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- W4287448692 abstract "The Food and Drug Administration (FDA) encourages the assessment of patient-reported outcomes (PROs) in oncology clinical trials. A 2015 review showed that approximately 26% of industry-sponsored oncology trials included assessment of PROs. However, the proportion of recent trials that supported new oncology drug approvals and assessed PROs is unknown. This review found that assessment of PROs was included in about 75% of registration trials that supported 55 new FDA drug approvals during 2014-2018. Patient-reported outcome assessment was included more in randomized controlled trials than in open-label trials (88% vs. 69%, respectively) and more in phase 3 than in phase 2 trials (89% vs. 66%, respectively)." @default.
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- W4287448692 date "2022-09-01" @default.
- W4287448692 modified "2023-10-06" @default.
- W4287448692 title "A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014–2018)" @default.
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- W4287448692 doi "https://doi.org/10.1016/j.cct.2022.106860" @default.
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