More Remdesivir Data, More Questions Linger
The latest data on the NIAID’s ACTT-1 study offers more help for clinicians trying to determine which coronavirus patients should receive remdesivir, but selection criteria – and supply – remain uncertain.
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The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.
Gilead says remdesivir improved mortality and clinical recovery in COVID-19 patients, but the findings come from a retrospective analysis, not a traditional clinical trial.
The coronavirus pandemic could be a turning point for master protocol and platform trial designs, but clear guidance and coordination are still needed.