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FDA Issues Guidance for Clinical Trials During COVID-19 Pandemic

By Taylor Carmichael - Mar 19, 2020 at 3:03PM

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Efforts to stem the coronavirus outbreak are liable to disrupt the protocols of a lot of drug trials.

Drug companies have run into another serious problem stemming from the COVID-19 outbreak -- the pandemic is making it harder to run clinical trials for all types of treatments. The Food and Drug Administration requires multiple successful clinical trials before a new drug can be sold to the public. These studies typically require medical professionals and researchers to have in-person contact with patients -- and usually, quite a lot of them. That's getting harder and harder to arrange as people are being advised to stay in their homes as much as possible.

For instance, Provention Bio (PRVB -14.25%) just called a halt to a clinical trial because of COVID-19 issues. If more companies do this, it could send vital drug development to the sidelines and delay the arrival of new medications.

In recognition of this, the FDA has issued new guidance for running a clinical trial during this national emergency.

patient behind glass during quarantine

Image source: Getty Images

First, the FDA outlines the problems drug companies may run into  related to the pandemic, among them quarantines, site closures, travel limitations, or interruptions to the supply chain. The problem is that in dealing with all these issues, companies might have to alter their study protocols. And typically, any change in a drug trial protocol has to be approved by an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC), or the FDA itself.

Now the FDA is making an important clarification. While drug companies might make significant alterations to their protocols to deal with COVID-19 issues, they don't have to seek approval first. In this emergency, drug companies are allowed to go ahead and make whatever changes are necessary to work around those issues, and report those alterations afterward.   

While the impacts of the pandemic will still bedevil drug researchers, this new process of protocol modification should mean that the clinical trial process won't be overly impeded by consultations with regulators.


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