Advancing Clinical Trial Participation: Leveraging Artificial and Geospatial Intelligence

Abstract Background The COVID-19 pandemic caused major socioeconomic disruptions nationally and globally, disproportionately affecting racial and ethnic minority populations (REMP) in terms of infection and hospitalization rates. Evidence suggests these disparities occurred during pre-hospitalization stages. To address these inequities, Texas A&M University partnered with the American Association of Colleges of Pharmacy to develop the 'Pharmacy Advances Clinical Trials' (PACT) Network. This initiative aims to achieve diversity in COVID-19 clinical trials through community-based and geospatial strategies. Aim To evaluate pharmacy and clinical trial proximity to racial and ethnic minority populations as an approach to optimize enrollments in COVID-19 clinical trials. Methods Open-source geospatial data including demographic, economic, and population data from the United States (US) Census Bureau, were overlayed with Clinicaltrials.gov data to build a database of ongoing and completed COVID-19 clinical trials in the US, and derive metrics related to their proximity to REMP, considering ongoing and completed clinical trials and enrollment by race and ethnicity. A separate database of 67,618 US community pharmacies from the National Council for Prescription Drug Programs was used to assess REMP's proximity to community pharmacies. The CDC COVID-19 Community Level and COVID-19 Community Vulnerability Index database was also incorporated to evaluate community transmission and overall vulnerability/risk. Results Despite living closer to clinical trial sites, REMP participation in COVID-19 trials was lower than that of the White population. Ninety-five percent of non-REMP reside within 102.5 miles of COVID-19 clinical trial sites, compared to 87 miles for REMP. Results for community pharmacies demonstrate that while 95% of the non-REMP US population reside within 7.25 miles of community pharmacies, REMP live within 3.75 miles. Participation in COVID-19 clinical trials was as follows: 8% Black or African American, 8% Hispanic or Latino, 11% Asian, 8% Other, 4% Not Applicable, and 61% White. Conclusion This study found that although REMP resided near community pharmacies and COVID-19 clinical trial sites, their enrollments were lower than non-REMP. The DCT model within the pharmacy setting could help mitigate and improve recruitment and retention challenges observed in centralized trials.