New guidance on pregnancy and breastfeeding during clinical trials

The European Medicines Agency (EMA) is working on guidelines for the inclusion of pregnant and breastfeeding individuals in clinical trials. The recommendations are designed to support better information on the benefits and risks of medicines for this population.

The guidance is now being finalised following a public consultation which ended on September 15. A draft was developed jointly by global regulators and medicines developers through the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It marks a change in paradigm in the development of medicines in pregnancy and breastfeeding.

The draft guidance highlights that in principle, including pregnant and breastfeeding people in clinical trials should be considered for all medicines intended for people who can potentially give birth to children. It lays out the principles and conditions that should be met to ensure the safety of clinical trial participants, as well as their fetuses and babies.

Currently, pregnant and breastfeeding people are often excluded from clinical trials and those who become pregnant while participating in a clinical trial are frequently discontinued from the clinical trial. Less than 0.4% of all clinical trials currently submitted in the EU include pregnant people, and this falls to 0.1% regarding lactating individuals, according to data from the Clinical Trials Information System (CTIS).

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. This can lead to suboptimal treatment decisions and potential harm. Meanwhile, the vast majority of pregnant people take medications, for example because of chronic diseases, infections, or pregnancy complications. The situation is similar in breastfeeding populations.

The guideline outlines the scientific and regulatory principles, as well as ethical considerations, for the inclusion of pregnant and breastfeeding individuals in clinical trials, both pre- and post-authorisation. A final text will be published after all public comments have been reviewed.