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Most trials copy the same kidney and liver cut-offs, such as creatinine clearance above 60, regardless of how the drug is cleared. Setting each threshold from the drug's own clearance route and organ-impairment pharmacokinetic studies would let patients with mild organ impairment join safely instead of being excluded.
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.
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses, Trials enrol too few, too slowly, Renal cell carcinoma.
Shares Wrong doses, Monoclonal antibodies, Antibody-drug conjugate (ADC).
Shares Older and multimorbid patients are excluded and undertreated, Trials enrol too few, too slowly.
Shares Older and multimorbid patients are excluded and undertreated, Monoclonal antibodies.
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.
Shares Wrong doses, Multiple myeloma, Antibody-drug conjugate (ADC).
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses.
Shares Older and multimorbid patients are excluded and undertreated, Renal cell carcinoma.