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Integration of patient-reported outcomes in multiregional confirmatory clinical trials()

INTRODUCTION: The increasing complexities of conducting multiregional trials and an evolving regulatory environment contribute to unprecedented new challenges for use of patient-reported outcome measures (PROMs) within clinical trials. This paper presents these challenges and potential solutions. ME...

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Detalles Bibliográficos
Autores principales: Gnanasakthy, Ari, DeMuro, Carla, Boulton, Caroline
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105971/
https://www.ncbi.nlm.nih.gov/pubmed/23415630
http://dx.doi.org/10.1016/j.cct.2013.02.006