{"entity":{"id":"idea-prev-mced-change-control-plan","kind":"idea","name":"Pre-agreed update rules so an MCED test is not obsolete when its trial reads out","aka":[],"tldr":"A cancer blood test improves every year, but a ten-year trial tests the old version. Regulators and sponsors could agree in advance how updates are validated and carried into the result.","summary":"FDA's Predetermined Change Control Plan for AI devices offers a model. Propose an MCED-specific plan: the classifier may be updated on banked baseline samples under locked-test-set rules, each version must be shown non-inferior on a sequestered set, and the primary analysis uses the enrolment version with a pre-specified sensitivity analysis re-scoring banked plasma.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (The hardest cancers are found late): Crosby et al., Early detection of cancer (Science 2022)","url":"https://doi.org/10.1126/science.aay9040"}],"tags":[],"related":[],"cancers":[],"sections":["early-detection"],"technologies":["mced","methylation-profiling"],"targets":[],"drugs":[],"companies":["grail"],"institutions":[],"pathways":[],"terms":[],"trials":["nhs-galleri","pathfinder-2"],"people":[],"bottlenecks":["b-early-detection","b-ai-validation","b-regulatory-fragmentation"],"keyPapers":["paper-crosby-science"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"With banked plasma re-scored by an updated classifier under pre-agreed rules, estimated effect sizes fall within 10% of those from the enrolment version, allowing an updated test to inherit trial evidence.","rationale":"Without this, each improved assay restarts the evidence clock, which is why the field keeps launching new observational studies instead of finishing randomised ones.","test":"Apply retrospectively in NHS-Galleri or PATHFINDER 2 banked plasma; publish agreement between classifier versions.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-prev-mced-change-control-plan/","neighbours":{"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"methylation-profiling","kind":"technology","name":"DNA methylation profiling","route":"/technologies/methylation-profiling/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"company":[{"id":"grail","kind":"company","name":"GRAIL","route":"/companies/grail/"}],"trial":[{"id":"nhs-galleri","kind":"trial","name":"NHS-Galleri","route":"/trials/nhs-galleri/"},{"id":"pathfinder-2","kind":"trial","name":"PATHFINDER 2","route":"/trials/pathfinder-2/"}],"bottleneck":[{"id":"b-ai-validation","kind":"bottleneck","name":"AI that is built but not validated or deployed","route":"/bottlenecks/b-ai-validation/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-early-detection","kind":"bottleneck","name":"The hardest cancers are found late","route":"/bottlenecks/b-early-detection/"}],"paper":[{"id":"paper-crosby-science","kind":"paper","name":"Early detection of cancer","route":"/key-papers/paper-crosby-science/"}]}}