Evidence map›Paper›PMID 36959158›Full record

ArticleReviews on recent clinical trials2023

Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.

Stéphane Vignot, Gaelle Guyader, Valérie Salomon, Philippe Vella, Isabelle Yoldjian, Patrick Maison, Christelle Ratignier-Carbonneil

Abstract read
In one paragraph

Article in Reviews on recent clinical trials, 2023. 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
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.

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

7 authors.

Stéphane VignotAgence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.ORCID 0000-0002-1292-6631
Gaelle GuyaderAgence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.
Valérie SalomonAgence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.
Philippe VellaAgence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.
Isabelle YoldjianAgence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.
Patrick MaisonAgence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.
Christelle Ratignier-CarbonneilAgence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.

Indexed as

Clinical Trials as TopicGovernment RegulationEuropeHumansaccess to innovationauthorisationClinical trialsEuropean regulationindicatorsregulatory science

Identifiers

PMID36959158
PMCPMC10514496

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.