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Considerations on covariates and endpoints in multi-arm multi-stage clinical trials selecting all promising treatments

Jaki, Thomas and Magirr, Dominic (2013) Considerations on covariates and endpoints in multi-arm multi-stage clinical trials selecting all promising treatments. Statistics in Medicine, 32 (7). pp. 1150-1163. ISSN 0277-6715

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Abstract

In early stages of drug development, there is often uncertainty about the most promising among a set of different treatments. To ensure the best use of resources in such situations, it is important to decide which, if any, of the treatments should be taken forward for further testing. In later development, it has been shown that evaluating more than one dose increases the chance of success substantially. In this work, we discuss how multi-arm multi-stage trials can be designed such that all promising treatments are kept in the study at the interim analyses. We first investigate the impact of deviating from the planned design and show how confidence intervals can be constructed before we consider the impact of important covariates. We show that under orthogonality, the inclusion of covariates has no effect on familywise error rate control in the strong sense. We further show that the derived methodology can be used to investigate non-normal endpoints.

Item Type: Article
Journal or Publication Title: Statistics in Medicine
Uncontrolled Keywords: confidence intervals ; Dunnett test ; multi-arm, multi-stage ; ordinal ; time-to-event
Subjects: Q Science > QA Mathematics
Departments: Faculty of Science and Technology > Mathematics and Statistics
ID Code: 58960
Deposited By: ep_importer_pure
Deposited On: 08 Oct 2012 13:33
Refereed?: Yes
Published?: Published
Last Modified: 09 Oct 2013 14:49
Identification Number:
URI: http://eprints.lancs.ac.uk/id/eprint/58960

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