October 25, 2010
NIH holds forum on enrolling pregnant women in trials
Ruth R. Faden, director of the Johns Hopkins Berman Institute of Bioethics and a leading advocate for increasing clinical studies on pregnant women, spoke on Oct. 18 at a forum that took aim at fears that keep soon-to-be mothers from participating in vital research.
The event was hosted by the NIH Office of Research on Women’s Health for researchers, physicians, policymakers, ethicists, scientists and regulatory officials.
“Pregnant women are no magical exception to the need for evidence-based medicine,” Faden said. “Like other people, pregnant women are best protected through research, not from it.”
Clinical investigators have historically failed to make meaningful efforts to encourage pregnant women to participate in drug trials and other research, out of concerns that the fetus or woman might be injured. But Faden and her colleagues say most of those fears are based on sparse evidence, and that persistent exclusion of pregnant women in clinical research is unethical and leaves them vulnerable. Every year, more than 400,000 women are estimated to face serious illnesses while pregnant, but because there is little data on how to safely and effectively treat them, neither doctor nor pregnant women know what to do.