Evidence map›Paper›PMID 25751205›Full record

ArticleObstetrics and gynecology2015

Lessons learned in pediatric clinical research to evaluate safe and effective use of drugs in pregnancy.

Daniel Gonzalez, Kim A Boggess, Michael Cohen-Wolkowiez

Abstract read
In one paragraph

Article in Obstetrics and gynecology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Challenges in conducting clinical research studies in pregnant women.Journal of pharmacokinetics and pharmacodynamics · 2020
    Review
  9. Article
  10. Vaccine Trials in Schools: We Must Not Ignore Progress.American journal of public health · 2019
    Article
  11. Review
  12. Article
  13. Epidemiology of medications use in pregnancy.Seminars in perinatology · 2015
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Daniel GonzalezDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, and the Division of Maternal- Fetal Medicine, School of Medicine, University of North Carolina, Chapel Hill, and the Duke Clinical Research Institute and the Department of Pediatrics, Duke University Medical Center, Durham, North Carolina.
Kim A Boggess
Michael Cohen-Wolkowiez

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Clinical Practice Data to Aid Narrow Therapeutic Index Drug ClassificationU01FD004858 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2013 to 2014
$497k
FDA HHS 1U01FD004858-01FDA HHS U01 FD004858NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1TR001117NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNICHD NIH HHS 1R01-HD076676-01A1NICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS R01 HD076676
6 · The paper itself

Abstract

Children and pregnant women are vulnerable populations lacking clinical data to guide drug dosing. For children, over the past 15 years, the knowledge gap in pharmacokinetic, safety, and efficacy data has been narrowed as a result of the use of innovative clinical trial designs, minimal risk research methods, increased understanding of developmental pharmacology, multidisciplinary research teams, increased clinical pharmacology expertise and training, collaborative research networks, and critical legislative changes. This progress has not been observed to a similar degree for pregnant women. These two populations, however, share similar drug development challenges and, therefore, lessons learned in pediatric clinical trials can be leveraged to advance drug development in pregnant women.

Indexed as

Models, TheoreticalPharmacological PhenomenaChildClinical Trials as TopicComputer SimulationDrug DiscoveryFemaleHumansMulticenter Studies as TopicPediatricsPharmacokineticsPregnancy

Identifiers

PMID25751205
PMCPMC4372491

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.