Design and Analysis of Bridging Studies 1st Edition Jen-Pei Liu (Editor)
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- 5. Design and Analysis of Bridging Studies 1st Edition Jen- Pei Liu (Editor) Digital Instant Download Author(s): Jen-pei Liu (Editor); Shein-Chung Chow(Editor); Chin-Fu Hsiao (Editor) ISBN(s): 9781439846353, 1439846359 Edition: 1 File Details: PDF, 6.97 MB Year: 2012 Language: english
- 6. Edited by Jen-pei Liu Shein-Chung Chow Chin-Fu Hsiao Design and Analysis of Bridging Studies
- 9. Editor-in-Chief Shein-Chung Chow, Ph.D. Professor Department of Biostatistics and Bioinformatics Duke University School of Medicine Durham, North Carolina Series Editors Byron Jones Biometrical Fellow Statistical Methodology Integrated Information Sciences Novartis Pharma AG Basel, Switzerland Jen-pei Liu Professor Division of Biometry Department of Agronomy National Taiwan University Taipei, Taiwan Karl E. Peace Georgia Cancer Coalition Distinguished Cancer Scholar Senior Research Scientist and Professor of Biostatistics Jiann-Ping Hsu College of Public Health Georgia Southern University Statesboro, Georgia Bruce W. Turnbull Professor School of Operations Research and Industrial Engineering Cornell University Ithaca, New York
- 10. Adaptive Design Methods in Clinical Trials, Second Edition Shein-Chung Chow and Mark Chang Adaptive Design Theory and Implementation Using SAS and R Mark Chang Advanced Bayesian Methods for Medical Test Accuracy Lyle D. Broemeling Advances in Clinical Trial Biostatistics Nancy L. Geller Basic Statistics and Pharmaceutical Statistical Applications, Second Edition James E. De Muth Bayesian Adaptive Methods for Clinical Trials Scott M. Berry, Bradley P. Carlin, J. Jack Lee, and Peter Muller Bayesian Analysis Made Simple: An Excel GUI for WinBUGS Phil Woodward Bayesian Methods for Measures of Agreement Lyle D. Broemeling Bayesian Missing Data Problems: EM, Data Augmentation and Noniterative Computation Ming T. Tan, Guo-Liang Tian, and Kai Wang Ng Bayesian Modeling in Bioinformatics Dipak K. Dey, Samiran Ghosh, and Bani K. Mallick Biostatistics: A Computing Approach Stewart J. Anderson Causal Analysis in Biomedicine and Epidemiology: Based on Minimal Sufficient Causation Mikel Aickin Clinical Trial Data Analysis using R Ding-Geng (Din) Chen and Karl E. Peace Clinical Trial Methodology Karl E. Peace and Ding-Geng (Din) Chen Computational Methods in Biomedical Research Ravindra Khattree and Dayanand N. Naik Computational Pharmacokinetics Anders Källén Controversial Statistical Issues in Clinical Trials Shein-Chung Chow Data and Safety Monitoring Committees in Clinical Trials Jay Herson Design and Analysis of Animal Studies in Pharmaceutical Development Shein-Chung Chow and Jen-pei Liu Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition Shein-Chung Chow and Jen-pei Liu Design and Analysis of Bridging Studies Jen-pei Liu, Shein-Chung Chow, and Chin-Fu Hsiao Design and Analysis of Clinical Trials with Time-to-Event Endpoints Karl E. Peace Design and Analysis of Non-Inferiority Trials Mark D. Rothmann, Brian L. Wiens, and Ivan S. F. Chan Difference Equations with Public Health Applications Lemuel A. Moyé and Asha Seth Kapadia DNA Methylation Microarrays: Experimental Design and Statistical Analysis Sun-Chong Wang and Arturas Petronis DNA Microarrays and Related Genomics Techniques: Design, Analysis, and Interpretation of Experiments David B. Allison, Grier P. Page, T. Mark Beasley, and Jode W. Edwards
- 11. Dose Finding by the Continual Reassessment Method Ying Kuen Cheung Elementary Bayesian Biostatistics Lemuel A. Moyé Frailty Models in Survival Analysis Andreas Wienke Generalized Linear Models: A Bayesian Perspective Dipak K. Dey, Sujit K. Ghosh, and Bani K. Mallick Handbook of Regression and Modeling: Applications for the Clinical and Pharmaceutical Industries Daryl S. Paulson Measures of Interobserver Agreement and Reliability, Second Edition Mohamed M. Shoukri Medical Biostatistics, Third Edition A. Indrayan Meta-Analysis in Medicine and Health Policy Dalene Stangl and Donald A. Berry Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies Mark Chang Multiple Testing Problems in Pharmaceutical Statistics Alex Dmitrienko, Ajit C. Tamhane, and Frank Bretz Randomized Clinical Trials of Nonpharmacological Treatments Isabelle Boutron, Philippe Ravaud, and David Moher Sample Size Calculations in Clinical Research, Second Edition Shein-Chung Chow, Jun Shao and Hansheng Wang Statistical Design and Analysis of Stability Studies Shein-Chung Chow Statistical Evaluation of Diagnostic Performance: Topics in ROC Analysis Kelly H. Zou, Aiyi Liu, Andriy Bandos, Lucila Ohno-Machado, and Howard Rockette Statistical Methods for Clinical Trials Mark X. Norleans Statistics in Drug Research: Methodologies and Recent Developments Shein-Chung Chow and Jun Shao Statistics in the Pharmaceutical Industry, Third Edition Ralph Buncher and Jia-Yeong Tsay Translational Medicine: Strategies and Statistical Methods Dennis Cosmatos and Shein-Chung Chow
- 12. Edited by Jen-pei Liu Shein-Chung Chow Chin-Fu Hsiao Design and Analysis of Bridging Studies
- 13. CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2013 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20120525 International Standard Book Number-13: 978-1-4398-4635-3 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmit- ted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www.copyright. com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com
- 14. vii Contents Preface.....................................................................................................................xv Contributors........................................................................................................xvii 1. Bridging Diversity: Extrapolating Foreign Data to a New Region ......1 Shein-Chung Chow and Chin-Fu Hsiao 1.1 Introduction...........................................................................................1 1.2 Impact of Ethnic Differences...............................................................2 1.3 Regulatory Guidelines .........................................................................4 1.3.1 ICH E5 Guideline on Bridging Studies.................................4 1.3.2 Regulatory Guidelines in Asia-Pacific Region.....................6 1.4 Current Issues........................................................................................7 1.4.1 Criteria for Similarity..............................................................7 1.4.2 Sample Size Estimation and Allocation................................8 1.5 Examples .............................................................................................. 10 1.6 Concluding Remarks..........................................................................12 1.7 Aim and Structure of the Book......................................................... 14 References .......................................................................................................15 2. Two-Stage Designs of Bridging Studies..................................................17 Chin-Fu Hsiao, Hsiao-Hui Tsou, Jen-pei Liu, and Yuh-Jenn Wu 2.1 Introduction.........................................................................................17 2.2 Two-Stage Design for Bridging Studies...........................................18 2.2.1 Two-Stage Design ..................................................................19 2.2.2 Determining Sample Size and Critical Values ..................19 2.3 Group Sequential Approach to Evaluating Bridging Studies ......25 2.3.1 Group Sequential Approach.................................................25 2.3.2 Sample Size Determination..................................................26 2.4 Concluding Remarks..........................................................................30 References .......................................................................................................31 3. Consistency of Treatment Effects in Bridging Studies and Global Multiregional Trials .......................................................................33 Weichung J. Shih and Hui Quan 3.1 Introduction.........................................................................................33 3.2 Global Clinical Trial............................................................................34 3.3 Consistency in Making Inference Regarding the Overall Treatment Effect θ .......................................................................................35 3.4 Consistency as a Method for Region-Specific Registration ..........39
- 15. viii Contents 3.5 Other Considerations .........................................................................43 3.5.1 Time-to-Event and Binary Endpoints .................................43 3.5.2 Noninferiority Trial...............................................................44 3.5.3 MRCT Monitoring .................................................................44 3.6 Example................................................................................................45 3.7 Discussion............................................................................................46 References .......................................................................................................47 Shein-Chung Chow, Ying Lu, and Lan-Yan Yang 4.1 Introduction.........................................................................................49 4.2 Criteria for Assessing Similarity ......................................................50 4.3 Reproducibility and Generalizability ..............................................51 4.3.1 Test for Reproducibility ........................................................52 4.3.1.1 Estimated Power Approach..................................52 4.3.1.2 Confidence Bound Approach ...............................56 4.3.1.3 Bayesian Approach ................................................57 4.3.2 Evaluating the Generalizability Probability ......................63 4.4 Assessing the Similarity-Based Sensitivity Index..........................64 4.4.1 Population Shift between Regions ......................................64 4.4.2 Case Where Both ε and C Are Fixed...................................65 4.4.3 Case Where ε Is Random and C Is Fixed............................66 4.4.3.1 E-Step .......................................................................67 4.4.3.2 M-Step......................................................................67 4.4.4 Case Where ε Is Fixed and C Is Random............................68 4.4.5 Case Where Both ε and C Are Random..............................71 4.5 Concluding Remarks..........................................................................75 References .......................................................................................................77 5. Combining Information in Clinical Drug Development: Bridging Studies and Beyond ....................................................................79 Kuang-Kuo Gordon Lan and José Pinheiro 5.1 Introduction.........................................................................................79 5.2 Leveraging Existing Information in Bridging Studies..................80 5.2.1 Weighted Z-Test Approach...................................................81 5.2.2 Discount Factor Approach....................................................83 5.3 Application: Bridging of Blood Pressure Drug...............................84 5.4 Discussion............................................................................................85 References .......................................................................................................87 6. A Bayesian Approach for Evaluation of Bridging Studies...................89 Chin-Fu Hsiao, Hsiao-Hui Tsou, Jen-pei Liu, and Yuh-Jenn Wu 6.1 Introduction.........................................................................................89 6.2 Mixture of Prior Information ............................................................91 6.3 Determination of Sample Size...........................................................94 6.4 Examples ..............................................................................................97
- 16. ix Contents 6.5 Concluding Remarks........................................................................ 102 References ..................................................................................................... 104 7. Issues of Sample Size in Bridging Trials and Global Clinical Trials.............................................................................................. 105 Hsien-Ming James Hung, Sue-Jane Wang, and Robert O’Neill 7.1 Issues of Sample Size Planning for Bridging Trial....................... 105 7.2 Issues of Sample Size Planning in Global Clinical Trial ............. 108 7.3 Impacts of Consistency Assessment on Sample Size................... 112 7.4 Discussion.......................................................................................... 117 References ..................................................................................................... 118 8. Design and Sample Size Considerations for Global Trials ............... 121 Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama, and Kazuhiko Kuribayashi 8.1 Introduction....................................................................................... 121 8.2 Points to Consider When Designing a Multiregional Trial ........126 8.2.1 Clinical Considerations.......................................................126 8.2.2 Statistical Considerations....................................................127 8.2.3 Regulatory Considerations.................................................128 8.2.4 Commercial Considerations...............................................128 8.2.5 Operational Considerations ...............................................129 8.3 Determination of Regional Sample Size in a Multiregional Study..........................................................................130 8.3.1 Assumption That Treatment Effect Is Uniform across Regions.................................................................................. 131 8.3.2 Variation in True Treatment Effect across Regions.........134 8.3.3 Consistency Range for Sample Sizing .............................. 139 8.3.4 Other Approaches................................................................ 140 8.4 Additional Analysis to Estimate Treatment Effects in Different Regions .............................................................................. 141 8.4.1 Notations............................................................................... 142 8.4.2 Estimation of Regional Effect Size .................................... 143 8.5 Real-Time Monitoring of Multiregional Trials ............................. 144 8.6 Concluding Remarks........................................................................ 146 References ..................................................................................................... 148 9. Application of Genomic Technologies for Bridging Strategy Involving Different Race and Ethnicity in Pharmacogenomics Clinical Trials.............................................................................................. 151 Sue-Jane Wang 9.1 Introduction....................................................................................... 151 9.2 Pharmacogenomics and Pharmacogenetics..................................153 9.2.1 Definition ..............................................................................153
- 17. x Contents 9.2.2 Genomic (Composite) Biomarker.......................................154 9.2.3 Clinical Utility......................................................................154 9.2.3.1 Prognostic..............................................................155 9.2.3.2 Predictive...............................................................156 9.2.3.3 Prognostic and Predictive...................................156 9.2.4 Assessment of Clinical Utility and Therapeutic Effect................................................................156 9.3 Bridging..............................................................................................158 9.3.1 New Region Trial—External Bridging Strategy..............158 9.3.1.1 External Bridging Strategy ................................. 159 9.3.1.2 NSCLC Patient Composition in Regional Pharmacogenomics Trials................................................... 160 9.3.1.3 Results Observed in Regional Pharmacogenomics Trials................................... 161 9.3.1.4 Consistent Observation between OTR and PFS in EGFR+ NSCLC Patient Subset................ 163 9.3.1.5 Inconsistent Observation of OS in EGFR+ NSCLC Patient Subset ......................................... 163 9.3.2 Original Region Trial—Internal Bridging Strategy........164 9.3.2.1 Internal Bridging Strategy ..................................164 9.3.2.2 Potential Genomics Factors Explored................ 165 9.3.2.3 Absence of Patients from East Asia ................... 165 9.4 Bridging Study Evaluation............................................................... 166 9.4.1 Treatment Effect Demonstrated in Original Region....... 166 9.4.1.1 Indirect Evaluation of Bridging Effect .............. 167 9.4.1.2 Type I Error Assessment ..................................... 168 9.4.1.3 Direct Evaluation.................................................. 169 9.4.1.4 Comparisons of Methods.................................... 169 9.4.2 Treatment Effect Not Demonstrated in Original Region.................................................................... 170 9.4.3 Internal Bridging Strategy in Multiregional Clinical Trial........................................................................................ 171 9.4.3.1 Blinded Two-Stage Adaptive Test...................... 171 9.4.3.2 Unblinded Two-Stage Adaptive Test.................172 9.5 Challenges of Bridging Strategy in Pharmacogenomics............. 174 9.5.1 Prospective–Retrospective Design and Analysis ........... 174 9.5.1.1 Probability of Observed Imbalance with Small Sample Size ................................................ 175 9.5.1.2 Close to Full Ascertainment of Genomic Samples in Pharmacogenomics Trials............... 176 9.5.2 Genomic Convenience Samples.........................................177 9.5.2.1 Baseline Imbalance .............................................. 178
- 18. xi Contents 9.5.2.2 Inferential Problems ............................................ 179 9.5.3 Genomics In Vitro Diagnostics........................................... 182 9.5.3.1 Impact of Misclassification of an IVD in Pharmacogenomics Clinical Trial......................183 9.5.4 Region as a Confounder to Ethnic Sensitivity.................184 9.5.5 Implication of Futility Analysis with an Unblinded Adaptive Test in MRCT.......................................................185 9.5.6 Other Complex Issues ......................................................... 186 9.5.7 Replication Issue .................................................................. 187 9.6 Concluding Remarks........................................................................ 189 References .....................................................................................................190 10. Interaction Effects in Bridging Studies ................................................. 197 Eric Tsung-Cheng Hsieh and Jen-pei Liu 10.1 Introduction....................................................................................... 197 10.2 Noninferiority Hypothesis for Treatment Similarity ..................199 10.3 Statistical Testing Procedures .........................................................200 10.4 Simulation Studies............................................................................205 10.5 Numerical Examples ........................................................................209 10.5.1 Applications to Evaluation of Bridging Studies ..............209 10.5.2 Application to Evaluation of Age Groups within the Same Study ........................................................................... 213 10.6 Discussion and Final Remarks........................................................ 214 References ..................................................................................................... 217 11. Multiregional Clinical Trials................................................................... 219 Yi Tsong and Hsiao-Hui Tsou 11.1 Introduction....................................................................................... 219 11.2 Different Regional Requirements...................................................220 11.2.1 Different Noninferiority Margins.....................................221 11.2.2 Different Time Points Requirements ................................221 11.2.3 Different Experimental Designs........................................222 11.2.4 Different Endpoints Required by Two Regions ..............223 11.2.4.1 Two Subset Testing...............................................224 11.2.4.2 Testing Two Sequential Overall Hypotheses Using All Sample Size ...................224 11.2.4.3 Testing Two Parallel Overall Hypotheses with No Adjustment ............................................225 11.2.4.4 Testing Two Parallel Overall Hypotheses with Type I Error Rate Adjustment ...................225 11.3 Bridging the Overall Treatment Effect to Regions.......................225 11.4 Summary............................................................................................232 References .....................................................................................................232
- 19. xii Contents 12. Multiregional Clinical Trials for Global Simultaneous Drug Development in Japan ...............................................................................235 Kihito Takahashi, Mari Ikuta, and Hiromu Nakajima 12.1 Introduction.......................................................................................235 12.2 Drug Lag.............................................................................................236 12.3 MRCTs as a Solution to Drug Lag...................................................236 12.4 Improvements in Clinical Trial Environment in Japan...............237 12.5 Growing Trends of MRCTs in Japan ..............................................238 12.5.1 Trends in CTN and PMDA Clinical Trial Consultations on MRCTs....................................................238 12.5.2 Industry Surveys..................................................................238 12.6 MRCTs in the Field of Oncology.....................................................239 12.6.1 Necessity of MRCTs in the Field of Oncology.................239 12.6.2 PMDA Consultation on MRCTs in the Field of Anticancer Drugs.................................................................240 12.6.3 Ethnic or Regional Differences..........................................240 12.6.4 Differences in Clinical Staging and Medical Environment......................................................................... 241 12.6.5 New Paradigm...................................................................... 241 12.7 MRCTs in the Field of CVM ............................................................242 12.7.1 Necessity of MRCTs in the Field of Oncology.................242 12.7.2 Ethnic Factors .......................................................................242 12.7.3 Intrinsic Factors....................................................................243 12.7.4 Extrinsic Factors...................................................................244 12.7.5 Key Determinants for Successful MRCTs in CVM Field.............................................................................244 12.8 Issues in MRCTs................................................................................245 12.8.1 Ethnic Factors .......................................................................245 12.8.2 Regulatory Requirements...................................................245 12.8.3 Operational Issues ...............................................................246 12.9 Future Prospects ...............................................................................246 References .....................................................................................................247 13. Feasibility and Implementation of Bridging Studies in Taiwan......251 Mey Wang, Yeong-Liang Lin, and Herng-Der Chern 13.1 Overview............................................................................................251 13.2 Regulatory History of Bridging Strategy ......................................252 13.3 Assessment Experiences Based on ICH E5 ...................................254 13.3.1 Case 1.....................................................................................255 13.3.2 Case 2.....................................................................................256 13.4 Bayesian Statistical Approach to Bridging Studies......................257 13.4.1 Evaluating Regional Treatment Effect in a Multiregional Trial...............................................................257
- 20. xiii Contents 13.4.2 Regional Power and Sample Size Allocation in a Multiregional Trial...............................................................259 13.5 Designing an External (Supplemental) Bridging Study..............260 13.6 Concluding Remarks........................................................................ 261 References .....................................................................................................262
- 22. xv Preface In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors have become a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on when and how to address the geographic variations of efficacy and safety for product development. To address this issue, a general framework has been provided by the International Conference Harmonisation (ICH) E5 in a document titled “Ethnic Factors in the Acceptability of Foreign Clinical Data” for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. The ICH E5 guideline provides regulatory strategies for minimizing duplication of clinical data and requirements for bridging evidence to extrapolate foreign clinical data to a new region. More specifically, the ICH E5 guideline sug- gests that a bridging study should be conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regi- men to allow extrapolation of the foreign clinical data to the population of the new region. However, a bridging study may require significant development resources and also delay availability of the tested medical product to the need- ing patients in the new region. To accelerate the development process and shorten approval time, the design of multiregional trials incorporates sub- jects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them. Recently, the trend for clinical development in Asian countries being under- taken simultaneously with clinical trials conducted in Europe and the United States has been rapidly rising. With increasing globalization of the development of medicines, creating strategies on when and how to address the geographic variations of efficacy and safety for the product development is now inevitable. This book explicitly addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, we will explore issues including ethnic sensitiv- ity, necessity of bridging studies, types of bridging studies, and assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, we dig into issues such as consideration of regional difference, assessment of the consistency of treatment effect across regions, and sample size determination for each region. Although several statistical procedures have been proposed for designing bridging studies and multiregional clini- cal trials, the statistical work is still in the preliminary stages. This book pro- vides a comprehensive and unified summary of the growing literature and
- 23. xvi Preface research activities on regulatory requirements, scientific and practical issues, and statistical methodology on designing and evaluating bridging studies and multiregional clinical trials. Most importantly, we sincerely hope that this book can inspire in academia new research activities in the design and analysis of bridging studies and multiregional clinical trials.
- 24. xvii Contributors Herng-Der Chern Center for Drug Evaluation Taipei, Taiwan Shein-Chung Chow Duke University School of Medicine Duke University Durham, North Carolina Christy Chuang-Stein Statistical Research and Consulting Center Pfizer, Inc. Kalamazoo, Michigan Chin-Fu Hsiao Institute of Population Health Sciences National Health Research Institutes Miaoli County, Taiwan Eric Tsung-Cheng Hsieh Buddhist Tzu-Chi University and Hospital Hualien, Taiwan Hsien-Ming James Hung Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring, Maryland Yoichi Ii Clinical Statistics Pfizer Japan Inc. Tokyo, Japan Mari Ikuta GlaxoSmithKline Tokyo, Japan Norisuke Kawai Clinical Statistics Pfizer Japan Inc. Tokyo, Japan Osamu Komiyama Clinical Statistics Pfizer Japan Inc. Tokyo, Japan Kazuhiko Kuribayashi Clinical Statistics Pfizer Japan Inc. Tokyo, Japan Kuang-Kuo Gordon Lan Janssen Pharmaceutical Companies of Johnson & Johnson Raritan, New Jersey Yeong-Liang Lin Center for Drug Evaluation Taipei, Taiwan Jen-pei Liu Department of Agronomy National Taiwan University Taipei, Taiwan Ying Lu Beijing University of Technology Beijing, China
- 25. xviii Contributors Hiromu Nakajima GlaxoSmithKline Tokyo, Japan Robert O’Neill Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring, Maryland José Pinheiro Janssen Pharmaceutical Companies of Johnson & Johnson Raritan, New Jersey Hui Quan Department of Biostatistics and Programming Sanofi Bridgewater, New Jersey Weichung J. Shih Department of Biostatistics University of Medicine and Dentistry of New Jersey–School of Public Health Piscataway, New Jersey Kihito Takahashi GlaxoSmithKline and Japanese Association of Pharmaceutical Medicine and Japanese Center of Pharmaceutical Medicine Tokyo, Japan Yi Tsong Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring, Maryland Hsiao-Hui Tsou National Health Research Institutes Miaoli County, Taiwan Mey Wang Center for Drug Evaluation Taipei, Taiwan Sue-Jane Wang Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring, Maryland Yuh-Jenn Wu Chung Yuan Christian University Chung Li City, Taiwan Lan-Yan Yang National Cheng Kung University Taiwan City, Taiwan
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- 28. Fanny’s Farm, 114 Faucourt, 309 Favreuil, 348 Fesny, 395 Fifth Army Headquarters, adverse report of, 145–146 Fighting Side, 46, 190 Flers, 63 Flesquières, 173, 177, 188, 363, 365 Fleury Redobut, 99 Foch, Marshal, on the Tanks, 403 Fontaine-Notre-Dame, 182, 187, 367 Forsyth-Major, Major, 225 Framerville, 311 Frémicourt, 348 French Tanks Corps, 209–218 Fresnoy, 357, 359 Frezenberg, 142, 145, 152 Fuller, Lieut.-Colonel, 165 Gauche Wood, 187 Gaza, Second and Third Battles of, 224–234 German Press, and the Tanks, 405 German Tanks, fights with, 261, 383 Germans and the Tanks, 55, 64, 106, 117, 323–333 Ginchy, 61 Glencorse Wood, 142, 152 Gomiécourt, 344 Gonnelieu, 369 Gould, Second Lieutenant, 301 Gouzeaucourt, 185, 362 Graincourt, 177, 179, 363
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- 30. Hedges, Second Lieutenant, W. R., 358 Henriques, Captain, 51, 60 Herleville Wood, 342 Hervilly Wood, 248 Hetherington, Major, 31, 36 Hickson, Second Lieutenant, 338 High Wood, 66 Hillock Farm, 149 Hotblack, Major, D.S.O., M.C., 75, 80, 120, 293, 375 “Hush Operation,” proposed, on the Belgian coast, 118–123 Ignaucourt Valley, 302 Inchy, 368 “Instructions for Training of Tank Corps in France,” 202–207 Inverness Copse, 153 Jerk House, 153 Johnson, Lieut. Col. Philip, 120 Jolimetz, 395 Jones, Second Lieutenant, 267 Juniper Cottage, 154 Kemmel, 253, 291 Knoll, The, 359, 362, 369 La Fère, 244 Lagnicourt, 352 Lamotte, 299 Landrecies, 392–395 Langemarck, 148 La Signy Farm, 72 Lateau Wood, 175
- 31. Latham, Sergeant F., M.M., 102 La Vacquerie, 187 Le Cateau, Second Battle of, 380–386 Le Maistre, General, 270 Le Quesneu, 301 Le Quesnoy, 310, 390, 395 Les-Trois-Boqueleaux, 282, 284 Le Tréport, 200 Lewis Gun Detachments, 251 Lihons, 312, 315 Lipsett, Major-General, 293 Littledale, Sergeant: Account of Tank Training at Bermicourt, 77–80 Logeast, Wood, 340 Longâtte, 349 Loop, The, 57–60 Losses of the Tank Corps, 268–269 Loucheur, M., on the Tanks, 403 Luce River, 292 Luck, Second Lieutenant C. W., 367 Ludendorff, General, and the Tanks, 319, 325 “Lusitania” Tank, Exploit of, 99, 103 Lyon, Private W., M.M., 252 Macavity, Major, 363 Machine Gun Corps, Heavy Section of, 50 Heavy Branch of, 80 Mailly-Raineval, 282 Mailly-Maillet Wood, 258 Marcelcave, 298 March, 1918, British Retreat of, 243–264
- 32. Marcoing, 187 Marcourt, 250 Maricourt, 254 Martell, Lieutenant, 384 Martinpuich, 61 Marwitz, General von der, 185 Masnières, 175, 185 Masvillers, 250 Maubeuge, 289, 386, 400 Maxse, General, 149 McFee, Mr., 34 McLagan, Major-General E. G. S., 321–322 Mecredy, Second Lieutenant C., 286 Menin, 385 Mercatel, 341 Merlaincourt, 250 Merlimont, 202 Merville, 256 Messines, Battle of, 110–117 Meteren, 252 Metz, 185 Mitchell, Lieutenant, 262 Molain, 388 Monash, General, 292, 314 Monchy, 104, 108, 347, 377 Mons, 400 Montbrehain, 379 Mont des Cats, 253 Montdidier, 288 Mont du Hibou, 149
- 33. Mont Rouge, 254 Morcourt, 292, 298 Moreuil, Battle of, 280–287 Mormal Forest, 389–396 Moroccans, and Tanks, 267 Mory Copse, 347 Moyenneville, 335, 340 Murray, General, 226 “Musical Box” Tank, adventures of, 303–308 Naedale, Lieutenant T. C., 374, 388 Neuve Eglise, 252 Neuville-Vitasse, 104, 347 Neuvilly, 389 Nieppe Forest, 256 Niergnies, 383 Noel, Sergeant J., D.C.M., 107 Norton, Major, 256 Nutt, Major, 225 Oisy, 392 O’Kelly, Colonel, 250 Oosthoek Wood, 130 Oosttaverne, 114 Palestine, Tanks in, 224–234 Pankhurst, Mrs., 38 Passchendaele, 143, 156, 159 Pear-Shaped Trench, 274 Peizière, 248 Péronne, 292 “Pill-Boxes,” 127, 148–151
- 34. Pitt, Lieutenant, 251 Poelcapelle Village, 154–158 Poelcapelle Road, Disaster on, 157 Pollard, Hugh, on the Future of Tanks, 408 Ponsonby, General John, 178 Pozières, 61 Prémont, 381 Premy Chapel, 366 Preux, 393 Proyart, 309, 314 Quadrilateral, 61, 357, 359 Quennemont Farm and Ridge, 359, 362, 369, 375 Ravenel, 270 Rawlinson, General Sir Henry, 320 Reconnaissance Branch, 29 Reconnaissance Officer, Narrative of, 256 Reconnaissance Service, 80, 133 Rees-Williams, Lieutenant O. L., 348 Renouf, Major, 46 Reutelbeek, 154 Ribbans, gunner, 303–308 Ribecourt, 360 Riddle, Second Lieutenant, 367 Riencourt, 105 Riquerval Wood, 386 Robertson, Captain, V.C., 155 Roeux, 107 Ronssoy, 357 Rosières, 312
- 35. Rossignol, 259 Rowe, Captain, 383 Rumilly, 175 St. Julien, the town, 142, 148, 158 Tanks’ Success at, 136 St. Léger, 107 St. Martin’s Wood, 342 St. Pol, 268, 291 St. Quentin, 244 St. Quentin Canal, 369–373 St. Quentin Wood, 360 St. Ribert Wood, 282 St. Souplet, 388 Sambre and Oise Canal, 387 Sambre, the River, 392 Sasse, Major, D.S.O., 382 Sauchy-Lestrée, 368 Saunders, Lieutenant, 352 Sauvillers, 282, 284 “Savage Rabbits,” 237 Schele, The, 390 Scheuch, General, on the Tanks, 405 Selency, 357, 359 Selle, Battle of the, 386–391 Sensée Valley, 349, 252 Serain, 381 Seranvillers, 175 Sewell, Lieutenant C. H., V.C., 349 Skeggs, Major, 366 Smallwood, Second Lieutenant G. F., 358
- 36. Smith, Captain G. A., 350 Smith, Second Lieutenant Henderson, M.C., 295 Soldier’s Treachery, a, 129 Solesmes, 389 Somme, Battle of the, 57–65 Spectator, on the Battle of Gaza, 233 Staden, 143 Steenbeek, 133, 137, 142 Stern, Sir Albert, 37, 44, 84, 87 Stewart, Ian, 257 Storm, Second Lieutenant, 251 Strachan, Captain C. H., 353 46, 50, 53 Swinton, General E. D., 31–34, 38, 39 Tactics, new, 246 Tanks, inception of the, 25 Different types of, 26 Uses of, 27–28 Training of the crews of, 30 Pre-1914 designs for, 31 First steps in designing of, 32 War Office and the, 33–39 Admiralty and the, 33–41 Further steps in progress of, 41–56 150 sanctioned, 53 Production, problem of, 81 Mechanical War Supply Department, 44, 82 Tank Committees, 86 Mark I. Tanks, 40, 44, 49, 62, 90, 114 Mark II. Tanks, 114 Mark IV. Tanks, 111, 117, 193, 194 Mark V. Tanks, the uses of, 27–30, 193, 269 Mark VI. Tanks, 193
- 37. Whippets, 193 Fascines, manufacture of, 164 Cribs, 269 Central workshops, 195, 199, 269, 399 Tank actions, minor, 270 “Tank Corps Intelligence Summary,” 380, 385, 393 Tank Commanders, Maintenance Course, etc., for, 203–207 Tank Crew, Military History of Member of, 199–202 Tank, itinerary of a, 196–199 Tank Officers, narrative by, 71, 94, 96, 178–181, 284 Tanks: destroying, 249 future of, 402–416 Tennyson-d’Eyncourt, Sir Eustace, 36, 87 Thetford, 48 Thiepval, 68 Tournai, 400 Triangle Farm, 149, 153 Tritton, Mr., 36 Tulloch, Major, 31–35 Tunnelling Company (184th), work of, 131 “Unditching Beam,” 131 Unit Histories, quotations from, 357–360 (See also Battalion and Brigade Histories.) Uzielli, Lieutenant, C. F., 350 Vaire Wood, 274, 278 Valenciennes, 389, 392, 395 Van Zeller, Second Lieutenant, T. E., M.C., 249 Vaulx-Vraucourt, 350 Vauvillers, 311 Vaux, 280
- 38. Vendhuille, 370 Villeret, 356 Villers Bretonneux, 251, 261–265, 272, 295 Villers Guislain, 187, 369 Vimy, the village, 98 Canadians at, 98 Wailly, the town, 108, 202 training ground at, 108 Wanbeke, 116 Warfusée, 251, 299 Warvillers, 303, 313 Watson, Major, on Battle of Bullecourt, 106 Weber, Second lieutenant, 99 Weekly Tank Notes, quotations from, 54, 125, 126, 135, 149, 184, 260, 275, 278, 293, 303–309, 330, 386, 406 West, Captain Richard Annesley, D.S.O. 337 West, Lieut.-Colonel R. A., D.S.O., M.C., 352 Westhoek, 143 Whatley, Sergeant, 367 Whyte, Second Lieutenant, M.C., 251 Wig, Comedy of a, 176 Wilkes, Major G. L., D.S.O., 158 Williams, Major-General, 108 Wilson, Lieutenant, 266 Wilson, Major, 36 Wool, 199, 207, 238 Worsap, Second Lieutenant, 383 Wrisberg, General, on the Tanks, 404–405 Wurst Farm, 154 Wytschaete, 114, 128
- 39. Ypres Salient, sand model of, 134 Ypres, Third Battle of, 124–159 Yvrench, training center at, 57 Zonnebeke, 152
- 40. FOOTNOTES 1 “I am building secure and covered chariots which are invulnerable, and when they advance with their guns into the midst of the foe even the largest enemy masses must retreat, and behind them the infantry can follow in safety and without opposition.” 2 It differed from an ordinary chariot in that the two little fat hollow-backed horses, which are depicted as providing the motive power, were like the crew, enclosed within the wooden armour. 3 It appears to have been the Committee which investigated Mr. Diplock’s machine, with some additional members. 4 Although the appeal was necessarily tentative and unofficial, and no details of the nature of the work could be given, sixty women immediately volunteered. 5 Major Renouf. 6 Major Renouf. 7 Most of these Tanks were training machines, in the sense that their “armour” was boiler-plate instead of hardened steel. 8 Colonel Swinton.
- 41. 9 Captain Henriques. 10 From Weekly Tank Notes, a confidential official periodical for private circulation. 11 W.T.N. 12 See Plate, Chapter VIII. (An unannotated air photograph of badly crumped ground.) 13 Among other Army Commanders was General Sir H. S. Rawlinson, who was later to be so good a friend to the Tanks. On this occasion, however, it is said that their performances left him completely cold and unconvinced. 14 Captain Henriques. 15 Sergeant Littledale of the Tank Corps writing in the Atlantic Monthly. 16 Sergeant Littledale of the Tank Corps writing in the Atlantic Monthly. 17 The progress of this decision has been slightly telescoped, the “operative” resolutions only being recorded, and the story of a good deal of proposal and counter-proposal omitted. 18 The list was as follows: Chairman.—Major-General Sir J. Capper. War Office.—Lieut.-Colonel Sir J. Keane. Lieut.-Colonel Mathew-Lannaw. Ministry of Munitions.—Lieut.-Colonel Stern. Sir Eustace Tennyson d’Eyncourt. 19 Achicourt. 20 Letter from a Tank officer dated “April 9, evening.”
- 42. 21 Letter from an eye-witness written on the evening of April 9. 22 The Harp. 23 Major Watson, the Tank Company Commander, writing in Blackwood’s Magazine. 24 “B” (2) Battalion History. 25 W.T.N. 26 Official paper. 27 Indirect fire may be defined as fire directed towards the spot where you believe the enemy to be. Fire is called “direct” when the target can be seen. 28 Mr. Buchan’s History of the War. 29 W.T.N. 30 Mr. Buchan’s History of the War. 31 W.T.N. 32 Sir Douglas Haig’s Despatch. 33 The size of these dumps was now always computed in “Tank Fills.” 1 fill consisting of: 60 galls. of Petrol. 10 galls. of Oil. 20 galls. of Water. 10 lb. of Grease. 10,000 rounds of S.A. Ammunition for a Female Tank, or 200 rounds of 6-pdr. Ammunition
- 43. and 6000 rounds of S.A. Ammunition for a Male. 34 W.T.N. 35 3rd Battalion History. 36 From Sir Douglas Haig’s Despatch. 37 From the History of 7th Battalion. 38 W.T.N. 39 W.T.N. 40 The second Tank detailed for this strong point had—in common with the two reserve Tanks—bellied or become ditched on the way up. 41 Official Summary. 42 Major Wilkes was awarded the D.S.O. for this piece of work. 43 Sir Douglas Haig’s Despatch. 44 “A” Battalion was borrowed from 2nd Brigade. 45 From “F” (6th) Battalion History. 46 W.T.N. 47 Sir Douglas Haig’s Despatch. 48 W.T.N. 49 Artillery of Assault, i.e., Tanks. 50 An aiming instrument. 51 W.T.N.
- 44. 52 Mr. Buchanan’s History of the War. 53 Major Forsyth-Major (the Second in Command of the E.T.D.), on whose report through Colonel Fuller this summary is largely based, was torpedoed on his return to England in 1918 and all his maps and documents were lost. 54 General Murray’s Despatch. 55 5th Battalion History. 56 2nd Battalion History. 57 Major Norton, commanding the Lewis gun detachment. 58 3rd Battalion History. 59 1st Battalion History. 60 W.T.N. 61 Case shot: bullets not enclosed in a shell, but fired direct from a 6-pounder and scattering like the charge of a shot gun. 62 Sir Douglas Haig’s Despatch. 63 5th Brigade History. 64 8th Battalion History. 65 W.T.N. 66 W.T.N. 67 The 1st, 4th, 5th, and 14th Battalions. 68 The 8th, 13th, 2nd, and 15th Battalions. 69 From W.T.N.
- 45. 70 13th Battalion History. 71 From the 5th Brigade History. 72 Honours and Awards. 73 From 14th Battalion History. 74 From 1st Battalion History. 75 From 3rd Battalion History. 76 From 8th Battalion History 77 From a Battalion History. 78 From a Battalion History. 79 Sir Douglas Haig’s Despatch. 80 Summer, 1919. 81 i.e., In the Battle of Amiens, 8.8.18. 82 W.T.N. 83 3rd Battalion History. 84 15th Battalion History. 85 6th Battalion History and “Honours and Awards.” 86 Despatch. 87 A Brigade History. 88 Unit History. 89 Ibid. 90 Unit History.
- 46. 91 Sir Douglas Haig’s Despatch. 92 15th Battalion Tank History. 93 Captain Denny, Daily Telegraph, April 1, 1919. 94 Captain Denny, Daily Telegraph, April 1, 1919. 95 The 301st was attached to the 27th American Division. 96 From information specially given to the author by Captain Hatton-Hall, Reconnaissance Officer of the Brigade. 97 16th Battalion. 98 Sir Douglas Haig’s Despatch. 99 Captain Hatton-Hall. 100 W.T.N. 101 Sir Douglas Haig’s Despatch. 102 Captain Hatton-Hall. 103 Sir Douglas Haig’s Despatch. 104 Sir Douglas Haig’s Despatch. 105 6th Battalion History. 106 6th Battalion History. 107 Ibid. 108 W.T.N. 109 Tradition relates that had General Swinton had his way, the Tanks for Palestine would have had hideous faces and minatory texts from the Koran painted upon them.
- 47. Transcriber’s Notes Punctuation, hyphenation, and spelling were made consistent when a predominant preference was found in the original book; otherwise they were not changed. Simple typographical errors were corrected; unbalanced quotation marks were remedied when the change was obvious, and otherwise left unbalanced. Illustrations in this eBook have been positioned between paragraphs and outside quotations. In versions of this eBook that support hyperlinks, the page references in the List of Illustrations lead to the corresponding illustrations. The text always uses “moral”, not “morale”. The index was not checked for proper alphabetization or correct page references. Chapter XV does not have a Section “V”; the section after “IV” is “VI”; no pages or text are missing.
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