Abstract

A decade of advocacy for the inclusion of pregnant women in the clinical research agenda is starting to pay off. In September, the United States Task Force on Research Specific to Pregnant Women and Lactating Women issued its advice to the secretary of Health and Human Services on addressing gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The task force is pushing for major reforms. If its recommendations are taken up, we can anticipate a significant shift in pregnancy research in the United States. This will affect pregnant women, clinicians caring for them, researchers, and institutional review boards.