Choice of futility boundaries for group sequential designs with two endpoints
Beteiligte Einrichtungen
Abstract
METHODS:
In this work, we propose a general method to construct 'optimal' futility boundaries according to predefined criteria. Further, we present three different group sequential designs for two endpoints applying these futility boundaries. Our methods are illustrated by a real clinical trial example and by Monte-Carlo simulations.
RESULTS:
By construction, the provided method of choosing futility boundaries maximizes the probability to correctly stop in case of small or opposite effects while limiting the power loss and the probability of stopping the study 'wrongly'. Our results clearly demonstrate the benefit of using such 'optimal' futility boundaries, especially compared to futility boundaries commonly applied in practice.
CONCLUSIONS:
As the properties of futility boundaries are often not considered in practice and unfavorably chosen futility boundaries may imply bad properties of the study design, we recommend assessing the performance of these boundaries according to the criteria proposed in here.
Bibliografische Daten
Originalsprache | Englisch |
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ISSN | 1471-2288 |
DOIs | |
Status | Veröffentlicht - 08.08.2017 |
PubMed | 28789615 |
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