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FDA Oncology Office Hopes Better Advice Will Lead To More Patient-Reported Outcomes Data

 
• By Sue Sutter

Office of Hematology and Oncology Products now has PRO leads in each clinical review division and is working more collaboratively with, rather than parallel to, the agency’s Study Endpoints and Labeling Development team to give sponsors consistent advice on use of PRO measures in trials.

FDA’s Office of Hematology and Oncology Products is taking steps to reverse the dearth of high-quality, patient-reported outcomes data in cancer drug labeling.

At an April 1 FDA workshop on clinical outcomes assessments, Office of Hematology and Oncology Products Acting Deputy Director Paul...

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