Patient-Reported Outcomes Tools Should Be Symptom Specific, FDA Says
Agency favors symptom-focused assessments over global quality-of-life evaluations when considering whether the data can support a drug labeling claim for use in treating pediatric cancer. Measures used for EU reimbursement considerations are usually not sufficient for FDA labeling claims, official cautions.
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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.
As FDA gains experience with its new Drug Development Tool qualification process, the agency has found that a narrowly defined patient population and condition-specific measures are preferable.
Under the five-year research collaboration, Genentech will have broad access to the online patient network PatientsLikeMe, which has 250,000 members.