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Data from routine care rather than clinical trials, used to check whether results hold outside the trial population.
Real-world evidence is data drawn from routine care rather than from clinical trials, used to check whether trial results hold in the broader population. Sources include the Flatiron and Foundation Medicine clinico-genomic database, Tempus, registries and claims. It is used to build external control arms, support label expansions and detect under-performance in patients who are older or sicker than those trials enrolled. The term is linked to OMOP common data model and OHDSI, to Digital twins and virtual control arms and Systematic drug repurposing, to the AACR Project GENIE collection and to Karolinska University Hospital and UNICANCER, and it features in the bottlenecks on trial design and cost, data silos and weak real-world evidence and registries.
Shares An open library pairing completed cancer trials with real-world emulations, Linked prescribing and outcome data to find drug interactions with cancer therapy, Wearable activity data as a validated real-world endpoint, One outcome record for every donated or discounted cancer drug pack.
Shares Automatic weekly linkage of cancer registries to deaths, prescriptions and imaging, Emulate the trial in real-world data first to decide which trials to run, Randomise inside the cancer registry: registry-based trials for everyday questions, Mandatory interval-cancer audit for every blood-based screening test.
Shares A global federated real-world evidence network at regulatory grade, Validate real-world progression against central imaging review, Emulate combination trials from real-world data to triage which ones to run, Watch routine care for drug combinations that quietly make cancer treatment worse.
Shares Point-of-care randomisation built into the oncology record, Simulate eligibility against real-world data before every protocol is locked, Registry-based randomised trials for oncology comparative effectiveness, A shared library of pooled control arms to shrink and speed future trials.
Shares Every patient on an accelerated-approval drug enrolled in a registry until confirmation, A public rulebook for when an external or synthetic control arm is acceptable, 21st Century Cures Act, External and synthetic control arms.
Shares A registry of every treatment sequence patients actually receive, with outcomes, Emulate combination trials from real-world data to triage which ones to run, Payers cover off-label combinations only inside registry-randomised trials, Watch routine care for drug combinations that quietly make cancer treatment worse.
Shares Good practice standards and inspection for real-world data sources, One international registry, not one per country, for conditional approvals, Require post-approval evidence in patients over 75 and update labels accordingly, A fast route to the matched drug when it is licensed for another cancer.