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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. ....

United States , Gary Oderda , Peter Lurie , Oncology Drugs Advisory Committee , American Society Of Clinical Oncology , Public Health Strategy , Drug Administration , Howard University , American Society , Clinical Oncology , Supportive Care , Drugs Advisory Committee , Ari Gnanasakthy , Managed Care , Executive Director , Public Interest , Associate Commissioner ,