With the onset of COVID-19, sponsors and CROs are actively looking for ways to continue non-COVID-19 trials that have been left in a standstill due to shelter-in-place and local lockdown enforcements. The modern and highly regulated clinical trial industry has never faced a pandemic of this magnitude, and trial continuation is critical when patients’ lives are in the balance.
The FDA has approved and encouraged the use of eSource since 2013, but some were still resistant to adopting virtual protocols. “I foresee COVID-19 being the catalyst to following the FDA guidelines on decentralized and virtual trials. Just doing the status quo is no longer going to be acceptable. Sponsors who were once resistant or hesitant to utilizing remote monitoring or eSource will be moving into doing so as a direct result of COVID-19,” said Brady Gilje, Sr. Data Manager at Trialrunners.