Biomarkers in early-phase trials: fundamental issues.
Bioanalysis
; 10(12): 933-944, 2018 Jun 01.
Article
en En
| MEDLINE
| ID: mdl-29923753
ABSTRACT
Biomarkers are frequently being included in early-phase clinical trials. This article is meant to introduce clinical investigators to the fundamentals of choosing a biomarker test for use in an early phase trial. Steps to consider are briefly outlined including defining the role of the biomarker in the early phase trial; selecting a fit-for-purpose biomarker test and laboratory; describing the test procedures; carrying out analytical validation testing appropriate for the research objectives and the risk involved in the trial; implementing the test in the trial; and planning for the future. Examples illustrate analytical validation approaches in the context of typical biomarker roles. The importance of collaboration between clinical investigators and laboratory researchers is emphasized.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Bioensayo
/
Ensayos Clínicos como Asunto
/
Estudios de Validación como Asunto
Tipo de estudio:
Diagnostic_studies
/
Guideline
Límite:
Humans
Idioma:
En
Revista:
Bioanalysis
Año:
2018
Tipo del documento:
Article
País de afiliación:
Estados Unidos