FDA Publishes Guidance on Impact of COVID-19 on Clinical Trials

FDA published guidance on June 16, 2020 on statistical considerations regarding the potential impact of COVID-19 on clinical trials that are conducted during the pandemic. Impacts may include the inability of trial participants to visit clinical sites for endpoint assessments. In the guidance, FDA outlines what should be considered when it comes to analysis of primary and key secondary endpoints in clinical trials impacted by COVID-19 “to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.”

Specifically, the guidance discusses trial integrity, including proactively planning for possible impacts of COVID-19 on the ability to meet trial objectives. It also addresses trial mitigation and analysis strategies, including recommendations for design and analysis strategies. “Multiple strategies may be needed to address the impact of COVID-19 adequately. These design and analysis strategies should be discussed with the relevant FDA review division,” the guidance states.

The policy within the guidance remains in effect for the duration of the COVID-19 health emergency. Comments regarding the guidance may be submitted to FDA at any time.