Conference report: Complex clinical, legal, and ethical issues of pregnant and postpartum women as subjects in clinical trials

Background: The Office of the Vice President for Research and School of Nursing of the University of Texas Medical Branch convened a multidisciplinary conference to address the national problem of underrepresentation of pregnant women in clinical trials. Methods: Conference participants reviewed pertinent issues through lectures and panel discussions. Results: More funded studies are needed to specifically examine pharmacokinetic, physiological, and pharmacological interactions in the pregnant woman. Legal, ethical, and financial issues need to be better delineated, and more focus is needed on specific diseases with particular import for pregnant women and their fetuses. Conclusions: This paper provides a report on the conference and the powerful consensus statements developed by the participants.