The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis

Abstract

ImportanceThe COVID-19 pandemic has impacted clinical research due to safety measures such as social distancing and lockdowns. However, developing treatments for COVID-19 relies on conducting clinical trials. Using telemedicine or virtual methods may support ongoing trials and limit the pandemic's impact on clinical research. ObjectiveTo examine the use of virtual methods among ongoing and discontinued COVID-19 clinical trials. DesignIn this cross-sectional analysis, we performed a systematic search of ClinicalTrials.gov for COVID-19 related trials registered since the pandemic began. In masked, duplicate fashion, authors extracted data from included studies, noting whether trialists reported using telecommunication, virtualization, or remote data collection to deliver interventions and monitor outcome measures. The authors also coded the use of virtual methods for recruitment, enrollment, or follow-up visits. Chi-square tests and Kruskal-Wallis tests were used to assess differences in the use of virtual methods between ongoing and discontinued studies and differences between intervention types. ResultsOur search returned 2549 clinical trials, of which 2383 were included. Of included studies, 2109 (88.5%) were ongoing and 274 (11.5%) were discontinued. Overall, 519 (24.6%) ongoing COVID-19 trials reported using virtual methods for trial conduct and 43 (15.7%) discontinued trials reported using virtual methods. There was a statistically significant difference in the rate of reporting virtual methods between discontinued and ongoing trials (X21 = 27.2, P < .001). Studies listed as Behavioral or Other were more likely to report using virtual methods for delivering interventions compared to other intervention types (X21 = 751.88, P < .001). Conclusions and relevanceThe COVID-19 pandemic has presented an unprecedented need for safe and efficient clinical trial conduct. Nearly a quarter of ongoing COVID-19 clinical trials in our sample reported using virtual methods for supporting trial progress. Ongoing trials were more likely to report virtual methods compared to discontinued trials. Developing strategies that allow for continuing trials during emergencies may limit trial disruption. Exploring and developing remote trial methods may continue to be valuable in light of emerging COVID-19 variants and may persist beyond the pandemic.