Biomarker informed add-arm design for unimodal response. Issue 4 (3rd July 2016)

• Record Type: Journal Article
• Authors: Wang, Jing; Chang, Mark; Menon, Sandeep
• Is Part Of: Journal of biopharmaceutical statistics. Volume 26:Issue 4(2016)
• Page Start: 694
• Page End: 711
• Publication Date: 2016-07-03
• Subjects: Adaptive design -- biomarker -- clinical trials -- dose-finding -- power -- Type I error; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2015.1052474
• Languages: English
• ISSNs: 1054-3406

Abstract

ABSTRACT: In this article, we propose a biomarker informed add-arm design for unimodal response. The new design contributes to optimizing the procedure of dose-finding when a biomarker of the study primary endpoint exists and prior evidence indicates a unimodal dose–response relationship. Designs with up to seven active treatment arms were considered. We propose the statistical approach for the Type I error control and carry out extensive simulation studies for the power performance of the design. The proposed design is shown to outperform the corresponding biomarker informed two-stage winner design in power on an average.