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When a trial has no comparison group, the comparison is sometimes built from old patient records. Set rules for how that is done so the answer is not rigged.
External control arms from real-world or historical trial data are increasingly used in rare cancers and single-arm approvals, with inconsistent methods. The proposal defines standards: pre-specification before trial unblinding, construction from federated data with documented eligibility mapping, minimum covariate set, quantitative bias analysis and tipping-point sensitivity analyses, plus public deposition of the control cohort definition. Regulatory guidance (FDA 2023 draft on externally controlled trials) is the starting point.
Shares Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, Real-world evidence, Weak real-world evidence and registries, Trial design, endpoints and cost.
Shares Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, Real-world evidence, Weak real-world evidence and registries.
Shares Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, Real-world evidence, Weak real-world evidence and registries.
Shares Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries, Rare and paediatric cancers without markets, Trial design, endpoints and cost.
Shares Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, Real-world evidence, Weak real-world evidence and registries.
Shares Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, Real-world evidence, Weak real-world evidence and registries.
Shares Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, Real-world evidence, Weak real-world evidence and registries.