Loading
Trials report side effects as a table of percentages that hides how long they lasted, how bad they felt and whether people stopped treatment. Tolerability should be measured with defined endpoints and a decision rule, like efficacy.
Protocols pre-specify tolerability estimands under ICH E9(R1): time to first dose modification, cumulative patient-reported symptom burden (PRO-CTCAE), treatment discontinuation for toxicity, and a toxicity-over-time summary, with hypotheses and analysis plans. Regulators include a tolerability summary in the label, and dose-optimisation decisions reference it.
Shares Immune-related adverse events (irAEs), Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Wrong doses, Toxicity and quality of life are undervalued.
Shares Immune-related adverse events (irAEs), Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Wrong doses, Toxicity and quality of life are undervalued.
Shares Wrong doses, Toxicity and quality of life are undervalued.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Wrong doses.
Shares Wrong doses, Toxicity and quality of life are undervalued.
Shares Wrong doses, Toxicity and quality of life are undervalued.