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Equitable Breakthroughs in Medicine Development Reaches Next Phase Driving Diversity in Clinical Trials in Georgia, South Carolina, Tennessee, and Texas

EQBMED is a collaborative, community-based partnership to address diversity in clinical trials supported by grant funding from PhRMA

The University of Texas Medical Branch and Texas Southern University are partners in a national effort to increase diversity and inclusion of under served communities in clinic trials.

Equitable Breakthroughs in Medicine Development (EQBMED), led by Yale School of Medicine, Morehouse School of Medicine, the Research Centers in Minority Institutions Coordinating Center (RCMI) at Morehouse School of Medicine, and Vanderbilt University Medical Center, is a partnership bringing clinical trial sites closer to the community to further equity and access for diverse populations. Today, EQBMED announced the selection of the first four Learning Phase sites, moving the needle closer to a scalable and sustainable clinical trial model in historically under served communities. The partnerships include:

  • Morehouse School of Medicine and Grady Health System in Atlanta, Georgia;
  • Yale School of Medicine and Medical University of South Carolina in Florence, South Carolina;
  • Research Centers in Minority Institutions Coordinating Center (RCMI) at Morehouse School of Medicine, Texas Southern University in Houston and University of Texas Medical Branch in Galveston, Texas; and
  • Vanderbilt University Medical Center and Meharry Medical College in Nashville, Tennessee.

The selection of these sites is part of EQBMED’s plan to identify an initial 10 community-facing clinical trial sites in historically underrepresented communities of color across the country.

EQBMED’s multi-stakeholder model employs a holistic approach that considers the baseline capabilities of each site, allowing EQBMED to focus on creating opportunities for communities of color to participate and stay true to the program’s mission to promote clinical trial access and education.

TSU and UTMB will work with RCMI-CC at Morehouse School of Medicine to implement the EQBMED model in the Houston – Galveston region. A storied academic medical center with decades’ worth of experience conducting clinical trials, UTMB is able to share their research expertise with TSU – which is in the process of building their infrastructure to one day do work like this on their own campus. In exchange, TSU is able to give UTMB invaluable insight and knowledge about the needs, behaviors and barriers of under served populations.

“It’s a two-way street,” said Dr. Randall Urban, chief research officer for UTMB. “The insight we’re gaining from working closely with our partners at TSU is critical, as it helps us ensure we are meeting the needs of the regional communities we serve. When only a portion of the population is represented in clinical trials, you are not accounting for health concerns, needs, and experiences, and thus, a full assessment of the proposed therapeutic or medication is missed. That’s a disservice to everyone.”

Beyond just ensuring all individuals are accounted for during the data gathering phase, this work will also help inform how treatments are implemented throughout the community.

"This EQBMED clinical research site represents a significant milestone in our ongoing mission to advance health equity among ethnic minority populations," stated Dr. Veronica Ajewole, Founding Director of the Community Engagement Core and Institute for Health Equity Advancement Research and Training, and EQBMED Site Director for TSU. "As the first initiative of its kind on TSU's campus, we believe this will position TSU and our partner UTMB to lead the charge in promoting diversity in clinical research. This endeavor will drive increased community engagement and outreach, student training, and further research and innovations aimed at advancing health equity."

The EQBMED model stands out from others in the field because of its collaborative approach to working with local sites and trusted voices within the community to address critical barriers facing communities of color and rural residents. The program works to increase awareness of clinical trials, address misinformation and historical mistrust, while ensuring the trial is easily accessible.

The EQBMED partnership meets sites where they are, building on their strengths and capabilities to become sustainable within the clinical trial ecosystem. This means developing a tailored approach to each site, which could include, fostering sustainable partnerships with community-based organizations and leaders, enhancing technology capabilities, augmenting infrastructure, and providing funding for dedicated personnel.

This tailored approach drove the development of a new model to consider site readiness – the site maturity assessment model – which enables a site to identify its current capabilities as well as aspirations and co-develop a roadmap to achieve them. The maturity 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.

"Advancing health equity, which includes diverse participation in clinical trials, means meeting individuals where they are, building trust, and responding to the needs of communities. This has continued to be a priority of the Yale School of Medicine,” said Dr. 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. “Establishing trust is step one in cultivating meaningful collaboration with communities. Our goal of having steadfast commitment to inclusivity and advancements in healthcare can only be achievable through genuine investment and an authentic establishment of trust over time.”

“We stand at a thrilling crossroads, having approached our efforts with intentionality, to foster meaningful connections with both our sites and communities,” said Tesheia Johnson, MBA, MHS, Chief Strategy Officer at Yale Center for Clinical Investigation (YCCI) at Yale School of Medicine. “Our site model has made incredible strides towards breaking barriers and fostering genuine partnership, building toward collective success in every step.”

Each EQBMED network partner is aligned with one of the four current sites and brings their individual strengths and opportunities, while serving in a mentor role to help each site thrive and meet their goals.

“Backed by a rich history, this diverse mix of clinical trial sites saves lives by giving their patients – the Atlanta, Florence, Houston, Galveston and Nashville communities – an opportunity to advance the science of lifesaving medicines as well as benefit from this extraordinary work,” said Dr. 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.”

“We are seeking to address systemic barriers that underserved patients often face when it comes to clinical trials, including a lack of outreach, patient mistrust, and a lack of clinical trial infrastructure in historically underserved communities,” said Dr. Elizabeth Ofili, MD, MPH, FACC, Professor of Medicine and Principal Investigator of the RCMI Coordinating Center at Morehouse School of Medicine. “The RCMI Coordinating Center and research consortium are pleased to partner with EQBMED to accelerate drug discovery for the benefit of our communities.”

“There are myriad challenges to overcome if we want to address the racial and economic disparities in clinical trials and health care. Moreover, communities of color are not a monolith, so we cannot expect any two sites to require the same solutions. I am excited to be working with a team that understands that unique needs require unique solutions, and I look forward to collaborating with my colleagues on this necessary and crucial initiative,” said Dr. Peter Embí, MD, MS, FACP, FACMI, FAMIA, FIAHSI, Professor and Chair of Biomedical Informatics and Medicine and Senior Vice-President for Research and Innovation at Vanderbilt University Medical Center.

“PhRMA’s funding for EQBMED was born from thousands of conversations with patients, community leaders, health providers, industry experts and policymakers about the importance of enhancing clinical trial diversity. Today’s announcement is years in the making and shows what’s possible when people from diverse backgrounds and areas of expertise come to the table to work towards solutions together,” said Stephen J. Ubl, President, and Chief Executive Officer of PhRMA.

EQBMED is building on and leveraging past and present work by the network partners to support local trial sites in historically underrepresented communities in this critical area of clinical research. As we work to increase access to clinical trials for diverse patient populations in pursuit of true health equity, we are committed to sharing our findings broadly to build a foundation of trust, innovate a new approach to clinical trial diversity, and create beneficial change for community-centric research, for medical science, and for society at large.

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About Equitable Breakthroughs in Medicine Development

Equitable Breakthroughs in Medicine Development (EQBMED) is a pioneering partnership committed to transforming the landscape of clinical trials by advancing diversity, transparency, and knowledge. By empowering community-based sites and addressing historical disparities, the program is dedicated to creating a more inclusive future in medicine development.

About Yale School of Medicine

Yale School of Medicine (YSM) is one of the world’s leading centers for biomedical research, advanced clinical care, and medical education. YSM’s research ranges from basic science research on the molecular mechanisms and underpinnings of diseases to translational and clinical studies aimed at improving diagnosis and treatment. More than 1,700 Yale physicians provide care to patients from across the region and around the world through Yale Medicine, the school’s clinical practice. With its emphasis on critical thinking and independent student research, YSM produces leaders in academic medicine. For almost two decades, the Yale Center for Clinical Investigation (YCCI), the academic home of the NIH NCATS-funded Clinical and Translational Sciences Award (CTSA), at the Yale School of Medicine has spearheaded efforts to change the landscape of diversity in clinical trials. YCCI provides infrastructure and training to support clinical research and works to improve the health of all individuals and communities by increasing participation in clinical research in communities of color and marginalized populations. For more information visit www.medicine.yale.edu.

About Morehouse School of Medicine

Founded in 1975, Morehouse School of Medicine (MSM) is among the nation’s leading educators of primary care physicians, biomedical scientists, and public health professionals. An independent and private historically-Black medical school, MSM was recognized by the Annals of Internal Medicine as the nation’s number one medical school in fulfilling a social mission—the creation and advancement of health equity. MSM faculty and alumni are noted for excellence in teaching, research, and public policy, as well as exceptional patient care. MSM is accredited by the Commission on Colleges of the Southern Association of Colleges and Schools to award doctoral and master’s degrees. To learn more about programs and donate today, please visit www.msm.edu or call 404-752-1500.

About the Research Centers in Minority Institutions (RCMI) Coordinating Center

The RCMI Coordinating Center supports the RCMI Consortium and research network, which has NIH-funded research centers and 1,300 scientists, located across the nation in twenty-two Historically Black, Hispanic and Minority-Serving Institutions, that are leading innovations in health disparities research across diverse communities. RCMI CC supports investigators with their collaborative, multi-site research occurring across the Network. Please visit www.rcmi-cc.org to learn more, and find research collaborators.

Research Centers in Minority Institutions (RCMI) Coordinating Center is supported by the National Institute on Minority Health and Health Disparities, National Institutes of Health (NIH), through Grant Number U24MD015970. The contents of this announcement are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is the largest comprehensive research, teaching and patient care health system in the Mid-South region, with the highest ranked adult and children’s hospitals in the Southeast by U.S. News & World Report. Based in Nashville, Tennessee, VUMC sees more than 3.2 million patient visits per year in over 180 ambulatory locations, performs 91,000 surgical operations and discharges 79,000 inpatients from its main-campus adult, children’s, psychiatric and rehabilitation hospitals and three regional community hospitals. The Medical Center is the largest non-governmental employer of Middle Tennesseans, with nearly 40,000 staff, including more than 3,000 physicians, advanced practice nurses and scientists appointed to the Vanderbilt University faculty. For more information and the latest news follow VUMC on Facebook, LinkedIn, X and in the VUMC Reporter.

About Grady Health System

Grady Health System is one of the largest safety net health systems in the United States. Grady consists of the 953-bed Grady Memorial Hospital, seven neighborhood health centers, Crestview Health & Rehabilitation Center, Correll Pavilion, and Children's Healthcare of Atlanta at Hughes Spalding, which is operated as a Children's affiliate. With its nationally acclaimed emergency medical services, Grady is Atlanta's only Level I trauma center and serves as the 911 ambulance provider for the city of Atlanta. Grady's Walter L. Ingram Burn Center is the leading burn center in North Georgia. And the Marcus Stroke and Neuroscience Center is a Joint Commission designated Advanced Comprehensive Stroke Center. Other key services/distinctions include Grady's Regional Perinatal Center with its Neonatal Intensive Care Unit, Georgia's first Cancer Center for Excellence, The Avon Comprehensive Breast Center, the Georgia Comprehensive Sickle Cell Center, and the Ponce de Leon Center - one of the top HIV/AIDS outpatient clinics in the country. Grady is one of an elite group of hospitals to earn the Baby-Friendly USA international recognition as a Baby-Friendly Designated birth facility. For more information, visit http://www.gradyhealth.org/.

About Meharry Medical College

Meharry Medical College, founded in 1876, is the nation’s largest private, independent historically Black academic health sciences center dedicated to educating minority and other health professionals. True to its heritage, it is a United Methodist Church related institution. The college is particularly well known for its uniquely nurturing, highly effective educational programs; emerging preeminence in health disparities research; culturally sensitive, evidence-based health services and significant contribution to the diversity of the nation’s health professions workforce. Meharry is a leading national educator of African Americans with M.D. and D.D.S. degrees and Ph.D. degrees in the biomedical sciences. For more information visit: https://home.mmc.edu/about/.

About Medical University of South Carolina Health

Founded in 1824 in Charleston, MUSC is the state’s only comprehensive academic health system, with a unique mission to preserve and optimize human life in South Carolina through education, research and patient care. Each year, MUSC educates more than 3,200 students in six colleges – Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy – and trains more than 900 residents and fellows in its health system. MUSC brought in more than $300 million in research funds in fiscal year 2023, leading the state overall in research funding. MUSC also leads the state in federal and National Institutes of Health funding. For information on academic programs, visit musc.edu.

As the health care system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest-quality and safest patient care while educating and training generations of outstanding health care providers and leaders to serve the people of South Carolina and beyond. Patient care is provided at 16 hospitals (includes owned or governing interest), with approximately 2,700 beds and four additional hospital locations in development, more than 350 telehealth sites and nearly 750 care locations situated in all regions of South Carolina. In 2023, for the ninth consecutive year, U.S. News & World Report named MUSC Health University Medical Center in Charleston the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.

MUSC has a total enterprise annual operating budget of $5.9 billion. The nearly 26,000 MUSC family members include world-class faculty, physicians, specialty providers, scientists, students, affiliates and care team members who deliver groundbreaking education, research, and patient care.

About Texas Southern University

Texas Southern University is one of the nation's largest and most comprehensive historically black colleges or universities in the United States. A distinguished educational pioneer since 1927, Texas Southern University (TSU) has become one of the most diverse and respected institutions in Texas. TSU provides higher education access to the nation's underserved communities with over 100 academic and research programs that address critical urban issues and prepare its diverse student population of nearly 8,000 students to become a force for positive change in a global society.

The Texas Southern University Joan M Lafleur College of Pharmacy & Health Sciences (COPHS) stands as a beacon of excellence and innovation in the field of healthcare education. Situated in the heart of Houston, Texas, COPHS is dedicated to advancing health care through its cutting-edge programs, research initiatives, and commitment to community service. With a rich history of producing highly skilled and compassionate healthcare professionals, the college is a pivotal part of TSU's mission to transform students into leaders who are prepared to meet the challenges of a dynamic and diverse healthcare landscape. The mission of the Texas Southern University College of Pharmacy and Health Sciences (COPHS) is to provide quality academic programming to produce an ethnically diverse population of health professionals, especially African Americans and underrepresented minorities, who are transformational leaders in the delivery of interdisciplinary health services while addressing critical and urban issues. https://www.tsu.edu/academics/colleges-and-schools/college-of-pharmacy-and-health-sciences/about-us/

About The University of Texas Medical Branch

Texas' first academic health center opened its doors in 1891 and today has four campuses, five health sciences schools, six institutes for advanced study, a research enterprise that includes one of only two national laboratories dedicated to the safe study of infectious threats to human health, a Level 1 Trauma Center and a health system offering a full range of primary and specialized medical services throughout the Texas Gulf Coast region. UTMB is an institution in the University of Texas System and a member of the Texas Medical Center. [www.utmbhealth.com]

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. PhRMA has convened thousands of stakeholders to explore a new potential infrastructure with diverse communities, health systems, and academia that seeks to show proof of concept for a network of connected, community-rooted and sustainable trial sites. PhRMA provided a grant to Yale University to support the creation and development of this initiative. Learn more about PhRMA’s Equity Initiative at PhRMA.org/Equity.

More information at: https://medicine.yale.edu/ycci/researchspectrum/collab/equitable-breakthroughs-medicine-development/.​​

 

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