Concordance between European medicine agency good clinical practice inspections and medical literature: a meta-research survey

This meta-research survey indicates that health authorities' GCP inspections are not reflected in the medical literature, even when the inspections have put the data reliability in doubt. This study raises the question of responsibility for any corrections that may be necessary in medical literature following the publication of EPARs.

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Publication Details

Journal
BMC Medicine
Published
2025-12-03
DOI
https://doi.org/10.1186/s12916-025-04499-9
Primary Topic
Healthcare Quality and Management
Type
article
Field-Weighted Citation Impact
0.00

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article

Concordance between European medicine agency good clinical practice inspections and medical literature: a meta-research survey

John P. A. Ioannidis, Alexandre Terré, Florian Naudet
BMC Medicine
Healthcare Quality and Management
article

Concordance between European medicine agency good clinical practice inspections and medical literature: a meta-research survey

John P. A. Ioannidis, Alexandre Terré, Florian Naudet
article en

Abstract

This meta-research survey indicates that health authorities' GCP inspections are not reflected in the medical literature, even when the inspections have put the data reliability in doubt. This study raises the question of responsibility for any corrections that may be necessary in medical literature following the publication of EPARs.

BMC MedicineVol. 23(1)
Inserm (FR), Institut Universitaire de France (FR), Sorbonne Université (FR), Hôpital Européen Georges-Pompidou (FR), Institut de Recherche en Santé, Environnement et Travail (FR), CIC Rennes (FR), Hôpital Ambroise-Paré (FR), European Hospital (IT), Stanford University (US)
Agence Nationale de la Recherche
Openalex Percentile: Top 55%
Healthcare Quality and Management
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Concordance between European medicine agency good clinical practice inspections and medical literature: a meta-research survey — John P. A. Ioannidis, Alexandre Terré, et al. · BMC Medicine (2025) | TGRS Research Map | TGRS