Evidence map›Paper›PMID 26968616›Full record

ArticleContemporary clinical trials2016

Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience.

Amanda England, Kelly Wade, P Brian Smith, Katherine Berezny, Matthew Laughon, Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee

Abstract read
In one paragraph

Article in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
11.1field-weighted citation impact, top 2% 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

22 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
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  6. JAMIA open · 2022
    Article
  7. Article
  8. Article
  9. Observational
  10. Article
  11. Review
  12. Association between neonatal intensive care unit medication safety practices, adverse events, and death.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. A directory for neonatal intensive care: potential for facilitating network-based research in neonatology.Journal of perinatology : official journal of the California Perinatal Association · 2018
    Article
  18. Review
  19. Article
  20. 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

6 authors at 3 institutions in 1 country.

Amanda EnglandDivision of Neonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill, N.C. Memorial Hospital, 101 Manning Drive, CB#7596, Chapel Hill, NC 27599-7596, USA.
Kelly WadeDivision of Neonatology, Children's Hospital of Pennsylvania, CHOP Newborn Care at the Hospital of the University of Pennsylvania, 800 Spruce St., Philadelphia, PA 19107, USA.
P Brian SmithDepartment of Pediatrics, Duke University School of Medicine, Durham, NC 27710, USA; Duke Clinical Research Institute, Duke University School of Medicine, P.O. Box 17969, Durham, NC 27715, USA.
Katherine BereznyDuke Clinical Research Institute, Duke University School of Medicine, P.O. Box 17969, Durham, NC 27715, USA.
Matthew LaughonDivision of Neonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill, N.C. Memorial Hospital, 101 Manning Drive, CB#7596, Chapel Hill, NC 27599-7596, USA. Electronic address: matt_laughon@med.unc.edu.
Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee
Duke University · USUniversity of North Carolina at Chapel Hill · USHospital of the University of Pennsylvania · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
Fungal biomarkers for diagnosis and response to therapy for pediatric candidemiaR01HD081044 · NICHD · DUKE UNIVERSITY · PI FISHER, BRIAN T, STEINBACH, WILLIAM J · 2014 to 2018
$3.2M
NIH Summer Research Experience Programs (R25)R25HD076475 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2013 to 2023
$1.1M
Echocardiogram to Diagnose Pulmonary Hypertension in Premature InfantsR34HL124038 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2015 to 2016
$719k
Antimicrobial pharmacokinetics and outcomes in vulnerable infantsK23HD068497 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2011 to 2015
$586k
FDA HHS 1R18-FD005292-01FDA HHS R18 FD005292NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1TR001117NHLBI NIH HHS R34 HL124038NICHD NIH HHS 1R01-HD081044-01NICHD NIH HHS 1R25-HD076475-01NICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD068497NICHD NIH HHS R01 HD081044NICHD NIH HHS R25 HD076475
6 · The paper itself

Abstract

Performing drug trials in pediatrics is challenging. In support of the Best Pharmaceuticals for Children Act, the Eunice Kennedy Shriver National Institute of Child Health and Human Development funded the formation of the Pediatric Trials Network (PTN) in 2010. Since its inception, the PTN has developed strategies to increase both efficiency and safety of pediatric drug trials. Through use of innovative techniques such as sparse and scavenged blood sampling as well as opportunistic study design, participation in trials has grown. The PTN has also strived to improve consistency of adverse event reporting in neonatal drug trials through the development of a standardized adverse event table. We review how the PTN is optimizing operational efficiencies in pediatric drug trials to increase the safety of drugs in children.

Indexed as

Drug TherapyPediatricsAdverse Drug Reaction Reporting SystemsChildClinical Trials as TopicEfficiency, OrganizationalHumansIntersectoral CollaborationMulticenter Studies as TopicPatient SafetyResearch DesignUnited StatesAdverse eventsOrganizational improvementsPediatric drug trials

Identifiers

PMID26968616
PMCPMC4997801
OpenAlexW2294679015

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.