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 renalandurologynews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from renalandurologynews.com Daily Mail and Mail on Sunday newspapers.
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.