Do advances in clinical trial diversity go far enough for women?

The clinical trial landscape has evolved significantly in the last years – with a focus on more inclusive approaches to ensure medicines get to the right patients.

For example, the Consolidated Appropriations Act of 2023, passed by Congress earlier this year, makes it mandatory in many instances for drug sponsors to submit clinical trial diversity action plans, an action that was previously recommended by FDA guidance.

While diversity has become an increasingly important priority in clinical research, the inclusion of pregnant and breastfeeding women in clinical trials still falls short, leading to few available medications that have been adequately tested and labelled to inform potential use during pregnancy and lactation. Currently, 7 in 10 women may have to take at least one prescription medicine during pregnancy – with physicians and women with chronic diseases forced to face the difficult task of deciding whether to stop or continue a medication during pregnancy and breastfeeding, despite the unknowns.

In partnership with clinical teams, UCB strives to address knowledge gaps in the care of women of childbearing age through the provision of validated evidence and quality disease management tools. Our pregnancy and lactation trials that are completed or ongoing in four of our products provide evidence to support disease management and help clinicians and women with chronic diseases make more informed decisions around their health and family planning.

We are now working to address further knowledge gaps by systematically evaluating the opportunity to conduct pregnancy and lactation trials in each of our current and future therapeutic areas. We are also collecting follow-up data in infants exposed to our medications during pregnancy and breastfeeding, to identify potential risks and to help support patient decisions.

Additionally, we continue to work in close collaboration with our external partners such as the ConcePTION Consortium and Coalition to Advance Maternal Therapeutics (CAMT) on research specific to pregnant and lactating women, TransCelerate to collaborate on common drug development challenges, and as a member of a working group with the ICH initiative to enable inclusion of pregnant and breastfeeding individuals in clinical studies.

We hope to continue our collaborations with physicians and women around the world by identifying potential educational needs and seeking to offer important information regarding patient care before, during and after pregnancy. 

Want to learn more about UCB’s ambition for women of childbearing age? Click here to learn more. Empowering Decisions for Women of Childbearing Age | UCB