Designing drug trials

Considerations for pregnant women

Jeanne S. Sheffield, David Siegel, Mark Mirochnick, R. Phillips Heine, Christine Nguyen, Kimberly L. Bergman, Rada M. Savic, Jill Long, Kelly E. Dooley, Mirjana Nesin

Research output: Contribution to journalArticle

24 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)S437-S444
JournalClinical Infectious Diseases
Volume59
DOIs
StatePublished - 2014

Fingerprint

Pregnant Women
Pharmaceutical Preparations
National Institute of Allergy and Infectious Diseases (U.S.)
Clinical Pharmacology
National Institutes of Health (U.S.)
Microbiology
Communicable Diseases
Fetus
Pharmacokinetics
Mothers
Newborn Infant
Safety
Pregnancy
Clinical Studies

Keywords

  • Drug trials
  • Pharmacokinetics
  • Pregnancy

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Sheffield, J. S., Siegel, D., Mirochnick, M., Heine, R. P., Nguyen, C., Bergman, K. L., ... Nesin, M. (2014). Designing drug trials: Considerations for pregnant women. Clinical Infectious Diseases, 59, S437-S444. https://doi.org/10.1093/cid/ciu709

Designing drug trials : Considerations for pregnant women. / Sheffield, Jeanne S.; Siegel, David; Mirochnick, Mark; Heine, R. Phillips; Nguyen, Christine; Bergman, Kimberly L.; Savic, Rada M.; Long, Jill; Dooley, Kelly E.; Nesin, Mirjana.

In: Clinical Infectious Diseases, Vol. 59, 2014, p. S437-S444.

Research output: Contribution to journalArticle

Sheffield, JS, Siegel, D, Mirochnick, M, Heine, RP, Nguyen, C, Bergman, KL, Savic, RM, Long, J, Dooley, KE & Nesin, M 2014, 'Designing drug trials: Considerations for pregnant women', Clinical Infectious Diseases, vol. 59, pp. S437-S444. https://doi.org/10.1093/cid/ciu709
Sheffield JS, Siegel D, Mirochnick M, Heine RP, Nguyen C, Bergman KL et al. Designing drug trials: Considerations for pregnant women. Clinical Infectious Diseases. 2014;59:S437-S444. https://doi.org/10.1093/cid/ciu709
Sheffield, Jeanne S. ; Siegel, David ; Mirochnick, Mark ; Heine, R. Phillips ; Nguyen, Christine ; Bergman, Kimberly L. ; Savic, Rada M. ; Long, Jill ; Dooley, Kelly E. ; Nesin, Mirjana. / Designing drug trials : Considerations for pregnant women. In: Clinical Infectious Diseases. 2014 ; Vol. 59. pp. S437-S444.
@article{890dfd24bc534f95a91d117f8f880d21,
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.",
keywords = "Drug trials, Pharmacokinetics, Pregnancy",
author = "Sheffield, {Jeanne S.} and David Siegel and Mark Mirochnick and Heine, {R. Phillips} and Christine Nguyen and Bergman, {Kimberly L.} and Savic, {Rada M.} and Jill Long and Dooley, {Kelly E.} and Mirjana Nesin",
year = "2014",
doi = "10.1093/cid/ciu709",
language = "English (US)",
volume = "59",
pages = "S437--S444",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",

}

TY - JOUR

T1 - Designing drug trials

T2 - Considerations for pregnant women

AU - Sheffield, Jeanne S.

AU - Siegel, David

AU - Mirochnick, Mark

AU - Heine, R. Phillips

AU - Nguyen, Christine

AU - Bergman, Kimberly L.

AU - Savic, Rada M.

AU - Long, Jill

AU - Dooley, Kelly E.

AU - Nesin, Mirjana

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - Drug trials

KW - Pharmacokinetics

KW - Pregnancy

UR - http://www.scopus.com/inward/record.url?scp=84979862120&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84979862120&partnerID=8YFLogxK

U2 - 10.1093/cid/ciu709

DO - 10.1093/cid/ciu709

M3 - Article

VL - 59

SP - S437-S444

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

ER -