Data-sharing and re-analysis for main studies assessed by the European Medicines Agency—a cross-sectional study on European Public Assessment Reports

Data-sharing and re-analysis for main studies assessed by the European Medicines Agency—a cross-sectional study on European Public Assessment Reports

Abstract Background Transparency and reproducibility are expected to be normative practices in clinical trials used for decision-making on marketing authorisations for new medicines. This registered report introduces a cross-sectional study aiming to assess inferential reproducibility for main trial...

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Bibliographic Details
Main Authors: Maximilian Siebert, Jeanne Gaba, Alain Renault, Bruno Laviolle, Clara Locher, David Moher, Florian Naudet
Format: Article
Language:English
Published: BMC 2022-05-01
Series:BMC Medicine
Subjects:
Reproducibility of results
Clinical trial
Drug approval
Online Access:https://doi.org/10.1186/s12916-022-02377-2

Internet

https://doi.org/10.1186/s12916-022-02377-2

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