Inclusion of pregnant and lactating people in clinical trials: a multi-disciplinary hub and framework for policy to action.

Prescriptions without testing.

Did you know? Pregnant and lactating people have been systematically excluded from many clinical trials including most recently vaccine and therapeutics trials for COVID-19. At the same time, up to 70% of pregnant and lactating people take at least one prescription medication, despite limited and sometimes no clinical trials of these medications in pregnancy or lactation.

As a result, providers caring for pregnant and lactating people make decisions based on limited, and sometimes no evidence.

Safe access to evidence-based treatments & medical care.

PREGTRIAL is a national and diverse group of researchers, knowledge users, non-government organizations, key stakeholders, representatives of Indigenous persons, and persons with lived experience who are committed to ensuring access to safe, evidence-based, and culturally sensitive pharmacological treatments and medical care for pregnant and lactating persons.

We propose a comprehensive multi-pronged implementation strategy to improve participation and representation of pregnant and lactating people in clinical trials, leveraging the experience, resources and infrastructure of existing pan-Canadian initiatives and training platforms. Principles of Equity, Diversity and Inclusion are integral to Hub activities as our hope is to generate evidence for clinical practice of pregnant and lactating people of all races, genders, abilities, and backgrounds.

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