title: Conference report: complex clinical, legal, and ethical issues of pregnant and postpartum women as subjects in clinical trials.
abstract: 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.
authors.affiliation: Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77555-0587, USA. lgoodrum@utmb.edu
authors.forename: Linda A
authors.initials: LA
authors.lastname: Goodrum
authors.forename: Gary D V
authors.initials: GD
authors.lastname: Hankins
authors.forename: Donna
authors.initials: D
authors.lastname: Jermain
authors.forename: Cheryl M
authors.initials: CM
authors.lastname: Chanaud
mesh_terms: 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