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Design Optimization for dose-finding trials: A review

Abstract : Dose selection is one of the most difficult and crucial decisions to make during drug development. As a consequence the dose-finding trial is a major milestone in the drug development plan and should be properly designed. This article will review the most recent methodologies for optimizing the design of dose-finding studies: all of them are based on the modeling of the dose-response curve, which is now the gold standard approach for analyzing dose-finding studies instead of the traditional ANOVA/multiple testing approach. We will address the optimization of both fixed and adaptive designs and briefly outline new methodologies currently under investigation, based on utility functions.
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https://hal.inria.fr/hal-03082449
Contributor : Gwladys Toulemonde <>
Submitted on : Friday, December 18, 2020 - 3:51:41 PM
Last modification on : Saturday, December 19, 2020 - 3:29:41 AM

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Jihane Aouni, Jean Noel Bacro, Gwladys Toulemonde, Pierre Colin, Loic Darchy, et al.. Design Optimization for dose-finding trials: A review. Journal of Biopharmaceutical Statistics, Taylor & Francis, 2020, 30 (4), pp.662-673. ⟨10.1080/10543406.2020.1730874⟩. ⟨hal-03082449⟩

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