Early Impact of Severe Acute Respiratory Syndrome Coronavirus 2 on Pediatric Clinical Research: A Pan-European and Canadian Snapshot in Time

Abstract

Objective: To capture the early effects of the coronavirus disease 2019 (COVID-19) pandemic on pediatric clinical research.

Study design: Pediatric clinical research networks from 20 countries and 50 of their affiliated research sites completed two surveys over one month from early May to early June 2020. Networks liaised with their affiliated sites and contributed to the interpretation of results through pan-European group discussions. Based on first detection dates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), countries formed 1 early detecting and 1 late detecting cluster. We tested the hypothesis that this clustering influenced clinical research.

Results: Research sites were first impacted by the pandemic in mid-March 2020 (March 16 ± 10 days, the same date as lockdown initiation; P = .99). From first impact up until early June, site initiation and feasibility analysis processes were affected for >50% of the sites. Staff were redirected to COVID-19 research for 44% of the sites, and 75.5% of sites were involved in pediatric COVID-19 research (only 6.3% reported COVID-19 cases in their other pediatric trials). Mitigation strategies were used differently between the early and late detecting country clusters and between countries with and without a pediatric COVID-19 research taskforce. Positive effects include the development of teleworking capacities.

Conclusions: Through this collaborative effort from pediatric research networks, we found that pediatric trials were affected and conducted with a range of unequally applied mitigations across countries during the pandemic. The global impact might be greater than captured. In a context where clinical research is increasingly multinational, this report reveals the importance of collaboration between national networks.

Keywords: COVID-19 pandemic; clinial research sites; clinical research networks.

Figure 1

Pediatric clinical research sites that contributed to this study. A, Pediatric clinical research sites that contributed to this study, by national network and B, reported numbers of ongoing pediatric clinical studies in which these sites were involved before the outbreak. No sites associated with the following networks contributed to this study: Finland, Germany, Norway, Poland, Switzerland, and the United Kingdom. More than one-half of the sites (58%) were involved in less than 20 pediatric clinical studies, 24% of the sites in 20 to 40 studies, and 18% in more than 40 studies.

Figure 2

A, Delay per country from the first detected case of SARS-CoV-2 infection until lockdown initiation as reported by the pediatric clinical research National Networks. Bars start, the day the first case was detected, end the day of lockdown initiation, and are colored according to whether there was a pediatric COVID-19 taskforce put in place by the networks. Countries are sorted according to the length of the bars. No lockdown initiation date was provided by the Swedish network, no data on the first detected case was provided by the Czech network, and the values for Canada are the average for the 2 networks that contributed. Differences between country clusters are reported in Table 2. Ten sites in Figure 1 (20%) located in Austria (2 sites out of 5, 40%), Greece (3 sites out of 5, 60%), Italy (1 site out of 3, 33%), and Sweden (4 sites out of 5, 80%) reported not be in lockdown when they completed the survey. B, Date of first impact on the activity as reported by the pediatric clinical research sites. The box represents the interquartile range (IQR), the dark line represents the median, whiskers extend to 1.5 times the IQR, and notches give an estimate of the 95% CI around the median.

Figure 3

Effect of the pandemic on pediatric clinical research visits. Total visits per month documented at a French site (Lille University Hospital) in 2019 (solid line; 404 visits in total) and 2020 (dotted line; 395 visits in total). The gray-shaded area indicates the first 2020 lockdown (March 17-May 10).