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Multi-cancer early detection blood tests take a decade to prove they save lives. Regulators could accept a fall in late-stage cancers as the first answer, validated against pooled data from completed screening trials, provided approval is conditional on continued mortality follow-up.
NHS-Galleri chose stage III/IV incidence as its primary endpoint; regulators have not said whether that suffices for approval or coverage. Propose a formal surrogate-validation exercise pooling individual data from completed screening RCTs (NLST, NELSON, UKCTOCS, ERSPC, Minnesota, NordICC) to estimate the trial-level correlation between late-stage incidence reduction and cancer-specific mortality reduction, and a conditional-approval pathway with mandated mortality follow-up.
NHS-Galleri is the trial that will decide whether a blood test for many cancers at once should be offered by a health system. Its endpoint is a reduction in late-stage cancer rather than deaths, so even a positive result leaves the mortality question to be settled by longer follow-up.
A drug that shrinks tumours or delays progression on scans has not necessarily been shown to help patients live longer or better. Patients and clinicians should ask what the endpoint was; regulators should insist on timely confirmatory trials; and trialists should validate surrogates before relying on them.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Stage shift.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Stage shift.
Shares NHS-Galleri, Stage shift, The hardest cancers are found late, Trial design, endpoints and cost.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).
Shares PATHFINDER 2, Galleri, NHS-Galleri, Stage shift.
Shares NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test, Stage shift, Multi-cancer early detection (MCED), The hardest cancers are found late.
Shares PATHFINDER 2, NHS-Galleri, Multi-cancer early detection (MCED), The hardest cancers are found late.