The US Food and Drug Administration (FDA) has issued new draft guidance for industry. It outlines the scientific and ethical issues that should be addressed when considering the dilemma of including pregnant women in clinical trials of medicinal and biological products.
There are more than 60 million women of reproductive age in the United States and nearly 4 million births each year, according to US National Vital Statistics data.
This project is intended to serve as a focus for ongoing discussions among the FDA, drug companies, the research community, institutional review boards, and other parties involved with the conduct of clinical trials in pregnant women.
Some of the information in the guidance refers to medicines indicated for the treatment of pregnancy-specific conditions, such as preterm labor and preeclampsia. However, more emphasis is placed on the drugs indicated for the problems that often occur in young women of reproductive age, explains the FDA.
Experts note several reasons for considering the inclusion of pregnant women in clinical trials. Women need safe and effective treatment during pregnancy, and failure to establish the dose/dosing regimen, safety, and efficacy of treatments during pregnancy may compromise the health of women and their fetuses, they point out. In some settings, enrolling pregnant women in clinical trials may offer the possibility of direct benefit to the woman and/or fetus that is unavailable outside the research setting. Developing accessible treatment options for the pregnant population is a “significant public health issue,” the agency says.