Innovative Trial Designs Are 'Life And Death Matter' For Pharma, Amgen Tells US FDA
Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.
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Levy, SVP of global development, notes that two years after launching an in-house Center for Design and Analysis, Amgen considers adaptive designs for most new studies and more than half include adaptive elements.
Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.