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

Research output: Contribution to journalJournal article

Published

Journal publication date30/03/2013
JournalStatistics in Medicine
Journal number7
Volume32
Number of pages14
Pages1150-1163
Early online date1/11/12
Original languageEnglish

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.