{"entity":{"id":"idea-data-target-trial-emulation-standard","kind":"idea","name":"A pre-registered standard for emulating trials with real-world data","aka":[],"tldr":"When researchers use hospital records to ask 'would drug A have beaten drug B in a trial', they should follow a published recipe and register their plan first, so the answer can be trusted.","summary":"Target trial emulation (specifying the hypothetical randomised trial, then mimicking it in observational data) is the accepted framework for causal inference from real-world data, but the rigour of oncology emulations is inconsistent. The proposal is a formal standard: a protocol template (eligibility, treatment strategies, assignment, time zero, outcomes, causal contrast, analysis plan), mandatory pre-registration, and a requirement to report a positive control emulation of a known RCT in the same dataset, adopted by regulators and journals as a condition of considering RWE.","asOf":"2026-09-08","links":[{"label":"RCT-DUPLICATE","url":"https://www.rctduplicate.org/"}],"tags":[],"related":[],"cancers":[],"sections":["ai-computation"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence","hazard-ratio"],"trials":[],"people":[],"bottlenecks":["b-real-world-evidence","b-trial-design"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Emulations that follow the standard and pass a positive-control calibration will agree with subsequent randomised trials on the direction of effect in more than 85 percent of cases, versus roughly 60 percent for unstandardised observational oncology studies.","rationale":"The RCT-DUPLICATE project showed that carefully designed emulations can reproduce RCT results when design elements are matched; the failures came from avoidable design flaws such as immortal time bias. A standard forces the fixes.","test":"Apply the standard prospectively to ten oncology questions with ongoing RCTs; lock the emulation results before the trials read out; compare.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-data-target-trial-emulation-standard/","neighbours":{"section":[{"id":"ai-computation","kind":"section","name":"AI & Computation","route":"/fronts/ai-computation/"}],"term":[{"id":"hazard-ratio","kind":"term","name":"Hazard ratio (HR)","route":"/terms/hazard-ratio/"},{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}],"idea":[{"id":"idea-data-rwe-rct-calibration-library","kind":"idea","name":"An open library pairing completed cancer trials with real-world emulations","route":"/ideas/idea-data-rwe-rct-calibration-library/"}]}}