Grant: Op. Grant: NWHRI: Innovation Fund - Healthcare implementation research

The COVID-19 pandemic drew attention to the challenges in evaluating drugs for use in pregnant and breastfeeding people. The status quo is to exclude pregnant and breastfeeding people from clinical trials because of concerns about exposing the developing fetus to medications with potentially harmful effects. This approach is short-sighted because pregnant women do require medical treatments when they fall ill, but doctors do not have sufficient information to choose the right treatment for them. In essence, excluding these patients from trials does not serve them well in the end. This same issue is true whether it relates to vaccines for existing or emerging infectious disease threats or medicines needed to stabilize chronic health issues that affect individuals in their reproductive years, which each require specific medical treatments during pregnancy or breastfeeding. We will review all of the evidence and plans that have been proposed to safely include pregnant and breastfeeding people in clinical trials so that we can gradually implement these into practice. We will also survey researchers to better understand their needs. Finally, we will develop standard tools that researchers can use. In our approach we will partner with many successful organizations focused on drug prescribing in pregnancy including with members of Health Canada - the organization that makes decisions about medications that are studied and that go to market. On our team, we will include experts in women's health, health of the fetus and child, pharmacology experts, and epidemiologists. We will engage directly with patients and physicians from diverse settings to hear their concerns about including pregnant and breastfeeding people in clinical trials and to address these concerns for future trials.