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Misalignment between COVID-19 hotspots and clinical trial sites
Lauren Franks1, Hao Liu2, Mitchell S V Elkind3,4,5
1Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York, USA.
Clinical trial enrollment for coronavirus disease 2019 (COVID-19) treatments is slow. Geographic misalignment between COVID-19 cases and trial sites has worsened, hindering research access and recruitment.
Area of Science:
- Public Health
- Clinical Research
- Epidemiology
Background:
- Numerous interventional clinical trials were initiated in the U.S. to find effective coronavirus disease 2019 (COVID-19) treatments.
- A significant challenge has been the slow enrollment in these trials, delaying critical research into COVID-19 and its therapeutic options.
Purpose of the Study:
- To develop and apply novel metrics for assessing the geographic alignment between COVID-19 hotspots and clinical trial sites.
- To evaluate changes in trial access over time throughout the evolving pandemic.
Main Methods:
- Utilized temporal COVID-19 case data from USAFacts.org and clinical trial data from ClinicalTrials.gov.
- Categorized U.S. counties based on COVID-19 case counts and the number of interventional clinical trials located within them.
Main Results:
- Analysis revealed a worsening trend in the alignment between COVID-19 cases and clinical trial sites as the pandemic progressed.
- Geographic access to interventional trials has diminished over time relative to disease prevalence.
Conclusions:
- The study highlights a critical misalignment between where COVID-19 cases are concentrated and where treatment trials are located.
- Recommends developing and implementing new strategies and metrics to better align trial sites with disease hotspots.
- Further research is needed to understand how this misalignment impacts clinical trial recruitment and overall research progress.
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