CLRM-16 PATIENT-FOCUSED DRUG DEVELOPMENT IN NEURO-ONCOLOGY: A PILOT STUDY OF QUALITATIVE PATIENT INTERVIEWS EMBEDDED WITHIN A NEUROFIBROMATOSIS 2 CLINICAL TRIAL

BACKGROUND: The Food and Drug Administration recently issued guidance on conducting qualitative research to support patient-focused drug development. In prior FDA submissions, qualitative data has been critical to demonstrate the content validity of and meaningfulness of change in quantitative trial...

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Detalles Bibliográficos
Autores principales: Merker, Vanessa, Von Imhof, Liesel, Park, Elyse, Babovic-Vuksanovic, Dusica, NghiemPhu, PhiOanh [Leia], Yohay, Kaleb, Plotkin, Scott
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Supplement Abstracts
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354217/
http://dx.doi.org/10.1093/noajnl/vdac078.036

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354217/
http://dx.doi.org/10.1093/noajnl/vdac078.036

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