Incorporating development of a patient-reported outcome instrument in a clinical drug development program: examples from a heart failure program

BACKGROUND: Patient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures...

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Detalles Bibliográficos
Autores principales: Wiklund, Ingela, Anatchkova, Milena, Oko-Osi, Hafiz, von Maltzahn, Robyn, Chau, Dina, Malik, Fady I., Patrick, Donald L., Spertus, John, Teerlink, John R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024511/
https://www.ncbi.nlm.nih.gov/pubmed/27629389
http://dx.doi.org/10.1186/s12955-016-0529-0

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024511/
https://www.ncbi.nlm.nih.gov/pubmed/27629389
http://dx.doi.org/10.1186/s12955-016-0529-0

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