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New cancer drugs should have to prove not only that they extend life but how they affect how people feel and function, with that result printed in the label like efficacy.
Trials are powered on progression or survival; tolerability is described from clinician-graded adverse events and rarely tested as a hypothesis. The proposal is a regulatory framework in which a pre-specified patient-reported tolerability endpoint (e.g., PRO-CTCAE composite or physical function decline) can be co-primary or a formal secondary endpoint eligible for a label claim, with the analysis methods (time to deterioration, area under the curve, cumulative burden) standardised by regulators and academic groups such as SISAQOL-IMI.
Shares Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials, Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials, Immune-related adverse events (irAEs), Toxicity and quality of life are undervalued.
Shares Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials, Toxicity and quality of life are undervalued.
Shares Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials, Toxicity and quality of life are undervalued.
Shares Immune-related adverse events (irAEs), Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Progression-free survival (PFS), Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials, Toxicity and quality of life are undervalued.
Shares Progression-free survival (PFS), Trial design, endpoints and cost, Toxicity and quality of life are undervalued.