Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases

BACKGROUND: Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently...

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Detalles Bibliográficos
Autores principales: Staab, Thomas, Isbary, Georg, Amelung, Volker E., Ruof, Jörg
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5109700/
https://www.ncbi.nlm.nih.gov/pubmed/27842592
http://dx.doi.org/10.1186/s12913-016-1902-8

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5109700/
https://www.ncbi.nlm.nih.gov/pubmed/27842592
http://dx.doi.org/10.1186/s12913-016-1902-8

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