Archive | 2021
Impact of the COVID-19 Pandemic on the Conduct of Clinical Trials: A Quantitative Analysis
Abstract
\n Background: Globally, healthcare has shouldered much of the socioeconomic brunt of the COVID-19 pandemic. In the area of clinical research, reports indicate that numerous clinical trials have had to be suspended or discontinued. However, these reports have been either qualitative in nature or limited in quantitative scope. The aim of the present analysis was to quantitatively estimate the impact of COVID-19 on the number of clinical trials worldwide. Methods: Data deposited by 219 countries in the ClinicalTrials.gov database between 2007 and 2020 were interrogated using targeted queries. A time series model was fitted to the data for studies ongoing, initiated, or ended between 2007 Quarter (Q) 1 and 2019 Q4 to predict the expected number of trials in 2020 in the absence of COVID-19. The predicted values were compared with the actual 2020 data to quantify the impact of the pandemic. Results: The number of ongoing registered trials showed continuous growth from 2007 Q1 to 2019 Q4 (from 33,739 to 80,319 trials). By contrast, there were markedly fewer ongoing trials in all four quarters of 2020 compared with forecasted values (1.6%–2.8% decrease). When excluding COVID-19-related studies, this disparity grew further (3.4%–5.8% decrease), to a peak of almost 5,000 fewer ongoing trials than estimated for 2020 Q2. Promisingly, however, the number of newly initiated non-COVID-19 trials was higher than predicted in 2020 Q4 (by 9.9%). Conclusions: This quantitative analysis confirmed that the pandemic has had an appreciable impact on clinical trials. Provided that current trends persist, clinical trial activities may soon recover to at least pre-COVID-19 levels.