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Instead of excluding sicker patients entirely, trials would run a side group for them, receiving the new drug with closer monitoring, so we learn how it behaves in the people who will actually get it.
Registrational trials open a non-randomised parallel cohort for patients who fail the main eligibility on performance status (ECOG 2), organ function, or comorbidity, treated with the experimental regimen under a pre-specified safety and dose-adjustment plan, with PK sampling. Data are analysed separately and included in the label as descriptive evidence. Precedent: NCI organ-dysfunction working group studies and some sponsor expansion cohorts.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, 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 Geriatric assessment, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
Shares Geriatric assessment, Older and multimorbid patients are excluded and undertreated, 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.