Sample size re-estimation and other midcourse adjustments with sequential parallel comparison design.
J Biopharm Stat
; 27(3): 416-425, 2017.
Article
en En
| MEDLINE
| ID: mdl-28166457
ABSTRACT
Sequential parallel comparison design (SPCD) was proposed to reduce placebo response in a randomized trial with placebo comparator. Subjects are randomized between placebo and drug in stage 1 of the trial, and then, placebo non-responders are re-randomized in stage 2. Efficacy analysis includes all data from stage 1 and all placebo non-responding subjects from stage 2. This article investigates the possibility to re-estimate the sample size and adjust the design parameters, allocation proportion to placebo in stage 1 of SPCD, and weight of stage 1 data in the overall efficacy test statistic during an interim analysis.
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Banco de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
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Ensayos Clínicos Controlados Aleatorios como Asunto
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Tamaño de la Muestra
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Revista:
J Biopharm Stat
Asunto de la revista:
FARMACOLOGIA
Año:
2017
Tipo del documento:
Article
País de afiliación:
Estados Unidos