Getting With The PRO-gram: Making Patient-Reported Outcomes Work
This article was originally published in RPM Report
Executive Summary
When FDA’s guidance document on patient-reported outcomes was finalized five years ago, it was lauded as a milestone event for an industry interested in advancing patient-centered drug development. But implementation of the guidance hasn’t gone the way some had hoped – and actually may be dissuading sponsors from pursuing PRO labeling claims. Can FDA’s patient-centered drug development initiative help?