along with engaging, caring for, and sharing information with people in diverse communities, a key component in the effort to reduce health disparities is creating a diverse research workforce, driven by scientists and clinicians who seek to address the particular health concerns of the communities they represent and serve. EQBMED has partnered with professional societies that have national reputations and have long done the work to bring and retain more people of color into clinical research professions.

EQBMED’s professional society partners include:

The Association of Black Cardiologists (ABC) unites health professionals, medical experts, community advocates, and corporate and institutional partners to improve cardiovascular health in communities of color and bridge health gaps. With a global community of over 2,500 members, ABC is dedicated to ensuring equitable healthcare access. “ABC is rooted in the belief that societal progress is intrinsically linked to achieving optimal health for everyone. In pursuit of this vision, we are committed to fostering diverse and inclusive participation in groundbreaking clinical trials, with a special focus on enhancing health outcomes in communities of color. Our collaboration with EQBMED amplifies this commitment, enabling us to uplift community voices and work together in creating educational programs and sustainable strategies aimed at addressing the complex challenges of cardiovascular health in diverse populations," said Paul Underwood, MD, ABC Board Chair.

The W. Montague Cobb Institute provides support for research career pathways for a diverse body of students, as well as community education and resources for implementing strategies to study and reduce health disparities. As an EQBMED infrastructure partner, the Cobb Institute will leverage its existing networks to help sites increase and diversify participation in clinical trials and will help identify and engage other community resources for training and mentoring.

"Through collaboration with EQBMED, the W. Montague Cobb Institute envisions a future of synergy and a revived talent pipeline, where our shared commitment to health equity serves as a beacon, illuminating pathways to transformative change,” said President and CEO Randall C. Morgan, Jr. MD, MBA. “As a leading institution dedicated to advancing racial and ethnic health disparities research, the W. Montague Cobb Institute brings a rich legacy of scholarship, advocacy, and community engagement to this partnership. Together, we harness our collective expertise to address the systemic inequities that persist in healthcare, ensuring that every individual has access to quality care and opportunities for optimal health outcomes.”

The National Black Nurses Association (NBNA) supports nurses across the country, enabling them to provide culturally compassionate and relevant care to patients. The NBNA works to ensure equal access to professional development and educational opportunities for Black nurses, and it facilitates health education and screenings for community residents in collaboration with community-based partners, including faith-based and community organizations, as well as hospitals and schools of nursing. NBNA represents over 300,000 Black nurses from the USA, Canada, the Eastern Caribbean, and Africa, with 111 chartered chapters nationwide.At NBNA, we provide a forum for collective action by Black nurses to advocate for and implement strategies to ensure access to the highest quality of health care for historically under-represented and marginalized people of color. We are thrilled to partner with EQBMED, to ensure that access includes equity to innovative clinical trials and to ensure our NBNA practitioners have the knowledge and resources to participate as providers at trial sites,” said Sheldon D. Fields, PhD, RN, FNP-BC, CRNP, AACRN, FNAP, FAANP, FAAN, 14th President and CEO of NBNA.

“Professional societies like the Association of Black Cardiologists (ABC), and the National Medical Association (NMA), represent frontline physicians with a longstanding commitment to serving African American communities, and advancing health equity,” said Elizabeth Ofili, MD, MPH, FACC, Professor of Medicine (Cardiology), and Principal Investigator of RCMI-CC at Morehouse School of Medicine. “EQBMED is partnering with the ABC, NMA, and other dynamic organizations whose members represent trusted voices, to amplify our collective efforts, and sustain access of diverse patients to clinical trials.”

The National Hispanic Health Foundation (NHHF) will work with EQBMED sites to design and deliver four professional development opportunities for diversity enrichment for clinical trials. They will hold sessions at national or regional conferences on a variety of topics related to diversity in clinical trials, as well as instruction for new researchers. NHHF will enhance and extend its existing clinical trials webinar series to adapt it to a diverse set of Hispanic populations in the US South. NHHF will build on ongoing efforts to develop a toolkit to support the recruitment and retention of Black, Hispanic, and Indigenous groups in the clinical trials workforce. Also in support of the health of the Latino community, the National Hispanic Medical Association (NHMA) will build on its expertise in supporting and mentoring the next generation of Hispanic health professionals to work with EQBMED Partners to design an effective communication strategy, for targeted outreach with both diverse medical students as well as the next generation and their families, designed to increase awareness of clinical trials, encourage membership in NHMA, as well as spotlight information on job opportunities in clinical trials.

“Representation and equity in all aspects of medical care are the reasons we created NHMA and NHHF 30 years ago,” said Elena Rios, MD, MSPH, MACP, president and CEO of both NHHF and NHMA. “We continue to fulfill this promise as we proudly join this project and help bring clinical research opportunities to Latino communities with the goal of improving health outcomes for all individuals."

The National Medical Association (NMA) is the largest and oldest national organization representing African American physicians and their patients in the United States. In its efforts to improve the quality of health for minority communities, it works toward creating career pathways for African American physicians and researchers, as well as community education programs on health issues of particular importance to minority communities. The NMA represents the interests of more than 50,000 African American physicians and the patients they serve. “The National Medical Association is committed to improving the quality of health in Black and other systematically disadvantaged communities through our membership engagement, professional development, health education, advocacy, research, and strategic partnerships. We are delighted to join forces with EQBMED to further our mission to expand access to - and ensure equity in - innovative clinical trials for communities of color through sustained partnership and engagement,” said Executive Director, Joy D. Calloway, MBA, MHSA.

EQBMED’s partner community and faith-based organizations have combined decades of experience working closely with the people they serve, based on strong, trusted networks of leaders and peers that can provide sustainability for EQBMED’s efforts.

“The support of these organizations provides an invaluable endorsement to the communities we are working to reach,” said Harris. “Their leadership are trusted messengers, who can sensitively convey the importance of clinical research diversity.”

EQBMED’s community partners include:

In New Haven, EQBMED will partner with the Community Action Agency of New Haven which assists area families who seek pathways out of poverty. Building their deep experience and on existing structures the organization aims, as part of EQBMED, to establish itself as a national resource for fostering community engagement with and diversity in clinical trials. It will guide EQBMED’s community-based sites in preparing to launch clinical trial diversity initiatives and develop procedures to address barriers to clinical trial participation. “Community Action Agency of New Haven (CAANH) is excited about the opportunity to partner with the Yale School of Medicine on the EQBMED initiative,” said President and CEO Amos Smith. “Many of our clients often are recipients of poor-quality care across various health issues. EQBMED provides Community Action Agencies (CAA’s) the opportunity to begin making a meaningful difference in the lives of the individuals and families we serve.”

The Urban League of Southern Connecticut works to secure and sustain economic self-reliance and parity through housing and workforce services, job training, homebuyer education, foreclosure prevention, as well as budget and credit counseling. As an EQBMED community partner, they will adapt their successful community conversations model, in which they host guided discussions on a range of topics important to the people they serve, to focus on the importance of diversity in clinical trials and health equity. “Embracing diversity in clinical trials isn't just about representation; it's about forging pathways to equitable medical breakthroughs,” said Acting CEO Virginia T. Spell. “The Urban League of Southern Connecticut is excited to play a role in shaping the conversation on equitable medical breakthroughs by leveraging its position as a trusted community organization by actively engaging with diverse communities across Southern Connecticut, facilitating discussions on the importance of diversity in clinical trials and its impact on health equity.”

Some partners will broaden their current and longstanding work in the Southern US, in the areas that EQBMED’s network partners will work.

The Community Education Group provides access to healthcare, public education, and job training to underserved rural communities and community-based organizations in West Virginia and Appalachia. It seeks to improve access to services and funding to combat widespread disease and public health crises, including HIV/AIDS, viral hepatitis, opioid addiction, and substance use disorder. Based on its record of work fostering community engagement, it will act as a resource in conducting community health needs assessments to identify key stakeholders, community influencers, and potential barriers to engagement in clinical trials. “This partnership represents a significant step forward in our commitment to enhancing health equity and access to quality care for underrepresented communities,” said Executive Director and Founder A. Toni Young. “By working together, we aim to address the disparities in clinical research and care, with a particular focus on increasing diversity, equity, and inclusion for Black, Hispanic, and Latino individuals. Our collective efforts will pave the way for more inclusive health solutions and contribute to a healthier, more equitable future for all."

The Urban Marketing Network (UMN) and the Creative Gods Agency will support EQBMED’s communication campaign to raise awareness of clinical trials and their importance as well as career pathways in clinical trials research, leveraging their existing speaker series with Historically Black Colleges and Universities (HBCUs) and contribute seminar content for groups in the US South.

UMN will also co-design, in collaboration with EQBMED, digital content to be shared via multiple communication channels, including social media. Content will be adapted for young people, particularly those at HBCUs, as well as for other UMN/Creative Gods network members, including faith-based organizations. “We at the Urban Marketing Network and the Creative Gods Agency are excited to be a part of this project,” said Scot X. Esdaile, CEO of Urban Marketing Network and President of the Connecticut State Conference of NAACP. “Engaging the community in a meaningful way is paramount to us, and we are honored to play a role in connecting the dots. Together, we look forward to making a positive impact and fostering connections that will benefit all involved."

Likewise, EQBMED will partner with organizations active in the Latino community. The Emerson Clinical Research Institute educates physicians and patients on the importance of participating in clinical research studies as a complement to clinical care. With a focus on the Latino community, they connect with underrepresented populations to educate about the importance of clinical trial participation, as a benefit to their communities and clinical research for all. It will work with EQBMED sites to provide operational support and mentorship based on emergent gaps/needs from sites’ maturity assessments.

“Emerson Clinical Research Institute is thrilled to join forces with the Yale School of Medicine for the EQBMED initiative,” said Fabian Sandoval, MD, CEO and Research Director. “Our Institute is dedicated to facilitating the participation of underserved patients in clinical trials, irrespective of their ethnic background, legal status, or socioeconomic standing while striving to modernize and enhance the development of existing and novel treatments. This collaboration is how we can make substantial and tangible differences in the lives of the communities we serve.”

The Balm in Gilead has more than 33 years of experience strengthening the capacity of faith communities to engage in programs that contribute to the elimination of health disparities for Black people everywhere. Using the expertise they have developed in building educational programs aimed at developing sustainable health programs built on a bedrock of the faith of the community, Balm in Gilead will aid EBQMED in creating and facilitating clinical trial training for communities new to medical research. “For 36 years, the Balm in Gilead has worked to reverse health disparities that diminish or shorten the lives of African Americans,” said Founder and CEO Pernessa C. Seele. “We are honored to be an EQBMED community partner and look forward to assisting Black faith communities in educating their members about the vital role clinical trials play in securing the health of our families and communities.”

EQBMED’s faith-based partners include:

Just as Yale’s Ambassadors program channeled the influence of the Black church in Connecticut to significantly increase clinical trial participation in their communities, several of EQBMED’s community partners will draw on the strength of the Black church to bring diverse voices to medical research.

With strong ties to the Black church, Choose Healthy Life will engage its network of pastors to create and lead engagement activities to advance clinical trial participation among the millions of African Americans in the US who count themselves as church members. The organization is highly experienced in employing vital resources, training, and support to address health disparities in hard-to-reach communities through the delivery of health services and community health programs, and will lend that expertise to EQBMED. “Our partnership with EQBMED is grounded in a shared commitment to dismantling barriers to health services and clinical trials in historically underserved communities,” said Executive Director Reverend Kimberly L. Williams. “Choose Healthy Life brings a unique model of community health improvement, rooted in the deep trust and historic presence of the Black Church in our communities. By integrating CHL's faith-based approach with EQBMED's resources and expertise, we are uniquely positioned to make significant strides in advancing health equity. We are grateful for the opportunity to contribute to this transformative endeavor. Together, we will build bridges of trust and access to healthcare that can truly make a difference.”

The Conference of National Black Churches (CNBC) is comprised of the national leadership of the largest historically Black denominations in America and represents more than 80 percent of Black Christians nationwide through the AME Zion Church, the Christian Methodist Episcopal Church, the Church of God in Christ, and the National Baptist Convention USA. CNBC employs the significant influence of leaders of Black historical religious denominations to collaborate in the areas of health, social justice, and public policy on behalf of Black communities. It will build on its experience collaborating with the Yale Ambassadors to foster and support diversity and inclusion in clinical trials. CNBC will develop a model for training trusted messengers, how to talk about clinical trials research to community members, and the importance of diversity in clinical trials.

“We are deeply appreciative of the opportunity to contribute to this transformative initiative,” said CNBC Board Member Bishop Dennis V. Proctor, AME Zion Church. “The Conference of National Black Churches represents a unified voice of Black religious bodies, striving to enhance the quality of life for all African Americans as they pursue their fullest potential in American society. We are empowered to drive significant progress in advancing health equity within our community through our collaboration with EQBMED's resources and expertise. Partnering with EQBMED is rooted in a mutual dedication to breaking down barriers to healthcare services and clinical trials in historically marginalized communities. This initiative will foster a foundation built on trust and equitable access to healthcare, creating tangible impact for all.”

“Clinical trial diversity is an issue of fairness,” said Nunez-Smith. “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. If we can bring our shared knowledge on clinical trial diversity closer to the communities we need to serve, we will all be the better for it.”

Submitted by Lisa Brophy on April 22, 2024