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Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements

Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instr...

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Detalles Bibliográficos
Autores principales: Nixon, Annabel, Kerr, Cicely, Breheny, Katie, Wild, Diane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3606363/
https://www.ncbi.nlm.nih.gov/pubmed/23497117
http://dx.doi.org/10.1186/1477-7525-11-38