Evidence map›Paper›PMID 38188909›Full record

ArticleFrontiers in pediatrics2023

Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation.

Eva Degraeuwe, Tessa van der Geest, Laura Persijn, Lieve Nuytinck, Ann Raes, Mark Turner, Ricardo M Fernandes, Johan Vande Walle, Saskia N de Wildt, IMI2 project conect4children (c4c) consortium, including National Hubs/Networks Belgian Pediatric Clinical Research Network (BPCRN) (Belgium) and Pedmed-NL (Netherlands)

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Frontiers in pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.7field-weighted citation impact, top 13% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 4 countries.

Eva DegraeuweFaculty of Medicine and Health Sciences, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
Tessa van der GeestDepartment of Pharmacy, Division Pharmacology and Toxicology, Radboud Institute for Health Science, Radboud University Medical Center, Nijmegen, Netherlands.
Laura PersijnFaculty of Medicine and Health Sciences, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
Lieve NuytinckDepartment of Pediatrics, Ghent University Hospital (UZGent), Ghent, Belgium.
Ann RaesFaculty of Medicine and Health Sciences, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
Mark TurnerDepartment of Pediatrics, University of Liverpool (ULIV), Liverpool, United Kingdom.
Ricardo M FernandesFaculty of Medicine, Laboratory of Clinical Pharmacology and Therapeutics, University of Lisbon, Lisbon, Portugal.
Johan Vande WalleFaculty of Medicine and Health Sciences, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
Saskia N de WildtDepartment of Pharmacy, Division Pharmacology and Toxicology, Radboud Institute for Health Science, Radboud University Medical Center, Nijmegen, Netherlands.
IMI2 project conect4children (c4c) consortium, including National Hubs/Networks Belgian Pediatric Clinical Research Network (BPCRN) (Belgium) and Pedmed-NL (Netherlands)
Ghent University · BEGhent University Hospital · BEErasmus MC - Sophia Children’s Hospital · NLRadboud University Medical Center · NLUniversity of Lisbon · PTUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The high failure rate of industry-driven pediatric clinical trials leads to insufficient timely labeling of drugs in children and a lack of scientific evidence, resulting in the persistently high off-label drug use. National clinical trial networks can facilitate collaboration between sites, investigators, and experts, increasing the likelihood of successful trials. Within the conect4children (c4c) network, an Innovative Medicines Initiative 2-funded project, National Hubs hosted by National Clinical Trials Networks were set up across 21 European countries to facilitate the setup and execution of pediatric clinical trials. In this paper, we aim to present the performance metrics of the trial feasibility process as well as learnings and challenges encountered by the Belgian and Dutch Networks in working within the European c4c project. Method: The c4c National Hubs streamline pediatric clinical trials by initiating early country outreach, identifying overlapping studies, recommending quality trial sites, and supporting trial budgeting for both industry and academic settings. To show the impact of Pedmed-NL and Belgian Pediatric Clinical Research Network (BPCRN), internal metrics were collected from 2019 to 2022 on four industry-sponsored and three academic trials performed within the c4c network. Timelines and outcomes of the site identification were collected and analyzed for industry trials. A qualitative analysis was conducted through c4c platforms, sponsor interactions, and stakeholder engagement to evaluate the added value of a research network. Results: In industry-sponsored trials, full feasibility questionnaires were completed within 2 weeks ( Conclusion: The early-facilitation examples from the c4c trials demonstrated promising metrics for two National Hubs, including optimized start-up timelines and aiding site selection quality. The learnings and challenges of the Belgian and Dutch Networks provided insights for the development of clinical research networks.

Indexed as

drug developmentfeasibilitymetricsnetworkspediatric

Identifiers

PMID38188909
PMCPMC10768052
OpenAlexW4390056045

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.