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Beyond the label: patient-reported outcomes and post-approval communication in oncology

bmjonc · 2026-04-07 · canonical JSON source

2 visible annotations · policy: published · automated confidence ≥ 75.00%

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Cancer clinical trials form the foundation for the approval and use of new anticancer therapies. Alongside traditional endpoints such as survival and tumour response, patient-reported outcomes (PROs) are now a cornerstone of oncology trials and are increasingly expected by regulators.1 By capturing symptoms and functional health directly from patients, PROs provide essential information for patient-focused drug development and shared decision-making.