FDA Recommends Switching to Virtual Visits in Clinical Trials

The FDA has recommended switching clinical trial protocols from in-person monitoring to virtual patient visits to help slow the spread of COVID-19. The agency also says travel limitations and protocol deviations caused by the outbreak may affect clinical trials.

Companies sponsoring trials are taking measures to ensure that medical staff and patients being tested stay safe. Iveric bio recently delayed a trial of its eye disease drug, while Provention Bio stopped an ongoing study of its diabetes drug but allowed enrolled patients to complete their course of treatment. The Institute for Clinical and Economic Review (ICER) postponed two public meetings to discuss therapies for sickle cell disease and cystic fibrosis.

“Trials that are fully recruited and those involving the critically ill seem likely to go on without too much disruption,” said Laura Sutcliffe, an analyst at financial services company UBS. “The situation is less clear for other trials, and several companies told us it is too early to tell if there will be any impact.”

Source: Reuters, March 18, 2020.