Misalignment between COVID-19 hotspots and clinical trial sites. (18th August 2021)

• Record Type: Journal Article
• Authors: Franks, Lauren; Liu, Hao; Elkind, Mitchell S V; Reilly, Muredach P; Weng, Chunhua; Lee, Shing M
• Is Part Of: Journal of the American Medical Informatics Association. Volume 28:Number 11(2021)
• Page Start: 2461
• Page End: 2466
• Publication Date: 2021-08-18
• Subjects: clinical research informatics -- clinical -- trial recruitment -- COVID-19 -- clinical trial site location; Medical informatics -- Periodicals; Information Services -- Periodicals; Medical Informatics -- Periodicals; Médecine -- Informatique -- Périodiques; Informatica; Geneeskunde; Informatique médicale; Computer network resources; Electronic journals; 610.285
• DOI: 10.1093/jamia/ocab167
• Languages: English
• ISSNs: 1067-5027

Abstract

Abstract: Hundreds of interventional clinical trials have been launched in the United States to identify effective treatment strategies for combating the coronavirus disease 2019 (COVID-19) pandemic. However, to date, only a small fraction of these trials have completed enrollment, delaying the scientific investigation of COVID-19 and its treatment options. This study presents novel metrics to examine the geographic alignment between COVID-19 hotspots and interventional clinical trial sites and evaluate trial access over time during the evolving pandemic. Using temporal COVID-19 case data from USAFacts.org and trial data from ClinicalTrials.gov, U.S. counties were categorized based on their numbers of cases and trials. Our analysis suggests that alignment and access have worsened as the pandemic shifted over time. We recommend strategies and metrics to evaluate the alignment between cases and trials. Future studies are warranted to investigate the impact of the misalignment of cases and clinical trial sites on clinical trial recruitment.