{"entity":{"id":"idea-moon-federated-rwe-network","kind":"idea","name":"A global federated real-world evidence network at regulatory grade","aka":[],"tldr":"Connect hospital records across countries so that questions about how treatments work in real patients can be answered in weeks without moving the data, to a standard regulators accept.","summary":"Real-world evidence is fragmented, of variable quality and rarely accepted for decisions beyond safety. Federated analytics (OHDSI, DARWIN EU, Flatiron-style curated networks) demonstrate feasibility. The proposal is a global federated oncology network: common data model with oncology extensions, automated quality scoring, pre-registered analysis protocols executed locally with only aggregates shared, external control arm generation for rare indications, and a regulatory framework specifying when network evidence can support label expansions, pricing revisions and post-approval commitments.","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":[],"technologies":[],"targets":[],"drugs":[],"companies":["tempus","foundation-medicine"],"institutions":[],"pathways":[],"terms":["real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-real-world-evidence","b-data-silos"],"keyPapers":["paper-gyawali-jama-intern-med"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Network-generated evidence supports at least ten regulatory or reimbursement decisions in five years and reproduces trial results in emulation studies with high fidelity.","rationale":"Trial emulation has shown real-world data can reproduce randomised results when design is rigorous; federation solves privacy and sovereignty and scale simultaneously.","test":"Run twenty pre-registered trial emulations across the network and compare with the trials; then submit external control evidence for a rare indication.","maturity":"early-clinical","actor":"data","cost":"large","horizonYears":4},"route":"/ideas/idea-moon-federated-rwe-network/","neighbours":{"company":[{"id":"foundation-medicine","kind":"company","name":"Foundation Medicine (Roche)","route":"/companies/foundation-medicine/"},{"id":"tempus","kind":"company","name":"Tempus AI","route":"/companies/tempus/"}],"term":[{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-data-silos","kind":"bottleneck","name":"Data silos","route":"/bottlenecks/b-data-silos/"},{"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/"}]}}