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Every patient on the new drug is compared with every patient on the old one: who lived longer, and if equal, who had fewer serious side effects, and if still equal, who felt better. The share of 'wins' becomes the result.
Net benefit endpoints (win ratio, generalised pairwise comparisons, desirability of outcome ranking) rank prioritised outcomes hierarchically across all patient pairs. Cardiology adopted the win ratio for composite endpoints; oncology has used it only in exploratory analyses. The proposal is a pre-specified net-benefit endpoint with a published hierarchy (OS, then grade 3+ toxicity, then QoL deterioration) as a co-primary or key secondary in phase 3.
Shares Nathan Cherny, Prasad: most surrogate endpoints in cancer trials correlate poorly with survival, European Society for Medical Oncology (ESMO), Progression-free survival (PFS).
Shares Prasad: most surrogate endpoints in cancer trials correlate poorly with survival, European Society for Medical Oncology (ESMO), Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Progression-free survival (PFS).
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 Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Immune-related adverse events (irAEs), Progression-free survival (PFS), Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Progression-free survival (PFS), Overall survival (OS), Toxicity and quality of life are undervalued.
Shares Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost.