Impact of Coronavirus Disease-era Clinical Trial Reform on Cancer Trial Access in Rural/Underserved Regions of the Midwest.

Objectives: The coronavirus disease 2019 pandemic refocused the cancer community on bringing clinical trials closer to patients and increasing access for traditionally underserved communities. Pandemic-era deregulation increased flexibility with telemedicine visits, less frequent testing, and the ability to have tests done locally. This study evaluates the impact of 2020 cancer clinical trial reform on trial accessibility in rural/underserved regions of the Midwest.

Methods: Publicly available clinicaltrials.gov data was accessed from January 1, 2018 to September 30, 2022 for the 3 leading causes of new cancer cases in Kentucky, Tennessee, Illinois, and Indiana. Interventional trials were categorized based on location using corresponding "Rural-Urban Commuting Area" codes (urban/metropolitan, suburban/micropolitan, small town/rural, and isolated/rural) and categorized as pre versus postpandemic (using March 15, 2020, when national regulatory guidelines were modified). Locations of trial offerings from pre and postpandemic dates were analyzed by paired t test. Comparison of trial location category by state and cancer type was analyzed by 1-way analysis of variance with pairwise multiple comparisons made using the Tukey-Kramer method.

Results: Pandemic-era deregulation had no impact on increasing trial availability in suburban and small-town/rural locales ( P = 0.1259). Only 18% of trials were offered outside of urban areas, with 15% in suburban and 3% in small town/rural areas. Results varied by state ( P < 0.0001) with Illinois offering the most suburban and small-town trial availability (27%) compared with Kentucky, Indiana, and Tennessee (18%, 6%, and 2%, respectively). Trial availability in rural versus urban areas did not differ by cancer type ( P = 0.07197).

Conclusions: More work must be done to increase access to cancer clinical trials in rural and suburban areas of the United States.