Resources - PregTrial

Q: 3. Who is PREGTRIAL for?

PREGTRIAL serves a wide range of stakeholders, including:Healthcare professionals seeking evidence-based guidelines for patient care.Researchers and trialists interested in ethical inclusion frameworks.Pregnant and lactating people seeking information on clinical trials.Policy makers and industry partners working on health innovation.Advocates and the general public promoting health equity.

Q: 8. How can I get involved with PregTrial?

Individuals can get involved by:Healthcare professionals, trialists and research teams can take our surveys and support our work through advocacy, and participation, and be open to utilizing tools and resources to improve the inclusion of pregnant and lactating people in clinical trials. Participate in safe clinical trials as a pregnant or lactating individual.

Resources

Learn more from several helpful frameworks & guidance documents, website, toolkits, training programs, and other resources on drugs in pregnancy.

PregTrial Resources

A Multidisciplinary Panel on Inclusion of Pregnant and Lactating Persons and Their Infants in Clinical Trials

Inclusion of Pregnant and Lactating People In Clinical Trials (PregTrial) – Evidence Scan

Health in Pregnancy and Postpartum

Healthy Pregnancy Hub:

Find various documents, tools and a factsheet for pregnant people, their families and healthcare professionals provided by Healthy Pregnancy Hub.

SOGC Resources:

Resources sourced from the Society of Obstetricians and Gynaecologists of Canada.

Participating in Clinical Trials

Be The Cure:

Search for existing studies on pregnancy and pregnant and lactating individuals across Canada, or explore opportunities to partake in studies via the Be The Cure website.

MICYRN Resources:

Find resources from the Maternal Infant Child Youth Research Network.

ACT Resources:

Find resources from ACT.

Clinical Trials Training

Impact Trials

CANTRAIN Collaborative Training Hub:

The Collaborative Training Hub by CANTRAIN is an open-access launchpad to quickly access unique clinical trial training resources and opportunities.

International Frameworks, Guidance Documents and Toolkits

World Health Organization Resources:

International Council of Harmonisation:

PRGLAC:

Health Canada / Tri-Council:

FDA:

Other

Frequently Asked Questions

Find answers to some Frequently Asked Questions by our community and stakeholders regarding our work, team, methods, goals and processes.

1. What is PREGTRIAL?

PREGTRIAL is a Canadian initiative focused on increasing the inclusion of pregnant and lactating people in clinical trials. By developing tools, frameworks, and educational resources, PREGTRIAL aims to promote ethical, evidence-based care and address long-standing gaps in maternal and child health research.

2. Why is there a need for PREGTRIAL?

Historically, pregnant and lactating people have been excluded from clinical trials due to concerns about fetal safety and ethical complexities. This has led to significant gaps in evidence-based guidelines for managing chronic conditions, emerging diseases, and medication use during pregnancy and lactation. PREGTRIAL seeks to address this issue by creating a framework for safe and responsible inclusion in trials.

3. Who is PREGTRIAL for?

PREGTRIAL serves a wide range of stakeholders, including:

Healthcare professionals seeking evidence-based guidelines for patient care.
Researchers and trialists interested in ethical inclusion frameworks.
Pregnant and lactating people seeking information on clinical trials.
Policy makers and industry partners working on health innovation.
Advocates and the general public promoting health equity.

4. What are the main goals of PREGTRIAL?

Generate evidence-based guidelines for including pregnant and lactating people in clinical trials.
Develop standardized tools to support trialists and research teams.
Promote health equity by ensuring diverse representation in research.
Educate stakeholders on the importance of inclusive clinical trials.

5. How does PREGTRIAL ensure diversity and inclusion in clinical trials?

PREGTRIAL integrates principles of Equity, Diversity, and Inclusion (EDI) into its work by:

Engaging with racialized and underrepresented groups.
Partnering with community leaders and organizations.
Tailoring tools and strategies to address unique cultural and societal needs.

6. How is PREGTRIAL funded?

PREGTRIAL receives funding from the Canadian Institute for Health Research.

7. What is PREGTRIAL's Research Plan?

PREGTRIAL’s research plan is built around the Consolidated Framework for Implementation Research (CFIR) and focuses on creating a foundation for the safe inclusion of pregnant and lactating people in clinical trials.

8. How can I get involved with PregTrial?

Individuals can get involved by:

Healthcare professionals, trialists and research teams can take our surveys and support our work through advocacy, and participation, and be open to utilizing tools and resources to improve the inclusion of pregnant and lactating people in clinical trials.
Participate in safe clinical trials as a pregnant or lactating individual.