Evidence map›Paper›PMID 21980319›Full record

ReviewExpert review of clinical pharmacology2011

Innovative clinical trial design for pediatric therapeutics.

Matthew M Laughon, Daniel K Benjamin, Edmund V Capparelli, Gregory L Kearns, Katherine Berezny, Ian M Paul, Kelly Wade, Jeff Barrett, Phillip Brian Smith, Michael Cohen-Wolkowiez

Open access · greenAbstract readReview
In one paragraph

Review in Expert review of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 3 pooled it
7.0field-weighted citation impact, top 4% 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

76 citing papers in PubMed, 3 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. A systematic review of randomized controlled trials for the prevention of bronchopulmonary dysplasia in infants.Journal of perinatology : official journal of the California Perinatal Association · 2014
    Pooled it
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16 more citing papers are in PubMed but not listed here.

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

10 authors at 8 institutions in 1 country.

Matthew M LaughonSchool of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Daniel K Benjamin
Edmund V Capparelli
Gregory L Kearns
Katherine Berezny
Ian M Paul
Kelly Wade
Jeff Barrett
Phillip Brian Smith
Michael Cohen-Wolkowiez
Clinical Research Institute · USDuke University · USChildren's Mercy Hospital · USPenn State Milton S. Hershey Medical Center · USPennsylvania State University · USUniversity of North Carolina at Chapel Hill · USUniversity of Pennsylvania · USUniversity of San Diego · US

Funding

Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01HD057956 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2012
$2.8M
North Carolina Collaborative PPRU NetworkU10HD045962 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2004 to 2009
$2.1M
Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01FD003519 · FDA · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2011
$1.6M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
Antimicrobial pharmacokinetics and outcomes in vulnerable infantsK23HD068497 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2011 to 2015
$586k
Pharmacokinetics and Pharmacodynamics of Antibiotics in Premature InfantsK23HD064814 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2010 to 2013
$474k
PHARMACOKINETICS OF ANTIMICROBIAL AGENTS IN HIGH RISK INFANTSK23HD060040 · NICHD · DUKE UNIVERSITY · PI SMITH, PHILLIP BRIAN · 2009 to 2012
$445k
ASPE HHS 1R18AE000028-01FDA HHS 1R01FD003519-01FDA HHS R01 FD003519NHLBI NIH HHS 1K23HL092225-01NICHD NIH HHS 1K23HD060040-01NICHD NIH HHS 1K23HD064814-01NICHD NIH HHS 1K24HD058735-01NICHD NIH HHS 1R01HD057956-02NICHD NIH HHS 1U10-HD45962-06NICHD NIH HHS HHSN267200700051CNICHD NIH HHS K23 HD060040NICHD NIH HHS K23 HD064814NICHD NIH HHS K23 HD068497NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD057956NICHD NIH HHS U10 HD045962NIDDK NIH HHS HHSN267200700051CNIEHS NIH HHS 27399I0001
6 · The paper itself

Abstract

Until approximately 15 years ago, sponsors rarely included children in the development of therapeutics. US and European legislation has resulted in an increase in the number of pediatric trials and specific label changes and dosing recommendations, although infants remain an understudied group. The lack of clinical trials in children is partly due to specific challenges in conducting trials in this patient population. Therapeutics in special populations, including premature infants, obese children and children receiving extracorporeal life support, are even less studied. National research networks in Europe and the USA are beginning to address some of the gaps in pediatric therapeutics using novel clinical trial designs. Recent innovations in pediatric clinical trial design, including sparse and scavenged sampling, population pharmacokinetic analyses and 'opportunistic' studies, have addressed some of the historical challenges associated with clinical trials in children.

Indexed as

Pharmaceutical PreparationsAge FactorsChildClinical Trials as TopicHumansPediatricsTherapies, InvestigationalPharmaceutical Preparationsclinical trial simulationopportunistic studypediatricspharmacodynamicspharmacokineticspharmacometricstherapeutics

Identifiers

PMID21980319
PMCPMC3184526
OpenAlexW1972576782

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.