Clinical Trials Day 2023 - Strategic Approaches in Pregnancy and Breastfeeding: Time for a Paradigm Shift

This year’s Clinical Trials Day (May 20^th) serves as a timely reminder that much still needs to be done to make clinical trials more inclusive, particularly for pregnant and breastfeeding women. 

I am proud to have presented at Regulatory Affairs Professionals Society (RAPS) Euro Convergence 2023, discussing strategic approaches in pregnancy and pediatrics alongside Dr Solange Corriol-Rohou, Senior Director of Regulatory Affairs and Policy at AstraZeneca, and Corinne de Vries, Head of Translational Sciences at European Medicines Agency. 

Today, although 70% of pregnant women take at least one prescription drug during pregnancy, only about 5% of drugs have been properly monitored, tested and include label data to inform use during pregnancy and breastfeeding. This reflects a widespread tendency not to include pregnant and breastfeeding women in clinical trials – often driven by public attitudes about risk, as well as outdated approaches to research. 

Due to the lack of inclusion of pregnant and breastfeeding women in clinical research, women around the world continue to be subjected to misinformation and misconceptions. The global clinical trial community needs more discussions like the one we had at RAPS Euro Convergence 2023, seeking to drive actions that ensure women have access to timely information about the safe and efficacious use of medicines. 

New efforts are urgently needed to change the mindset when it comes to benefit-risk considerations. We should stop focusing solely on the risks to the unborn baby and consider the benefits to the mother of being treated – as well, of course, as the consequences to both the mother and baby of not being treated.  

There is a clinical and ethical imperative to generate more and better standardized data, informing decision-making on medication use during pregnancy and breastfeeding. Such a change can only be achieved through collective action from all relevant stakeholders.

At UCB, we remain committed to addressing such health disparities and closing gaps in clinical trial diversity. No woman should ever have to choose between managing her health and starting a family. So, this May 20^th, let’s rally together and call for better representation of pregnant and breastfeeding women in clinical trials.