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Interim analysis of sequential estimation-adjusted urn models with sample size re-estimation
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Interim analysis of sequential estimation-adjusted urn models with sample size re-estimation
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Journal Article
Interim analysis of sequential estimation-adjusted urn models with sample size re-estimation
2021
Overview
Clinical trials usually involve efficient and ethical objectives. Different adaptive designs have been proposed to satisfy these needs. We combine interim analysis, the sequential estimation-adjusted urn model (SEU), and sample size re-estimation (SSR) in one clinical trial. We show that the asymptotic distribution, under the null hypothesis, of the proposed sequential statistic follows Brownian motion by simultaneously addressing the three sequential procedures (allocation of patients, urn composition, and sequential parameter estimators) and the sequential statistics with revised information time due to SSR. Therefore, to control the type I error rate, traditional critical values for sequential monitoring based on Brownian motion can be used for the proposed procedure. Numerical studies with three types of urn models demonstrate that our proposed approach can control the type I error rate well and also achieve efficient and ethical objectives.
Les études cliniques comportent des objectifs d’éthique et d’efficacité. Différents plans d’expérience adaptatifs proposés permettent de les atteindre. Les auteurs combinent dans une même étude clinique des analyses intérimaires, le modèle séquentiel d’urnes ajusté pour l’estimation, ainsi que la ré-estimation de la taille d’échantillon (RTE). Sous l’hypothèse nulle, ils montrent que la distribution asymptotique de la statistique séquentielle proposée suit un mouvement brownien en abordant les trois procédures séquentielles (attribution des patients, composition de l’urne et estimation séquentielle des paramètres) ainsi que les statistiques séquentielles avec l’information révisée due à la RTE. Ainsi, les valeurs critiques traditionnelles pour le monitoring séquentiel basées sur un mouvement brownien peuvent être utilisées pour contrôler l’erreur de type I avec la procédure proposée. Les auteurs illustrent leur approche à l’aide d’études numériques pour trois types de modèles d’urnes et montrent qu’ils peuvent bien contrôler le taux d’erreur de type I et atteindre leurs objectifs d’éthique et d’efficacité.
