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 Towers

Research output: Contribution to journalArticle

11 Citations (Scopus)

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

Fingerprint

Phase IV Clinical Trials
Pregnant Women
Pharmaceutical Preparations
Pregnancy
Clinical Trials
United States Food and Drug Administration
Uncertainty
Reproduction
Physicians

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Cite this

Should pregnant women be included in phase IV clinical drug trials? / Briggs, Gerald G.; Polifka, Janine E.; Wisner, Katherine L.; Gervais, Eric; Miller, Richard K.; Berard, Anick; Koren, Gideon; Forinash, Alicia; Towers, Craig.

In: American Journal of Obstetrics and Gynecology, Vol. 213, No. 6, 01.01.2015, p. 810-815.

Research output: Contribution to journalArticle

Briggs, GG, Polifka, JE, Wisner, KL, Gervais, E, Miller, RK, Berard, A, Koren, G, Forinash, A & Towers, C 2015, 'Should pregnant women be included in phase IV clinical drug trials?', American Journal of Obstetrics and Gynecology, vol. 213, no. 6, pp. 810-815. https://doi.org/10.1016/j.ajog.2015.05.047
Briggs, Gerald G. ; Polifka, Janine E. ; Wisner, Katherine L. ; Gervais, Eric ; Miller, Richard K. ; Berard, Anick ; Koren, Gideon ; Forinash, Alicia ; Towers, Craig. / Should pregnant women be included in phase IV clinical drug trials?. In: American Journal of Obstetrics and Gynecology. 2015 ; Vol. 213, No. 6. pp. 810-815.
@article{f820f73e16764a41b9d4d42dd86a7c3d,
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.",
author = "Briggs, {Gerald G.} and Polifka, {Janine E.} and Wisner, {Katherine L.} and Eric Gervais and Miller, {Richard K.} and Anick Berard and Gideon Koren and Alicia Forinash and Craig Towers",
year = "2015",
month = "1",
day = "1",
doi = "10.1016/j.ajog.2015.05.047",
language = "English (US)",
volume = "213",
pages = "810--815",
journal = "American Journal of Obstetrics and Gynecology",
issn = "0002-9378",
publisher = "Mosby Inc.",
number = "6",

}

TY - JOUR

T1 - Should pregnant women be included in phase IV clinical drug trials?

AU - Briggs, Gerald G.

AU - Polifka, Janine E.

AU - Wisner, Katherine L.

AU - Gervais, Eric

AU - Miller, Richard K.

AU - Berard, Anick

AU - Koren, Gideon

AU - Forinash, Alicia

AU - Towers, Craig

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84932147675&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84932147675&partnerID=8YFLogxK

U2 - 10.1016/j.ajog.2015.05.047

DO - 10.1016/j.ajog.2015.05.047

M3 - Article

C2 - 26008178

AN - SCOPUS:84932147675

VL - 213

SP - 810

EP - 815

JO - American Journal of Obstetrics and Gynecology

JF - American Journal of Obstetrics and Gynecology

SN - 0002-9378

IS - 6

ER -