The U.S. Food and Drug Administration on March 18 recommended switching to virtual patient visits instead of in-person monitoring for clinical studies, as signs emerge that the rapid spread of the coronavirus outbreak is disrupting trials.
U.S.-based Iveric bio, Inc delayed enrolment in a trial of its eye disease drug on Wednesday, two days after Provention Bio paused a study of its diabetes drug but allowed trial patients to complete their course.
The companies said these measures were taken to ensure the safety of the patients being tested and the medical staff.
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The FDA said the outbreak may impact clinical trials of products including drugs and devices, as travel limitations and other considerations cause protocol deviations.
The restrictions have begun to disrupt the global pharmaceutical industry, as companies cancel public meetings.
The Boston-based research group Institute for Clinical and Economic Review said on Wednesday it was postponing two public meetings to discuss therapies for sickle cell diseases and cystic fibrosis.
“Trials that are fully recruited and those involving the critically ill seem likely to go on without too much disruption,” UBS analyst Laura Sutcliffe said in a client note. “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.”
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Drugmakers are making the switch. Catalyst Pharmaceuticals Inc told Reuters that it was implementing a virtual approach with doctors and company representatives to ensure patients had continued access to its rare neuromuscular disorder drug Firdapse, and remained on track to report results from its ongoing late-stage trial in the second quarter.
