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

Katia Audisio,David Chadow,Deepak Bhatt,Hillary Lia,Mario Gaudino,Michael Farkouh,Newell Robinson,Gianmarco Cancelli,Roberto Perezgrovas Olaria,Derrick Tam,Stephen Fremes,Mohamed Rahouma,Giovanni Soletti,Dominique Vervoort

doi:10.3390/jcdd9010019

Abstract

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.

Highlights

The Coronavirus Disease 2019 (COVID-19) pandemic has had a profound impact on all areas of the healthcare system, including clinical research [1]
Faced with the challenges of the COVID-19 pandemic, Randomized controlled trials (RCT) had to adjust protocols to accommodate the sudden suspension of recruitment, in-person data collection, and safety visits, as well as delivery of interventions, which may lead to a pause or premature closure of the trial
We found that during the COVID-19 pandemic, there was a significant increase in the stoppage of non-COVID-19-related trials compared to the non-pandemic years, with no difference in trial completion

Summary

Introduction

The Coronavirus Disease 2019 (COVID-19) pandemic has had a profound impact on all areas of the healthcare system, including clinical research [1]. Faced with the challenges of the COVID-19 pandemic, RCTs had to adjust protocols to accommodate the sudden suspension of recruitment, in-person data collection, and safety visits, as well as delivery of interventions, which may lead to a pause or premature closure of the trial. Prior analyses have attempted to characterize the impact of the pandemic on trial status, funding, and recruitment. These analyses, were published early in the pandemic [4] or focused on COVID-19-related RCTs [5]. We characterize the effect of the COVID-19 pandemic on non-COVID-19 RCTs

Methods

Results

Discussion

Conclusion