To fully benefit from medical advances, all populations need to be included in clinical trials. If particular populations are excluded from clinical trial participation, either actively or passively, the safety and efficacy of drugs, devices and other therapeutic approaches will remain unknown for individuals in these populations. Women, ethnic and racial minorities, and children have all experienced the consequences of exclusion from clinical trials. However, over the last two decades, federal legislation along with changes in Food and Drug Administration (FDA) and National Institutes of Health (NIH) policies have greatly improved the inclusion of women, ethnic and racial minorities, and children in clinical research.1,2

However, one important population that remains severely underrepresented in clinical trials is pregnant women.3 Although there is understandable concern about protecting the developing fetus, the consequences of systematically excluding pregnant women from clinical trials is profound. Over 90% of women take at least one drug during pregnancy and lactation, but there is very little safety and efficacy information about their use in this circumstance.4 This lack of safety and efficacy information is not only true of older drugs, but also for more recently approved drugs. For example no data were recorded about the risk in pregnancy of 73% of the drugs approved by the FDA between 2000 and 2010.5 Without adequate information, clinicians are appropriately reluctant to utilize medications that may be of great benefit to pregnant women with a wide variety of conditions. As was true for children, protecting pregnant women and their fetuses from the possible risks of research has resulted in even greater harms. Millions of pregnant women each year are exposed to drugs without adequate safety, efficacy, or drug–drug interaction information, and potentially important new therapies are unavailable.

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