skip navigation nih record
Vol. LXIII, No. 2
January 21, 2011
cover

previous story

next story



ORWH Forum Examines Clinical Research, Pregnancy
On hand at the recent ORWH forum were (from l) Dr. Duane Alexander of the Fogarty International Center, Dr. Sara Goldkind and Karen Feibus, both of FDA.
On hand at the recent ORWH forum were (from l) Dr. Duane Alexander of the Fogarty International Center, Dr. Sara Goldkind and Karen Feibus, both of FDA.

“Pregnant women get ill, sick women get pregnant,” admonished a recent editorial in Nature. Clinicians have meager evidence on which to base treatment of pregnant women. Clinical research investigates mechanisms of human disease and tests therapeutic interventions. However, pregnant women are often excluded from clinical studies and few studies are designed to address health concerns and questions relevant to pregnant women. This results in a lack of evidence to inform health care and treatment decisions.

The Office of Research on Women’s Health recently convened a research forum to address the ethical/Institutional Review Board and recruitment issues that investigators face in the process of conceptualizing, initiating and conducting clinical research studies enrolling pregnant women. ORWH director Dr. Vivian Pinn and NICHD director Dr. Alan Guttmacher opened the forum by highlighting the need to address research to the health concerns of pregnant women.

The forum challenged the audience to increase the knowledge base from clinical research on pregnant women, to conduct appropriate scientifically and ethically designed clinical research and to address gaps in knowledge.

Medical ethicists, clinical investigators and academic researchers and those with an interest in clinical research in women presented information on the ethics of balancing risks and benefits, risk perception and risk reasoning. Additionally, presenters shared examples of challenges and strategies for overcoming barriers to clinical research on the health of pregnant women.

There were examples of maternal-fetal medicine research, research on chronic or infectious diseases and on evaluating preventive measures such as vaccines. The challenges to successful enrollment of pregnant women in various countries, in prospective registries and in randomized trials were described by the investigators who conquered those challenges.

Cosponsors of the forum included NICHD, NIAID, NIDA, OBSSR, OAR and the FDA Office of Women’s Health. NIHRecord Icon


back to top of page