Kidney and liver impairment dosing studies completed before approval, not years after
Dosing advice for people with weak kidneys or liver is often missing at approval and added years later, if ever. Requiring those studies before approval would protect a large group of real-world patients from day one.
Regulators require dedicated or population-PK-based organ impairment dosing recommendations (mild, moderate and, where feasible, severe renal and hepatic impairment) as part of the initial marketing application for oncology drugs, rather than as post-marketing commitments, using sparse PK from broadened-eligibility trials and small dedicated cohorts. Ties to relaxing organ-function eligibility criteria.
- Wrong doses · Most drug doses were chosen as the highest a person can tolerate, which is often more than they need.
- 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 enrol too few, too slowly · Fewer than one in ten adults with cancer joins a trial. Trials close for lack of patients, not lack of ideas.
Pages like this
not linked directly; found by shared links- IdeaReplace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholds
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses, Trials enrol too few, too slowly, Renal cell carcinoma.
- IdeaPragmatic trials in patients over 75 with function, not just survival, as the primary endpoint
Shares Older and multimorbid patients are excluded and undertreated, Trials enrol too few, too slowly.
- IdeaA mandatory over-70s cohort with geriatric assessment in every pivotal trial
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.
- IdeaWatch small kidney tumours rather than remove them, with a national registry
Shares Older and multimorbid patients are excluded and undertreated, Renal cell carcinoma.
- IdeaFix the neutrophil count rule that excludes many people of African ancestry
- IdeaUpfront reduced-dose regimens tested head-to-head in frail older patients
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.
- IdeaDose-finding in older and frail patients, not extrapolation from fit ones
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.
- IdeaShorter venetoclax courses in unfit AML
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.