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New cancer drugs are approved on trials of younger, fitter patients, then given mostly to older ones. Regulators should require real-world safety and benefit data in the over-75s and put it on the label.
The median age of trial participants is often a decade below that of patients treated in practice, and older patients experience more toxicity and discontinuation. Regulators could require, as a condition of approval, a post-marketing registry or pragmatic study in patients over 75 with reporting within three years, and mandate label updates summarising the findings. This would create the evidence that geriatric oncology currently lacks.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Older and multimorbid patients are excluded and undertreated, Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Older and multimorbid patients are excluded and undertreated, Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.