Blog | FDA guidance available for COVID-related questions

DID YOU KNOW?

There's an FDA guidance available for COVID-related questions.

There is no doubt COVID has changed the face of clinical research.  At last count, there were no fewer than 65 FDA guidances related to COVID.  Initially information was sparse. We had no idea how long the pandemic would last or how extensive the “damage” would be.  Now, as vaccines slowly begin to be available, things are starting to head towards a new sort of normal.

Has the way we conduct clinical trials changed forever? 

To address some of the questions and situations that have arisen, the FDA has provided a Guidance for Industry, Investigators, and Institutional Review Boards titled “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”.  Since its first iteration in March 2020, the Guidance has been updated multiple times to address new questions from the clinical research community.

Here's a peek at some of the questions and answers within the Guidance:

When is a vaccine or medical product for the prevention or treatment of COVID-19 considered an investigational product and when isn’t it?

  • A medical product being used under an EUA (Emergency Use Authorization) is not being studied under an IND or IDE therefore the FDA does not consider it an investigational product.
  •  If the medical product is part of a clinical investigation that is under an IND or IDE, the product’s safety and/or effectiveness is being studied and the FDA would consider it an investigational product.
  • The Sponsor, IRB, and site should also follow any applicable rules/criteria, regulations, or guidances that are in place that may differ from the above or be specific to an individual study or patient situation.
Do investigators have to review ALL the IND safety reports that are being generated due to the higher number of serious and unexpected adverse events experienced by trial participants with COVID? 
Is it acceptable to just review the ones the sponsor indicates have an effect on the IB, ICF, or protocol?
  • No, it is not acceptable for an investigator to review only certain IND safety reports.
  • Under 21 CFR 312.60 IND safety reports must be sent to all participating investigators when the sponsor determines that a serious adverse event is unexpected and there is a reasonable possibility that the drug caused the serious adverse event.
  • Reviewing IND safety reports is essential for protecting the safety of trial participants because a serious and unexpected adverse event represents a new potential risk associated with the investigational product. The FDA considers the review of all IND safety reports critical to fulfilling investigators’ responsibility to protect the safety of trial participants in a clinical investigation.

Check out the Guidance at https://www.fda.gov/media/136238/download for more information.

There is no question changes had to be made to accommodate shelter in place orders, remote monitoring, and the numerous other safety precautions that have been necessary.  Some of these changes are here to stay.  Some are improvements as they allow for greater flexible for our study participants, our sites, and our monitors.  In the end, we may be able to help more people through clinical studies with these increased options.

The COVID pandemic has not been easy for any of us, but increased interest and participation in clinical trials could well be a positive outcome.

Now you know.