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Trials often stop following patients once the main result is in, so we never learn whether the drug extended life. Linking participants to national death and cancer registries costs almost nothing and would answer that question.
With participant consent at enrolment, trials link identifiers to national death indices and cancer registries so that OS and second-cancer follow-up continues indefinitely at negligible cost after study closure. Regulators require OS reporting at 5 and 10 years for drugs approved on surrogate endpoints, using this linkage. Precedent: registry-linked follow-up in Nordic and UK trials and in US cooperative-group studies via the National Death Index.
Shares Accelerated approval, Weak real-world evidence and registries, Overall survival (OS).
Shares SEER (Surveillance, Epidemiology, and End Results), Weak real-world evidence and registries.
Shares Accelerated approval, Weak real-world evidence and registries, Trial design, endpoints and cost.
Shares SEER (Surveillance, Epidemiology, and End Results), Weak real-world evidence and registries, Trial design, endpoints and cost.
Shares SEER (Surveillance, Epidemiology, and End Results), Weak real-world evidence and registries.
Shares Accelerated approval, Trial design, endpoints and cost.
Shares SEER (Surveillance, Epidemiology, and End Results), Weak real-world evidence and registries, Trial design, endpoints and cost.
Shares SEER (Surveillance, Epidemiology, and End Results), Weak real-world evidence and registries.