The EMA has published a draft guideline for public consultation that offers recommendations on how to include and/or continue pregnant and breastfeeding individuals in clinical trials. The aim is to help ensure that reliable clinical data is collected for these groups, allowing them and their healthcare providers to make informed, evidence-based decisions about using medicines.
Global regulators & medicine developers like the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) highlights how it is crucial to incorporate pregnant & breastfeeding women in clinical trials while providing correct safety measures for both mothers & their fetuses, this can help fill in the gap of missing product leaflets often lack specific information on the benefits and risks of medicines during pregnancy and breastfeeding. This leaves patients and healthcare providers without the data needed for informed decisions, despite the fact that most pregnant and breastfeeding individuals use medications for various health conditions.
Currently, pregnant and breastfeeding women are typically excluded from clinical trials. If participants become pregnant during a study, they are often withdrawn, resulting in less than 0.4% of trials including pregnant women and only 0.1% including breastfeeding women.
The guideline outlines scientific, regulatory, and ethical principles for including pregnant and breastfeeding individuals in clinical trials, both before and after authorization. It encourages early, proactive engagement with regulators to ensure treatment safety and efficacy in these populations.
