Evidence map›Paper›PMID 21345195›Full record

ReviewItalian journal of pediatrics2011

Framework conditions facilitating paediatric clinical research.

Anne-Laure Knellwolf, Stéphane Bauzon, Ornella Della Casa Alberighi, Irja Lutsar, Ernö Bácsy, Deborah Alfarez, Pietro Panei

Abstract readReview
In one paragraph

Review in Italian journal of pediatrics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Pediatric clinical trials.Perspectives in clinical research · 2013
    Article
  10. Ethical challenges in paediatric clinical trials in multiple sclerosis.Therapeutic advances in neurological disorders · 2012
    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

7 authors.

Anne-Laure KnellwolfDept, of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy. anne.knellwolf@iss.it
Stéphane Bauzon
Ornella Della Casa Alberighi
Irja Lutsar
Ernö Bácsy
Deborah Alfarez
Pietro Panei

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The use of unlicensed and "off-label" medicines in children is widespread. Between 50-80% of the medicines currently administered to children have neither been tested nor authorized for their use in the paediatric population which represents approximately 25% of the whole European population. On 26 January 2007, entered into force the European Regulation of Paediatric Medicines. It aims at the quality of research into medicines for children but without subjecting the paediatric population to unnecessary clinical trial. This article addresses ethical and legal issues arising from the regulation and makes recommendations for the framework conditions facilitating the development of clinical research with children.

Indexed as

Biomedical ResearchChildClinical Trials as TopicEuropeHumansPediatrics

Identifiers

PMID21345195
PMCPMC3055809

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.