Clinical Trial Deserts for Gastrointestinal Cancer in the United States: Association with Area Deprivation and Digital Divide.

Abstract

We sought to define potential census-tract level differences between areas designated as clinical trial (CT) deserts versus non-CT deserts, and assess the association of area deprivation and digital divide with CT access. CTs serve as the foundation of evidence-based medicine, influencing multiple aspects of patient care; therefore, ensuring equitable access is important. CT data for 2024 were obtained from the Clinical Trials Transformation Initiative's Aggregate Analysis of ClinicalTrials.gov database. Multivariable logistic regression was used to assess the association between Area Deprivation Index (ADI), Digital Divide Index (DDI), and outcomes of interest. Among 381 GI cancer CT studies recruiting patients in 2024, the majority were Phase II (n=307, 80.6%), followed by Phase III (n=55, 14.4%); 53.3% (n=203) were associated with a sole facility and 62.5% (n=238) received funding from a non-federal, non-industrial source. In total, 40,870,834 adults resided in CT deserts for GI cancers, accounting for 12.5% of the US population. Populations living in CT deserts were more likely to live below the federal poverty line (14.2% [IQR 8.7, 22.0] vs. 9.8% [IQR 5.3, 17.2]) compared with non-CT deserts. On multivariable analysis, tracts with high ADI and high DDI were associated with 220.6% (aOR 3.206, 95%CI 3.013-3.412) and 169% (aOR 2.690, 95%CI 2.511-2.882) higher odds of being CT deserts compared with low ADI and DDI tracts, respectively. Approximately 40 million adults resided in GI cancer CT deserts in 2024. Underserved neighborhoods could benefit from telemedicine and expansion of clinical trial networks to community hospitals to improve CT access.