Advanced search
Publication Cover
Journal of Biopharmaceutical Statistics Volume 14, 2004 - Issue 2
Submit an article Journal homepage
210
Views
25
CrossRef citations to date
0
Altmetric
Original Articles

Multiple Testing of Noninferiority Hypotheses in Active Controlled Trials

H. M. James Hung Division of Biometrics I, Food and Drug Administration, Rockville, Maryland, USA; Division of Biometrics I, OB/CDER/FDA, HFD-710, Room 5062, WOCII, 5600 Fishers Lane, Rockville, MD, 20852, USACorrespondence[email protected]
&
Sue-Jane Wang Division of Biometrics II, Food and Drug Administration, Rockville, Maryland, USA
Pages 327-335 | Received 01 Mar 2003, Accepted 01 Oct 2003, Published online: 02 Feb 2007

Citations (25)

Keep up to date with the latest research on this topic with citation updates for this article.

Subscribe to citation updates

Read on this site (7)

Erina Paul, Ram C. Tiwari, Shrabanti Chowdhury & Samiran Ghosh. (2023) A more powerful test for three-arm non-inferiority via risk difference: Frequentist and Bayesian approaches. Journal of Applied Statistics 50:4, pages 848-870.
Read now
Shrabanti Chowdhury, Ram C. Tiwari & Samiran Ghosh. (2019) Bayesian Approach for Assessing Non-Inferiority in Three-Arm Trials for Risk Ratio and Odds Ratio. Statistics in Biopharmaceutical Research 11:1, pages 34-43.
Read now
H.M. James Hung & Sue-Jane Wang. (2013) Statistical Considerations for Noninferiority Trial Designs Without Placebo. Statistics in Biopharmaceutical Research 5:3, pages 239-247.
Read now
Christopher Jennison & BruceW. Turnbull. (2007) Adaptive Seamless Designs: Selection and Prospective Testing of Hypotheses. Journal of Biopharmaceutical Statistics 17:6, pages 1135-1161.
Read now
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.
Read now
Yi Tsong & Wen-Jen Chen. (2007) Noninferiority Testing Beyond Simple Two-Sample Comparison∗ . Journal of Biopharmaceutical Statistics 17:2, pages 289-308.
Read now
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.
Read now

Articles from other publishers (18)

Samiran Ghosh, Erina Paul, Shrabanti Chowdhury & Ram C. Tiwari. (2022) New approaches for testing non-inferiority for three-arm trials with Poisson distributed outcomes. Biostatistics 23:1, pages 136-156.
Crossref
Shrabanti Chowdhury, Ram C. Tiwari & Samiran Ghosh. (2019) Non-inferiority testing for risk ratio, odds ratio and number needed to treat in three-arm trial. Computational Statistics & Data Analysis 132, pages 70-83.
Crossref
Santu Ghosh, Ram C. Tiwari & Samiran Ghosh. (2018) Bayesian approach for assessing noninferiority in a three-arm trial with binary endpoint. Pharmaceutical Statistics 17:4, pages 342-357.
Crossref
Samiran GhoshSantu GhoshRam C. Tiwari. (2016) Bayesian approach for assessing non-inferiority in a three-arm trial with pre-specified margin. Statistics in Medicine 35:5, pages 695-708.
Crossref
Wenqing Li, Ming-Hui Chen, Huaming Tan & Dipak K. Dey. 2015. Applied Statistics in Biomedicine and Clinical Trials Design. Applied Statistics in Biomedicine and Clinical Trials Design 17 33 .
H. M. James Hung, Sue‐Jane Wang & Robert O'Neill. 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 .
Koon Shing Kwong, Siu Hung Cheung, Anthony J. HayterMiin-Jye Wen. (2012) Extension of three-arm non-inferiority studies to trials with multiple new treatments. Statistics in Medicine 31:24, pages 2833-2843.
Crossref
Ton J. Cleophas & Aeilko H. Zwinderman. (2012) A Novel Approach to Noninferiority Testing. American Journal of Therapeutics 19:2, pages 101-107.
Crossref
Ton J. Cleophas & Aeilko H. ZwindermanTon J. Cleophas & Aeilko H. Zwinderman. 2012. Statistics Applied to Clinical Studies. Statistics Applied to Clinical Studies 675 686 .
Ning Li, Yonghong Gao & Shiowjen Lee. 2010. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development 26-1 26-14 .
Lei Nie & Guoxing Soon. (2010) A covariate‐adjustment regression model approach to noninferiority margin definition. Statistics in Medicine 29:10, pages 1107-1113.
Crossref
Mark A. Munger, Gregory J. Stoddard, Allen R. Wenner, John W. Bachman, John H. Jurige, Laura Poe & Diana L. Baker. (2008) Safety of Prescribing PDE-5 Inhibitors via e-Medicine vs Traditional Medicine. Mayo Clinic Proceedings 83:8, pages 890-896.
Crossref
Mark A. Munger, Gregory J. Stoddard, Allen R. Wenner, John W. Bachman, John H. Jurige, Laura Poe & Diana L. Baker. (2008) Safety of Prescribing PDE-5 Inhibitors via e-Medicine vs Traditional Medicine. Mayo Clinic Proceedings 83:8, pages 890-896.
Crossref
H. M. James Hung, Sue-Jane Wang & Robert O'Neill. 2007. Wiley Encyclopedia of Clinical Trials. Wiley Encyclopedia of Clinical Trials.
H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang & John Lawrence. (2006) A Regulatory View on Adaptive/Flexible Clinical Trial Design. Biometrical Journal 48:4, pages 565-573.
Crossref
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 .
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

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.