Abstract
There is paucity of evidence to support clinical decision making and
counseling related to medication use in pregnancy. Despite multiple
efforts from legislative bodies and advocacy groups, the inclusion of
pregnant women in clinical drug trials assessing efficacy and safety
remains scarce. Pregnancy can be complicated by multiple co-morbidities
that require pharmacological intervention; these interventions primarily
target the pregnant women but also sometimes have secondary effects for
the fetus. The U.S. Food and Drug Administration has issued multiple
guidance documents on incorporating pregnant women in clinical trials to
aid pharmaceutical companies in designing a protocol to ensure safety
and adherence to ethical standards. Advances in pediatric pharmacology
studies provide lessons for researchers on the best practice of
designing clinical trials with inclusion of patients from special
populations. In this review, we present the status of pregnant women in
clinical trials, highlighting the ethical stigma and possible future
directives.