Small Research Sites: The Unsung Heroes of Clinical Trials

Clinical research is a complex landscape, often dominated by large academic medical centers (AMCs) and key opinion leaders (KOLs). However, the role of small research sites in advancing clinical research, particularly within the context of the FDA's new diversity initiative guidelines, cannot be overlooked. These small, often family-owned sites, like my own Yuma Clinical Trials , play a crucial role in reaching underserved populations and ensuring that clinical trials are more inclusive and representative.

Understanding Small Research Sites

Unlike AMCs, which are typically non-profit and often supported by grants and large institutions, small research sites operate on a for-profit basis. They are usually mom-and-pop operations, often involving a partnership between a physician and an entrepreneur or a nurse practitioner. These sites lack the financial backing and resources that larger institutions enjoy, but they compensate with a deep-rooted commitment to their communities.

At Yuma Clinical Trials, we bootstrapped our way to success without any investment capital. Our team includes community-based clinicians who genuinely care about their patients, many of whom belong to underserved populations. Our location, just 20 minutes from the Mexican border, means we serve a large Hispanic community that has historically been underrepresented in clinical research.

Challenges and Strategies

One significant challenge small sites face is the lack of recognition for our principal investigators (PIs). Unlike KOLs, our PIs are not on the speaking circuit nor are they paid to present on behalf of pharmaceutical companies. Yet, they are dedicated clinicians who know their patients by name and actively engage in their care. This personalized approach is invaluable, especially in communities with widespread misconceptions about healthcare and clinical research.

To overcome these challenges, small sites must be savvy in negotiating contracts to secure resources for community outreach. For example, our Clinical Research Coordinators (CRCs) participate in local events, such as the annual July 3rd celebration at a nearby casino, to raise awareness about our trials. These activities, which are not typically covered by study budgets, are essential for community engagement and education.

Marketing and Outreach Efforts

At Yuma Clinical Trials, we utilize every penny of our community outreach and marketing budgets to maximize our reach. We run a YouTube channel and an active Instagram account where we interview local business leaders, most of whom are minorities. While these efforts are not always funded by sponsors, they are crucial for building trust and awareness within our community.

Many small sites such as ours are deeply committed to community outreach and engagement. Our particular initiatives include organizing clinician office lunch-and-learns to educate local healthcare providers about our studies, volunteering at local food banks, participating in farmers markets, and hosting health fairs. These efforts aim to raise awareness about clinical research and its benefits, particularly among underserved populations. By actively involving ourselves in community events, we strive to build trust and ensure that diverse patient groups have access to clinical trial opportunities. While it is not impossible for larger AMCs to engage in similar endeavors, the incentive structure is not in place for these strategies to make a noticeable dent in their overall business outcomes.

Additionally, we run targeted ads on Facebook and Instagram, often exceeding the allocated budget to ensure maximum impact. This approach has proven effective, as evidenced by our enrollment numbers and the visible presence we maintain on social media and our website.

Efficiency and Impact

One key advantage small sites have over larger institutions is efficiency. A $500 marketing campaign at a small site can go a long way, whereas larger institutions may face inefficiencies and higher costs due to their size and structure. Sponsors and Contract Research Organizations (CROs) should recognize that small sites can deliver more value for their investment, especially when it comes to reaching diverse populations.

The diversity guidelines set forth by the FDA highlight the importance of including underserved populations in clinical research. Small sites are often better positioned to achieve this goal, given their proximity to and relationship with these communities. While AMCs provide valuable contributions to research, small sites offer unique advantages in terms of efficiency, outreach, and impact.

Conclusion

In conclusion, sponsors should not overlook small research sites simply because their PIs are not KOLs. These sites are on the front lines of community engagement, serving diverse populations that are crucial for the success of clinical trials. By supporting small sites, sponsors can ensure that their trials are more inclusive and representative, ultimately advancing the goals of the FDA's diversity initiatives.

For those interested in learning more about the strategies employed by small sites like ours, Latinos In Clinical Research will soon release a white paper detailing these efforts. Together, we can push the industry forward and make clinical research more inclusive and impactful for all communities.

To watch the video that inspired this article please check it out here: