Should pregnant women be included in phase IV clinical drug trials?

Gerald G. Briggs*, Janine E. Polifka, Katherine L. Wisner, Eric Gervais, Richard K. Miller, Anick Berard, Gideon Koren, Alicia Forinash, Craig V. Towers

*Corresponding author for this work

Research output: Contribution to journalArticle

13 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)810-815
Number of pages6
JournalAmerican journal of obstetrics and gynecology
Volume213
Issue number6
DOIs
StatePublished - Jan 1 2015

Keywords

  • birth defects
  • developmental toxicity
  • drugs
  • phase IV clinical trials
  • pregnancy

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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