Closing the Inclusion Gap: Progress and Innovation in Pregnancy Research

A majority of pregnant and lactating people use at least one medication, yet evidence about medication safety and effectiveness during pregnancy and lactation remains limited. Historical tragedies such as thalidomide, prescribed for morning sickness in the 1950s and 1960s, contributed to the widespread exclusion of women from clinical research. Despite efforts to improve inclusion since the 1990s, major knowledge gaps persist—particularly for pregnant and lactating women and people.

So, how can researchers generate the evidence patients and healthcare providers need to make informed treatment decisions?

In this session, Dr. Natalie Dayan will review the history of clinical trials in pregnancy. Dr. Dayan will examine the persistent “inclusion gap” for pregnant and breastfeeding women and other birthing and postpartum individuals in clinical trials. Drawing on PregTrial – an implementation science initiative, she will review barriers to meaningful inclusion and introduce novel practical tools that her team is developing to help researchers determine when and how pregnant people can be safely included in clinical trials.

Dr. Anick Bérard will discuss and highlight different, complementary approaches to generating clinical evidence about drug safety and effectiveness in pregnancy when clinical trials are not feasible or safe. She will explore the role of real-world data and initiatives such as the Canadian Mother-Child Cohort Active Surveillance Initiative (CAMCCO) in building evidence to inform clinical practice. The consensus-based algorithm developed by Bérard and Dayan will be shared that helps researchers and policy-makers prioritize study designs in different contexts.

Together, the speakers will consider how randomized trials, observational research, real-world evidence and new decision-making tools can complement one another to increase participation in research and improve clinical care. Using emerging questions around medications such as GLP-1 receptor agonists, they will explore how we can move from identifying gaps in pregnancy research to finding practical solutions.