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Flexible sequential designs for multi-arm clinical trials

Magirr, Dominic and Stallard, Nigel and Jaki, Thomas (2014) Flexible sequential designs for multi-arm clinical trials. Statistics in Medicine, 33 (19). pp. 3269-3279. ISSN 0277-6715

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Abstract

Adaptive designs that are based on group-sequential approaches have the benefit of being efficient as stopping boundaries can be found that lead to good operating characteristics with test decisions based solely on sufficient statistics. The drawback of these so called ‘pre-planned adaptive’ designs is that unexpected design changes are not possible without impacting the error rates. ‘Flexible adaptive designs’ on the other hand can cope with a large number of contingencies at the cost of reduced efficiency. In this work, we focus on two different approaches for multi-arm multi-stage trials, which are based on group-sequential ideas, and discuss how these ‘pre-planned adaptive designs’ can be modified to allow for flexibility. We then show how the added flexibility can be used for treatment selection and sample size reassessment and evaluate the impact on the error rates in a simulation study. The results show that an impressive overall procedure can be found by combining a well chosen pre-planned design with an application of the conditional error principle to allow flexible treatment selection.

Item Type: Article
Journal or Publication Title: Statistics in Medicine
Uncontrolled Keywords: adaptive designs ; closed testing ; combination test ; conditional error ; multi-arm
Subjects:
Departments: Faculty of Science and Technology > Mathematics and Statistics
ID Code: 69335
Deposited By: ep_importer_pure
Deposited On: 02 May 2014 09:59
Refereed?: Yes
Published?: Published
Last Modified: 23 Oct 2017 03:56
Identification Number:
URI: http://eprints.lancs.ac.uk/id/eprint/69335

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