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Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

OBJECTIVE: To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. DESIGN: Cross-sectional analysis of all c...

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Detalles Bibliográficos
Autores principales: Miller, Jennifer E, Korn, David, Ross, Joseph S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654354/
https://www.ncbi.nlm.nih.gov/pubmed/26563214
http://dx.doi.org/10.1136/bmjopen-2015-009758