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Journal of Biopharmaceutical Statistics Volume 13, 2003 - Issue 1
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Original Articles

Statistical Issues On Objective, Design, And Analysis Of Noninferiority Active-controlled Clinical Trial

Yi Tsong Quantitative Methods and Research Staff, OB/CDER/FDA, Rockville, Maryland, USACorrespondence[email protected]
,
Sue Jane Wang Division of Biometrics II, OB/CDER/FDA, Rockville, Maryland, USA
,
H. M. James Hung Division of Biometrics I, OB/CDER/FDA, Rockville, Maryland, USA
&
Lu Cui Aventis Pharmaceuticals Inc., Bridgewater, New Jersey, USA
Pages 29-41 | Published online: 16 Aug 2006

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Seung-Ho Kang. (2016) Avoiding ambiguity with the Type I error rate in noninferiority trials. Journal of Biopharmaceutical Statistics 26:3, pages 452-465.
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Siyan Xu, Kerry Barker, Sandeep Menon & Ralph B. D’Agostino. (2014) Covariate Effect on Constancy Assumption in Noninferiority Clinical Trials. Journal of Biopharmaceutical Statistics 24:6, pages 1173-1189.
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So-Young Wang & Seung-Ho Kang. (2013) Strength of Evidence of Noninferiority Trials with the Two Confidence Interval Method with Random Margin. Journal of Biopharmaceutical Statistics 23:2, pages 307-321.
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Seung-Ho Kang & Yuman Ryu. (2011) The Adjustment of the Type I Error Rate in Noninferiority Trials with λ-Margin Approach: Each of Two Different New Drugs is Approved with Two Independent Trials with the Same Active Control. Journal of Biopharmaceutical Statistics 21:3, pages 498-510.
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Yan Hou, Victoria Ding, Kang Li & Xiao-Hua Zhou. (2010) Two New Covariate Adjustment Methods for Non-Inferiority Assessment of Binary Clinical Trials Data. Journal of Biopharmaceutical Statistics 21:1, pages 77-93.
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Mark Chang. (2009) Discussion of “Some Controversial Multiple Testing Problems in Regulatory Applications”. Journal of Biopharmaceutical Statistics 19:1, pages 35-41.
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Yi Tsong, Jinglin Zhong & Wen Jen Chen. (2008) Validation Testing in Thorough QT/QTc Clinical Trials∗ . Journal of Biopharmaceutical Statistics 18:3, pages 529-541.
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Yi Tsong & Joanne Zhang. (2007) Simultaneous Test for Superiority and Noninferiority Hypotheses in Active-Controlled Clinical Trials∗ . Journal of Biopharmaceutical Statistics 17:2, pages 247-257.
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Yi Tsong, Joanne Zhang & Mark Levenson. (2007) Choice of δ Noninferiority Margin and Dependency of the Noninferiority Trials∗ . Journal of Biopharmaceutical Statistics 17:2, pages 279-288.
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Yi Tsong & Wen-Jen Chen. (2007) Noninferiority Testing Beyond Simple Two-Sample Comparison∗ . Journal of Biopharmaceutical Statistics 17:2, pages 289-308.
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H. M. James Hung, Sue-Jane Wang & Robert O'Neill. (2007) Issues with Statistical Risks for Testing Methods in Noninferiority Trial Without a Placebo ARM. Journal of Biopharmaceutical Statistics 17:2, pages 201-213.
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Michael Chen, Farid Kianifard & SunilK. Dhar. (2006) A Bootstrap-Based Test for Establishing Noninferiority in Clinical Trials. Journal of Biopharmaceutical Statistics 16:3, pages 357-363.
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H. M. James Hung & Sue-Jane Wang. (2004) Multiple Testing of Noninferiority Hypotheses in Active Controlled Trials. Journal of Biopharmaceutical Statistics 14:2, pages 327-335.
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Articles from other publishers (24)

Arsene Brunelle Sandie, Nicolas Molinari, Anthony Wanjoya, Charles Kouanfack, Christian Laurent & Jules Brice Tchatchueng-Mbougua. (2022) Non-inferiority test for a continuous variable with a flexible margin in an active controlled trial: an application to the “Stratall ANRS 12110 / ESTHER” trial. Trials 23:1.
Crossref
H. M. James Hung, Sue‐Jane Wang & Robert O'Neill. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
Stephanie Green. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
H. M. James Hung, Sue-J. Wang & Robert O'Neill. 2014. Methods and Applications of Statistics in Clinical Trials. Methods and Applications of Statistics in Clinical Trials 598 608 .
Stephanie Green. 2014. Methods and Applications of Statistics in Clinical Trials. Methods and Applications of Statistics in Clinical Trials 263 272 .
Maya H. Buch, Sue Pavitt, Mahesh Parmar & Paul Emery. (2013) Creative trial design in RA: optimizing patient outcomes. Nature Reviews Rheumatology 9:3, pages 183-194.
Crossref
Seung-Ho Kang & So-Young Wang. (2012) Statistical Methods in Non-Inferiority Trials - A Focus on US FDA Guidelines -. Korean Journal of Applied Statistics 25:4, pages 575-587.
Crossref
Yi Tsong & Joanne Zhang. 2013. Modern Clinical Trial Analysis. Modern Clinical Trial Analysis 167 182 .
Sue-Jane Wang & Jeffrey D. Blume. (2011) An evidential approach to non-inferiority clinical trials. Pharmaceutical Statistics 10:5, pages 440-447.
Crossref
Mark ChangMark Chang. 2011. Modern Issues and Methods in Biostatistics. Modern Issues and Methods in Biostatistics 1 30 .
Gang Li & Shan Gao. (2010) A group sequential type design for three‐arm non‐inferiority trials with binary endpoints. Biometrical Journal 52:4, pages 504-518.
Crossref
Seung‐Ho Kang & Yi Tsong. (2010) Strength of evidence of non‐inferiority trials—The adjustment of the type I error rate in non‐inferiority trials with the synthesis method. Statistics in Medicine 29:14, pages 1477-1487.
Crossref
Lei Nie & Guoxing Soon. (2010) A covariate‐adjustment regression model approach to noninferiority margin definition. Statistics in Medicine 29:10, pages 1107-1113.
Crossref
Young-Yeol Seo & Dong-Jae Kim. (2009) An Approximate Unconditional Test of Non-Inferiority for Two Proportions Based on Odds Ratio. Korean Journal of Applied Statistics 22:4, pages 793-804.
Crossref
Tie‐Hua Ng. (2008) Noninferiority hypotheses and choice of noninferiority margin. Statistics in Medicine 27:26, pages 5392-5406.
Crossref
Yi Tsong, Mark Levenson, Joanne Zhang & Jinglin Zhong. (2007) Choice of λ‐Margin and dependency of non‐inferiority trials. Statistics in Medicine 27:4, pages 520-528.
Crossref
Stephanie Green. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials.
H. M. James Hung, Sue-Jane Wang & Robert O'Neill. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials.
Richard J. Cook, Ker-Ai Lee & Hongdan Li. (2007) Non-inferiority trial design for recurrent events. Statistics in Medicine 26:25, pages 4563-4577.
Crossref
Yi Tsong. (2007) The Utility of Active-Controlled Noninferiority/Equivalence Trials in Drug Development. International Journal of Pharmaceutical Medicine 21:3, pages 225-233.
Crossref
Samuel Kotz, Campbell B. Read, N. Balakrishnan, Brani Vidakovic & Norman L. JohnsonStephanie Green. 2004. Encyclopedia of Statistical Sciences. Encyclopedia of Statistical Sciences 1 9 .
Samuel Kotz, Campbell B. Read, N. Balakrishnan, Brani Vidakovic & Norman L. JohnsonH. M. James Hung, Sue‐Jane Wang & Robert O'Neill. 2004. Encyclopedia of Statistical Sciences. Encyclopedia of Statistical Sciences 1 9 .
Sunil K. Sinha, Thierry Lacaze-Masmonteil, Adolf Valls i Soler, Thomas E. Wiswell, Janusz Gadzinowski, Julia Hajdu, Graham Bernstein, Manuel Sanchez-Luna, Robert Segal, Christopher J. Schaber, Joseph Massaro & Ralph d'Agostino. (2005) A Multicenter, Randomized, Controlled Trial of Lucinactant Versus Poractant Alfa Among Very Premature Infants at High Risk for Respiratory Distress Syndrome. Pediatrics 115:4, pages 1030-1038.
Crossref
Yi Tsong & Juan (Joanne) Zhang. (2005) Testing Superiority and Non-Inferiority Hypotheses in Active Controlled Clinical Trials. Biometrical Journal 47:1, pages 62-74.
Crossref

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