Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review

OBJECTIVES: Non-randomised clinical trial designs involving comparisons against external controls or specific standards can be used to support regulatory submissions for indications in diseases that are rare, with high unmet need, without approved therapies and/or where placebo is considered unethic...

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Detalles Bibliográficos
Autores principales: Goring, Sarah, Taylor, Aliki, Müller, Kerstin, Li, Tina Jun Jian, Korol, Ellen E, Levy, Adrian R, Freemantle, Nick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Pharmacology and Therapeutics
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398650/
https://www.ncbi.nlm.nih.gov/pubmed/30819708
http://dx.doi.org/10.1136/bmjopen-2018-024895

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398650/
https://www.ncbi.nlm.nih.gov/pubmed/30819708
http://dx.doi.org/10.1136/bmjopen-2018-024895

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