Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says

19 Mar 2020

Quarantines, travel restrictions and supply chain interruptions are likely to cause "unavoidable protocol deviations" in ongoing clinical trials, the FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by COVID-19.

A walking path in a forrest splits and leads two different directions — Sponsors may need to find alternative ways of collecting clinical trial efficacy and safety data due to the impacts of COVID-19. • Source: shutterstock.com

The US Food and Drug Administration is urging trial sponsors, clinical research organizations and investigators to consider alternative methods for collecting safety and efficacy data to mitigate the impacts of the COVID-19 pandemic on ongoing clinical trials of medical products, including medical devices.

In a new guidance released on 18 March, the agency addresses the pandemic’s potential effects on the conduct of...