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Most cancer patients are over 65 and a large share have other illnesses, yet trials routinely exclude them on organ function, prior cancers, HIV or brain metastases. Regulators should require sponsors to justify each exclusion, include patients with controlled comorbidities by default, drop upper age limits, and report enrolment over 75 in labels.
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.
Shares Older and multimorbid patients are excluded and undertreated, Trial design, endpoints and cost.
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
Shares Older and multimorbid patients are excluded and undertreated, Trial design, endpoints and cost.
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
Shares Accelerated approval, Trial design, endpoints and cost.
Shares Accelerated approval, Trial design, endpoints and cost.
Shares Older and multimorbid patients are excluded and undertreated, Trial design, endpoints and cost.
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.