Closing the Knowledge Gap: Including Pregnant and Breastfeeding Individuals in Clinical Trials

For too long, significant data gaps around the use of medicinal products during pregnancy and breastfeeding have impeded healthcare decision-making. This lack of information is particularly challenging for individuals living with chronic diseases during the stages of pregnancy and breastfeeding, as it does not all allow for an informed dialogue with their healthcare providers (HCPs) about optimal management and treatment of their diseases at those times.

As a member of the E21 Expert Working Group (EWG), a part of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), I am proud to be part of efforts to change this paradigm. It is high time all individuals, regardless of reproductive status, have access to the most effective treatments and information to make better decisions.

The E21 EWG was formed to create a new guideline for the inclusion of pregnant and breastfeeding individuals in clinical trials (CTs) – one that harmonises strategies and methodologies to ensure the appropriate inclusion and/or retention of pregnant and breastfeeding individuals in CTs.

This new efficacy guideline will provide a globally accepted framework and best practices to enable inclusion and/or retention of pregnant and breastfeeding individuals in clinical trials – including practical guidance for planning trials that include pregnant and breastfeeding individuals, as well as comprehensive communication and stakeholder engagement plans.

A global-level agreement is needed to improve the situation for pregnant and breastfeeding individuals who need medicines, and to be inclusive of all patient populations. This will help reduce the risk of prescribing medicinal products without adequate evidence in these patient populations. The guideline, based on globally accepted principles, will be implementable worldwide, thereby promoting inclusive patient care and ensuring ethical data generation in global trials.

This work is more than just a professional responsibility; it is a moral imperative. UCB is committed to improving the care for pregnant and breastfeeding individuals of childbearing age by addressing any gaps in knowledge. These individuals have often been overlooked in the past, but they are a crucial part of the patient population, and we believe that they deserve access to information that empowers them to make optimal disease management decisions throughout their reproductive journey.