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Statistics in Biopharmaceutical Research Volume 3, 2011 - Issue 1
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Articles

Chain Procedures: A Class of Flexible Closed Testing Procedures With Clinical Trial Applications

Brian A. Millen
&
Alex Dmitrienko
Pages 14-30 | Received 01 May 2009, Published online: 01 Jan 2012

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Hong Zhou & Huajiang Li. (2023) Applications of covering principle to clinical trials with multiple objectives. Communications in Statistics - Simulation and Computation 52:6, pages 2752-2764.
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Thomas Ondra, Alex Dmitrienko, Tim Friede, Alexandra Graf, Frank Miller, Nigel Stallard & Martin Posch. (2016) Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review. Journal of Biopharmaceutical Statistics 26:1, pages 99-119.
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BrianL. Wiens, Alex Dmitrienko & Olga Marchenko. (2013) Selection of Hypothesis Weights and Ordering When Testing Multiple Hypotheses in Clinical Trials. Journal of Biopharmaceutical Statistics 23:6, pages 1403-1419.
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MohammadF. Huque, Alex Dmitrienko & Ralph D’Agostino. (2013) Multiplicity Issues in Clinical Trials With Multiple Objectives. Statistics in Biopharmaceutical Research 5:4, pages 321-337.
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Willi Maurer & Frank Bretz. (2013) Multiple Testing in Group Sequential Trials Using Graphical Approaches. Statistics in Biopharmaceutical Research 5:4, pages 311-320.
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Alex Dmitrienko, JuliaN. Soulakova & BrianA. Millen. (2011) Three Methods for Constructing Parallel Gatekeeping Procedures in Clinical Trials. Journal of Biopharmaceutical Statistics 21:4, pages 768-786.
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Articles from other publishers (33)

Todd J. Schwedt, Tina M. Myers Oakes, James M. Martinez, Bert B. Vargas, Hitendra Pandey, Eric M. Pearlman, Diane R. Richardson, Oralee J. Varnado, Michael Cobas Meyer & Peter J. Goadsby. (2023) Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial. Neurology and Therapy.
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Jiajun Liu & Shein-Chung Chow. (2022) A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission. Therapeutic Innovation & Regulatory Science 57:2, pages 196-208.
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Hui Wang, Ilana Belitskaya-Lévy & Ying Lu. 2020. Design and Analysis of Subgroups with Biopharmaceutical Applications. Design and Analysis of Subgroups with Biopharmaceutical Applications 19 31 .
Thomas Ondra, Sebastian Jobjörnsson, Robert A Beckman, Carl-Fredrik Burman, Franz König, Nigel Stallard & Martin Posch. (2017) Optimized adaptive enrichment designs. Statistical Methods in Medical Research 28:7, pages 2096-2111.
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Holland C. DetkePeter J. Goadsby, Shufang WangDeborah I. FriedmanKatherine J. SelzlerSheena K. Aurora. (2018) Galcanezumab in chronic migraine. Neurology 91:24.
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Huiling Li, Jianming Wang, Xiaolong Luo, Janis Grechko & Christopher Jennison. (2018) Improved two-stage group sequential procedures for testing a secondary endpoint after the primary endpoint achieves significance. Biometrical Journal 60:5, pages 893-902.
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Ilana Belitskaya-Lévy, Hui Wang, Mei-Chiung Shih, Lu Tian, Gheorghe Doros, Robert A. Lew & Ying Lu. (2016) A New Overall-Subgroup Simultaneous Test for Optimal Inference in Biomarker-Targeted Confirmatory Trials. Statistics in Biosciences 10:2, pages 297-323.
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Christina Habermehl, Axel Benner & Annette Kopp-Schneider. (2018) Addressing small sample size bias in multiple-biomarker trials: Inclusion of biomarker-negative patients and Firth correction. Biometrical Journal 60:2, pages 275-287.
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Alex Dmitrienko, Brian MillenIlya Lipkovich. (2017) Multiplicity considerations in subgroup analysis. Statistics in Medicine 36:28, pages 4446-4454.
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Abdul J. SankohHaihong Li & Ralph B. D'AgostinoSr.Sr.. (2017) Composite and multicomponent end points in clinical trials. Statistics in Medicine 36:28, pages 4437-4440.
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Mohamed AloshMohammad F. HuqueFrank Bretz & Ralph B. D'AgostinoSr.Sr.. (2017) Tutorial on statistical considerations on subgroup analysis in confirmatory clinical trials. Statistics in Medicine 36:8, pages 1334-1360.
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Gavin Lynch, Wenge Guo, Sanat K. Sarkar & Helmut Finner. (2017) The control of the false discovery rate in fixed sequence multiple testing. Electronic Journal of Statistics 11:2.
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Hui Wang, Ilana Belitskaya-Lévy, Mei-Chiung Shih & Ying Lu. 2017. Clinical Trials Design in Operative and Non Operative Invasive Procedures. Clinical Trials Design in Operative and Non Operative Invasive Procedures 163 179 .
Kentaro Sakamaki, Toshifumi Kamiura, Yusuke Morita, Katsuhiro Iba, Seitaro Yoshida, Akira Wakana, Satoru Tsuchiya, Satoru Fukimbara & Hideki Suganami. (2016) Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials: An Industry Survey in Japan. Therapeutic Innovation & Regulatory Science 50:6, pages 846-852.
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Thomas Ondra, Sebastian Jobjörnsson, Robert A. Beckman, Carl-Fredrik Burman, Franz König, Nigel Stallard & Martin Posch. (2016) Optimizing Trial Designs for Targeted Therapies. PLOS ONE 11:9, pages e0163726.
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Kaushik Patra, Bruce A. C. Cree, Eliezer Katz, Erik Pulkstenis, Alex Dmitrienko & Gary Cutter. (2016) Statistical Considerations for an Adaptive Design for a Serious Rare Disease. Therapeutic Innovation & Regulatory Science 50:3, pages 375-384.
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Zhiying QiuWenge GuoGavin Lynch. (2015) On generalized fixed sequence procedures for controlling the FWER. Statistics in Medicine 34:30, pages 3968-3983.
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Zhiwei ZhangChenguang WangJames F. Troendle. (2015) Optimizing the order of hypotheses in serial testing of multiple endpoints in clinical trials. Statistics in Medicine 34:9, pages 1467-1482.
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Alex DmitrienkoGautier PauxThomas Brechenmacher. (2015) POWER CALCULATIONS IN CLINICAL TRIALS WITH COMPLEX CLINICAL OBJECTIVES. Journal of the Japanese Society of Computational Statistics 28:1, pages 15-50.
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Vera Lisovskaja & Carl-Fredrik Burman. (2015) A decision theoretic approach to optimization of multiple testing procedures. Biometrical Journal 57:1, pages 64-75.
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Willi Maurer & Frank Bretz. (2014) A note on testing families of hypotheses using graphical procedures. Statistics in Medicine 33:30, pages 5340-5346.
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Abdul J. SankohHaihong LiRalph B. D'AgostinoSrSr. (2014) Use of composite endpoints in clinical trials. Statistics in Medicine 33:27, pages 4709-4714.
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Brian A. Millen, Alex Dmitrienko, Sumithra J. Mandrekar, Zongjun Zhang & Dominique Williams. (2014) Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations. Therapeutic Innovation & Regulatory Science 48:4, pages 453-462.
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Mohamed AloshFrank Bretz & Mohammad Huque. (2014) Advanced multiplicity adjustment methods in clinical trials. Statistics in Medicine 33:4, pages 693-713.
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Alex DmitrienkoRalph D'AgostinoSrSr. (2013) Traditional multiplicity adjustment methods in clinical trials. Statistics in Medicine 32:29, pages 5172-5218.
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Willi Maurer & Frank Bretz. (2013) Memory and other properties of multiple test procedures generated by entangled graphs. Statistics in Medicine 32:10, pages 1739-1753.
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Mohamed Alosh & Mohammad F. Huque. (2013) Multiplicity considerations for subgroup analysis subject to consistency constraint. Biometrical Journal 55:3, pages 444-462.
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Alex Dmitrienko & Ajit C. Tamhane. (2013) General theory of mixture procedures for gatekeeping. Biometrical Journal 55:3, pages 402-419.
Crossref
Alex DmitrienkoRalph B. D'AgostinoSr.Sr. & Mohammad F. Huque. (2013) Key multiplicity issues in clinical drug development. Statistics in Medicine 32:7, pages 1079-1111.
Crossref
George KordzakhiaAlex Dmitrienko. (2013) Superchain procedures in clinical trials with multiple objectives. Statistics in Medicine 32:3, pages 486-508.
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Brian A. Millen, Alex Dmitrienko, Stephen Ruberg & Lei Shen. (2012) A Statistical Framework for Decision Making in Confirmatory Multipopulation Tailoring Clinical Trials. Drug Information Journal 46:6, pages 647-656.
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Alex Dmitrienko, Brian A. Millen, Thomas Brechenmacher & Gautier Paux. (2011) Development of gatekeeping strategies in confirmatory clinical trials. Biometrical Journal 53:6, pages 875-893.
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Frank Bretz, Martin Posch, Ekkehard Glimm, Florian Klinglmueller, Willi Maurer & Kornelius Rohmeyer. (2011) Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests. Biometrical Journal 53:6, pages 894-913.
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