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Accountability in Research
Ethics, Integrity and Policy
Volume 4, 1996 - Issue 3-4
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Original Articles

Problems in interpreting active control equivalence trials

Pages 267-275 | Published online: 11 Jun 2008

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Mark A. Gamalo & Ram C. Tiwari. (2011) Testing Noninferiority Through Generalized p-values. Statistics in Biopharmaceutical Research 3:1, pages 87-96.
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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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W. W. B. Wang, D. V. Mehrotra, I. S. F. Chan & J. F. Heyse. (2006) Statistical Considerations for NonInferiority/Equivalence Trials in Vaccine Development. Journal of Biopharmaceutical Statistics 16:4, pages 429-441.
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Yong-Cheng Wang, Gang Chen & GeorgeY.H. Chi. (2006) A Ratio Test in Active Control Non-Inferiority Trials with a Time-to-Event Endpoint. Journal of Biopharmaceutical Statistics 16:2, pages 151-164.
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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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Gang Chen, Yong-Cheng Wang & George YH. Chi. (2004) Hypotheses and Type I Error in Active-Control Noninferiority Trials. Journal of Biopharmaceutical Statistics 14:2, pages 301-313.
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Yi Tsong, Sue Jane Wang, H. M. James Hung & Lu Cui. (2003) Statistical Issues On Objective, Design, And Analysis Of Noninferiority Active-controlled Clinical Trial. Journal of Biopharmaceutical Statistics 13:1, pages 29-41.
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Ivan S. F. Chan. (2002) POWER AND SAMPLE SIZE DETERMINATION FOR NONINFERIORITY TRIALS USING AN EXACT METHOD. Journal of Biopharmaceutical Statistics 12:4, pages 457-469.
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Articles from other publishers (50)

Victor A. Voicu, Constantin Mircioiu, Cristina Plesa, Mariana Jinga, Vasile Balaban, Roxana Sandulovici, Ana Maria Costache, Valentina Anuta & Ion Mircioiu. (2019) Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back Pain. Frontiers in Pharmacology 10.
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Lingrui Gan & Zhaowei Hua. 2019. Pharmaceutical Statistics. Pharmaceutical Statistics 167 180 .
Gil Amarilyo, Simon Tarp, Ivan Foeldvari, Neta Cohen, Tracy D. Pope, Jennifer M.P. Woo, Robin Christensen & Daniel E. Furst. (2016) Biological agents in polyarticular juvenile idiopathic arthritis: A meta-analysis of randomized withdrawal trials. Seminars in Arthritis and Rheumatism 46:3, pages 312-318.
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Mark D. Rothmann, Brian L. Wiens & Ivan S.F. Chan. 2016. Design and Analysis of Non-Inferiority Trials. Design and Analysis of Non-Inferiority Trials 236 267 .
William F. Rosenberger & John M. Lachin. 2016. Randomization in Clinical Trials. Randomization in Clinical Trials 15 36 .
H. M. James Hung. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
H. M. James Hung, Sue‐Jane Wang & Robert O'Neill. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
William C. Blackwelder. 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 .
Shein‐Chung Chow & Jen‐Pei Liu. 2013. Design and Analysis of Clinical Trials. Design and Analysis of Clinical Trials 799 844 .
George Chi, Gang Chen, Mark Rothmann & Ning Li. 2012. Encyclopedia of Biopharmaceutical Statistics, Third Edition. Encyclopedia of Biopharmaceutical Statistics, Third Edition 8 15 .
Lei Nie & Guoxing Soon. (2010) A covariate‐adjustment regression model approach to noninferiority margin definition. Statistics in Medicine 29:10, pages 1107-1113.
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Shein-Chung ChowIvan S. F. Chan, William W. B. Wang & Joseph Heyse. 2010. Encyclopedia of Biopharmaceutical Statistics. Encyclopedia of Biopharmaceutical Statistics 1402 1415 .
Shein-Chung ChowSue-Jane Wang, H. M.James Hung & Yi Tsong. 2010. Encyclopedia of Biopharmaceutical Statistics. Encyclopedia of Biopharmaceutical Statistics 904 907 .
Shein-Chung ChowDevan V. Mehrotra & Ivan S. F. Chan. 2010. Encyclopedia of Biopharmaceutical Statistics. Encyclopedia of Biopharmaceutical Statistics 601 603 .
Shein-Chung ChowGang Chen, George Y. H. Chi & Yong-Cheng Wang. 2010. Encyclopedia of Biopharmaceutical Statistics. Encyclopedia of Biopharmaceutical Statistics 595 600 .
Shein-Chung ChowP. A. Lachenbruch, A. D. Horne, C. J. Lynch, J. Tiwari, Susan S. Ellenberg, A.D. Horne, C.J. Lynch, J. Tiwari & Susan S. Ellenberg. 2010. Encyclopedia of Biopharmaceutical Statistics. Encyclopedia of Biopharmaceutical Statistics 158 166 .
Shein-Chung ChowGeorge Y. H. Chi, Gang Chen, Mark Rothmann & Ning Li. 2010. Encyclopedia of Biopharmaceutical Statistics. Encyclopedia of Biopharmaceutical Statistics 8 15 .
G. Zhao. (2007) Tests of non‐null hypothesis on proportions for stratified data. Statistics in Medicine 27:9, pages 1429-1446.
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H. M. James Hung. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials 1 2 .
H. M. James Hung, Sue‐Jane Wang & Robert O'Neill. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials 1 9 .
Meinhard Kieser & Tim Friede. (2006) Planning and analysis of three‐arm non‐inferiority trials with binary endpoints. Statistics in Medicine 26:2, pages 253-273.
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Kenneth A. Katz, Jason H. Karlawish, David S. Chiang, Rachel A. Bognet, Katherine J. Propert & David J. Margolis. (2006) Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: A cross-sectional study. Journal of the American Academy of Dermatology 55:5, pages 814-822.
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Matthew P. Fox & LeAnne M. Fox. (2006) Resolving design problems in equivalency trials. The Journal of Pediatrics 149:1, pages 12-16.e1.
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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 .
Peter Lurie & Dirceu B Greco. (2005) US exceptionalism comes to research ethics. The Lancet 365:9465, pages 1117-1119.
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William C. Blackwelder. 2005. Encyclopedia of Biostatistics. Encyclopedia of Biostatistics.
H. M. James Hung, Sue‐Jane Wang & Robert O'Neill. (2005) A Regulatory Perspective on Choice of Margin and Statistical Inference Issue in Non‐inferiority Trials. Biometrical Journal 47:1, pages 28-36.
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Kathleen Cranley Glass & Duff Waring. (2021) The Physician/Investigator's Obligation to Patients Participating in Research: The Case of Placebo Controlled Trials. Journal of Law, Medicine & Ethics 33:3, pages 575-585.
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J.L. Moran & P.J. Solomon. (2003) The interpretation of lack of evidence of a difference in efficacy: equivalence trials and the treatment of fungal infections. Critical Care and Resuscitation 5:3, pages 216-223.
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Sue-Jane Wang, H Hung & Yi Tsong. 2003. Encyclopedia of Biopharmaceutical Statistics, Second edition. Encyclopedia of Biopharmaceutical Statistics, Second edition 674 677 .
Nian‐Sheng Tang, Man‐Lai Tang & Ivan Siu Fung Chan. (2003) On tests of equivalence via non‐unity relative risk for matched‐pair design. Statistics in Medicine 22:8, pages 1217-1233.
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I SF Chan. (2016) Proving non-inferiority or equivalence of two treatments with dichotomous endpoints using exact methods. Statistical Methods in Medical Research 12:1, pages 37-58.
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Ralph B. D'AgostinoSr.Sr., Joseph M. Massaro & Lisa M. Sullivan. (2002) Non‐inferiority trials: design concepts and issues – the encounters of academic consultants in statistics. Statistics in Medicine 22:2, pages 169-186.
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Sue‐Jane Wang & H. M. James Hung. (2002) TACT method for non‐inferiority testing in active controlled trials. Statistics in Medicine 22:2, pages 227-238.
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H. M. James Hung, Sue‐Jane Wang, Yi Tsong, John Lawrence & Robert T. O'Neil. (2002) Some fundamental issues with non‐inferiority testing in active controlled trials. Statistics in Medicine 22:2, pages 213-225.
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Robert Temple. (2002) Policy developments in regulatory approval. Statistics in Medicine 21:19, pages 2939-2948.
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Ahmad Beydoun. (2002) Sequential Design Studies for Antiepileptic Drugs. Epilepsy & Behavior 3:2, pages 107-108.
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Brian L. Wiens. (2002) Choosing an equivalence limit for noninferiority or equivalence studies. Controlled Clinical Trials 23:1, pages 2-14.
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Sue-Jane Wang, H.M.James Hung & Yi Tsong. (2002) Utility and pitfalls of some statistical methods in active controlled clinical trials. Controlled Clinical Trials 23:1, pages 15-28.
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Tie-Hua Ng. (2001) Choice of Delta in Equivalence Testing. Drug Information Journal 35:4, pages 1517-1527.
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Robert I. Misbin. (2001) Placebo-Controlled Trials in Type 2 Diabetes. Diabetes Care 24:4, pages 773-774.
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Robert M. Califf & Susan S. Ellenberg. (2001) Statistical approaches and policies for the operations of Data and Safety Monitoring Committees. American Heart Journal 141:2, pages 301-305.
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JOHN T. FARRAR & SCOTT D. HALPERN. 2010. Cancer Pain. Cancer Pain 568 582 .
Scott W. Woods, Marilyn Stolar, Michael J. Sernyak & Dennis S. Charney. (2001) Consistency of atypical antipsychotic superiority to placebo in recent clinical trials. Biological Psychiatry 49:1, pages 64-70.
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Patricia Backlar. 2002. Encyclopedia of Ethical, Legal and Policy Issues in Biotechnology. Encyclopedia of Ethical, Legal and Policy Issues in Biotechnology.
Dennis S Charney. (2000) The use of placebos in randomized clinical trials of mood disorders: well justified, but improvements in design are indicated. Biological Psychiatry 47:8, pages 687-688.
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Philip W Lavori. (2000) Placebo control groups in randomized treatment trials: a statistician’s perspective. Biological Psychiatry 47:8, pages 717-723.
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Robert Temple. (1999) Role of government agencies regarding cost-effectiveness claims: FDA perspective. American Heart Journal 137:5, pages S75-S77.
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Charles Weijer. (1999) Placebo-controlled trials in schizophrenia:. Schizophrenia Research 35:3, pages 211-218.
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