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.
Goodrum
Linda A
LA
Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-0587, USA. lgoodrum@utmb.edu
Hankins
Gary D V
GD
Jermain
Donna
D
Chanaud
Cheryl M
CM
D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D004341:Drug Evaluation / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D032984:Ethics, Research; D005260:Female; D006801:Humans; D049590:Postpartum Period / Q000187:drug effects*; D017410:Practice Guidelines as Topic; D011247:Pregnancy / Q000187:drug effects*; D035842:Research Subjects; D012306:Risk; D013781:Texas; D016387:Women's Health