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A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021).

Ari GnanasakthyLindsey NorcrossMarci ClarkKristina Fitzgerald
Published 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.
Keyphrases
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  • robot assisted
  • randomized controlled trial
  • systematic review
  • deep learning
  • drug induced