Why We Exist
Historically, pregnant and lactating people have been systematically excluded from clinical trials – including recent vaccine and therapeutic trials for COVID-19, limiting evidence-based treatment options.
At the same time, up to 70% of pregnant and lactating people take at least one prescription medication, despite limited and sometimes nonexistent clinical trials of these medications in pregnancy or lactation.
This exclusion puts the burden on healthcare providers caring for pregnant and lactating individuals. They are left to make crucial decisions based on limited and sometimes no evidence, often leading to under-treatment or discontinuation of necessary medications.
Who We Are
PREGTRIAL is a national and diverse group of researchers, knowledge users, non-government organizations, key stakeholders, representatives of Indigenous persons, and persons with lived experiences.
We are committed to ensuring access to safe, evidence-based, and culturally sensitive pharmacological treatments and medical care for pregnant and lactating persons. We are working to generate evidence to improve care for people of all races, genders, abilities, and backgrounds.
PREGTRIAL’S Vision
Through our work, we hope to achieve the following long-term outcomes:
Diverse
Inclusion
A significant representation of pregnant and lactating people of all races, genders, abilities, and backgrounds in Canadian clinical trials.
Policy
Change
Adoption of tools and recommendations by regulatory bodies.
Stakeholder
Engagement
Strong partnerships with industry, clinicians, researchers, and marginalized communities.
Public
Awareness
Improved understanding and acceptance of clinical trial participation among pregnant and lactating individuals.
What We Envision
We cannot achieve gender equity in research if pregnant and lactating people are left out of clinical trials.
Our work will make important progress, but real change depends on working with Canadian stakeholders to create a long-term, nationwide solution. PREGTRIAL aims to be the central hub of expertise, ensuring inclusive and evidence-based research for the future.
Ultimately, we envision a landscape in which the default is to “consider inclusion of pregnant and/or lactating people with additional safeguards” when designing clinical trials to improve the health of women and gender-diverse people across Canada.
