Impact of the SARS-CoV-2 pandemic on clinical trials in the ECFS-CTN during 2020

ABSTRACT

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has disrupted clinical trials. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) tracked disruption to CF trials via regular surveys to adult and paediatric clinics of member sites throughout 2020. We published preliminary results to May 2020 (doi 10.1183/13993003.02114-2020). Here we report updated data to the end of 2020. Ongoing trials were heavily impacted up to May. Trial participant visits, new enrollment and monitoring visits were widely banned, with frequent home delivery of study drug (Table 1). From June to December, trial visits, new enrollment and onsite monitoring were mostly allowed, and home delivery of study drug dropped accordingly. The set-up of new trials was heavily impacted in March but recovered substantially from June on. Some sites had reduced staff available to work on CF trials. Table 1 presents how remote visits and measures were used by sites from June to December. Much of the early trial disruption resolved by end 2020;however, challenges remain to protect the progress of clinical research in CF during the pandemic.