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Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis

OBJECTIVE: To examine the design characteristics, risk of bias, and reporting adequacy of pivotal randomised controlled trials of cancer drugs approved by the European Medicines Agency (EMA). DESIGN: Cross sectional analysis. SETTING: European regulatory documents, clinical trial registry records, p...

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Detalles Bibliográficos
Autores principales: Naci, Huseyin, Davis, Courtney, Savović, Jelena, Higgins, Julian P T, Sterne, Jonathan A C, Gyawali, Bishal, Romo-Sandoval, Xochitl, Handley, Nicola, Booth, Christopher M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6749182/
https://www.ncbi.nlm.nih.gov/pubmed/31533922
http://dx.doi.org/10.1136/bmj.l5221