Randomized reverse marker strategy design for prospective biomarker validation.
Stat Med
; 33(18): 3089-99, 2014 Aug 15.
Article
en En
| MEDLINE
| ID: mdl-24639051
ABSTRACT
We describe a novel study design for validating marker-based treatment strategies meant to select among possible therapeutic options using a biologic marker. Studying existing designs in realistic scenarios, we demonstrate that this design is more than four times more efficient for testing the interaction between a marker and its intended treatment. Our analysis employs a simple parametric framework that uncovers systematic biases in currently proposed designs and suggests how they may be accommodated or enumerated. In the context of markers for choosing a treatment for recurrent ovarian cancer, our proposal requires sample sizes on the order of recently completed phases II and III studies making validation studies for this clinical decision scenario viable.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Biomarcadores de Tumor
/
Ensayos Clínicos Controlados Aleatorios como Asunto
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Female
/
Humans
Idioma:
En
Año:
2014
Tipo del documento:
Article