The push to bring patient opinions about what risk versus benefit they will accept into the formal regulatory process has advanced in recent days with the release of FDA draft guidance
MDIC Catalog Outlines Patient Preference Methods
Sponsors who think patient preference could be a key factor to the approval of their device can look to the appendix section of the new MDIC report for study methods that can help support claims with information showing that patients may be willing to take on more risks to get their hands on the treatment.