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Journal of Biopharmaceutical Statistics Volume 17, 2007 - Issue 6
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Original Articles

Adaptive Seamless Designs: Selection and Prospective Testing of Hypotheses

Christopher Jennison Department of Mathematical Sciences, University of Bath, Bath, UKCorrespondence[email protected]
&
Bruce W. Turnbull Department of Statistical Science, Cornell University, Ithaca, New York, USA
Pages 1135-1161 | Received 15 May 2007, Accepted 27 Jun 2007, Published online: 14 Nov 2007

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JordanJ. Elm, YukoY. Palesch, GaryG. Koch, Vanessa Hinson, Bernard Ravina & Wenle Zhao. (2012) Flexible Analytical Methods for Adding a Treatment Arm Mid-Study to an Ongoing Clinical Trial. Journal of Biopharmaceutical Statistics 22:4, pages 758-772.
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Bin Cheng & Shein-Chung Chow. (2010) On Flexibility of Adaptive Designs and Criteria for Choosing A Good One—A Discussion of FDA Draft Guidance. Journal of Biopharmaceutical Statistics 20:6, pages 1171-1177.
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Zhantao Lin, Nancy Flournoy & William F. Rosenberger. (2021) Inference for a two-stage enrichment design. The Annals of Statistics 49:5.
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Richard Simon. 2017. Frontiers of Biostatistical Methods and Applications in Clinical Oncology. Frontiers of Biostatistical Methods and Applications in Clinical Oncology 1 9 .
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Baldur P. Magnusson & Bruce W. Turnbull. (2013) Group sequential enrichment design incorporating subgroup selection. Statistics in Medicine 32:16, pages 2695-2714.
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Yujun WuPeng-Liang Zhao. (2013) Interim treatment selection with a flexible selection margin in clinical trials. Statistics in Medicine 32:15, pages 2529-2543.
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Michael Rosenblum. (2013) Confidence intervals for the selected population in randomized trials that adapt the population enrolled. Biometrical Journal 55:3, pages 322-340.
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Meihua Wang, James J Dignam, Qiang E Zhang, John F DeGroot, Minesh P Mehta & Sally Hunsberger. (2012) Integrated phase II/III clinical trials in oncology: A case study. Clinical Trials 9:6, pages 741-747.
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Ajit C. TamhaneYi WuCyrus R. Mehta. (2012) Adaptive extensions of a two‐stage group sequential procedure for testing primary and secondary endpoints (II): sample size re‐estimation. Statistics in Medicine 31:19, pages 2041-2054.
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Tim Friede & Frank Miller. (2012) Blinded continuous monitoring of nuisance parameters in clinical trials. Journal of the Royal Statistical Society: Series C (Applied Statistics) 61:4, pages 601-618.
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Marc Buyse. (2012) Limitations of Adaptive Clinical Trials. American Society of Clinical Oncology Educational Book:32, pages 133-137.
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Jay Herson, Marc Buyse & Janet Turk Wittes. 2012. Designs for Clinical Trials. Designs for Clinical Trials 109 137 .
M. Rosenblum & M. J. van der Laan. (2011) Optimizing randomized trial designs to distinguish which subpopulations benefit from treatment. Biometrika 98:4, pages 845-860.
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Stephen C. Reingold, Henry F. McFarland & A. John Petkau. 2011. Multiple Sclerosis Therapeutics. Multiple Sclerosis Therapeutics 253 260 .
. 2011. Multiple Sclerosis Therapeutics. Multiple Sclerosis Therapeutics 56 299 .
Martin Jenkins, Andrew Stone & Christopher Jennison. (2010) An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints†. Pharmaceutical Statistics 10:4, pages 347-356.
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Stephane Heritier, Serigne N. Lô & Caroline C. Morgan. (2011) An adaptive confirmatory trial with interim treatment selection: Practical experiences and unbalanced randomization. Statistics in Medicine, pages n/a-n/a.
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Roland B. WalterFrederick R. AppelbaumMartin S. TallmanNoel S. Weiss, Richard A. Larson & Elihu H. Estey. (2010) Shortcomings in the clinical evaluation of new drugs: acute myeloid leukemia as paradigm. Blood 116:14, pages 2420-2428.
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Marc Vandemeulebroecke. (2008) Group Sequential and Adaptive Designs – A Review of Basic Concepts and Points of Discussion. Biometrical Journal 50:4, pages 541-557.
Crossref
B. W. Turnbull. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
Samuel Kotz, Campbell B. Read, N. Balakrishnan, Brani Vidakovic & Norman L. JohnsonB. W. Turnbull. 2004. Encyclopedia of Statistical Sciences. Encyclopedia of Statistical Sciences 1 7 .

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