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A quicker, easier measurement used as a stand-in for what really matters. Tumour shrinkage or delayed growth stands in for living longer, on the assumption, not always true, that one leads to the other.
Progression-free survival, response rate, pathologic complete response, minimal residual disease and ctDNA clearance are the main surrogates in oncology; they are available months or years before overall survival and need fewer patients, so they drive most accelerated approvals and a share of full ones. A surrogate is valid for a given drug class and disease only if trials show that improving it reliably improves survival, and this correlation is strong in some settings (PFS in ovarian cancer maintenance) and weak in others (response rate in many solid tumours). When a surrogate-based approval is not confirmed by later survival data, the approval can be withdrawn, as has happened repeatedly since 2021.
Shares Objective response rate (ORR), Accelerated approval, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Pathologic complete response (pCR).
Shares Partial response, Objective response rate (ORR), Accelerated approval, Progression-free survival (PFS).
Shares Primary, secondary and co-primary endpoints, Crossover in trials, Phase 1, 2 and 3 trials, Progression-free survival (PFS).
Shares JAMA Internal Medicine, Objective response rate (ORR), Accelerated approval, Progression-free survival (PFS).
Shares AMNOG (Germany, 2011), Surrogate endpoint validation: which stand-ins have earned trust, Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover, Phase 1, 2 and 3 trials.
Shares Crossover in trials, Surrogate endpoint validation: which stand-ins have earned trust, Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover, Progression-free survival (PFS).
Shares ANNOUNCE, Confirmatory trial, Phase 1, 2 and 3 trials, KEYNOTE-522.
Shares Confirmatory trial, Surrogate endpoint validation: which stand-ins have earned trust, Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover, Objective response rate (ORR).