Key takeaways:
Patients who are pregnant or breastfeeding are often excluded, but that creates risk for these patients.
An expert said it is important to include them when it is safe to do so for better data generalization.
Including pregnant and breastfeeding women in clinical trials is a step in the right direction to gathering better, more generalizable data, according to an expert.
The FDA recently released a draft guidance document on the appropriate inclusion of women who are pregnant and breastfeeding in clinical trials.
“Pregnant and breastfeeding women are often excluded from clinical trials and those who become pregnant while participating in a clinical trial are frequently discontinued from the clinical trial,” according to the guidance. “As a result, pregnancy- as well a