Please ensure Javascript is enabled for purposes of website accessibility

FDA Issues Guidance for Clinical Trials During COVID-19 Pandemic

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

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

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.

  

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Provention Bio, Inc. Stock Quote
Provention Bio, Inc.
PRVB
$3.43 (-14.25%) $0.57

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
316%
 
S&P 500 Returns
112%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 07/05/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.