title: Designing drug trials: considerations for pregnant women.
abstract: Clinical pharmacology studies that describe the pharmacokinetics and pharmacodynamics of drugs in pregnant women are critical for informing on the safe and effective use of drugs during pregnancy. That being said, multiple factors have hindered the ability to study drugs in pregnant patients. These include concerns for maternal and fetal safety, ethical considerations, the difficulty in designing appropriate trials to assess the study objectives, and funding limitations. This document summarizes the recommendations of a panel of experts convened by the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. These experts were charged with reviewing the issues related to the development of preclinical and clinical drug studies in pregnant women and to develop strategies for addressing these issues. These findings may also be utilized in the development of future drug studies involving pregnant women and their fetus/neonate.
authors.affiliation: Division of Maternal-Fetal Medicine, University of Texas Southwestern Medical Center, Dallas.
authors.forename: Jeanne S
authors.initials: JS
authors.lastname: Sheffield
authors.affiliation: National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
authors.forename: David
authors.initials: D
authors.lastname: Siegel
authors.affiliation: Division of Neonatology, Boston University, Massachusetts.
authors.forename: Mark
authors.initials: M
authors.lastname: Mirochnick
authors.affiliation: Division of Maternal-Fetal Medicine, Duke University, Durham, North Carolina.
authors.forename: R Phillips
authors.initials: RP
authors.lastname: Heine
authors.affiliation: Division of Bone, Reproductive, and Urologic Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research.
authors.forename: Christine
authors.initials: C
authors.lastname: Nguyen
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Kimberly L
authors.initials: KL
authors.lastname: Bergman
authors.affiliation: Department of Bioengineering, School of Pharmacy, University of California, San Francisco.
authors.forename: Rada M
authors.initials: RM
authors.lastname: Savic
authors.affiliation: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
authors.forename: Jill
authors.initials: J
authors.lastname: Long
authors.affiliation: Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Kelly E
authors.initials: KE
authors.lastname: Dooley
authors.affiliation: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
authors.forename: Mirjana
authors.initials: M
authors.lastname: Nesin
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007223:Infant; D008431:Maternal-Fetal Exchange; D010599:Pharmacokinetics; D010920:Placenta / Q000502:physiology; D011247:Pregnancy; D011256:Pregnancy Outcome; D037841:Pregnant People; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
keywords: drug trials; pharmacokinetics; pregnancy