A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021).
Ari GnanasakthyLindsey NorcrossMarci ClarkKristina FitzgeraldPublished in: JCO oncology practice (2023)
Less than half of ODAC reviews in 2016-2021 included PROs, and reviewers expressed frustration at the lack of PRO data. Even when included, evidence on the basis of PROs was rarely deemed adequate for benefit-risk assessments.