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Once a drug is in wide use, real-world records could be checked routinely for whether side effects differ by ancestry or sex, since trials were too small in those groups to notice. Findings would go into the label.
Regulators run active pharmacovigilance on linked EHR, claims and registry data for new oncology drugs, pre-specifying analyses of serious adverse events and discontinuation by self-reported race, genetic ancestry where available, and sex, with a defined signal threshold that triggers label review. Sentinel-type systems exist in the US and EU but rarely stratify this way.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Real-world evidence, Weak real-world evidence and registries, Trials do not represent the people who get cancer.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.