Designing a series of decision-theoretic phase II trials in a small population.
Stat Med
; 31(30): 4337-51, 2012 Dec 30.
Article
en En
| MEDLINE
| ID: mdl-22927289
ABSTRACT
This paper introduces a decision-theoretic design for a series of phase II trials. Instead of designing phase II trials individually, we proposed a development plan that consists of a series of phase II trials and one phase III trial such that the long-term expected utility on the whole is optimized. The phase II trials are conducted sequentially, and patients are recruited sequentially to each phase II trial. At each interim stage, a decision is made to continue recruiting patients to the current trial, to stop and recommend the treatment proceeds to a phase III trial, to stop and initiate a new phase II trial or to stop and cease the development plan. The methodology uses a hybrid approach in which it is assumed that the data from the final phase III trial will be analysed using a classical frequentist hypothesis test. The expected power of this test based on some specified prior distribution for the effect of the experimental treatment is then used in a utility function, which is used to obtain the optimal design for the whole series of trials.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Teoría de las Decisiones
/
Diseño de Investigaciones Epidemiológicas
/
Ensayos Clínicos Fase III como Asunto
/
Ensayos Clínicos Fase II como Asunto
Tipo de estudio:
Health_economic_evaluation
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Stat Med
Año:
2012
Tipo del documento:
Article
País de afiliación:
Reino Unido