Abstract
Despite a wealth of case studies and recent FDA guidance highlighting the advantages of community-level engagement in clinical trials, local clinics and research sites with access, trust, and experience in treating diverse patient populations are frequently overlooked and under-resourced in the drug development process. Lloryn Hubbard and Zoé Felicié, patient diversity experts at the PPD Clinical Research Business of Thermo Fisher Scientific, explores the distinctive outreach and engagement approaches being employed at the community level and highlights strategies for how pharmaceutical and biotech companies can better empower and integrate sites with a track record of reaching underserved communities to overcome well-documented barriers.
Introduction
As global and U.S. populations continue to become increasingly diverse, clinical trials have not kept pace and have remained largely homogeneous. This lack of representation limits our understanding of how new treatments affect different populations, particularly underserved groups. With the U.S. Food and Drug Administration (FDA) introducing requirements for diversity plans to ensure that sponsors thoughtfully consider the characteristics of the patient populations they aim to treat, achieving real progress will require more than just checking off compliance boxes. It will require investment in creating genuine and ongoing partnerships with the communities involved, moving beyond the standard patient engagement practices for study recruitment to building authentic relationships that invite community members into the decision-making process.
Evidence shows that tailored and sustained community engagement is crucial for the success of representative clinical trials. Despite the wealth of case studies and recent FDA guidance highlighting the advantages of community-level engagement in improving clinical trial diversity, local clinics and research sites with access, trust, and experience in treating diverse patient populations are frequently overlooked and under-resourced in the drug development process. These sites play a vital role in relationship-building that bridges gaps in understanding and addresses hesitations about clinical research through direct, “boots on the ground” outreach. However, many of these efforts are constrained by the need to self-fund staff and local engagement activities that ultimately support sponsor trials. Although some research sites have designated roles or programs for community engagement and patient services, many staff members go above and beyond their job descriptions, dedicating personal time to attend events, often after hours. Their commitment demonstrates how critical these relationships are in fostering community trust.
By investing in community sites and other trust brokers working with underrepresented communities, developing culturally tailored recruitment strategies, and sustaining relationships over time, clinical trial sponsors and contract research organizations (CROs) can build a more inclusive and effective clinical trial ecosystem. These strategies not only benefit the patients and communities involved but also contribute to the long-term success of drug development, ensuring that medical products truly reflect the populations they are intended to help.
Beginning and Ending with the Community
“Boots on the ground” outreach is all about direct, hands-on engagement with a community. It means meeting people where they live, work, worship, and socialize, tailoring the approach to fit the unique culture and character of each community. The core objectives remain constant: to actively listen, understand community needs, demonstrate genuine commitment, and build meaningful relationships founded on trust. These relationships are crucial in fostering positive outcomes for all involved.
Across various regions, research sites are adopting creative, bi-directional approaches to engage and educate their communities about clinical research – regardless of recruitment for specific clinical trials. There are also advocacy groups and dedicated organizations focused on engaging and empowering patients around their health. While this approach demands time and continuous effort, there is mounting evidence that community engagement boosts diversity among research participants. For example, in a randomized trial enrolling patients with metabolic syndrome, the research team collaborated with community experts and employed an engagement strategy tailored to the cultural values of African American women. This resulted in a 78% increase in enrollment, achieving recruitment targets 16 months ahead of schedule.1
The National Institutes of Health’s (NIH) All of Us Research Program also prioritizes ongoing community engagement and partnership. Through a community-centered engagement strategy that includes collaboration with more than 1,000 community-based organizations, the initiative has enrolled over 75% of participants from underrepresented populations to date, including 50% from racial and ethnic minority groups.2,3,4 Much of the success observed stems from the simple but powerful act of showing up – week after week, year after year, listening, and being seen as an invested community partner.
While engagement strategies vary depending on the region and population, research sites that follow this formula are achieving strong results. They are not only sparking interest in clinical research among historically underrepresented groups but also alleviating warranted historical skepticism toward clinical research through transparency and sincerity.
Consider These Compelling Examples
Omaha, Nebraska. A site in Omaha is making strides in engaging American Indian and Native American populations, who face significant health disparities and are often underrepresented in trials for diseases that disproportionately affect them. Recognizing the historical context of cultural misunderstanding and mistreatment, the site has appointed a community engagement coordinator to work closely with the tribal community’s “circle of trust” — cultural leaders and elders. This role is crucial for delivering information about clinical research in a culturally sensitive manner, bridging gaps in awareness and trust. The site also has a dedicated “street team” that actively engages with the local community to ensure no one who may benefit from a clinical trial is left behind. This proactive approach has been crucial in boosting their patient database, which now grows by 60-100 patients per month.
Miami, Florida. A site in Miami has pioneered a creative program to engage with its predominantly Hispanic community. They’ve introduced a food truck strategically positioned near business parks and high-traffic areas with local cuisine, which serves as a welcoming and familiar environment for building connections. The site staff, who reflect the community’s diversity and are fluent in multiple languages, effectively bridge gaps caused by language barriers, apprehensions about the medical system, and other social or cultural challenges. Their approach to creating genuine, organic interactions helps them to be viewed as valued and credible members of the community. The powerful impact of this work is reflected in study metrics, with the site consistently meeting and exceeding contractual enrollment targets and achieving an eDiary compliance rate of 98% across all supported studies.
San Juan, Puerto Rico. A site in San Juan arranges entertainment for pediatric patients and their families, bringing in a clown to provide laughter during overnight stays or extended visits. The site also provides a professional hairstylist and nail technician for participants during extended stays, adding a personal touch to their trial experience. Recognized for their impactful efforts, this site secured a research grant to investigate food access and security, healthcare, and glycemic control in adults with diabetes.
These innovative approaches demonstrate how thoughtful, culturally sensitive engagement can not only build trust but also create more inclusive, patient-centered clinical trial experiences that resonate deeply within diverse communities.
Strategies for Ethical and Impactful Community Engagement
Based on our experience supporting diversity planning and execution, we have identified four best practices that can effectively enhance the ethical engagement and inclusion of underrepresented patient populations. These practices are designed to foster deeper relationships with communities, optimize site selection, and create more effective, inclusive clinical trials.
1. Understand and Maximize Site Engagement Efforts
When selecting research sites for clinical trials, sponsors and CROs should thoroughly assess how sites engage with underrepresented patient populations and the broader community. This includes inquiring about the demographic makeup of their patient base and outreach efforts beyond the clinical trial setting. As previously noted, many sites take proactive steps to connect with the community in meaningful ways outside of research, often with limited resources. Sponsors can play a key role in amplifying these efforts by providing even modest financial support to strengthen these outreach initiatives, ultimately benefiting both the community and the long-term success of their clinical operations.
A detailed understanding of each site’s patient community also enables the development of culturally and linguistically tailored recruitment materials once selected. Generic, “one-size-fits-all” materials often fail to resonate with diverse populations. Recruitment efforts should be reflective of the language(s), culture, and norms of the communities being targeted, making them more effective and inclusive.
Finally, while it may seem obvious, sponsors and CROs need to stress to investigators and site staff the importance of asking all potentially eligible patients about their interest in participating in a trial. Even the most well-intentioned professionals can be influenced by unconscious biases. Reinforcing this investigative practice helps mitigate assumptions about who might be interested in a trial based on factors such as health status, age, race, ethnicity, and other characteristics.
2. Embrace Community-Based Sites
Despite growing regulatory and legislative emphasis on enhancing clinical trial diversity, many studies continue to rely on the same research sites and academic institutions. To drive real progress, we must expand beyond the usual research hubs by engaging qualified community clinics and medical practices with strong ties to underserved communities and target patient populations.
Several studies and industry reports indicate that a small percentage of research sites conduct a disproportionately large share of clinical trials. Recognizing feedback from community-based research sites feeling underutilized, our team at the PPD clinical research business of Thermo Fisher Scientific recently formed an alliance of U.S. research sites that are experienced at engaging communities of diverse backgrounds and cultures. Through this initiative, we hold quarterly meetings to exchange best practices and collaboratively address challenges related to recruiting, engaging, and retaining underrepresented patient populations. Additionally, we work to facilitate connections between these sites and our clients, fostering relationships that aim to bring often overlooked sites into the research process. Building long-term relationships with community sites and principal investigators can enhance future collaborations and contribute to increased opportunities and sustained improvements in community health.
3. Research Trusted Organizations to Augment Engagement Efforts
In addition to supporting sites in their efforts to engage diverse communities, advocacy groups, community organizations, and vendors with nuanced expertise in engaging specific patient populations may complement and enhance these efforts, especially when aligned with the therapeutic area being studied. When researching and identifying community-based organizations and vendors, it is crucial to start with baseline data on the specific needs of a community. With this information, one can then identify local organizations that address these needs, such as food insecurity, lack of access to care, or housing issues. It is essential to ensure these organizations align with the intended messaging in a genuine and authentic manner to effectively collaborate and serve the community’s most pressing needs.
4. Sustain, Sustain, Sustain
As the late tennis player and civil rights activist Arthur Ashe wisely said, “Trust has to be earned and should come only after the passage of time.” Simple gestures, such as sending thank-you letters to individuals following their participation in a trial and sharing lay summaries of study results with both participants and the community, can make people feel valued and appreciated. It is equally important for sponsors to work with trial sites and others involved in the process to gather feedback from patients and caregivers after the trial concludes. This not only affirms the participants’ experiences but also provides sponsors with critical insights on what resonates and what does not, which can improve recruitment and retention efforts and potentially drive cost savings for future trials.
Finally, engagement shouldn’t be a one-time effort. Sponsors need to build and sustain authentic relationships with the community – whether through trial sites, community partners, or local employees’ outreach – and remain actively involved. Otherwise, they stand to lose much more than they gained in the trial. By partnering with trusted community leaders and investing in grassroots outreach, we can build a clinical research ecosystem deeply connected to the communities we serve. This approach doesn’t just invite participation – it builds lasting trust and drives real, long-term progress in contributing to the development of safer and more effective treatments for all patients.
Conclusion
There is strong evidence to support that a community-based approach to clinical development has a positive impact on diverse enrollment across various indications. Community-based research sites exist and are well-experienced in running clinical trials. As sponsors and CROs, it’s time for us to reframe our mindset on traditional approaches to site selection, recruitment, and engagement. We must overcome apprehensions about conducting research in new ways and decisively implement the evidence-based solutions proven to more effectively reach underserved and underrepresented communities. By embracing change and community-driven solutions, we can transform the future of drug development into one that truly serves all populations.
References
- Johnson DA, Joosten YA, Wilkins CH, Shibao CA. Case Study: Community Engagement and Clinical Trial Success: Outreach to African American Women. Clin Transl Sci. 2015;8(4):388-390.
- National Institutes of Health. All of Us Research Program Division of Engagement and Outreach Annual Report 2023. Available here as a PDF. Accessed September 2024.
- Denny JC, Rutter JL, Goldstein DB, Philippakis A, Smoller JW, Jenkins G, Dishman E: The “All of Us” Research Program. N Engl J Med. 2019, 381:668-76. 10.1056/NEJMsr1809937
Filed Under: clinical trials, Drug Discovery