Replace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholds
Most trials use the same blood-test cut-offs for kidney and liver function regardless of how the drug is cleared from the body. Setting the cut-off from the drug's own pharmacology would let many more people join safely.
Organ-function eligibility criteria (creatinine clearance, bilirubin, transaminases) would be set per drug from its clearance route and the results of early organ-impairment pharmacokinetic studies, rather than the default 'creatinine clearance above 60 ml/min' copied between protocols. Drugs with negligible renal clearance would have no renal cut-off; drugs with hepatic clearance would have a dose-adjusted cohort instead of an exclusion.
- 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.
- 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.
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not linked directly; found by shared links- IdeaKidney and liver impairment dosing studies completed before approval, not years after
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses, Trials enrol too few, too slowly, Renal cell carcinoma.
- IdeaTest flat versus weight-based dosing of antibodies, and use dose banding to cut waste
Shares Wrong doses, Monoclonal antibodies, Antibody-drug conjugate (ADC).
- IdeaHome administration of selected chemotherapy and immunotherapy for older and frail patients
Shares Older and multimorbid patients are excluded and undertreated, Monoclonal antibodies.
- 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.
- IdeaReduce the dose once the cancer responds: response-adapted de-escalation trials
Shares Wrong doses, Multiple myeloma, Antibody-drug conjugate (ADC).
- IdeaWatch small kidney tumours rather than remove them, with a national registry
Shares Older and multimorbid patients are excluded and undertreated, Renal cell carcinoma.
- ProductElotuzumab
Shares Monoclonal antibodies, Multiple myeloma.