EU: Trials should include pregnant subjects where possible

New guidance from the EMA has introduced a shift in thinking at the regulator on the inclusion of pregnant and breastfeeding women in clinical trials.

The new document, which is open for public consultation, represents "a change in paradigm" and recommends that including pregnant and breastfeeding subjects in clinical trials should be considered "for all medicines intended for people who can potentially give birth to children."

At the moment, it is well recognised that pregnant and breastfeeding individuals are under-represented in clinical research, with a recent study estimating that less than 1% of US clinical drug trials include pregnant participants.

Europe follows a similar pattern, with data from the EU Clinical Trials Information System (CTIS) estimating that less than 0.4% of all trials carried out in the region include pregnant subjects, falling to 0.1% for those who are lactating.

The low numbers are because they are often excluded from clinical trials at the outset, while subjects who become pregnant while participating in a trial are frequently blocked from participating further.

"As a result, product leaflets usually lack details about the benefits and risks of a medicine, specifically in pregnancy and breastfeeding, requiring patients and healthcare professionals to make treatment decisions without this essential information," said the EMA as it introduced the new guidance (PDF).

"This can lead to suboptimal treatment decisions and potential harm," it added. "Meanwhile, the vast majority of pregnant people take medications, for example, because of chronic diseases, infections, or pregnancy complications."

The recent US study also found that rates of inclusion of pregnant participants in drug trials have not changed in 15 years, despite calls for greater involvement and a recognition that this under-representation raises concerns about the safety and efficacy of medicines on maternal and child health.

Meanwhile, a recent paper in The Lancet concluded that the current low rates of inclusion "contributes to fragmented maternal health policies and practice, as well as exacerbating gender, social, and geographical inequalities."

The new EMA guidance is open for comment until 15th September. It outlines scientific, regulatory, and ethical considerations for the design of pre- and post-marketing trials so pregnant and breastfeeding individuals can be included and retained in studies.

The EMA said it is encouraging developers to carry out "proactive planning and early consultation" with regulators "to ensure the safety and efficacy of treatments during pregnancy and breastfeeding."

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