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.
Source: renalandurologynews.com