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Designing Multi-arm Multi-stage Clinical Studies

In: Developments in Statistical Evaluation of Clinical Trials

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  • Thomas Jaki

    (Lancaster University, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics)

Abstract

In the early stages of drug development there often is uncertainty about the most promising among a set of different treatments, different doses of the same treatment or sets of combinations of treatments. An efficient solution to determine which intervention is most promising are multi-arm multi-stage clinical studies (MAMS). In this chapter we will discuss the general concept to designing MAMS studies within the group sequential framework and provide detailed solutions for multi-arm multi-stage studies with normally distributed endpoints in which all promising treatments are continued at the interim analyses. An approach to find optimal designs is discussed as well as asymptotic solutions for binary, ordinal and time-to event endpoints.

Suggested Citation

  • Thomas Jaki, 2014. "Designing Multi-arm Multi-stage Clinical Studies," Springer Books, in: Kees van Montfort & Johan Oud & Wendimagegn Ghidey (ed.), Developments in Statistical Evaluation of Clinical Trials, edition 127, chapter 0, pages 51-69, Springer.
    • Handle: RePEc:spr:sprchp:978-3-642-55345-5_3
    DOI: 10.1007/978-3-642-55345-5_3
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