Pregnant women have historically been excluded from clinical research due to ethical concerns about harming the fetus or the perception of increased risk to the woman.
As a result of excluding pregnant women from clinical trials, the safety and efficacy of therapies cannot be evaluated for them.
[3] Regulators, researchers, and bioethicists generally agree that clinical trials should include pregnant women.
[2] Several projects and coalitions have formed to promote the inclusion of pregnant women in clinical research.
These include the Coalition to Advance Maternal Therapeutics, which consists of twenty member organizations,[4] and the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT), a project that sought to increase the inclusion of pregnant women in vaccine trials during epidemics.