Will Patient-Reported Data Require New Drug Labeling Framework?

Whether US FDA may need to create a special labeling section for patient experience data is a ‘huge question that’s going to require a lot of discussion,’ Oncology Center of Excellence’s Kluetz says; agency is currently exploring non-labeling alternatives to communicating PRO data.

Puzzle

The growing interest in patient-reported outcomes may require FDA to come up with new ways to incorporate such data in drug labeling as it also explores alternative methods for communicating this information to patients.

At an April 25 workshop on clinical outcome assessments in cancer trials, FDA officials said the agency is trying to figure out how to present patient-reported outcomes (PRO) data within...

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