Key Takeaways and Learnings
Building trust in clinical trials takes time, intention, and work. Sponsors and CROs must take the initiative and design a community-first approach if they want better, more representative research outcomes.
However, that goal is easier said than done—especially in communities of color. Why? Trust is the very root of effective people-first engagement. And racial and ethnic disparities in health and healthcare remain a persistent challenge to cultivating that trust, reflecting longstanding systemic inequities and historical and ongoing racism and discrimination.
If clinical research sponsors are to engage with the communities they aim to serve genuinely and effectively, they’ll need better strategies for listening, understanding, and, ultimately, connecting.
Mention lack of trust in clinical research among communities of color, and the conversation will likely turn to the Tuskegee Syphilis Experiment. But the erosion of trust in clinical research didn’t begin or end with that single atrocity. Rather, it reflects a long-standing pattern of systemic disregard for consent, safety, and representation, particularly among Black women. For example, in the 1840s, J. Marion Sims, once dubbed the “Father of Gynecology,” performed surgeries, including sterilization, on enslaved women with neither anesthesia nor consent.
More than a century later, involuntary sterilization continued—sometimes funded by the federal government. Medical professionals performed these “Mississippi appendectomies” on thousands of Black women without their knowledge or consent—one of whom was civil rights activist Fannie Lou Hamer in 1961. These atrocities were not isolated; they represent a legacy that continues to shape community skepticism toward clinical research today.
Systemic bias, historical exclusion, and unethical research have fueled long-standing mistrust of clinical studies—particularly among communities of color. These ongoing problems have perpetuated health disparities, and the continued absence of inclusive planning exacerbates the problem.
Consider: Black, Hispanic, and American Indian and Alaska Native people fare worse than White people across most measures of health, healthcare, and social determinants of health. Yet too often, CROs and sponsors overlook the need for early community partnership—missing critical opportunities to build trust and improve representation.
Underrepresentation distorts research outcomes, deepens existing disparities, and signals that the medical establishment doesn’t value communities of color.
These patterns of exclusion highlight the need for upstream solutions that support relationship-building, transparency, and shared power. Rebuilding trust demands more than acknowledgment. It requires consistent action through inclusive research design and authentic partnership.
Effective community engagement in research isn’t just a one-off information session or a booth at a health fair. It’s an ongoing relationship built on trust, shared power, and cultural relevance. To achieve meaningful inclusion and representative enrollment, CROs and sponsors must engage people early in the process. Building trust in clinical trials begins well before the first participant is recruited.
Upstream engagement builds trust and helps ensure fair representation. When CROs and sponsors partner with communities from the outset—through inclusive campaign design, shared planning, and transparent communication—they increase the likelihood of representative participation. These efforts lead to more reliable, generalizable, and ethically sound trial results.
In contrast, reactive mid-trial outreach often begins only after enrollment falls short of diversity goals. These efforts, although well-intentioned, are often transactional and too brief to repair long-standing mistrust.
Community engagement isn’t a one-time event or a recruitment tactic—it’s an ongoing relationship that should begin at the protocol stage and extend across trials, conditions, and even generations.
Acclinate’s community-based strategy focuses on sustained engagement, education, and empowerment. Our goal isn’t to merely increase enrollment. It’s about building trust that endures.
In a national maternal and fetal health initiative, Acclinate used its NOWINCLUDED platform and e-DICT analytics to engage BIPOC women through culturally relevant education and storytelling.
The results were powerful:
These results show how culturally relevant, person-centered engagement translates into interest in clinical research among communities of color.
Download: The Ultimate Guide to Advancing Health Equity in Clinical Trials
For a deeper dive into ensuring representation and building trust in clinical trials, download our Ultimate Guide to Advancing Health Equity in Clinical Trial.
Acclinate’s approach is based on affective trust—emotional connection, shared values, and cultural alignment. Instead of asking communities to participate before trust has been established, Acclinate’s model supports listening, education, and engagement.
Acclinate’s e-DICT platform uses real-time analytics to identify likely participants, while NOWINCLUDED fosters education, storytelling, and trust through grassroots engagement. Together, they blend data with dialogue, supporting outreach that’s based on trust and community connection, not expedience. CROs and sponsors can monitor what’s working, adjust quickly, and ensure outreach stays inclusive, effective, and culturally relevant.
Through this approach, trust isn’t an afterthought. It’s the foundation that makes data-driven engagement meaningful.
CROs and sponsors need to earn trust, of course. But they also need to keep it. Sustaining it requires transparency, respect, and meaningful collaboration. For CROs and sponsors, that means inviting participants into the research process itself.
What does that look like for communities of color?
It means returning individual and community-level results, involving participants in trial design, and co-creating educational materials with community partners. Above all, it entails honoring patient autonomy and helping people connect with one another through storytelling. All of this helps cultivate patient trust in medical studies.
Acclinate operationalizes this process through its Affective Trust Framework, which prioritizes authentic, two-way communication as the foundation of equitable research engagement. The framework outlines actionable guidance for building trust, fostering transparency, and achieving long-term inclusion through shared decision-making.
Acclinate partners with local organizations to engage individuals where they already feel safe, informed, and respected. These trusted environments provide fertile soil for ongoing involvement rather than one-time participation, improving both retention and representation in clinical trials.
Building trust in clinical trials isn’t just one task among many. It’s a long-term, community-centered strategy that’s pivotal to successful, effective, and inclusive research.
By prioritizing early and sustained relationships, honoring community insights, and committing to shared decision-making, sponsors and CROs can build mutually fruitful, enduring relationships with potential participants. It’s never too early to start.
Want to learn more about how to build trust early in clinical research? Schedule a 1:1 meeting with our team.