# Stop over-excluding people who could become pregnant; study pregnancy exposure

Source: https://onco.cc/ideas/idea-tr1-include-pregnancy-capable-people-sensibly/  
OnCo record `idea-tr1-include-pregnancy-capable-people-sensibly` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- 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): https://doi.org/10.1001/jamaoncol.2019.1870

## Connected records

- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Hodgkin lymphoma](https://onco.cc/cancers/hodgkin-lymphoma/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- bottlenecks: [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)
- key papers: [Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018](https://onco.cc/key-papers/paper-loree-jama-oncol/)

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