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Journal of Biopharmaceutical Statistics Volume 26, 2016 - Issue 5
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Articles

Bayesian methods for the design and analysis of noninferiority trials

Margaret Gamalo-SiebersCenter for Food Safety and Applied Nutrition, FDA, College Park, Maryland, USA
,
Aijun GaoInVentiv Health Clinical, Princeton, New Jersey, USA
,
Mani LakshminarayananBiotechnology Clinical Development Statistics, Pfizer Inc., Collegeville, Pennsylvania, USACorrespondence[email protected]
,
Guanghan LiuMerck Sharp & Dohme Corp., North Wales, Pennsylvania, USA
,
Fanni NatanegaraEli Lilly and Company, Indianapolis, Indiana, USA
,
Radha RailkarBiotechnology Clinical Development Statistics, Pfizer Inc., Collegeville, Pennsylvania, USA
,
Heinz SchmidliNovartis Pharma AG, Basel, Switzerland
&
Guochen SongQuintiles, Durham, North Carolina, USA
 show all
Pages 823-841 | Received 12 Nov 2014, Accepted 18 Jul 2015, Published online: 16 Feb 2016

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Wenlin Yuan, Ming-Hui Chen & John Zhong. (2022) Bayesian Design of Superiority Trials: Methods and Applications. Statistics in Biopharmaceutical Research 14:4, pages 433-443.
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Articles from other publishers (18)

Francesco Mariani, Fulvio De Santis & Stefania Gubbiotti. (2023) A dynamic power prior approach to non‐inferiority trials for normal means. Pharmaceutical Statistics.
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Fulvio De Santis & Stefania Gubbiotti. (2023) Borrowing historical information for non-inferiority trials on Covid-19 vaccines. The International Journal of Biostatistics 19:1, pages 177-189.
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Rebecca M. Turner, Michelle N. Clements, Matteo Quartagno, Victoria Cornelius, Suzie Cro, Deborah Ford, Conor D. Tweed, A. Sarah Walker & Ian R. White. (2023) Practical approaches to Bayesian sample size determination in non‐inferiority trials with binary outcomes. Statistics in Medicine 42:8, pages 1127-1138.
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Cassandra Lane, Luke Wolfenden, Alix Hall, Rachel Sutherland, Patti-Jean Naylor, Chris Oldmeadow, Lucy Leigh, Adam Shoesmith, Adrian Bauman, Nicole McCarthy & Nicole Nathan. (2022) Optimising a multi-strategy implementation intervention to improve the delivery of a school physical activity policy at scale: findings from a randomised noninferiority trial. International Journal of Behavioral Nutrition and Physical Activity 19:1.
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Patrick P. J. Phillips & David V. Glidden. 2022. Principles and Practice of Clinical Trials. Principles and Practice of Clinical Trials 1297 1323 .
Fulvio De Santis & Stefania Gubbiotti. 2022. Studies in Theoretical and Applied Statistics. Studies in Theoretical and Applied Statistics 15 30 .
Kartik Sehgal, Anushi Bulumulle, Heather Brody, Ritu R. Gill, Shravanti Macherla, Aleksandra Qilleri, Danielle C. McDonald, Cynthia R. Cherry, Meghan Shea, Mark S. Huberman, Paul A. VanderLaan, Glen J. Weiss, Paul R. Walker, Daniel B. Costa & Deepa Rangachari. (2021) Association of Extended Dosing Intervals or Delays in Pembrolizumab-based Regimens With Survival Outcomes in Advanced Non–small-cell Lung Cancer. Clinical Lung Cancer 22:3, pages e379-e389.
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Patrick P. J. Phillips & David V. Glidden. 2020. Principles and Practice of Clinical Trials. Principles and Practice of Clinical Trials 1 28 .
Junjiang Zhong, Miin-Jye Wen & Siu Hung Cheung. (2020) Identification of the minimum non-inferior dose in a three-arm non-inferiority trial. Journal of the Korean Statistical Society 49:4, pages 1238-1254.
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Camille Aupiais, Corinne Alberti, Thomas Schmitz, Olivier Baud, Moreno Ursino & Sarah Zohar. (2019) A Bayesian non-inferiority approach using experts’ margin elicitation – application to the monitoring of safety events. BMC Medical Research Methodology 19:1.
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Don van Ravenzwaaij, Rei Monden, Jorge N. Tendeiro & John P. A. Ioannidis. (2019) Bayes factors for superiority, non-inferiority, and equivalence designs. BMC Medical Research Methodology 19:1.
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Ying Yang, Yunling Xu, Nelson T. Lu & Ram C. Tiwari. 2019. Contemporary Biostatistics with Biopharmaceutical Applications. Contemporary Biostatistics with Biopharmaceutical Applications 239 249 .
Mark J. Ratain & Daniel A. Goldstein. (2018) Time Is Money: Optimizing the Scheduling of Nivolumab. Journal of Clinical Oncology 36:31, pages 3074-3076.
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Wenqing Li, Ming-Hui Chen, Xiaojing Wang & Dipak K. Dey. (2017) Bayesian Design of Non-inferiority Clinical Trials Via the Bayes Factor. Statistics in Biosciences 10:2, pages 439-459.
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Camille Aupiais, Sarah Zohar, Garry Taverny, Enora Le Roux, Rym Boulkedid & Corinne Alberti. (2018) Exploring how non-inferiority and equivalence are assessed in paediatrics: a systematic review. Archives of Disease in Childhood, pages archdischild-2018-314874.
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Masaaki Doi, Fumihiro Takahashi & Yohei Kawasaki. (2017) Bayesian noninferiority test for 2 binomial probabilities as the extension of Fisher exact test. Statistics in Medicine 36:30, pages 4789-4803.
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Don van Ravenzwaaij & John P. A. Ioannidis. (2017) A simulation study of the strength of evidence in the recommendation of medications based on two trials with statistically significant results. PLOS ONE 12:3, pages e0173184.
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Junjing Lin, Margaret Gamalo-Siebers & Ram Tiwari. (2016) Non-inferiority and networks: inferring efficacy from a web of data. Pharmaceutical Statistics 15:1, pages 54-67.
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