{"entity":{"id":"idea-tr1-eligibility-impact-statement","kind":"idea","name":"Simulate eligibility against real-world data before every protocol is locked","aka":[],"tldr":"Before a trial is finalised, run its entry rules against records of real patients with that cancer and report what fraction would qualify. If it is under half, explain why.","summary":"An 'eligibility impact statement' in the protocol: the criteria are applied to a de-identified real-world cohort (EHR-derived or registry) and the eligible fraction, its demographic profile and the criteria excluding the most patients are reported. Work using real-world oncology data has shown that relaxing common criteria roughly doubles the eligible population with little change in estimated treatment effect.","asOf":"2026-09-08","links":[{"label":"Evaluating eligibility criteria of oncology trials using real-world data and AI (Nature 2021)","url":"https://www.nature.com/articles/s41586-021-03430-5"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["ai-trial-matching"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-trial-enrolment","b-real-world-evidence"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Protocols with a pre-lock eligibility impact statement will end up with a higher real-world eligible fraction and faster accrual than protocols without one, because the statement makes the cost of each criterion visible to the team writing it.","rationale":"Teams over-restrict because restriction feels safe and its cost is invisible. A number on the page changes the conversation; this is how carbon and cost-impact statements work in other fields.","test":"A sponsor introduces the statement for half of its new protocols by random allocation of programmes and compares eligible fraction and accrual speed after 18 months.","maturity":"early-clinical","actor":"industry","cost":"small","horizonYears":1},"route":"/ideas/idea-tr1-eligibility-impact-statement/","neighbours":{"technology":[{"id":"ai-trial-matching","kind":"technology","name":"AI trial matching & clinical decision support","route":"/technologies/ai-trial-matching/"}],"term":[{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}],"roadmap":[{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}]}}