title: Should pregnant women be included in phase IV clinical drug trials?
abstract: Relatively few drugs, especially those recently approved by the US Food and Drug Administration, have published human pregnancy experience. Although all drugs contain animal reproduction data, these are usually not predictive of human risk. Clinical trials in pregnant women are rarely conducted because of ethical and legal concerns, and it may be many years before sufficient observational data are collected to guide clinical treatment decisions. Because many of these drugs will be used in pregnancy, human data are needed shortly after the drugs come to the market. Lack of human data leads to uncertainty over whether a drug can be safely prescribed for a pregnant patient. Unless there are compelling scientific and ethical reasons to exclude them, pregnant women should be included in phase IV clinical trials (postmarketing studies to obtain additional information, including the risks, benefits, and optimal use of a drug). This paper examines how physicians currently counsel pregnant women when there are no human data and proposes an alternative method in which knowledge regarding risks associated with the use of drugs during pregnancy can be enhanced in a clinical trial setting.
authors.affiliation: University of California, San Francisco, San Francisco, CA; Department of Pharmacy Practice, University of Southern California, Los Angeles, Los Angeles, CA; Department of Pharmacotherapy, Washington State University, Spokane, WA. Electronic address: dplbriggs@gmail.com.
authors.forename: Gerald G
authors.initials: GG
authors.lastname: Briggs
authors.affiliation: University of Washington, Seattle, WA.
authors.forename: Janine E
authors.initials: JE
authors.lastname: Polifka
authors.affiliation: Departments of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL.
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Wisner
authors.affiliation: Duchesnay, Blainville, QC, Canada.
authors.forename: Eric
authors.initials: E
authors.lastname: Gervais
authors.affiliation: Department of Obstetrics-Gynecology, School of Medicine and Dentistry, University of Rochester, Rochester, NY.
authors.forename: Richard K
authors.initials: RK
authors.lastname: Miller
authors.affiliation: Faculty of Pharmacy, University of Montreal, Research Center, CHU Ste-Justine, Montreal, QC, Canada.
authors.forename: Anick
authors.initials: A
authors.lastname: Berard
authors.affiliation: The Motherisk Program, The Hospital for Sick Children, Department of Pediatrics, Pharmacology, Pharmacy, and Medical Genetics, University of Toronto, Department of Physiology/Pharmacology, University of Western Ontario, London, Ontario.
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
authors.affiliation: Saint Louis College of Pharmacy, Maternal-Fetal Care Clinic, Saint Mary's Health Center, St Louis, MO.
authors.forename: Alicia
authors.initials: A
authors.lastname: Forinash
authors.affiliation: Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of Tennessee Medical Center, Knoxville, TN.
authors.forename: Craig V
authors.initials: CV
authors.lastname: Towers
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000517:prevention & control; D000818:Animals; D017327:Clinical Trials, Phase IV as Topic; D003376:Counseling; D005260:Female; D006801:Humans; D010348:Patient Care Team; D018579:Patient Selection; D011247:Pregnancy; D037841:Pregnant People; D035842:Research Subjects; D013723:Teratogens
chemical_list: D013723:Teratogens
keywords: birth defects; developmental toxicity; drugs; phase IV clinical trials; pregnancy