Gilead’s Veklury becomes first FDA approved COVID-19 therapy, with NIH adaptive trial as focal point

Data from NIH’s master protocol trial was the cornerstone for the first FDA approval of a COVID-19 therapy, granted to Gilead’s Veklury Thursday.

The approval highlights the critical role of master protocols for generating substantive evidence on a tight timeline, the relatively limited value of open-label studies, and the challenges of interpreting clinical trial results in the context of a rapidly evolving standard of care...