{"entity":{"id":"idea-acc-post-approval-evidence-over-75","kind":"idea","name":"Require post-approval evidence in patients over 75 and update labels accordingly","aka":[],"tldr":"New cancer drugs are approved on trials of younger, fitter patients, then given mostly to older ones. Regulators should require real-world safety and benefit data in the over-75s and put it on the label.","summary":"The median age of trial participants is often a decade below that of patients treated in practice, and older patients experience more toxicity and discontinuation. Regulators could require, as a condition of approval, a post-marketing registry or pragmatic study in patients over 75 with reporting within three years, and mandate label updates summarising the findings. This would create the evidence that geriatric oncology currently lacks.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Older and multimorbid patients are excluded and undertreated): Mohile et al., Evaluation of geriatric assessment and management on toxic effects of cancer treatment (GAP70+, Lancet 2021)","url":"https://doi.org/10.1016/S0140-6736(21)01789-X"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-aging-comorbidity","b-real-world-evidence","b-regulatory-fragmentation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Drugs with mandated post-approval studies in the over-75s will have label-specific dosing or safety information for older patients within four years, and prescribing patterns will change measurably in response.","rationale":"Paediatric investigation requirements created an evidence base for children within a decade; the same lever applied to older adults, the majority of patients, would do more.","test":"Pilot the requirement for a set of new approvals and compare completion of studies, label updates, and post-marketing safety signals with historical controls.","maturity":"speculative","actor":"regulator","cost":"medium","horizonYears":4},"route":"/ideas/idea-acc-post-approval-evidence-over-75/","neighbours":{"term":[{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}]}}