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Patients' Voices Largely Absent From FDA Reviews of New Cancer Drugs - Vimarsana News

Patients' Voices Largely Absent From FDA Reviews of New Cancer Drugs

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: empr.com
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 - Vimarsana News

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.