Getting With The PRO-gram: Making Patient-Reported Outcomes Work

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?

Over the last several years, a cottage industry has sprung up around the business of patient-reported outcomes.

Patent-reported outcomes – clinical endpoints collected directly from the patient, without interpretation by clinicians or others – have been used for decades. But since the Food & Drug Administration’s release...

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