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Sometimes a trial cannot randomise, so the new drug is compared with past patients' records. Clear published rules on when that is allowed, and how it must be done, would replace case-by-case guesswork.
Regulators publish a binding checklist for externally controlled trials: pre-registration of the comparator cohort and analysis before unblinding; target-trial emulation framing; minimum data quality (endpoint ascertainment, line of therapy, index date); quantitative bias analysis and tipping-point reporting; and the settings where it is acceptable (rare disease, effect size large relative to plausible confounding, randomisation infeasible). Submissions meeting the rulebook receive predictable review.
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 Hazard ratio (HR), Real-world evidence, Weak real-world evidence and registries, Trial design, endpoints and cost.
Shares Real-world evidence, Weak real-world evidence and registries, Rare and paediatric cancers without markets, Trial design, endpoints and cost.
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.
Shares Accelerated approval, Weak real-world evidence and registries, Trial design, endpoints and cost.
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 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 Accelerated approval, Real-world evidence, Weak real-world evidence and registries.