Parallel real-world cohorts for sicker patients alongside every pivotal trial
Instead of excluding sicker patients entirely, trials would run a side group for them, receiving the new drug with closer monitoring, so we learn how it behaves in the people who will actually get it.
Registrational trials open a non-randomised parallel cohort for patients who fail the main eligibility on performance status (ECOG 2), organ function, or comorbidity, treated with the experimental regimen under a pre-specified safety and dose-adjustment plan, with PK sampling. Data are analysed separately and included in the label as descriptive evidence. Precedent: NCI organ-dysfunction working group studies and some sponsor expansion cohorts.
- 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.
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not linked directly; found by shared links- IdeaA mandatory over-70s cohort with geriatric assessment in 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.
- 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.
- 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.