Gatekeeping Procedure in Confirmatory Clinical Trials
Author:
Affiliation:
1. Biostatistics Group1 Clinical Science & Strategy Dept. CHUGAI PHARMACEUTICAL CO., LTD
2. Department of Biostatistics, Yokohama City University
Publisher
The Biometric Society of Japan
Subject
General Medicine
Link
https://www.jstage.jst.go.jp/article/jjb/36/Special_Issue_2/36_S165/_pdf
Reference12 articles.
1. Brechenmacher, T., Xu, J., Dmitrienko, A., Tamhane, A. C. (2011). A mixture gatekeeping procedure based on the Hommel test for clinical trial applications. Journal of Biopharmaceutical Statistics. 21, 748-767.
2. Bretz, F., Maurer, W., Brannath, W., Posch, M. (2009). A graphical approach to sequentially rejective multiple test procedures. Statistics in Medicine. 28, 586-604.
3. Dmitrienko, A., Offen, W., Westfall, P. H. (2003). Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Statistics in Medicine. 22, 2387-2400.
4. Dmitrienko, A., Tamhane, A. (2007). Gatekeeping procedures with clinical trial applications. Pharmaceutical Statistics. 6, 171-180.
5. Dmitrienko, A., D’ Agostino, R. B, (2013). Tutorial in Biostatistics: Traditional multiplicity adjustment methods in clinical trials. Statistics in Medicine. 32, 5172-5218.
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