The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy

J. Scaffidi, B. W. Mol, J. A. Keelan

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Objective: To undertake a survey of the world's clinical trial registries to provide current data on the number, nature, funding source and geographical distribution of pregnancy drug trials (PDT). Design and setting: Comprehensive analysis of WHO-certified clinical trial registries. Methods: Sixteen registries containing 301 538 trials (168 826 active in 2013–2014) were analysed to identify the numbers, location, funding sources, and areas of interest/development of PDTs. Results: The percentage of PDTs varied from 0 to 7.4% across registries. Overall, just 0.32% (534) of all active registered studies were PDTs. The US registry (Clinicaltrials.gov) was the largest database, but contributed just 14% of all active PDTs. The majority of PDTs focused on anaesthesia/analgesia, preterm birth/tocolysis, labour induction, endocrine and hypertensive disorders. Less than 6% of active PDTs focused on maternal or fetal health as a specific primary outcome, and only 4.4% included a preplanned pharmacokinetic analysis of the trial medications. A third of all active PDTs involved repurposing of existing medicines for applications in pregnancy, whereas only three new investigational drugs had been developed for a pregnancy indication. Seven percent of all active PDTs identified were pharmaceutical industry-funded. Inter-disease comparisons identified a ~50-fold disparity in trial activity between pregnancy and other comparable areas. Conclusions: This study demonstrates unequivocally the marked under-representation of medication development, evaluation and safety trials in pregnancy. The likelihood that the current pharmaceutical landscape in pregnancy will improve in the foreseeable future is slim. Advocacy and increased awareness of the issue is necessary to achieve positive change. Tweetable abstract: Pregnant women are significantly under-represented in global clinical drug trials.

LanguageEnglish
Pages132-140
Number of pages9
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume124
Issue number1
DOIs
Publication statusPublished - 1 Jan 2017

Keywords

  • Clinical trials
  • drug development
  • drug safety
  • pharmaceuticals
  • pregnancy

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

@article{eaa27f65ff0b403c98867e190f5515ab,
title = "The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy",
abstract = "Objective: To undertake a survey of the world's clinical trial registries to provide current data on the number, nature, funding source and geographical distribution of pregnancy drug trials (PDT). Design and setting: Comprehensive analysis of WHO-certified clinical trial registries. Methods: Sixteen registries containing 301 538 trials (168 826 active in 2013–2014) were analysed to identify the numbers, location, funding sources, and areas of interest/development of PDTs. Results: The percentage of PDTs varied from 0 to 7.4{\%} across registries. Overall, just 0.32{\%} (534) of all active registered studies were PDTs. The US registry (Clinicaltrials.gov) was the largest database, but contributed just 14{\%} of all active PDTs. The majority of PDTs focused on anaesthesia/analgesia, preterm birth/tocolysis, labour induction, endocrine and hypertensive disorders. Less than 6{\%} of active PDTs focused on maternal or fetal health as a specific primary outcome, and only 4.4{\%} included a preplanned pharmacokinetic analysis of the trial medications. A third of all active PDTs involved repurposing of existing medicines for applications in pregnancy, whereas only three new investigational drugs had been developed for a pregnancy indication. Seven percent of all active PDTs identified were pharmaceutical industry-funded. Inter-disease comparisons identified a ~50-fold disparity in trial activity between pregnancy and other comparable areas. Conclusions: This study demonstrates unequivocally the marked under-representation of medication development, evaluation and safety trials in pregnancy. The likelihood that the current pharmaceutical landscape in pregnancy will improve in the foreseeable future is slim. Advocacy and increased awareness of the issue is necessary to achieve positive change. Tweetable abstract: Pregnant women are significantly under-represented in global clinical drug trials.",
keywords = "Clinical trials, drug development, drug safety, pharmaceuticals, pregnancy",
author = "J. Scaffidi and Mol, {B. W.} and Keelan, {J. A.}",
year = "2017",
month = "1",
day = "1",
doi = "10.1111/1471-0528.14151",
language = "English",
volume = "124",
pages = "132--140",
journal = "BJOG: An International Journal of Obstetrics and Gynaecology",
issn = "1470-0328",
publisher = "Wiley-Blackwell",
number = "1",

}

The pregnant women as a drug orphan : a global survey of registered clinical trials of pharmacological interventions in pregnancy. / Scaffidi, J.; Mol, B. W.; Keelan, J. A.

In: BJOG: An International Journal of Obstetrics and Gynaecology, Vol. 124, No. 1, 01.01.2017, p. 132-140.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The pregnant women as a drug orphan

T2 - BJOG: An International Journal of Obstetrics and Gynaecology

AU - Scaffidi, J.

AU - Mol, B. W.

AU - Keelan, J. A.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Objective: To undertake a survey of the world's clinical trial registries to provide current data on the number, nature, funding source and geographical distribution of pregnancy drug trials (PDT). Design and setting: Comprehensive analysis of WHO-certified clinical trial registries. Methods: Sixteen registries containing 301 538 trials (168 826 active in 2013–2014) were analysed to identify the numbers, location, funding sources, and areas of interest/development of PDTs. Results: The percentage of PDTs varied from 0 to 7.4% across registries. Overall, just 0.32% (534) of all active registered studies were PDTs. The US registry (Clinicaltrials.gov) was the largest database, but contributed just 14% of all active PDTs. The majority of PDTs focused on anaesthesia/analgesia, preterm birth/tocolysis, labour induction, endocrine and hypertensive disorders. Less than 6% of active PDTs focused on maternal or fetal health as a specific primary outcome, and only 4.4% included a preplanned pharmacokinetic analysis of the trial medications. A third of all active PDTs involved repurposing of existing medicines for applications in pregnancy, whereas only three new investigational drugs had been developed for a pregnancy indication. Seven percent of all active PDTs identified were pharmaceutical industry-funded. Inter-disease comparisons identified a ~50-fold disparity in trial activity between pregnancy and other comparable areas. Conclusions: This study demonstrates unequivocally the marked under-representation of medication development, evaluation and safety trials in pregnancy. The likelihood that the current pharmaceutical landscape in pregnancy will improve in the foreseeable future is slim. Advocacy and increased awareness of the issue is necessary to achieve positive change. Tweetable abstract: Pregnant women are significantly under-represented in global clinical drug trials.

AB - Objective: To undertake a survey of the world's clinical trial registries to provide current data on the number, nature, funding source and geographical distribution of pregnancy drug trials (PDT). Design and setting: Comprehensive analysis of WHO-certified clinical trial registries. Methods: Sixteen registries containing 301 538 trials (168 826 active in 2013–2014) were analysed to identify the numbers, location, funding sources, and areas of interest/development of PDTs. Results: The percentage of PDTs varied from 0 to 7.4% across registries. Overall, just 0.32% (534) of all active registered studies were PDTs. The US registry (Clinicaltrials.gov) was the largest database, but contributed just 14% of all active PDTs. The majority of PDTs focused on anaesthesia/analgesia, preterm birth/tocolysis, labour induction, endocrine and hypertensive disorders. Less than 6% of active PDTs focused on maternal or fetal health as a specific primary outcome, and only 4.4% included a preplanned pharmacokinetic analysis of the trial medications. A third of all active PDTs involved repurposing of existing medicines for applications in pregnancy, whereas only three new investigational drugs had been developed for a pregnancy indication. Seven percent of all active PDTs identified were pharmaceutical industry-funded. Inter-disease comparisons identified a ~50-fold disparity in trial activity between pregnancy and other comparable areas. Conclusions: This study demonstrates unequivocally the marked under-representation of medication development, evaluation and safety trials in pregnancy. The likelihood that the current pharmaceutical landscape in pregnancy will improve in the foreseeable future is slim. Advocacy and increased awareness of the issue is necessary to achieve positive change. Tweetable abstract: Pregnant women are significantly under-represented in global clinical drug trials.

KW - Clinical trials

KW - drug development

KW - drug safety

KW - pharmaceuticals

KW - pregnancy

UR - http://www.scopus.com/inward/record.url?scp=84994383135&partnerID=8YFLogxK

U2 - 10.1111/1471-0528.14151

DO - 10.1111/1471-0528.14151

M3 - Article

VL - 124

SP - 132

EP - 140

JO - BJOG: An International Journal of Obstetrics and Gynaecology

JF - BJOG: An International Journal of Obstetrics and Gynaecology

SN - 1470-0328

IS - 1

ER -