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Older, frailer and sicker patients are usually kept out of trials but make up most of those treated. Require companies to report how these patients do in practice.
Pivotal trials exclude patients over 75, with poor performance status, organ dysfunction, brain metastases or HIV, yet these groups receive the drug after approval. The proposal is a post-marketing requirement: within two years of approval, sponsors report real-world effectiveness and toxicity in pre-specified excluded subgroups using structured registry data, with results added to the label.
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 Older and multimorbid patients are excluded and undertreated, 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 Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
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.