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This project aims to assess how drug clinical trials in Canada approach the inclusion and exclusion of people who are pregnant, lactating or who have the potential to become pregnant. This is necessary because pregnant and lactating individuals have been historically excluded from clinical trials, limiting knowledge on treatment safety and efficacy for this population. The review will identify and synthesize the characteristics of drug clinical trials registered on clinicaltrials.gov with recruitment in Canada from May 2013 to December 2024, focusing on their inclusion and exclusion criteria related to pregnancy and lactation, the condition under study, and other trial features. The findings will identify research areas where these individuals are routinely excluded, highlight treatment gaps on relevant conditions, and help inform trialists and funders on strategies to target their inclusion in future studies.
Jennifer Brooks
Maternal Infant Child and Youth Research Network
Life Sciences
Professional, scientific and technical services
University of Toronto
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Mitacs is funded by the Government of Canada, the Government of Alberta, the Government of British Columbia, Research Manitoba, the Government of New Brunswick, the Government of Newfoundland and Labrador, the Government of Nova Scotia, the Government of Ontario, Innovation PEI, the Government of Quebec, the Government of Saskatchewan, and the Government of Yukon.