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.

FDA would prefer to see specific symptom assessments, rather than global evaluations of health-related quality of life, when patient-reported outcomes tools are incorporated into clinical trials for pediatric oncology treatments, agency officials told the Oncologic Drugs Advisory Committee’s pediatric oncology subcommittee Nov. 4.

During a half-day discussion on use of patient-reported outcomes (PRO) in the pediatric cancer setting, FDA officials highlighted problems with...

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