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Article

Impact of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials

1
Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY 10065, USA
2
Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON M4N 3M5, Canada
3
Peter Munk Cardiac Centre, University of Toronto, Toronto, ON M5G 2N2, Canada
4
Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Andy Wessels
J. Cardiovasc. Dev. Dis. 2022, 9(1), 19; https://doi.org/10.3390/jcdd9010019
Received: 21 October 2021 / Revised: 13 December 2021 / Accepted: 6 January 2022 / Published: 10 January 2022
Randomized controlled trials (RCT) were impacted by the COVID-19 pandemic, but no systematic analysis has evaluated the overall impact of COVID-19 on non-COVID-19-related RCTs. The ClinicalTrials.gov database was queried in February 2020. Eligible studies included all randomized trials with a start date after 1 January 2010 and were active during the period from 1 January 2015 to 31 December 2020. The effect of the pandemic period on non-COVID-19 trials was determined by piece-wise regression models using 11 March 2020 as the start of the pandemic and by time series analysis (models fitted using 2015–2018 data and forecasted for 2019–2020). The study endpoints were early trial stoppage, normal trial completion, and trial activation. There were 161,377 non-COVID-19 trials analyzed. The number of active trials increased annually through 2019 but decreased in 2020. According to the piece-wise regression models, trial completion was not affected by the pandemic (p = 0.56) whereas trial stoppage increased (p = 0.001). There was a pronounced decrease in trial activation early during the pandemic (p < 0.001) which then recovered. The findings from the time series models were consistent comparing forecasted and observed results (trial completion p = 0.22; trial stoppage p < 0.01; trial activation, p = 0.01). During the pandemic, there was an increase in non-COVID-19 RCTs stoppage without changes in RCT completion. There was a sharp decline in new RCTs at the beginning of the pandemic, which later recovered. View Full-Text
Keywords: COVID-19; randomized controlled trials; ClinicalTrials.gov COVID-19; randomized controlled trials; ClinicalTrials.gov
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MDPI and ACS Style

Audisio, K.; Lia, H.; Robinson, N.B.; Rahouma, M.; Soletti, G., Jr.; Cancelli, G.; Perezgrovas Olaria, R.; Chadow, D.; Tam, D.Y.; Vervoort, D.; Farkouh, M.E.; Bhatt, D.L.; Fremes, S.E.; Gaudino, M. Impact of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials. J. Cardiovasc. Dev. Dis. 2022, 9, 19. https://doi.org/10.3390/jcdd9010019

AMA Style

Audisio K, Lia H, Robinson NB, Rahouma M, Soletti G Jr., Cancelli G, Perezgrovas Olaria R, Chadow D, Tam DY, Vervoort D, Farkouh ME, Bhatt DL, Fremes SE, Gaudino M. Impact of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials. Journal of Cardiovascular Development and Disease. 2022; 9(1):19. https://doi.org/10.3390/jcdd9010019

Chicago/Turabian Style

Audisio, Katia, Hillary Lia, Newell B. Robinson, Mohamed Rahouma, Giovanni Soletti Jr., Gianmarco Cancelli, Roberto Perezgrovas Olaria, David Chadow, Derrick Y. Tam, Dominique Vervoort, Michael E. Farkouh, Deepak L. Bhatt, Stephen E. Fremes, and Mario Gaudino. 2022. "Impact of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials" Journal of Cardiovascular Development and Disease 9, no. 1: 19. https://doi.org/10.3390/jcdd9010019

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