FDA Recommends Clinical Trials Go Virtual

As originally reported in Yahoo Finance, the coronavirus is disrupting many of our expectations of how we planned to live out the next few months. Some frequenters of the hospitals (chronic patients and doctors) are particularly affected as their space will be shared with coronavirus patients and their contagious disease. Researchers of long term projects are re-calibrating to 2020, and like much other work, will head online. The U.S. Food and Drug Administration (FDA) has now recommended that clinical trials that use in-patient checkups and monitoring to go digital and switch to virtual patient visits. This allows the trials to carry on developing results, while helping keep patients and doctors safe from the emerging virus.

The virus is expected to delay the development of some drugs and medial trials because of the travel restrictions and heightened prevention techniques which necessitates social distancing. This includes cancellations of the Institute for Clinical and Economic Review’s public meetings that were meant to work on potential therapies for sickle cell diseases and cystic fibrosis. Some firms have paused their studies, while others like Provention Bio has put new trials on hold, but let other patients carry out their ongoing trials. According to UBS analyst Laura Sutcliffe,

“Trials that are fully recruited and those involving the critically ill seem likely to go on without too much disruption. 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.”

Luckily, we live in a world where these trials don’t have to be terminated and many pharmaceutical manufacturers have already moved online. Various companies have already released new policies. Catalyst Pharmaceuticals Inc. has made a virtual method to track trials for the rare neuromuscular disorder drug Firdapse, and Aimmune Therapeutics has created a virtual workforce of physicians. Provention Bio also put their patients undergoing trial for a diabetes drug online, letting those in the process continue their trial to completion.

The world is in flux, but trials march on. The world of technology has been a saving grace for many rare disease patients, and it allows the show to go on.


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