Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.
Radiology
; 259(3): 875-84, 2011 Jun.
Article
em En
| MEDLINE
| ID: mdl-21325035
ABSTRACT
UNLABELLED Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) processes (often referred to as pathways) relate, nor is it clear which data need to be collected to support these different pathways most efficiently, given the time- and cost-intensive nature of doing so. The purpose of this article is to describe current thinking regarding these pathways emerging from diverse stakeholders interested and active in the definition, validation, and qualification of quantitative imaging biomarkers and to propose processes to facilitate the development and use of quantitative imaging biomarkers. A flexible framework is described that may be adapted for each imaging application, providing mechanisms that can be used to develop, assess, and evaluate relevant biomarkers. From this framework, processes can be mapped that would be applicable to both imaging product development and to quantitative imaging biomarker development aimed at increasing the effectiveness and availability of quantitative imaging. SUPPLEMENTAL MATERIAL:
http//radiology.rsna.org/lookup/suppl/doi10.1148/radiol.10100800/-/DC1.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Avaliação da Tecnologia Biomédica
/
Diagnóstico por Imagem
/
Biomarcadores
/
Difusão de Inovações
Tipo de estudo:
Diagnostic_studies
/
Health_technology_assessment
/
Prognostic_studies
/
Sysrev_observational_studies
Limite:
Humans
País/Região como assunto:
America do norte
/
Europa
Idioma:
En
Revista:
Radiology
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Estados Unidos