{"entity":{"id":"idea-data-accelerated-approval-registry-condition","kind":"idea","name":"Every patient on an accelerated-approval drug enrolled in a registry until confirmation","aka":[],"tldr":"Accelerated approvals rest on surrogate endpoints, and confirmatory trials take years and are sometimes never completed. Making registry enrolment with automatic outcome capture a condition of prescribing under accelerated approval would give regulators a real-world signal on benefit and toxicity within about two years, while the confirmatory trial runs.","summary":"Accelerated approvals rest on surrogate endpoints; confirmatory trials take a median of several years and some are never completed. The proposal makes registry enrolment with automatic outcome capture (via mCODE and registry linkage) a condition of prescribing under accelerated approval, giving regulators an interim real-world signal on survival and toxicity while the confirmatory trial runs. The FDA's 2023 authority to require confirmatory trials be underway at approval is the policy hook; the registry is the complementary data hook.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Weak real-world evidence and registries): Gyawali, Hey & Kesselheim, Assessment of the clinical benefit of cancer drugs receiving accelerated approval (JAMA Intern Med 2019)","url":"https://doi.org/10.1001/jamainternmed.2019.0462"}],"tags":[],"related":[],"cancers":[],"sections":["ai-computation"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["accelerated-approval","real-world-evidence","os"],"trials":[],"people":[],"bottlenecks":["b-real-world-evidence","b-regulatory-fragmentation"],"keyPapers":["paper-gyawali-jama-intern-med"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Mandatory registries will detect lack of overall survival benefit for accelerated-approval indications that later fail confirmation at least 18 months earlier than the confirmatory trial does.","rationale":"Several accelerated-approval oncology indications were withdrawn only after years of use; real-world survival on those drugs was knowable much earlier had the data been collected.","test":"Retrospectively emulate the registry for five withdrawn indications using existing real-world data and estimate when a survival signal would have been detectable; prospectively apply to the next ten accelerated approvals.","maturity":"speculative","actor":"regulator","cost":"medium","horizonYears":3},"route":"/ideas/idea-data-accelerated-approval-registry-condition/","neighbours":{"section":[{"id":"ai-computation","kind":"section","name":"AI & Computation","route":"/fronts/ai-computation/"}],"term":[{"id":"accelerated-approval","kind":"term","name":"Accelerated approval","route":"/terms/accelerated-approval/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}],"paper":[{"id":"paper-gyawali-jama-intern-med","kind":"paper","name":"Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval","route":"/key-papers/paper-gyawali-jama-intern-med/"}]}}