For years, conversations around improving representation in clinical trials have focused on eligibility criteria, awareness, and education. While these elements are important, another critical factor that demands greater attention is location.
Where clinical trials take place directly influences who is able to participate. When studies are limited to large academic centers or select geographic regions, participation inevitably reflects only those with the means, proximity, and access to those sites. As a result, many populations remain consistently underrepresented.
This is why the conversation must evolve into something more actionable, expanding into new sites, empowering new investigators, and reaching new locations.
Expanding Beyond Traditional Trial Sites
The U.S. Food and Drug Administration has emphasized the importance of placing clinical trial sites in geographic areas with higher concentrations of underrepresented racial and ethnic populations, as well as Indigenous communities. Restricting trials to a narrow set of locations creates structural barriers that limit participation, regardless of eligibility. -> Read the FDA Guidance on Clinical Trial Participation
Patients outside these regions often face practical challenges, including transportation constraints, time limitations, financial burden, and lack of exposure to clinical research opportunities. Even when individuals are eligible, participation becomes impractical.
Expanding trials into the communities where patients already live and receive care directly addresses one of the most fundamental barriers to participation, which is access.
Bringing Trials Into the Community
Access extends beyond physical distance; it is deeply tied to familiarity and trust. Patients are more likely to engage in clinical research when it is offered within environments they recognize and rely on, such as local clinics, community health centers, or neighborhood healthcare providers.
Establishing clinical trial sites within these community-based settings allows research to become integrated into routine care rather than remaining a distant or unfamiliar concept. This shift transforms clinical trials from being perceived as exclusive to being accessible and relevant.
The Role of New Principal Investigators
Equally important is the need to expand the pool of principal investigators and study teams to better reflect the communities they serve. Representation within the clinical research workforce plays a critical role in building trust and encouraging participation.
Patients are often more comfortable engaging with providers who understand their cultural context, language, and lived experiences. When healthcare providers and study coordinators reflect participant demographics, communication improves, hesitation decreases, and relationships become stronger.
This is about creating a research environment where patients feel understood, respected, and confident in their participation.
A Necessary Shift
Improving representation in clinical trials is both a scientific and ethical imperative. Variations in genetics, environmental exposure, and social determinants of health can all influence how patients respond to treatments. Without diverse participation, clinical data may fail to capture these differences, limiting the effectiveness and applicability of new therapies.
Addressing this gap requires a deliberate shift away from traditional models. It calls for investment in new infrastructure, stronger community partnerships, and a rethinking of how and where clinical research is conducted.
New sites. New investigators. New locations.
Because where trials happen ultimately shapes who participates, and access remains the key to making clinical research inclusive, equitable, and effective.
