{"entity":{"id":"idea-tr1-include-pregnancy-capable-people-sensibly","kind":"idea","name":"Stop over-excluding people who could become pregnant; study pregnancy exposure","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Trials do not represent the people who get cancer): Loree et al., Disparity of race reporting and representation in trials leading to cancer drug approvals (JAMA Oncology 2019)","url":"https://doi.org/10.1001/jamaoncol.2019.1870"}],"tags":[],"related":[],"cancers":["tnbc","cervical","hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-diversity","b-trial-enrolment"],"keyPapers":["paper-loree-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Evidence-based reproductive criteria will increase enrolment of women under 45 without increasing exposed pregnancies, and lactation and pregnancy registries will generate label information for most oncology drugs within a decade.","rationale":"Cancer in pregnancy and in lactating women is treated on almost no data; young women decline trials because of contraception burden; other therapeutic areas have moved to risk-based reproductive criteria.","test":"Audit contraception criteria against reproductive toxicology for approved agents; pilot risk-based criteria in one cooperative group and measure enrolment of women under 45 and exposed pregnancies.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-tr1-include-pregnancy-capable-people-sensibly/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"hodgkin-lymphoma","kind":"cancer","name":"Hodgkin lymphoma","route":"/cancers/hodgkin-lymphoma/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"bottleneck":[{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}],"paper":[{"id":"paper-loree-jama-oncol","kind":"paper","name":"Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018","route":"/key-papers/paper-loree-jama-oncol/"}]}}