BioCentury
ARTICLE | Regulation

Getting personal in breast cancer

Breast cancer patients tell FDA they want more precision in risk-benefit data

April 20, 2015 7:00 AM UTC

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...