title: Accelerating the paradigm shift toward inclusion of pregnant women in drug research: Ethical and regulatory considerations.
abstract: Although there has been long-standing reluctance to include pregnant women as clinical trial participants, increasing recognition of profound gaps in research on the safety and efficacy of drugs often prescribed to pregnant women calls into question the practice of routinely excluding them. This article presents compelling reasons for including pregnant women in clinical research, highlights certain regulatory barriers to the inclusion of pregnant women, and proposes that professional societies with expertise in obstetrics and maternal-fetal medicine can be instrumental in hastening the paradigm shift from the systematic exclusion of pregnant women in research to a one of responsible and fair inclusion.
authors.affiliation: National Institutes of Health, Department of Bioethics, Clinical Center, 10 Center Dr, 1C118, Bethesda, MD 20892-1156. Electronic address: Amina.white@nih.gov.
authors.forename: Amina
authors.initials: A
authors.lastname: White
mesh_terms: D000328:Adult; D035843:Biomedical Research / Q000941:ethics*; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008431:Maternal-Fetal Exchange; D009774:Obstetrics / Q000941:ethics; D056687:Off-Label Use / Q000941:ethics*; D010920:Placenta / Q000187:drug effects*; D011247:Pregnancy; D037841:Pregnant People; D055553:Prescription Drugs / Q000493:pharmacokinetics; D012107:Research Design; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D055553:Prescription Drugs