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The official information about a new cancer drug must include what patients on the trial actually reported about side-effects and daily life, not only survival curves.
The FDA Oncology Center of Excellence's Project Patient Voice began publishing patient-reported symptom data from trials, but labels remain silent on patient-reported outcomes for most drugs. The proposal is a required, standardised patient-experience section (PRO-CTCAE symptom frequency, physical function trajectory, time toxicity) in every oncology label and public assessment report, and a voting patient member on advisory committees with access to the same data.
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