Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy.
Bioanalysis
; 14(13): 911-917, 2022 Jul.
Article
en En
| MEDLINE
| ID: mdl-35904153
ABSTRACT
Since 2011, the European Bioanalysis Forum has been discussing the topic of context-of-use for biomarker assays, in support of a cross-industry implementation of its principles. The discussions have led to the acknowledgement of the challenges that we face as an industry in implementing these principles. In addition to scientific recommendations, the European Bioanalysis Forum has addressed these challenges by providing recommendations on organizational design, and what works in both sponsor and contract research organizations, to support and enable context-of-use across biomarker strategies. Here, we highlight the key considerations for organizational design to help ensure that biomarker assays are characterized and validated according to the right context-of-use, to ensure that the right decisions based on the biomarker data can be made during drug development.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Bioensayo
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
Bioanalysis
Año:
2022
Tipo del documento:
Article
País de afiliación:
Alemania