Clinical Trials Access Collaborative: Expanding clinical trial participation for all

Clinical research is the cornerstone of medical innovation, yet access to clinical trials remains disproportionately limited to a small fraction of the population.

Enter Clinical Trials Access Collaborative (CTAC), an organization dedicated to making medical research more accessible, striving to ensure those who wish to participate in clinical trials can do so. CTAC, which is currently applying for a 501(c)(3) status, grew from a preceding grant and learning phase, Equitable Breakthroughs in Medicine Development (EQBMED).

Clinical trials are key to advancing new interventions to prevent, manage, and cure disease, but opportunities to participate haven’t been available to all. When scientific understanding improves, so do the solutions.

Lucy Pérez

Senior Partner

The collaboration is a scalable model that connects clinical trial sponsors, healthcare institutions, community organizations, and the research ecosystem to accelerate trial participation in communities with access gaps. Its goal is to create a network of connected clinical care sites closer to each community and equipped with tools and resources for sustainable participation in clinical research. This is especially important because some communities have been left out of medical research, which limits what we know about how treatments work across all populations and geographies. Improving access can ultimately advance health outcomes across generations and unlock greater economic mobility.

“Communities with higher rates of chronic conditions often have fewer opportunities to join trials,” says McKinsey Senior Expert and Associate Partner Tamara Baer, MD. “About 50 percent of clinical trials take place in 2 percent of US zip codes. If we can change these statistics, we can potentially improve health outcomes across generations.”

CTAC’s creation and development were supported by Pharmaceutical Research and Manufacturers of America (PhRMA), along with Morehouse School of Medicine, Vanderbilt Medical Center, and the Research Centers in Minority Institutions Coordinating Center (RCMI-CC).

PhRMA convened thousands of stakeholders in the process to design the grant, working with ten sites to help expand access to—and participation in—clinical trials for all communities across the United States and uncover learnings to promote sustainability and success.

Partnering for impact

During this 18-month phase, McKinsey supported CTAC/EQBMED on a number of efforts, including:

• Creating a Site Maturity Assessment Model, which provided a framework to understand what it looked like when sites were ready to begin or scale up medical research. They assessed each site for readiness and/or maturity to conduct clinical trials at sites in communities that historically have not engaged in research.
• Enabling sites to understand their strengths and identify practical steps to grow their research programs by assessing their current infrastructure and opportunities for improvement. The tool was primarily based on research during the learning phase and prior work at Yale School of Medicine, which uncovered strategies for community engagement. The team also drew on the work of the National Academies of Sciences, Engineering, and Medicine; the Forum on Drug Discovery, Development, and Translation; the Clinical Trials Transformation Initiative (CTTI); and the Multi-Regional Clinical Trials Center at Harvard. These actions help clinical trial leaders reach out to trial participants, leading to fuller participation.

• Holding a competitive process to solicit sites that were interested and select ten sites to represent a range of health systems and clinical practice models. These included academic medical centers, safety net/community health systems, Federally Qualified Health Centers, private practices, and others interested in starting or growing their clinical trial programs.
• Working directly with each site to assess site maturity and identify specific goals to increase clinical trials maturity.
• Bringing on two sponsors (Merck and Amgen) to place trials at these sites and others.
• Developing the web-based Sponsor Front Door platform to connect trial sponsors with trial-ready, community-based sites. Sponsors investigate trial placement by reviewing site information, including demographic data, clinical trial experience, therapeutic capabilities, and community priorities.

• Nurturing a network of partner organizations that collaborated on this work. CTAC brought together more than 50 experienced leaders—researchers, physicians, and community advocates—to support the sites with mentorship, guidance, and resources. For example, Meharry Medical College, a historically Black institution, received mentorship from Vanderbilt Medical Center and RCMI-CC. Grady, a safety-net hospital, received support from Morehouse School of Medicine, and MUSC Health Florence Medical center, a community-based academically partnered hospital, received support from Yale School of Medicine.

Next, CTAC plans to scale this project to more than 15 sites over the next five years. These sites will broaden the availability of clinical trials to communities across the United States to ensure access for those who might not otherwise have the opportunity to participate.

CTAC worked with ten community-based sites across 14 states in the southern United States. Each site developed a scalable model that could potentially be replicated nationwide, broadening its reach to people who have not historically had access to clinical trials. The CTAC team estimates that millions of individuals will have the opportunity to engage in and benefit from more accessible research because of these efforts.

To date, seven out of ten sites have launched more than 20 trials, reaching 4,600 people. The remaining trial sites are rapidly progressing toward initiating more. Additionally, CTAC is expanding its model to include workforce training, flexible staffing approaches, and new ways to support student and community interest in clinical research careers.

“Creating a workforce development program helps ensure that this clinical research ecosystem is sustainable,” says McKinsey Partner Melvin Mezue, MD. “By training and retaining staff at community-based sites, we can build a pipeline of talent that will support the long-term growth of these institutions.”

Tesheia Harris (right), CTAC CEO, and partners

CTAC is also developing mentoring hubs to help sites learn from each other and help CTAC as a whole take on more sites for the program. The team plans to expand to 15 new sites while maintaining progress and momentum at the original ten. They are working at rural and urban sites to reach all communities across the United States.

“At CTAC, we’re advancing clinical research capacity through collaboration with community institutions that understand local priorities—because inclusion doesn’t happen in isolation,” says Marcella Nunez-Smith, MD, CTAC’s Chief Scientific Officer and co-founder. She is also the faculty director at the Yale School of Medicine Hub. “By supporting these sites with the tools, training, and partnerships they need to lead, we’re expanding access to medical research participation and accelerating innovation that reflects—and benefits—everyone.”