| Literature DB >> 26892481 |
Toshimitsu Ochiai1,2, Toshimitsu Hamasaki2,3,4, Scott R Evans5, Koko Asakura3,4, Yuko Ohno2.
Abstract
We discuss group-sequential three-arm noninferiority clinical trial designs that include active and placebo controls for evaluating both assay sensitivity and noninferiority. We extend two existing approaches, the fixed margin and fraction approaches, into a group-sequential setting with two decision-making frameworks. We investigate the operating characteristics including power, Type I error rate, maximum, and expected sample sizes, as design factors vary. In addition, we discuss sample size recalculation and its impact on the power and Type I error rate via a simulation study.Entities:
Keywords: Assay sensitivity; Cui-Hung-Wang statistics; Type I error; average sample number; fixed margin approach; fraction approach; maximum sample size; sample size recalculation
Mesh：
Year: 2016 PMID： 26892481 PMCID： PMC4990829 DOI： 10.1080/10543406.2016.1148710
Source DB: PubMed Journal: J Biopharm Stat ISSN： 1054-3406 Impact factor: 1.051