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Trials often impose heavy contraception rules and exclude anyone pregnant or breastfeeding, even when the drug is unlikely to be harmful. Sensible, evidence-based rules and pregnancy registries would include more young women and produce data they currently lack.
Contraception requirements are set from the drug's actual reproductive toxicology rather than a blanket demand for two contraceptive methods; breastfeeding exclusion is replaced by lactation PK studies where feasible; and pregnancy exposure registries are funded for oncology drugs so that the inevitable exposures generate data. Adolescent and young adult women are disproportionately affected by current rules.
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, Trials enrol too few, too slowly, Triple-negative breast cancer (TNBC).
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, Trials enrol too few, too slowly.
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, Trials enrol too few, too slowly.
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 Trials do not represent the people who get cancer, Trials enrol too few, too slowly.
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, Trials enrol too few, too slowly.
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, Trials enrol too few, too slowly.