The FDA has issued draft guidance recommending that pharmaceutical companies include pregnant women in their clinical trials. The document outlines how the inclusion can be exercised safely and ethically.
In the draft, the agency notes there is limited clinical information on how medications may affect pregnant women, which is mainly due to the fact that researchers have historically excluded pregnant women from clinical trials to protect them and their unborn babies from “research-related side effects.” However, the FDA noted that pregnant women and unborn babies may greatly benefit from participation in a clinical trial.
For instance, “a pregnant woman may need access to experimental therapies in a clinical trial setting because there are no approved treatment options available. Sometimes a drug treatment offered only through a clinical trial will hold out the prospect of direct benefit to the pregnant woman and/or her fetus beyond otherwise available therapies,” according to the FDA.
The agency indicated that the inclusion would require careful risk-benefit assessments, and that the trials must be organized in a way that significantly minimizes the risks.