FDA Will Be Pushing Adaptive Trials Heavily. Ready?
Scott Gottlieb, the new head of U.S. FDA, has suggested he will promote wider use of adaptive design, and Abi Millar at Pharmaceutical Technology examines whether pharma companies are willing to make the changes to both infrastructure and mindset to allow for more flexible protocols.
Abi talks with Wade Wirta, Medidata’s managing director of Balance, about Medidata’s partnership with Tesaro for randomization and trial supply management:
“One primary difference around Balance, compared to other systems of its kind, is that it’s a pre-validated, parameter-driven, SaaS-based platform which reduces the timeline significantly in each protocol.”