{"entity":{"id":"idea-moon-patient-experience-label","kind":"idea","name":"A mandatory patient-experience section in every cancer drug label and approval","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"FDA Project Patient Voice","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-patient-voice","b-regulatory-fragmentation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Labels with patient-experience sections change prescribing towards better-tolerated regimens when efficacy is similar and increase sponsors' collection of high-quality PRO data in registrational trials.","rationale":"Sponsors collect what regulators read. Making patient experience a labelled claim gives it commercial value and standardises how it is measured.","test":"Regulator pilots the section for all approvals over two years; survey prescribers and measure uptake of PRO instruments in subsequent pivotal protocols.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-moon-patient-experience-label/","neighbours":{"bottleneck":[{"id":"b-patient-voice","kind":"bottleneck","name":"Patients lack understanding, navigation and agency","route":"/bottlenecks/b-patient-voice/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}