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Design optimization for dose-finding trials: a review
Jihane Aouni1,2, Jean Noel Bacro2, Gwladys Toulemonde2,3
1Research and Development, Sanofi , Chilly-Mazarin, France.
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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