A mandatory over-70s cohort with geriatric assessment in every pivotal trial
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.
- Trials do not represent the people who get cancer · Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.
- Older and multimorbid patients are excluded and undertreated · Most people with cancer are over 65 but most trial patients are younger and fitter. We guess how to treat the majority.
- Wrong doses · Most drug doses were chosen as the highest a person can tolerate, which is often more than they need.
Pages like this
not linked directly; found by shared links- IdeaParallel real-world cohorts for sicker patients alongside every pivotal trial
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaMandatory real-world reporting for patients excluded from pivotal trials
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaGeriatrician co-management for older patients having cancer surgery
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated.
- IdeaStop screening by life expectancy, not birthday, with a tool in the record
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated.
- IdeaGeriatric assessment by default for every older patient, and trials that admit them
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaA trials fund reserved for older and multimorbid patients
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaPragmatic trials in patients over 75 with function, not just survival, as the primary endpoint
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated.
- IdeaA defined pathway for patients with both dementia and cancer
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated.