Make sponsors justify every trial exclusion of older and multimorbid patients
Most cancer patients are over 65 and many have other illnesses, yet trials routinely exclude them. Regulators should require sponsors to justify each exclusion, so the evidence matches the patients.
ASCO and Friends of Cancer Research published recommendations to broaden eligibility (organ function thresholds, prior malignancies, HIV, brain metastases) and the FDA issued guidance, but uptake in industry protocols is partial. A regulatory requirement that each eligibility exclusion be justified in the protocol, with default inclusion of patients with controlled comorbidities and no upper age limit, would shift the baseline. Enrolment of patients over 75 should be reported in labels.
- 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.
- 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.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
Pages like this
not linked directly; found by shared links- IdeaParallel real-world cohorts for sicker patients alongside every pivotal trial
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaA mandatory over-70s cohort with geriatric assessment in every pivotal trial
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaRegulators accept shrinking of precancer as the endpoint for prevention drug approval
Shares Accelerated approval, Trial design, endpoints and cost.
- IdeaPragmatic trials in patients over 75 with function, not just survival, as the primary endpoint
Shares Older and multimorbid patients are excluded and undertreated, Trial design, endpoints and cost.
- IdeaMandatory real-world reporting for patients excluded from pivotal trials
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaReport time toxicity, the days spent in healthcare, as a standard outcome for older patients
Shares Older and multimorbid patients are excluded and undertreated, Trial design, endpoints and cost.
- IdeaDedicated cohorts for patients with performance status 2 in first-line trials
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaAfter approval, a pragmatic trial in the patients the pivotal trial excluded
Shares Older and multimorbid patients are excluded and undertreated, Trial design, endpoints and cost.