Design Optimization for dose-finding trials: A review - Inria - Institut national de recherche en sciences et technologies du numérique Access content directly
Journal Articles Journal of Biopharmaceutical Statistics Year : 2020

Design Optimization for dose-finding trials: A review


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.
Fichier principal
Vignette du fichier
Aouni_etal_2020.pdf (240.45 Ko) Télécharger le fichier
Origin Files produced by the author(s)

Dates and versions

hal-03082449 , version 1 (18-12-2020)



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, 2020, 30 (4), pp.662-673. ⟨10.1080/10543406.2020.1730874⟩. ⟨hal-03082449⟩
54 View
423 Download



Gmail Mastodon Facebook X LinkedIn More