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Drugs are approved on trials of fit, younger patients and then given to everyone. A required follow-on trial in older, sicker and more diverse patients would show whether the benefit holds in real life.
As a condition of approval, sponsors fund a pragmatic randomised trial with broad eligibility run in community settings, using routinely collected endpoints (OS, hospitalisation, treatment discontinuation) and minimal extra visits, modelled on the FDA's Project Pragmatica and the Pragmatica-Lung trial. Results feed label updates on dosing and benefit in the broader population.
Shares Older and multimorbid patients are excluded and undertreated, 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 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 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 Older and multimorbid patients are excluded and undertreated, Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries, Trial design, endpoints and cost.