Bayesian approach for assessing noninferiority in a three-arm trial with binary endpoint

Pharmaceutical Statistics
Santu GhoshSamiran Ghosh

Abstract

With the recent advancement in many therapeutic areas, quest for better and enhanced treatment options is ever increasing. While the "efficacy" metric plays the most important role in this development, emphasis on other important clinical factors such as less intensive side effects, lower toxicity, ease of delivery, and other less debilitating factors may result in the selection of treatment options, which may not beat current established treatment option in terms efficacy, yet prove to be desirable for subgroups of patients. The resultant clinical trial by means of which one establishes such slightly less efficacious treatment is known as noninferiority (NI) trial. Noninferiority trials often involve an active established comparator arm, along with a placebo and an experimental treatment arm, resulting into a 3-arm trial. Most of the past developments in a 3-arm NI trial consider defining a prespecified fraction of unknown effect size of reference drug, i.e., without directly specifying a fixed NI margin. However, in some recent developments, more direct approach is being considered with prespecified fixed margin, albeit in the frequentist setup. In this article, we consider Bayesian implementation of such trial when primary o...Continue Reading

References

Jan 10, 2003·Statistics in Medicine·Ralph B D'AgostinoLisa M Sullivan
Mar 11, 2003·Statistics in Medicine·Iris PigeotDieter Hauschke
Jun 23, 2004·Journal of Biopharmaceutical Statistics·Jen-Pei LiuChin-Fu Hsiao
Jun 23, 2004·Journal of Biopharmaceutical Statistics·H M James Hung, Sue-Jane Wang
May 11, 2006·Statistics in Medicine·Meinhard Kieser, Tim Friede
Aug 24, 2006·Statistics in Medicine·Christy Chuang-SteinWalter Offen
Mar 10, 2010·Biostatistics·Mengye Guo, Daniel F Heitjan
Jan 8, 2011·Statistics in Medicine·Eisuke Hida, Toshiro Tango
Apr 27, 2011·Statistics in Medicine·Pulak GhoshRam C Tiwari
May 5, 2011·Trials·Jennifer Schumi, Janet T Wittes
Aug 13, 2011·Journal of Biopharmaceutical Statistics·Mark A GamaloRam C Tiwari
Jun 1, 1984·IEEE Transactions on Pattern Analysis and Machine Intelligence·S Geman, D Geman
May 24, 2012·Statistical Methods in Medical Research·M Amper GamaloRam C Tiwari
Jun 30, 2012·Statistics in Medicine·Koon Shing KwongMiin-Jye Wen
Aug 6, 2013·Pharmaceutical Statistics·Meg A GamaloLisa M LaVange
Jul 1, 2014·Biometrical Journal. Biometrische Zeitschrift·Meinhard Kieser, Kathrin Stucke

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Citations

Jun 27, 2018·Pharmaceutical Statistics·David Morgan
Oct 12, 2019·Statistics in Biopharmaceutical Research·Shrabanti ChowdhurySamiran Ghosh

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