Evidence map›Paper›PMID 31708158›Full record

ArticleThe Journal of pediatrics2020

Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.

Jonathan M Davis, Gerri R Baer, Susan McCune, Agnes Klein, Junko Sato, Laura Fabbri, Alexandra Mangili, Mary A Short, Susan Tansey, Barry Mangum and 10 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. 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

20 authors.

Jonathan M DavisThe Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Boston, MA. Electronic address: jdavis@tuftsmedicalcenter.org.
Gerri R BaerUS Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, MD.
Susan McCuneUS Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, MD.
Agnes KleinHealth Canada, Ottawa, Ontario, Canada.
Junko SatoPharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Laura FabbriChiesi Farmaceutici SpA, Parma, Italy.
Alexandra MangiliTakeda Pharmaceutical Company Limited, Zug, Switzerland.
Mary A ShortEli Lilly and Co, Indianapolis, IN.
Susan TanseyIndependent Consultant Pharmaceutical Physician, Durham, NC.
Barry MangumPaidion Research Inc, Durham, NC.
Isamu HokutoSt. Marianna University, Kawasaki, Japan.
Hidefumi NakamuraNational Center for Child Health and Development, Tokyo, Japan.
Thomas SalaetsDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.
Karel AllegaertDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Lynne YaoUS Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD.
Michael BlumUS Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD.
Joseph ToernerUS Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD.
Mark TurnerInstitute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.
Ron PortmanNovartis Pharmaceuticals, East Hanover, NJ.
International Neonatal ConsortiumCritical Path Institute, Tucson, AZ.

Funding

Critical Path to Public Private PartnershipsU18FD005320 · FDA · CRITICAL PATH INSTITUTE · PI Klaus Romero · 2014 to 2026
$127.1M
FDA HHS U18 FD005320Intramural FDA HHS FD999999
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Clinical Trials as TopicHumansInfant, NewbornPatient SafetyResearch Design

Identifiers

PMID31708158
PMCPMC7096275

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.