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Most people with cancer are over 65, but trials mostly enrol younger, fitter people. Requiring a group of older patients, assessed for frailty, in every big trial would show whether the drug works and is safe for those most likely to receive it.
Registrational trials include a pre-specified cohort or stratum of patients aged 70 and over, enrolled in proportion to disease incidence, with baseline geriatric assessment (function, cognition, comorbidity, falls, nutrition) recorded, and with efficacy, toxicity and dose modification reported by frailty category. FDA's Project Silver and the older-adults guidance support inclusion; the proposal makes it a quantitative requirement.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Trials do not represent the people who get cancer.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Wrong doses.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated.