FDA Oncology Office Hopes Better Advice Will Lead To More Patient-Reported Outcomes Data
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.
You may also be interested in...
New trial designs would be needed to support labeling claim using National Cancer Institute's PRO-CTCAE instrument.
As new repository website launches, agency acknowledges that it must do more to create patient-focused risk management.
FDA doesn’t seem ready to support clinical trial endpoint asked for by metastatic breast cancer patients at patient-focused drug development meeting.