The Impact of COVID-19 on the Initiation of Clinical Trials in Europe and the United States

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has a major impact not only on public health and daily living, but also on clinical trials worldwide. To investigate the potential impact of the COVID-19 pandemic on the initiation of clinical trials, we have descriptively analyzed the longitudinal change in phase II and III interventional clinical trials initiated in Europe and in the United States. Based on the public clinical trial register EU Clinical Trials Register and clinicaltrials.gov, we conducted (i) a yearly comparison of the number of initiated trials from 2010 to 2020 and (ii) a monthly comparison from January 2020 to February 2021 of the number of initiated trials. The analyses indicate that the COVID-19 pandemic affected both the initiation of clinical trials overall and the initiation of non-COVID-19 trials. An increase in the overall numbers of clinical trials could be observed both in Europe and the United States in 2020 as compared with 2019. However, the number of non-COVID-19 trials initiated is reduced as compared with the previous decade, with a slightly larger relative decrease in the United States as compared to Europe. Additionally, the monthly trend for the initiation of non-COVID-19 trials differs between regions. In the United States, after a sharp decrease in April 2020, trial numbers reached the levels of 2019 from June 2020 onward. In Europe, the decrease was less pronounced, but trial numbers mainly remained below the 2019 average until February 2021.

Figure 1

Trial initiation in Europe and the United States by year from 2010 to 2020. For each calendar year, the monthly average number of initiated phase II and III clinical trials is depicted for the European Union based on the EU Clinical Trials Register (EUCTR) and for the United States based on clinicaltrials.gov, relative decreases indicate the change in non‐coronavirus disease 2019 (COVID)‐19 trials from 2019 to 2020.

Figure 2

Trial initiation in Europe and the United States by month from January 2020 to February 2021. Horizontal lines mark the monthly average number of initiated trials in 2019 in Europe (red) and the United States (blue). Major events related to the coronavirus disease 2019 (COVID)‐19 pandemic and affecting the data source are highlighted by E (the World Health Organization (WHO) declared COVID‐19 a global health emergency), P (the WHO declared COVID‐19 a pandemic), L (most European countries have initiated lockdowns) and wave 2 (both in Europe and the United States, a second wave materialized in November).