Why Physicians and Women Should Want Pregnant Women Included in Clinical Trials

Abstract

A direct consequence of the routine exclusion of pregnant women from clinical trials is pregnant women using over-the-counter and prescription medications in the absence of population-specific clinical trial data about the potential benefits and harms of these medications for themselves, their foetuses, and their future children. In our view, pregnant women are as entitled as other patient populations to robust clinical trial data about safety and dosing on the basis of which to make evidence-informed decisions. To this end, we maintain that pregnant women should be presumed eligible to participate in clinical trials. This chapter asks and answers the following questions: Why are clinical trials in pregnancy important from a physician’s perspective? And, why are clinical trials in pregnancy important from a pregnant woman’s perspective? Having addressed these questions, we next consider why pregnant women might choose not to participate in clinical trials, and what can be done to encourage their participation.