EMA issues guide on including pregnant and breastfeeding people in trials

A new guideline explaining how to safely include pregnant and breastfeeding people in trials will help developers generate robust data, according to the EMA.

The Amsterdam regulator released the guideline for consultation last week, describing it as a set of principles and conditions that should ensure the safety of clinical trial participants, as well as their fetuses and babies.

According to EMA data, fewer than 0.4% of trials submitted in the EU include pregnant people, and this falls to 0.1% for lactating individuals. As a result, product leaflets often lack details about the benefits and risks of a drug in such individuals.

This is a problem, according to an EMA spokesperson, as the “vast majority” of pregnant people take medicines.

“Medicine use in pregnancy or breastfeeding is necessary to prevent or treat a disease. Some diseases, when they are poorly controlled, increase the risk of unfavorable pregnancy outcomes such as pregnancy loss, stillbirth, premature birth, or birth defects, and taking medicines helps reduce such risks.

“Sometimes, medicines are taken in pregnancy when a patient doesn’t yet realize they are pregnant,” the spokesperson continued. “In all these cases, having information in the product label that helps weigh up the benefits of treatment and the risks of the medicine for the person treated and their baby is helpful.”

Proceed with caution

The new guideline, which was developed in partnership with global regulators and medicines developers through the ICH, also makes clear when pregnant and breastfeeding people should not be included in trials.

The spokesperson said, “Examples include of course products that are a known teratogen, especially if the current standard of care is known to be safe for use in pregnancy or breastfeeding.

“The draft guideline also notes that to allow inclusion of pregnant and breastfeeding people in clinical trials, there should be a reasonable likelihood that the investigational product is effective, and we should have information from the preclinical studies that does not suggest unacceptable harm. The general approach recommended is to proceed with caution when considering inclusion of these populations in clinical trials.”

The spokesperson added that, because the guideline was developed through the ICH, “ultimately, it is expected to apply globally.”

Cost impact

Including more pregnant and breastfeeding people in trials is likely to impact costs. For example, studies on the transfer of medicine into breastmilk, or the additional monitoring of how a pregnancy progresses during a clinical trial, will all be extra.

However, the guideline has the potential to reduce costs in other areas, according to the EMA spokesperson.

“We are encouraging a change in thinking, a more rational approach. And the information generated through clinical trials may reduce the need — and hence the cost — of setting up pregnancy registries or other post-authorization studies for this population.”

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