A review of patient reported outcome considerations in Oncologic Drugs Advisory Committee meetings (2016-2021)

J Clin Oncol Clin Practice

28 February 2023 - The purpose of this project was to gain insight into the role of patient reported outcome data in US FDA Oncologic Drugs Advisory Committee (ODAC) reviews and recommendations by documenting patient reported outcome related considerations that appear in transcripts of ODAC meetings over a 6 year period (2016-2021).

Twenty-seven transcripts of reviews were identified for 2016-2021. Topics related to patient reported outcomes were included in 12 of those 27 reviews. 

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Michael Wonder

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Michael Wonder