Geographic Disparities in Vaccine Clinical Trial Access in the Mid-West: Impact of COVID-Era Clinical Trial Reform Direct Original Research

Main Article Content

Dr. Elizabeth A. Gordon

Keywords

Underserved, COVID-19 pandemic, Telemedicine.

Abstract

Introduction: The COVID-19 pandemic prompted numerous vaccine studies. The Food and Drug Administration (FDA) also modified research regulatory guidelines, such as allowing virtual visits, in March 2020 that could make clinical research in rural areas more feasible. This study evaluates the effect of 2020 clinical trial reform on vaccine trial access in rural/underserved regions of the mid-West.  


Methods:  Clinicaltrials.gov data was accessed from 1/1/2018-9/30/2022 for vaccination studies conducted in Kentucky, Tennessee, Illinois, Indiana, and Ohio. Trial locations were categorized by Rural-Urban Commuting Area codes (urban, suburban, small town and isolated rural) and identified as pre- vs. post-pandemic regulations. Trial locations from pre- and post-pandemic regulation dates were analyzed by paired t-test. Comparison of trial location category by state was analyzed by one-way ANOVA with pairwise multiple comparisons.


Results: Pandemic-era deregulation had no impact on vaccine trial geographic availability (p=0.8637). Overall, 95% of study locations were in urban/metropolitan areas, 4% in suburban/micropolitan areas, 0.5% in small town/rural areas, and 0.1% in isolated rural areas. Results varied by state (p<0.0001) with Kentucky offering the most suburban and rural trial availability (31%).


Conclusions: While modifications in the FDA’s regulatory guidelines may have increased flexibility for patients, these changes did not improve access to vaccine clinical trials at community sites in suburban, small town, and rural areas as measured by RUCA code. Increasing geographic diversity in vaccine clinical trials is critical for the development of more effective and equitable vaccines, as well as enhancing public trust in vaccination programs.

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