Loading
Accelerated approvals rest on surrogate endpoints, and confirmatory trials take years and are sometimes never completed. Making registry enrolment with automatic outcome capture a condition of prescribing under accelerated approval would give regulators a real-world signal on benefit and toxicity within about two years, while the confirmatory trial runs.
Accelerated approvals rest on surrogate endpoints; confirmatory trials take a median of several years and some are never completed. The proposal makes registry enrolment with automatic outcome capture (via mCODE and registry linkage) a condition of prescribing under accelerated approval, giving regulators an interim real-world signal on survival and toxicity while the confirmatory trial runs. The FDA's 2023 authority to require confirmatory trials be underway at approval is the policy hook; the registry is the complementary data hook.
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, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
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, Regulatory divergence between regions.
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.