The March edition of DIA’s Global Forum magazine features a special section on clinical research in Ukraine, over one year on from the beginning of the Russian invasion. Anina Adelfio of the Association of Clinical Research Organizations (ACRO) looks back on an extremely challenging two years for the clinical trial industry, which has managed to maintain operations during both the COVID-19 pandemic and the ongoing war in Ukraine.
The years 2020 and 2021 shaped how clinical trials are currently operationalized. When the COVID-19 pandemic began in early 2020, sponsors and Clinical Research Organizations (CROs) were up against unforeseen changes, including site closures and a shift to remote monitoring of source data. Sponsors and CROs set up business continuity teams to keep trials running despite the site closures they were seeing and unprecedented circumstances they were up against, and were able to deploy remote technologies while prioritizing patient safety and data integrity.
Remote Trial Operations During the COVID-19 Pandemic
In 2020 and 2021, as a result of the COVID-19 pandemic, clinical trials were utilizing more remote components. This was already spreading across the clinical trial industry because of the increase in the speed, quality, and availability of the technology and the regulatory and clinical flexibility to use centralized monitoring and remote monitoring. But the response to COVID-19 really brought it to the next level.
A landscape survey conducted by ACRO of approximately 5,000 clinical trials shows that centralized monitoring increased by 119% between 2020 and 2021 and off-site or remote monitoring increased by 72% in the same timeframe. When you look back at 2019, you also see off-site or remote monitoring increase by 150% in 2020. This shows the dramatic shift made by CROs and sponsors during the COVID-19 pandemic. This same landscape report shows a slowing of the uptick of these components in new studies started in 2021 as on-site visits resumed, and we see the normalization of COVID-19 and fewer site shutdowns. The data reported on new study starts illustrates how remote approaches might impact post-pandemic clinical trial operations.
