Enrolling Pregnant Women in Research — Lessons from the H1N1 Influenza Pandemic

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Abstract
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. Not only could the lack of these data result in incorrect dosing and ineffective or subtherapeutic treatment for pregnant women, but inadequate dosing could also potentially accelerate the development of drug resistance and negatively affect the general usefulness of antiviral treatments during a pandemic. In the early 1990s, the Food and Drug Administration (FDA) removed restrictions on, and actually began encouraging, the inclusion of women of “child-bearing potential” in clinical studies. We would argue that it is not only permissible but also imperative that pregnant women be judiciously included in research.1,2

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