Require post-approval evidence in patients over 75 and update labels accordingly
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.
- 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.
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
Pages like this
not linked directly; found by shared links- IdeaGood practice standards and inspection for real-world data sources
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaOne international registry, not one per country, for conditional approvals
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaAfter approval, a pragmatic trial in the patients the pivotal trial excluded
Shares Older and multimorbid patients are excluded and undertreated, Weak real-world evidence and registries, Real-world evidence.
- IdeaMandatory real-world reporting for patients excluded from pivotal trials
Shares Older and multimorbid patients are excluded and undertreated, Weak real-world evidence and registries, Real-world evidence.
- IdeaEvery patient on an accelerated-approval drug enrolled in a registry until confirmation
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaLinked prescribing and outcome data to find drug interactions with cancer therapy
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaWearable activity data as a validated real-world endpoint
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaNo mCODE, no payment: tie oncology reimbursement to a minimal structured record
Shares Weak real-world evidence and registries, Real-world evidence.