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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Group-sequential three-arm noninferiority clinical trial designs
Toshimitsu Ochiai1,2, Toshimitsu Hamasaki2,3,4, Scott R Evans5
1a Biostatistics Department , Shionogi & Co., Ltd. , Osaka , Japan.
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.
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