{"entity":{"id":"idea-data-rwe-rct-calibration-library","kind":"idea","name":"An open library pairing completed cancer trials with real-world emulations","aka":[],"tldr":"Build a public library in which every phase 3 cancer trial is paired with a real-world emulation in federated hospital data, publishing how far the two agree in direction, magnitude and confidence interval overlap. Oncology needs its own calibration set because RCT-DUPLICATE covered mostly cardiometabolic disease, and it would map which question types can be trusted.","summary":"RCT-DUPLICATE calibrated real-world methods against trials mostly in cardiometabolic disease; oncology, with its time-varying treatments and surrogate endpoints, needs its own calibration set. The proposal funds a standing programme that emulates every phase 3 oncology trial with a real-world counterpart in federated data, publishes agreement metrics (direction, magnitude, confidence interval overlap), and maintains a public map of which question types (first-line comparisons, sequencing, dose) are emulable.","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":["idea-data-target-trial-emulation-standard"],"cancers":[],"sections":["ai-computation"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-real-world-evidence"],"keyPapers":["paper-gyawali-jama-intern-med"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Across 100 oncology trials, emulation agreement will be high for first-line drug-versus-drug comparisons with hard endpoints and poor for questions involving progression-based endpoints or treatment switching, giving regulators an evidence-based rule for when RWE can substitute for a trial.","rationale":"Without a calibration library, every RWE submission is argued case by case. A map of emulability converts the debate into a lookup table.","test":"Fund the first 30 emulations across breast, lung and prostate; publish agreement metrics; test whether the resulting rule predicts agreement in the next 20.","maturity":"early-clinical","actor":"research","cost":"medium","horizonYears":3},"route":"/ideas/idea-data-rwe-rct-calibration-library/","neighbours":{"idea":[{"id":"idea-data-target-trial-emulation-standard","kind":"idea","name":"A pre-registered standard for emulating trials with real-world data","route":"/ideas/idea-data-target-trial-emulation-standard/"}],"section":[{"id":"ai-computation","kind":"section","name":"AI & Computation","route":"/fronts/ai-computation/"}],"term":[{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"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/"}]}}