Evidence map›Paper›PMID 32370820›Full record

ArticleEpidemiology and psychiatric sciences2020

Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries.

Giovanni Ostuzzi, Chiara Gastaldon, Carlo Petrini, Brian Godman, Corrado Barbui

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Epidemiology and psychiatric sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

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

  1. Pooled it
  2. Article
  3. 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

5 authors.

Giovanni OstuzziDepartment of Neuroscience, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.ORCID https://orcid.org/0000-0003-2248-9524
Chiara GastaldonDepartment of Neuroscience, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.ORCID https://orcid.org/0000-0001-7257-2962
Carlo PetriniBioethics Unit, Istituto Superiore di Sanità (Italian National Institute of Health), Rome, Italy.
Brian GodmanStrathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow, UK.
Corrado BarbuiDepartment of Neuroscience, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.ORCID https://orcid.org/0000-0003-1073-9282

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.

Indexed as

Drug TherapyClinical Trials as TopicEuropeEuropean UnionHumansPolicy MakingAntidepressantspsychopharmacologyrandomised controlled trialsresearch design and methodsresearch governance

Identifiers

PMID32370820
PMCPMC7214710

What OpenQuestion holds

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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.