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Patients' Voices Largely Absent From FDA Reviews of New Cancer Drugs Patient Reported Outcomes Largely Absent From FDA Reviews of New Cancer Drugs- Renal and Urology News

The FDA encourages collection and reporting of patient-reported outcomes (PROs) in clinical trials, but a substantial proportion of applications seeking product approval lack these data. Assessment of patient-reported outcomes in clinical trials is on the rise, but they frequently are absent from requests for FDA drug approvals.
United States North Carolina Wake Forest University Peter Lurie Gary Oderda Edward Haksing Ip

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