At its patient-focused drug development workshop on breast cancer, FDA departed from its normal script of asking patients what they were seeking in a new treatment and instead probed how patients weigh benefits and risks when choosing among existing therapies.
Some of the suggestions from patients who attended the April 2 workshop reflect ideas that industry has already adopted, such as developing prognostic tests that can predict responses to treatment and side effects. But the discussion also highlighted that in some cases, what is logical and desirable to patients cannot easily be delivered within the current regulatory and drug development framework.
The discussion also highlighted that patient decision-making criteria are highly variable, both across and within different subgroups.
"For young women out there, particularly those raising families - they are willing to put up with so much more toxicity for the sake of being there as long as they possibly can for their children," said Ginny Knackmuhs, VP of the Metastatic Breast