Evidence map›Paper›PMID 26358805›Full record

ReviewSeminars in perinatology2015

Pharmacologic studies in vulnerable populations: Using the pediatric experience.

Kanecia Zimmerman, Daniel Gonzalez, Geeta K Swamy, Michael Cohen-Wolkowiez

Abstract readReview
In one paragraph

Review in Seminars in perinatology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
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

14 citing papers in PubMed, 26 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Use of vasopressors for septic shock in the neonatal intensive care unit.Journal of perinatology : official journal of the California Perinatal Association · 2023
    Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Challenges in conducting clinical research studies in pregnant women.Journal of pharmacokinetics and pharmacodynamics · 2020
    Review
  11. Article
  12. Review
  13. Article
  14. Article
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

4 authors at 3 institutions in 1 country.

Kanecia ZimmermanDuke University Medical Center, Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705; Department of Pediatrics, Duke University Medical Center, Durham, NC.
Daniel GonzalezDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC.
Geeta K SwamyDivision of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.
Michael Cohen-WolkowiezDuke University Medical Center, Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705; Department of Pediatrics, Duke University Medical Center, Durham, NC. Electronic address: michael.cohenwolkowiez@duke.edu.
Clinical Research Institute · USDuke Medical Center · USUniversity of North Carolina at Chapel Hill · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Duke Research Training Program for PediatriciansT32HD043029 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2002 to 2017
$3.7M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
NICHD Maternal Fetal Medicine Units NetworkU10HD068258 · NICHD · DUKE UNIVERSITY · PI SWAMY, GEETA K. · 2011 to 2015
$1.5M
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 FD004858Intramural NIH HHSNCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1TR001117NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNICHD NIH HHS 1R01-HD076676-01A1NICHD NIH HHS 5U10-HD068258-04NICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS R01 HD076676NICHD NIH HHS T32 HD043029NICHD NIH HHS T32HD043029NICHD NIH HHS U10 HD068258
6 · The paper itself

Abstract

Historically, few data exist to guide dosing in children and pregnant women. Multiple barriers to inclusion of these vulnerable populations in clinical trials have led to this paucity of data. However, federal legislation targeted at pediatric therapeutics, innovative clinical trial design, use of quantitative clinical pharmacology methods, pediatric thought leadership, and collaboration have successfully overcome many existing barriers. This success has resulted in improved knowledge on pharmacokinetics, safety, and efficacy of therapeutics in children. To date, research in pregnant women has not been characterized by similar success. Wide gaps in knowledge remain despite the common use of therapeutics in pregnancy. Given the similar barriers to drug research and development in pediatric and pregnant populations, the route toward success in children may serve as a model for the advancement of drug development and appropriate drug administration in pregnant women.

Indexed as

PediatricsPregnant PeopleUnited States Food and Drug AdministrationAdultChildChild, PreschoolClinical Trials as TopicCooperative BehaviorDosage FormsDrug Administration RoutesFemaleHumansInfantInfant, NewbornMaleMaternal-Fetal ExchangeDosage FormsPrescription Drugschildrendrug developmentdrug trialspregnancy

Identifiers

PMID26358805
PMCPMC4628576
OpenAlexW2106322356

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.