All Times EDT
To meet the urgent need to treat and prevent COVID-19, the FDA advocates for the development of master protocols to evaluate multiple COVID-19 drug and vaccine candidates. Appropriately designed and conducted master protocols facilitate clinical trial efficiency, which may translate into accelerated and optimized product development. While the benefits are numerous, there are challenging aspects of COVID-19 that add complexity to the design and conduct of master protocols. This talk will highlight some of the key design and analysis considerations for master protocols in the setting of the COVID-19 pandemic.