Bass, Berry & Sims attorney Clint Hermes discussed the short- and long-term impacts of the COVID-19 pandemic on clinical research on an episode of the AHLA’s Speaking of Health Law podcast. “There’s the impact on studies that were underway when the lockdowns happened or when you get another wave in a particular geographic area,” said Clint. “’I am worried about new trial enrollment in general … the National Cancer Institute said enrollment in trials has been dropping by about 10% each month since the pandemic started. That is catastrophic really.”

On a more positive note, some of the FDA guidance issued in response to the pandemic are updated protocols and can be implemented going forward in all clinical trials. “A lot of these [FDA] changes, if they permanently take hold, will continue to facilitate global research collaborations,” said Clint. Clint also discussed access to investigational products outside of clinical trials, including through Emergency Use Authorizations.

The podcast, “COVID-19’s Impact on Clinical Research,” was produced as part of the AHLA’s Speaking of Health Law podcast series and is available online or wherever you get your podcast content.