Doctor's duty in incorporating expectant and nursing mothers into medical trials
Pregnant and breastfeeding women are often overlooked in clinical trials worldwide, prompting a call for change from researchers to address this critical knowledge gap. Dr. Natalie Dayan, an obstetrician-internist at McGill University Health Centre's Research Institute, initiated the PregTrial initiative to establish safer guidelines for including these women in such trials.
Women who are pregnant or breastfeeding are often denied access to the latest treatments for chronic diseases due to a lack of relevant data regarding their safety. Moreover, doctors frequently prescribe medications that haven't been thoroughly tested in these populations, potentially exposing them to either less effective drugs or treatments with poorly understood risks.
To rectify this situation, Dr. Dayan has been working to introduce a maternal investigation framework that prioritizes the inclusion of pregnant and breastfeeding women in relevant clinical research. She emphasizes that this isn't about including them in every trial, but rather focusing on studies concerning chronic or infectious diseases that can cause severe complications, as well as infectious diseases like COVID-19 that affect broad populations.
The first step in implementing this framework is to conduct tests on pregnant animals to evaluate whether a drug can cross the placenta and reach the fetus. Following this, small pre-clinical trials can be carried out with informed volunteers, who will be closely monitored throughout the process. Once the appropriate dose is established and the drug's safety is demonstrated in the general population, more pregnant or breastfeeding women can be included in subsequent trials.
Inclusion of pregnant and breastfeeding women in clinical trials is essential for generating accurate data on medication safety and efficacy during pregnancy and breastfeeding. This information is crucial for developing better-informed treatment guidelines that prioritize the health and well-being of both mothers and infants.
The 'exclusion culture' of pregnant and breastfeeding women in medication research, to some extent, stems from the thalidomide disaster of the 1950s and 1960s, during which the drug caused severe birth defects in infants when given to pregnant women. While clinical trial standards have been strengthened since then to prevent such events, the fear remains. Balancing potential risks with the benefits of acquiring robust data is important when considering these studies.
By developing and implementing a structured, ethical, and scientifically rigorous framework for including pregnant and breastfeeding women in clinical trials, we can fill critical knowledge gaps and establish a new standard for maternal and infant health research. This approach will ultimately lead to better-informed treatment guidelines during pregnancy and breastfeeding, benefiting both mothers and infants worldwide.
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