Designing drug trials: considerations for pregnant women.


Journal Article

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.

Full Text

Cited Authors

  • Sheffield, JS; Siegel, D; Mirochnick, M; Heine, RP; Nguyen, C; Bergman, KL; Savic, RM; Long, J; Dooley, KE; Nesin, M

Published Date

  • December 2014

Published In

Volume / Issue

  • 59 Suppl 7 /

Start / End Page

  • S437 - S444

PubMed ID

  • 25425722

Pubmed Central ID

  • 25425722

Electronic International Standard Serial Number (EISSN)

  • 1537-6591

International Standard Serial Number (ISSN)

  • 1058-4838

Digital Object Identifier (DOI)

  • 10.1093/cid/ciu709


  • eng