Researchers at the Yale School of Public Health and Yale School of Medicine, in conjunction with Equitable Breakthroughs in Medicine (EQBMED), a multi-institute collaboration focused on clinical trial diversity, have published a Site Maturity Assessment Model in the journal Trials.
The model is designed to support clinical trial sites to identify opportunities for growth in conducting industry-sponsored clinical trials and enrich diversity of those trials. The approach is holistic, collaborative and site-driven. The model assesses an organization’s current and aspirational capabilities, mapping a logical path from initial state to full maturity regarding specific goals. It serves as a diagnostic tool to determine current capacity, prioritize areas for improvement, and track progress toward maturity goals.
Developed over two years in collaboration with a diverse group of partners—including representatives from pharmaceutical companies, federal organizations, community leaders, scientists, health care sites with varying levels of trial readiness, and academic experts—the model has undergone over 20 iterations, demonstrating its adaptability and impact. The process of synthesizing this collective expertise was led by Drs. Leslie Curry and Marcella Nunez-Smith and Ms. Tesheia Harris. The Site Maturity Model integrates two traditionally siloed components of clinical trials—research operations and community engagement—and reflects the importance of organizational leadership in achieving meaningful diversity in clinical trials. The model includes assessment of a site’s capacity to address critical barriers to trial diversity, including social determinants of health, trustworthiness of health care providers and research institutions, and the competing pressures on potential participants, such as limited resources and time constraints.
“Our innovative approach with the EQBMED model supports sites in identifying site-specific challenges and developing tailored, actionable strategies to enhance health equity in clinical research,” said Dr. Leslie Curry, a professor of public health and management at Yale School of Public Health with expertise in organizational culture, model creation, and mixed methods research.
“Working in partnership with clinical trial sites using the model’s rigorous approach to readiness assessment and co-designed goal setting is filling a critical gap in the field," 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. “The Site Maturity Model and EQBMED as a whole, underscores the importance of partnerships that break down silos and drive operational excellence in advancing the reach of clinical trials.”
“Strategic investment in clinical trial diversity requires structured assessment of site maturity as a starting point for transformative, inclusive action,” said Tesheia Harris, MBA, MHS, EQBMED senior advisor and former chief strategy officer at Yale Center for Clinical Investigation (YCCI) at Yale School of Medicine. “The EQBMED model is pivotal in guiding sites to identify and prioritize key areas to enhance their capability for diverse clinical trials.”
The Site Maturity Assessment Model will continue to be implemented at a range of clinical trial sites such as FQHC’s, safety net hospitals and health systems with EQBMED and Yale School of Public Health committed to supporting sites on their journey to ensure communities of color and rural residents have access to innovative clinical trials. This model stands as a new standard to support the creation of an accessible landscape medical research, ultimately achieving more representative trial populations and improving health outcomes across diverse communities.
Equitable Breakthroughs in Medicine Development is a pioneering partnership committed to transforming the landscape of clinical trials by advancing diversity, transparency, and knowledge. This collaborative partnership is led by Yale School of Medicine, Morehouse School of Medicine, the Research Centers in Minority Institutions Coordinating Center at Morehouse School of Medicine, and Vanderbilt University Medical Center, and supported by grant funding from PhRMA. By empowering community-based sites and addressing historical disparities, the program is dedicated to creating a more inclusive future in medicine development.