Evidence map›Paper›PMID 28612093›Full record

ArticlePaediatric drugs2017

Clinical Trial Design in Juvenile Idiopathic Arthritis.

Stephen J Balevic, Mara L Becker, Michael Cohen-Wolkowiez, Laura E Schanberg

Open access · greenAbstract read
In one paragraph

Article in Paediatric drugs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.1field-weighted citation impact, top 22% 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

9 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Sample Size Calculation for an Individual Stepped-Wedge Randomized Trial.Biometrical journal. Biometrische Zeitschrift · 2024
    Article
  6. Article
  7. Observational
  8. Article
  9. 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

4 authors at 4 institutions in 1 country.

Stephen J BalevicDivision of Pediatric Rheumatology, Duke University Medical Center, 2301 Erwin Road, CHC, T-Level, Durham, NC, 27710, USA. stephen.balevic@duke.edu.
Mara L BeckerDepartment of Pediatrics, Children's Mercy Kansas City, UMKC School of Medicine, 2401 Gillham Road, Kansas City, MO, 64108, USA.
Michael Cohen-WolkowiezPharmacometrics Center, Duke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA.
Laura E SchanbergDivision of Pediatric Rheumatology, Duke University Medical Center, 2301 Erwin Road, CHC, T-Level, Durham, NC, 27710, USA.
Clinical Research Institute · USDuke Medical Center · USDuke University Hospital · USMercy Hospital · US

Funding

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
Enhancing Meaningfulness and Usefulness of Pediatric and Caregiver PROMIS Measures Across Illness GroupsU19AR069522 · NIAMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI REEVE, BRYCE B, SCHANBERG, LAURA E · 2015 to 2015
$2.9M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Enhancing the CARRA: Integration and Dissemination of Clinical DataR01AR063890 · NIAMS · DUKE UNIVERSITY · PI SCHANBERG, LAURA E · 2012 to 2013
$407k
NIAID NIH HHS HHSN272201300017INIAMS NIH HHS R01 AR063890NIAMS NIH HHS U19 AR069522NICHD NIH HHS HHSN275201000003INICHD NIH HHS R01 HD076676NIGMS NIH HHS T32 GM086330NIH HHS 2T32GM086330-06
6 · The paper itself

Abstract

Randomized clinical trials provide the gold standard evidence base to guide clinical practice. Despite major advances in trial design, pediatric clinical trials are still difficult to perform and pose unique challenges, including the need to consider the impact of developmental changes in trial design. Advances within pediatric rheumatology combined with the need to comply with legislative requirements have driven new approaches to performing pediatric clinical trials such as utilization of large research networks, incorporation of patient and family stakeholders in the planning and implementation of clinical trials, and the development of novel trial designs. The expansion of available biological therapeutics that now includes biosimilar drugs highlights the important and difficult balance of providing new and cost-effective drugs to children while ensuring safety in a vulnerable population. Future advances in juvenile idiopathic arthritis (JIA) clinical trials will likely be the application of precision medicine based on biologic, rather than phenotypic, classification of JIA, with improved understanding of pediatric clinical pharmacology. Clinical trial simulations and comparative effectiveness studies are important supplements to traditional clinical trials, permitting efficient studies and results that are more generalizable.

Indexed as

Clinical Trials as TopicAntirheumatic AgentsArthritis, JuvenileChildDrug CostsHumansRandomized Controlled Trials as TopicAntirheumatic Agents

Identifiers

PMID28612093
PMCPMC6105333
OpenAlexW2624794415

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.