Optimal designs for two-arm, phase II clinical trial design with multiple constraints.
J Biopharm Stat
; 20(1): 106-24, 2010 Jan.
Article
en En
| MEDLINE
| ID: mdl-20077252
ABSTRACT
Multi-stage Phase II trials are often employed in practice but may not be the best approach when the endpoint of interest is not obtained soon after enrollment and/or when a control arm is desired. We present a new design in which sample size determination includes a control arm and allows for the estimation of response for each treatment as well as estimation of the difference in the response rates. We evaluate this design under varying allocation schemes to treatment arms and response rates for each treatment.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos Controlados Aleatorios como Asunto
/
Ensayos Clínicos Fase II como Asunto
Tipo de estudio:
Clinical_trials
/
Guideline
Idioma:
En
Revista:
J Biopharm Stat
Asunto de la revista:
FARMACOLOGIA
Año:
2010
Tipo del documento:
Article
País de afiliación:
Estados Unidos