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Journal of Biopharmaceutical Statistics Volume 24, 2014 - Issue 5: The 2013 ASA Biopharmaceutical FDA/Industry Statistics Workshop
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Original Articles

Some Challenges With Statistical Inference in Adaptive Designs

H. M. James HungDivision of Biometrics I, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USACorrespondence[email protected]
,
Sue-Jane WangOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
&
Peiling YangDivision of Biometrics I, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
Pages 1059-1072 | Received 01 Jul 2013, Accepted 23 Sep 2013, Published online: 11 Aug 2014

Citations (11)

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Read on this site (4)

Jian Zhu, Xin Li & Yi Liu. (2022) An Optimal Hybrid Approach to Calculate Conditional Power. Statistics in Biopharmaceutical Research 14:4, pages 480-492.
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H.M. James Hung, Sue-Jane Wang & Peiling Yang. (2016) Rejoinder to Dr. Cyrus R. Mehta. Journal of Biopharmaceutical Statistics 26:2, pages 405-405.
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Cyrus R. Mehta. (2016) Comments on “Some Challenges with Statistical Inference in Adaptive Designs” by Hung, Wang, and Yang. Journal of Biopharmaceutical Statistics 26:2, pages 402-404.
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H. M. James Hung, Sue-Jane Wang, Peiling Yang, Kun Jin, John Lawrence, George Kordzakhia & Tristan Massie. (2016) Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials. Journal of Biopharmaceutical Statistics 26:1, pages 37-43.
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Articles from other publishers (7)

Julia M. Edwards, Stephen J. Walters, Cornelia Kunz & Steven A. Julious. (2020) A systematic review of the “promising zone” design. Trials 21:1.
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Lu Cui & Lanju Zhang. (2018) On the efficiency of adaptive sample size design. Statistics in Medicine 38:6, pages 933-944.
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Lu Cui, Lanju Zhang & Bo Yang. (2017) Optimal adaptive group sequential design with flexible timing of sample size determination. Contemporary Clinical Trials 63, pages 8-12.
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Kaspar Rufibach, Meng Chen & Hoa Nguyen. (2016) Comparison of different clinical development plans for confirmatory subpopulation selection. Contemporary Clinical Trials 47, pages 78-84.
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Weichung Joe Shih, Gang Li & Yining Wang. (2016) Methods for flexible sample-size design in clinical trials: Likelihood, weighted, dual test, and promising zone approaches. Contemporary Clinical Trials 47, pages 40-48.
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Peter Bauer, Frank Bretz, Vladimir DragalinFranz König & Gernot Wassmer. (2015) Twenty‐five years of confirmatory adaptive designs: opportunities and pitfalls. Statistics in Medicine 35:3, pages 325-347.
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John W Loewy. (2015) Novel adaptive designs: aligning drug development and patient incentives. Clinical Investigation 5:4, pages 367-371.
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