Evidence map›Paper›PMID 35560985›Full record

ArticleFrontiers in pediatrics2022

Analysis of Paediatric Clinical Trial Characteristics and Activity Over 23 Years-Impact of the European Paediatric Regulation on a Single French Clinical Research Center.

Johanna Arnadottir, François Luc, Florentia Kaguelidou, Evelyne Jacqz-Aigrain, Collaborative CIC1426 Investigator Group

Open access · goldAbstract read
In one paragraph

Article in Frontiers in pediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 90% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

5 authors at 2 institutions in 1 country.

Johanna ArnadottirClinical Investigation Center CIC1426, Hôpital Robert Debré Assistance Publique-Hôpitaux de Paris INSERM, Paris, France.
François LucClinical Investigation Center CIC1426, Hôpital Robert Debré Assistance Publique-Hôpitaux de Paris INSERM, Paris, France.
Florentia KaguelidouClinical Investigation Center CIC1426, Hôpital Robert Debré Assistance Publique-Hôpitaux de Paris INSERM, Paris, France.
Evelyne Jacqz-AigrainClinical Investigation Center CIC1426, Hôpital Robert Debré Assistance Publique-Hôpitaux de Paris INSERM, Paris, France.
Collaborative CIC1426 Investigator Group
Assistance Publique – Hôpitaux de Paris · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As unlicensed or off-label drugs are frequently prescribed in children, the European Pediatric Regulation came into force in 2007 to improve the safe use of medicinal products in the pediatric population. This present report analyzes the pediatric research trials over 23 years in a clinical research center dedicated to children and the impact of regulation. The database of trial characteristics from 1998 to 2020 was analyzed. We also searched for differences between two periods (1998-2006 and 2007-2020) and between institutional and industrial sponsors during the whole period (1998-2020). A total of 379 pediatric trials were initiated at our center, corresponding to inclusion of 7955 subjects and 19448 on-site patient visits. The trials were predominantly drug evaluation trials (

Indexed as

drug evaluationEuropean paediatric regulationindustrial trialspaediatric trialpublic trials

Identifiers

PMID35560985
PMCPMC9086591
OpenAlexW4286832308

What Socratic 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 Socratic graph.