Background
The U.S. Food and Drug Administration (FDA) is actively seeking diversity in clinical trials. While Caucasians represent 58% of the U.S. population, they historically comprise 80% of participants across clinical trials.1 Only 6% of clinical trial participants are Hispanic, though this demographic accounts for 19% of the population.1 Despite increased regulatory emphasis on diversity, enrollment in clinical research studies remains relatively low among racial and ethnic minority groups. Yet, these groups carry a disproportionately high burden of the chronic diseases that garner the most drug development interest.
Objective
Increasing clinical trial diversity is critical for enhancing representation and ensuring the generalizability of study results. However, effective diversification strategies remain elusive and meaningful strides must still be made. Alliance Clinical Network launched a decade-long initiative to evaluate whether establishing de novo study sites in communities with underrepresented populations would impact clinical trial diversity.
Methods
General outreach and targeted advertising were used to build a database of individuals with an interest in participating in clinical research, with a focus on underrepresented populations. This database was analyzed using commercially available tools and services to create a model for the types of patients within it. Consumer intelligence technology was applied to this model to identify the closest matches to the database population across the U.S.
The closest matches were used to narrow down potential geographies for establishing de novo study sites in racially diverse metropolitan areas. Locations with existing clinical research sites were excluded. Feasibility of the remaining areas was assessed based on proximity to a local hospital and confirmation of population demographics.
Once a site was established, specific media targeting and channel strategies were used to recruit African American, Hispanic/Latino, and other diverse audiences to participate in Phase 1-4 clinical trials across multiple therapeutic indications. Racial demographic information was collected for all studies. On an ongoing basis, Alliance Clinical’s in-house call center makes over 1,000 outbound calls per day and more than 700 patients are prescreened per month.
Conclusion
The FDA draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials underscores the agency’s commitment to promoting health equity and ensuring that studies adequately reflect the populations that will use medical products. The guidance goes beyond racial and ethnic diversity to include a broad representation of all demographic attributes, including gender, age, geographic location, socioeconomic status, physical and mental disabilities, and co-morbidities.
Diversity action plans (DAPs) will eventually be mandatory for all clinical trials and sites will be the cornerstones of delivering diversity in the role as hubs for study recruitment and participation. Intentionally establishing sites in strategic locations with underrepresented populations can increase participation by underrepresented racial and ethnic populations and may help improve the strength and generalizability of clinical trial evidence.
Increasing clinical trial diversity is critical for enhancing representation and ensuring the generalizability of study results.
Results
Clinical Site Network
Seven wholly-owned and operated clinical research sites, each affiliated with a local hospital, have been established in California, Nevada, and Texas (Figure 1). All sites are staffed to reflect the diversity of their respective patient populations.
Figure 1. Alliance Clinical Network flagship locations
The database across these sites includes more than 250,000 consented and prescreened participants. Of these participants, more than 60% are from underrepresented populations and more than 20% are over the age of 65 (Figure 2).
Figure 2. Alliance Clinical patient breakdown by race
Based on estimates supported by racial demographic information from large vaccine studies.
These sites were utilized for recruiting, enrolling, and conducting clinical trials across a range of therapeutic areas, including metabolics, dermatology, immunology, and central nervous system (CNS) conditions. Alliance Clinical sites have participated in 50 vaccine studies in 5 years. Across these studies, the demographic breakdown among enrolled participants was 50% African American and 30% Hispanic/Latino.
CNS Study Enrollment Data
Alliance Clinical’s database includes 27,000 participants with type 2 diabetes. Five of Alliance Clinical’s sites are participating in an ongoing study of diabetic peripheral neuropathic pain.
As of August 8, 2024, Alliance Clinical sites have been responsible for 37% of total enrollment. Across the entire study, approximately 20% of participants are Black or African American. In contrast, among the participants enrolled by Alliance Clinical sites, over 40% are Black or African American.
Figure 3. Alliance Clinical aggregate enrollment by demographic
Figure 4. Alliance Clinical Lewisville (Texas) enrollment breakdown by race
Figure 5. Alliance Clinical Dallas (Texas) enrollment breakdown by race
Figure 6. Alliance Clinical Los Angeles (California) enrollment breakdown by race
Figure 7. Alliance Clinical Canoga Park (California)enrollment breakdown by race
Figure 8. Alliance Clinical San Diego enrollment breakdown by race and ethnicity vs San Diego population as a whole.2
Black or African American study enrollment is outpacing underlying population diversity and enrollment by ethnicity is representative of underlying population diversity, based on 2022 San Diego population data.
Contact Alliance Clinical Network today to learn how we can support your next study.
1 Turner BE, et al. Race/ethnicity reporting and representation in US clinical trials: a cohort study. Lancet Reg Health Am. 2022;11:100252.
2 Data USA. San Diego County, CA. Available at https://datausa.io/profile/geo/san-diego-county-ca
