Design optimization for dose-finding trials: a review. Issue 4 (3rd July 2020)

• Record Type: Journal Article
• Authors: Aouni, Jihane; Bacro, Jean Noel; Toulemonde, Gwladys; Colin, Pierre; Darchy, Loic; Sebastien, Bernard
• Is Part Of: Journal of biopharmaceutical statistics. Volume 30:Issue 4(2020)
• Page Start: 662
• Page End: 673
• Publication Date: 2020-07-03
• Subjects: Adaptive trials -- design optimization -- dose selection -- patient allocation -- utility functions; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2020.1730874
• Languages: English
• ISSNs: 1054-3406

Abstract

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.