Breaking Down the Barriers to Underrepresented Community Participation in Clinical Trials

Full interview summary

In a recent video interview with Applied Clinical Trials, Del Smith, PhD, CEO and co-founder of Acclinate, discussed how structural and relational barriers continue to limit participation from underrepresented communities in clinical trials, and what research teams and sponsors can do to meaningfully address them. He opened by drawing a clear distinction between the two barrier categories, explaining that structural challenges around site location, scheduling, travel distance, and compensation are often more visible and easier to identify, while relational barriers around trust, sustained engagement, and cultural relevance are frequently overlooked and just as consequential.

Smith went on to contrast authentic community engagement with the transactional, just-in-time recruitment outreach that has long characterized the industry. True engagement, he argued, is sustained well before and well after a study closes, and is grounded in a genuine understanding of the lived experiences of the communities being asked to participate. Meeting people where they are, both literally and culturally, is not a logistical nicety but a foundational requirement for building the kind of trust that leads to meaningful representation.

He was equally focused on making the business case for this approach, emphasizing that sustained community engagement carries real, measurable ROI for sponsors. When engagement is maintained consistently across an indication or therapeutic area rather than spun up and down around individual study timelines, sponsors build a ready and willing pool of potential participants that makes enrollment faster, more efficient, and more representative across the board.

Smith closed by broadening the value proposition of deep community engagement beyond enrollment targets entirely. The insights gathered through sustained community relationships, he noted, can inform protocol design, endpoint selection, and site placement in ways that improve overall study quality. And perhaps most importantly, that groundwork carries forward, creating an on-ramp to future studies that compounds in value over time and produces an exponential impact on the efficiency and reach of a sponsor's broader research program.