New England Journal of Medicine
Volume 362 — June 17, 2010 — Number 24
http://content.nejm.org/current.shtml
Perspective
Enrolling Pregnant Women in Research — Lessons from the H1N1 Influenza Pandemic
S. F. Goldkind, L. Sahin, and B. Gallauresi
The global H1N1 influenza pandemic disproportionately affected pregnant women, drawing attention to the fact that although they need safe and effective medical treatment, they have always been a marginalized study population. Antiviral agents for treating influenza have been available in the United States for more than 10 years and are widely prescribed for pregnant women. Despite the understanding that physiological changes associated with pregnancy (e.g., changes in renal and hepatic function) can markedly alter pharmacokinetics, pharmacokinetic studies have not routinely been conducted in this population.