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- Toshimitsu Ochiai
- Biostatistics Department, Shionogi & Co., Ltd., Osaka, Japan
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- Scott R. Evans
- Department of Biostatistics and the Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA
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- Toshimitsu Hamasaki
- Department of Mathematical Health Science, Osaka University Graduate School of Medicine, Suita, Japan
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- Koko Asakura
- Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Suita, Japan
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- Yuko Ohno
- Department of Mathematical Health Science, Osaka University Graduate School of Medicine, Suita, Japan
書誌事項
- 公開日
- 2016-05-13
- 資源種別
- journal article
- DOI
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- 10.1080/10543406.2016.1148710
- 公開者
- Informa UK Limited
この論文をさがす
説明
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.
収録刊行物
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- Journal of Biopharmaceutical Statistics
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Journal of Biopharmaceutical Statistics 27 (1), 1-24, 2016-05-13
Informa UK Limited
