|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
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.