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Before spending millions on a randomised trial, analyse existing patient records as if the trial had already happened. If the answer is obvious or the question is unanswerable, skip or redesign the trial.
Funders require a target-trial emulation in linked EHR or registry data as part of any application for a comparative-effectiveness trial: the emulation estimates the likely effect size, event rates, eligible population and recruitment feasibility, and identifies confounders to stratify on. Trials proceed where emulation is inconclusive or where residual confounding is plausible; the emulation also serves as a pre-registered comparator for the trial's result.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, AACR Project GENIE, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Real-world evidence.
Shares SEER (Surveillance, Epidemiology, and End Results), Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Real-world evidence, Weak real-world evidence and registries.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Real-world evidence, Weak real-world evidence and registries, Trial design, endpoints and cost.
Shares AACR Project GENIE, SEER (Surveillance, Epidemiology, and End Results), Real-world evidence, Weak real-world evidence and registries.
Shares SEER (Surveillance, Epidemiology, and End Results), Real-world evidence, Weak real-world evidence and registries.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Real-world evidence, Weak real-world evidence and registries, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Funding follows fashion, not burden, Trial design, endpoints and cost.
Shares SEER (Surveillance, Epidemiology, and End Results), Weak real-world evidence and registries, Trial design, endpoints and cost.