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

ABSTRACT:

Background

Health authorities, such as the European Medicines Agency (EMA), inspect clinical sites performing clinical trials and occasionally find evidence of substantial departures from Good Clinical Practice (GCP). However, if the findings are not transposed in the medical literature, publication of those trials may convey inaccurate messages.

Methods

OBJECTIVE: to describe the differences between EMA GCP inspection reports and medical literature on drugs with withdrawn or refused applications.

Design

a retrospective study comparing studies included in European Public Assessment Reports (EPARs) and the corresponding articles published in the medical literature. Data sources-we screened all EPARs released by the EMA from inception to April 2024 for drugs that were r

SUBMITTER: Terre A 

PROVIDER: S-EPMC12676876 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature