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Handbook_of_Adaptive_Designs_in_Pharmaceutical_and_Clinical_Development.pdf
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CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742
© 2011 by Taylor and Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, an Informa business
Preface..........................................................................................................................................vii
Editors........................................................................................................................................... ix
Contributors................................................................................................................................ xi
1 Overview of Adaptive Design Methods in Clinical Trials............................. 1-1
Annpey Pong and Shein-Chung Chow
2 Fundamental Theory of Adaptive Designs with Unplanned Design
Change in Clinical Trials with Blinded Data.................................................2-1
Qing Liu and George Y. H. Chi
3 Bayesian Approach for Adaptive Design........................................................3-1
Guosheng Yin and Ying Yuan
4 The Impact of Protocol Amendments in Adaptive Trial Designs.................4-1
Shein-Chung Chow and Annpey Pong
5 From Group Sequential to Adaptive Designs.................................................5-1
Christopher Jennison and Bruce W. Turnbull
6 Determining Sample Size for Classical Designs............................................6-1
Simon Kirby and Christy Chuang-Stein
7 Sample Size Reestimation Design with Applications in Clinical Trials....... 7-1
Lu Cui and Xiaoru Wu
8 Adaptive Interim Analyses in Clinical Trials................................................8-1
Gernot Wassmer
9 Classical Dose-Finding Trial..........................................................................9-1
Naitee Ting
10 Improving Dose-Finding: A Philosophic View............................................ 10-1
Carl-Fredrik Burman, Frank Miller, and Kiat Wee Wong
11 Adaptive Dose-Ranging Studies................................................................... 11-1
Marc Vandemeulebroecke, Frank Bretz, José Pinheiro, and Björn Bornkamp
12 Seamless Phase I/II Designs......................................................................... 12-1
Vladimir Dragalin
vi Contents
13 Phase II/III Seamless Designs.......................................................................13-1
Jeἀ Maca
14 Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive
Trial Designs................................................................................................. 14-1
Shein-Chung Chow and Annpey Pong
15 Optimal Response-Adaptive Randomization for Clinical Trials................15-1
Lanju Zhang and William Rosenberger
16 Hypothesis-Adaptive Design........................................................................ 16-1
Gerhard Hommel
17 Treatment Adaptive Allocations in Randomized Clinical Trials:
An Overview.................................................................................................. 17-1
Atanu Biswas and Rahul Bhattacharya
18 Integration of Predictive Biomarker Diagnostics into Clinical
Trials for New Drug Development................................................................ 18-1
Richard Simon
19 Clinical Strategy for Study Endpoint Selection........................................... 19-1
Siu Keung Tse, Shein-Chung Chow, and Qingshu Lu
20 Adaptive Infrastructure................................................................................20-1
Bill Byrom, Damian McEntegart, and Graham Nicholls
21 Independent Data Monitoring Committees................................................. 21-1
Steven Snapinn and Qi Jiang
22 Targeted Clinical Trials................................................................................22-1
Jen-Pei Liu
23 Functional Genome-Wide Association Studies of Longitudinal Traits......23-1
Jiangtao Luo, Arthur Berg, Kwangmi Ahn, Kiranmoy Das, Jiahan Li, Zhong Wang,
Yao Li, and Rongling Wu
24 Adaptive Trial Simulation.............................................................................24-1
Mark Chang
25 Efficiency of Adaptive Designs.....................................................................25-1
Nigel Stallard and Tim Friede
26 Case Studies in Adaptive Design..................................................................26-1
Ning Li, Yonghong Gao, and Shiowjen Lee
27 Good Practices for Adaptive Clinical Trials................................................ 27-1
Paul Gallo
Index...................................................................................................... Index-1
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