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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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Principais autores: Maximilian Siebert, Jeanne Gaba, Alain Renault, Bruno Laviolle, Clara Locher, David Moher, Florian Naudet
Formato: Artigo
Idioma:Inglês
Publicado em: BMC 2022-05-01
coleção:BMC Medicine
Assuntos:
Reproducibility of results
Clinical trial
Drug approval
Acesso em linha:https://doi.org/10.1186/s12916-022-02377-2
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