FDA Issues Guidelines on Conducting Trials During COVID-19 Pandemic

The US Food and Drug Administration (FDA) has issued new guidance for conducting clinical trials during the COVID-19 pandemic. These guidelines, while not legally binding, represent the agency’s current position on the best ways for clinical trial investigators to adapt to the COVID-19 outbreak.

The FDA has issued this guidance both to aid with changing procedures and to communicate that protocols may be modified due to challenges as a result of COVID-19.

“The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19,” according to the FDA’s press release.

While the particular impact will vary depending on study design, some of the guidelines are broadly applicable. For example, the FDA recommends that when possible, in-person safety evaluations be shifted to telemedicine platforms or a local laboratory site.

The guidelines point out that if there are situations wherein trial participants no longer can travel to the investigational site or access the investigational product, additional safety monitoring may be necessary.

At this time, COVID-19 screening measures implemented into a study because of requirements by the institutional health systems conducting the trial do not need to be explained as a modified protocol. Cxplanation is required if there are new objectives incorporated into the study related to the COVID-19 screening.

However, it will be important if study data is missing due to COVID-19 pertinent disruptions to explain the reasons for this when submitting or publishing trial results.

Investigators are encouraged to contact institutional review boards about protocol changes they have in mind as soon as possible.

The new guidelines come as the United States government escalates measures intended to curb the COVID-19 outbreak. New recommendations include advice from President Trump to stay home and avoid gatherings of 10 or more.

As far as clinical trials concerning COVID-19 themselves go, a phase 1 clinical trial in Seattle, Washington, evaluating a COVID-19 vaccine candidate has already launched.

“The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants,” Anand Shah, MD, deputy commissioner for medical and scientific affairs at the FDA said in the statement.

On March 25, 2020, at 6PM ET, Contagion® is hosting a live CME webinar on what clinicians need to know amid the COVID-19 pandemic. Register here.