COVID-19 Study Of Gilead’s Remdesivir Using Ebola-Style Adaptive Platform Trial
First COVID-19 experimental treatment trial in US is a master protocol that echoes NIH’s Ebola treatment approach.
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US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols
Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.
US FDA Welcomes Variety Of Phase II/III Trial Designs For COVID-19 Therapies, But With Standards
Final guidance on COVID-19 treatment development emphasizes need for clinical endpoints to reflect drug mechanism, patient population, clinical setting and fast-evolving standard of care – with a cautious embrace of platform and adaptive designs.
Gilead's Remdesivir Results Encouraging, Safety Brings Skepticism
Analysts see NIAID’s placebo-controlled data as more important than Gilead’s open-label data. Quick emergency use authorization by FDA is possible, but the US agency has not confirmed EUA.