A Phase I/II adaptive design for heterogeneous groups with application to a stereotactic body radiation therapy trial.
Pharm Stat
; 14(4): 302-10, 2015.
Article
en En
| MEDLINE
| ID: mdl-25962576
ABSTRACT
Dose-finding studies that aim to evaluate the safety of single agents are becoming less common, and advances in clinical research have complicated the paradigm of dose finding in oncology. A class of more complex problems, such as targeted agents, combination therapies and stratification of patients by clinical or genetic characteristics, has created the need to adapt early-phase trial design to the specific type of drug being investigated and the corresponding endpoints. In this article, we describe the implementation of an adaptive design based on a continual reassessment method for heterogeneous groups, modified to coincide with the objectives of a Phase I/II trial of stereotactic body radiation therapy in patients with painful osseous metastatic disease. Operating characteristics of the Institutional Review Board approved design are demonstrated under various possible true scenarios via simulation studies.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Dosificación Radioterapéutica
/
Proyectos de Investigación
/
Neoplasias Óseas
/
Radiocirugia
/
Ensayos Clínicos Fase II como Asunto
/
Ensayos Clínicos Fase I como Asunto
Tipo de estudio:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Pharm Stat
Asunto de la revista:
FARMACOLOGIA
Año:
2015
Tipo del documento:
Article
País de afiliación:
Estados Unidos