Simulate eligibility against real-world data before every protocol is locked
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.
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.
- Trials enrol too few, too slowly · Fewer than one in ten adults with cancer joins a trial. Trials close for lack of patients, not lack of ideas.
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
Pages like this
not linked directly; found by shared links- InstitutionHL7 International
Shares AI trial matching & clinical decision support, Trials enrol too few, too slowly, Weak real-world evidence and registries, Real-world evidence.
- IdeaRegistry-based randomised trials for oncology comparative effectiveness
Shares Trials enrol too few, too slowly, Weak real-world evidence and registries, Real-world evidence.
- IdeaPatients are told which trials they qualify for at every treatment decision, in writing
Shares AI trial matching & clinical decision support, Trials enrol too few, too slowly.
- IdeaLinked prescribing and outcome data to find drug interactions with cancer therapy
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaWearable activity data as a validated real-world endpoint
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaNo mCODE, no payment: tie oncology reimbursement to a minimal structured record
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaGood practice standards and inspection for real-world data sources
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaOne international registry, not one per country, for conditional approvals
Shares Weak real-world evidence and registries, Real-world evidence.