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