
FDA Publishes Guidance on Impact of COVID-19 on Clinical Trials
The guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the pandemic.
FDA published
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.
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