{"product_id":"design-and-analysis-of-clinical-trials-isbn-9780470887653","title":"Design and Analysis of Clinical Trials","description":"\u003cp\u003ePraise for the \u003ci\u003eSecond Edition:\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003ci\u003e“...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eThe \u003ci\u003eThird Edition\u003c\/i\u003e of \u003ci\u003eDesign and Analysis of Clinical Trials\u003c\/i\u003e provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this \u003ci\u003eThird Edition\u003c\/i\u003e include:\u003c\/p\u003e \u003cp\u003e• New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine\u003c\/p\u003e \u003cp\u003e• A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies\u003c\/p\u003e \u003cp\u003e• Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts\u003c\/p\u003e \u003cp\u003e• New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT\/QTc prolongation\u003c\/p\u003e \u003cp\u003e• A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines\u003c\/p\u003e \u003cp\u003e• An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development\u003c\/p\u003e \u003cp\u003e\u003ci\u003eDesign and Analysis of Clinical Trials, Third Edition\u003c\/i\u003e continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists\/researchers, statisticians, and graduate-level students.\u003c\/p\u003e  Preface xi  \u003cp\u003ePART I PRELIMINARIES\u003c\/p\u003e \u003cp\u003e1 Introduction 3\u003c\/p\u003e \u003cp\u003e1.1 What are Clinical Trials?, 3\u003c\/p\u003e \u003cp\u003e1.2 History of Clinical Trials, 4\u003c\/p\u003e \u003cp\u003e1.3 Regulatory Process and Requirements, 10\u003c\/p\u003e \u003cp\u003e1.4 Investigational New Drug Application, 17\u003c\/p\u003e \u003cp\u003e1.5 New Drug Application, 24\u003c\/p\u003e \u003cp\u003e1.6 Clinical Development and Practice, 31\u003c\/p\u003e \u003cp\u003e1.7 AIMS and Structure of the Book, 42\u003c\/p\u003e \u003cp\u003e2 Basic Statistical Concepts 45\u003c\/p\u003e \u003cp\u003e2.1 Introduction, 45\u003c\/p\u003e \u003cp\u003e2.2 Uncertainty and Probability, 46\u003c\/p\u003e \u003cp\u003e2.3 Bias and Variability, 49\u003c\/p\u003e \u003cp\u003e2.4 Confounding and Interaction, 57\u003c\/p\u003e \u003cp\u003e2.5 Descriptive and Inferential Statistics, 66\u003c\/p\u003e \u003cp\u003e2.6 Hypotheses Testing and p-Values, 68\u003c\/p\u003e \u003cp\u003e2.7 Clinical Significance and Clinical Equivalence, 75\u003c\/p\u003e \u003cp\u003e2.8 Reproducibility and Generalizability, 79\u003c\/p\u003e \u003cp\u003e3 Basic Design Considerations 85\u003c\/p\u003e \u003cp\u003e3.1 Introduction, 85\u003c\/p\u003e \u003cp\u003e3.2 Goals of Clinical Trials, 86\u003c\/p\u003e \u003cp\u003e3.3 Target Population and Patient Selection, 90\u003c\/p\u003e \u003cp\u003e3.4 Selection of Controls, 97\u003c\/p\u003e \u003cp\u003e3.5 Statistical Considerations, 105\u003c\/p\u003e \u003cp\u003e3.6 Other Issues, 112\u003c\/p\u003e \u003cp\u003e3.7 Discussion, 115\u003c\/p\u003e \u003cp\u003e4 Randomization and Blinding 117\u003c\/p\u003e \u003cp\u003e4.1 Introduction, 117\u003c\/p\u003e \u003cp\u003e4.2 Randomization Models, 118\u003c\/p\u003e \u003cp\u003e4.3 Randomization Methods, 124\u003c\/p\u003e \u003cp\u003e4.4 Implementation of Randomization, 144\u003c\/p\u003e \u003cp\u003e4.5 Generalization of Controlled Randomized Trials, 149\u003c\/p\u003e \u003cp\u003e4.6 Blinding, 153\u003c\/p\u003e \u003cp\u003e4.7 Discussion, 160\u003c\/p\u003e \u003cp\u003ePART II DESIGNS AND THEIR CLASSIFICATIONS\u003c\/p\u003e \u003cp\u003e5 Designs for Clinical Trials 165\u003c\/p\u003e \u003cp\u003e5.1 Introduction, 165\u003c\/p\u003e \u003cp\u003e5.2 Parallel Group Designs, 167\u003c\/p\u003e \u003cp\u003e5.3 Clustered Randomized Designs, 172\u003c\/p\u003e \u003cp\u003e5.4 Crossover Designs, 177\u003c\/p\u003e \u003cp\u003e5.5 Titration Designs, 185\u003c\/p\u003e \u003cp\u003e5.6 Enrichment Designs, 191\u003c\/p\u003e \u003cp\u003e5.7 Group Sequential Designs, 195\u003c\/p\u003e \u003cp\u003e5.8 Placebo-Challenging Designs, 197\u003c\/p\u003e \u003cp\u003e5.9 Blinded Reader Designs, 203\u003c\/p\u003e \u003cp\u003e5.10 Discussion, 207\u003c\/p\u003e \u003cp\u003e6 Designs for Cancer Clinical Trials 211\u003c\/p\u003e \u003cp\u003e6.1 Introduction, 211\u003c\/p\u003e \u003cp\u003e6.2 General Considerations for Phase I Cancer Clinical Trials, 213\u003c\/p\u003e \u003cp\u003e6.3 Single-Stage Up-and-Down Phase I Designs, 214\u003c\/p\u003e \u003cp\u003e6.4 Two-Stage Up-and-Down Phase I Designs, 217\u003c\/p\u003e \u003cp\u003e6.5 Continual Reassessment Method Phase I Designs, 219\u003c\/p\u003e \u003cp\u003e6.6 Optimal and Flexible Multiple-Stage Designs, 222\u003c\/p\u003e \u003cp\u003e6.7 Randomized Phase II Designs, 229\u003c\/p\u003e \u003cp\u003e6.8 Discussion, 232\u003c\/p\u003e \u003cp\u003e7 Classification of Clinical Trials 237\u003c\/p\u003e \u003cp\u003e7.1 Introduction, 237\u003c\/p\u003e \u003cp\u003e7.2 Multicenter Trials, 238\u003c\/p\u003e \u003cp\u003e7.3 Superiority Trials, 245\u003c\/p\u003e \u003cp\u003e7.4 Active Control and Equivalence\/Noninferiority Trials, 248\u003c\/p\u003e \u003cp\u003e7.5 Dose–Response Trials, 261\u003c\/p\u003e \u003cp\u003e7.6 Combination Trials, 266\u003c\/p\u003e \u003cp\u003e7.7 Bridging Studies and Global Trials, 278\u003c\/p\u003e \u003cp\u003e7.8 Vaccine Clinical Trials, 285\u003c\/p\u003e \u003cp\u003e7.9 QT Studies, 291\u003c\/p\u003e \u003cp\u003e7.10 Discussion, 299\u003c\/p\u003e \u003cp\u003ePART III ANALYSIS OF CLINICAL DATA\u003c\/p\u003e \u003cp\u003e8 Analysis of Continuous Data 305\u003c\/p\u003e \u003cp\u003e8.1 Introduction, 305\u003c\/p\u003e \u003cp\u003e8.2 Estimation, 306\u003c\/p\u003e \u003cp\u003e8.3 Test Statistics, 310\u003c\/p\u003e \u003cp\u003e8.4 Analysis of Variance, 316\u003c\/p\u003e \u003cp\u003e8.5 Analysis of Covariance, 323\u003c\/p\u003e \u003cp\u003e8.6 Nonparametric Methods, 325\u003c\/p\u003e \u003cp\u003e8.7 Repeated Measures, 332\u003c\/p\u003e \u003cp\u003e8.8 Discussion, 341\u003c\/p\u003e \u003cp\u003e9 Analysis of Categorical Data 343\u003c\/p\u003e \u003cp\u003e9.1 Introduction, 343\u003c\/p\u003e \u003cp\u003e9.2 Statistical Inference for One Sample, 345\u003c\/p\u003e \u003cp\u003e9.3 Inference of Independent Samples, 358\u003c\/p\u003e \u003cp\u003e9.4 Ordered Categorical Data, 364\u003c\/p\u003e \u003cp\u003e9.5 Combining Categorical Data, 368\u003c\/p\u003e \u003cp\u003e9.6 Model-Based Methods, 374\u003c\/p\u003e \u003cp\u003e9.7 Repeated Categorical Data, 382\u003c\/p\u003e \u003cp\u003e9.8 Discussion, 387\u003c\/p\u003e \u003cp\u003e10 Censored Data and Interim Analysis 389\u003c\/p\u003e \u003cp\u003e10.1 Introduction, 389\u003c\/p\u003e \u003cp\u003e10.2 Estimation of the Survival Function, 391\u003c\/p\u003e \u003cp\u003e10.3 Comparison Between Survival Functions, 399\u003c\/p\u003e \u003cp\u003e10.4 Cox’s Proportional Hazard Model, 405\u003c\/p\u003e \u003cp\u003e10.5 Calendar Time and Information Time, 419\u003c\/p\u003e \u003cp\u003e10.6 Group Sequential Methods, 424\u003c\/p\u003e \u003cp\u003e10.7 Discussion, 438\u003c\/p\u003e \u003cp\u003e11 Sample Size Determination 441\u003c\/p\u003e \u003cp\u003e11.1 Introduction, 441\u003c\/p\u003e \u003cp\u003e11.2 Basic Concept, 442\u003c\/p\u003e \u003cp\u003e11.3 Two Samples, 447\u003c\/p\u003e \u003cp\u003e11.4 Multiple Samples, 456\u003c\/p\u003e \u003cp\u003e11.5 Censored Data, 459\u003c\/p\u003e \u003cp\u003e11.6 Dose–Response Studies, 464\u003c\/p\u003e \u003cp\u003e11.7 Crossover Designs, 471\u003c\/p\u003e \u003cp\u003e11.8 Equivalence and Noninferiority Trials, 481\u003c\/p\u003e \u003cp\u003e11.9 Multiple-Stage Design in Cancer Trials, 490\u003c\/p\u003e \u003cp\u003e11.10 Multinational Trials, 490\u003c\/p\u003e \u003cp\u003e11.11 Comparing Variabilities, 500\u003c\/p\u003e \u003cp\u003e11.12 Discussion, 517\u003c\/p\u003e \u003cp\u003ePART IV ISSUES IN EVALUATION\u003c\/p\u003e \u003cp\u003e12 Issues in Efficacy Evaluation 521\u003c\/p\u003e \u003cp\u003e12.1 Introduction, 521\u003c\/p\u003e \u003cp\u003e12.2 Baseline Comparison, 523\u003c\/p\u003e \u003cp\u003e12.3 Intention-to-Treat Principle and Efficacy Analysis, 528\u003c\/p\u003e \u003cp\u003e12.4 Adjustment for Covariates, 536\u003c\/p\u003e \u003cp\u003e12.5 Multicenter Trials, 541\u003c\/p\u003e \u003cp\u003e12.6 Multiplicity, 548\u003c\/p\u003e \u003cp\u003e12.7 Data Monitoring, 558\u003c\/p\u003e \u003cp\u003e12.8 Use of Genetic Information for Evaluation of Efficacy, 564\u003c\/p\u003e \u003cp\u003e12.9 Sample Size Reestimation, 570\u003c\/p\u003e \u003cp\u003e12.10 Discussion, 572\u003c\/p\u003e \u003cp\u003e13 Safety Assessment 573\u003c\/p\u003e \u003cp\u003e13.1 Introduction, 573\u003c\/p\u003e \u003cp\u003e13.2 Extent of Exposure, 574\u003c\/p\u003e \u003cp\u003e13.3 Coding of Adverse Events, 582\u003c\/p\u003e \u003cp\u003e13.4 Analysis of Adverse Events, 595\u003c\/p\u003e \u003cp\u003e13.5 Analysis of Laboratory Data, 602\u003c\/p\u003e \u003cp\u003e13.6 Analysis of QT\/QTc Prolongation, 610\u003c\/p\u003e \u003cp\u003e13.7 Discussion, 615\u003c\/p\u003e \u003cp\u003ePART V RECENT DEVELOPMENT\u003c\/p\u003e \u003cp\u003e14 Biomarkers and Targeted Clinical Trials 619\u003c\/p\u003e \u003cp\u003e14.1 Introduction, 619\u003c\/p\u003e \u003cp\u003e14.2 Concepts and Strategies, 620\u003c\/p\u003e \u003cp\u003e14.3 Biomarker Development and Validation, 623\u003c\/p\u003e \u003cp\u003e14.4 Designs of Targeted Clinical Trials, 630\u003c\/p\u003e \u003cp\u003e14.5 Analyses of Targeted Clinical Trials, 640\u003c\/p\u003e \u003cp\u003e14.6 Discussion, 647\u003c\/p\u003e \u003cp\u003e15 Trials for Evaluating Accuracy of Diagnostic Devices 649\u003c\/p\u003e \u003cp\u003e15.1 Introduction, 649\u003c\/p\u003e \u003cp\u003e15.2 Study Design, 651\u003c\/p\u003e \u003cp\u003e15.3 Measures of Diagnostic Accuracy, 656\u003c\/p\u003e \u003cp\u003e15.4 Reporting Results, 663\u003c\/p\u003e \u003cp\u003e15.5 Sample Size Estimation, 672\u003c\/p\u003e \u003cp\u003e15.6 Discussion, 675\u003c\/p\u003e \u003cp\u003e16 Statistical Methods in Translational Medicine 677\u003c\/p\u003e \u003cp\u003e16.1 Introduction, 677\u003c\/p\u003e \u003cp\u003e16.2 Biomarker Development, 678\u003c\/p\u003e \u003cp\u003e16.3 Bench-to-Bedside, 682\u003c\/p\u003e \u003cp\u003e16.4 Animal Model Versus Human Model, 689\u003c\/p\u003e \u003cp\u003e16.5 Translation in Study Endpoints, 691\u003c\/p\u003e \u003cp\u003e16.6 Bridging Studies, 696\u003c\/p\u003e \u003cp\u003e16.7 Discussion, 699\u003c\/p\u003e \u003cp\u003e16.8 Appendix, 700\u003c\/p\u003e \u003cp\u003e17 Adaptive Clinical Trial Designs 703\u003c\/p\u003e \u003cp\u003e17.1 Introduction, 703\u003c\/p\u003e \u003cp\u003e17.2 What Is Adaptive Design?, 704\u003c\/p\u003e \u003cp\u003e17.3 Well-Understood and Less Well-Understood Designs, 709\u003c\/p\u003e \u003cp\u003e17.4 Clinical\/Statistical and Regulatory Perspectives, 713\u003c\/p\u003e \u003cp\u003e17.5 Impact of Protocol Amendments, 716\u003c\/p\u003e \u003cp\u003e17.6 Challenges in By-Design Adaptations, 721\u003c\/p\u003e \u003cp\u003e17.7 Obstacles of Retrospective Adaptations, 727\u003c\/p\u003e \u003cp\u003e17.8 Discussion, 729\u003c\/p\u003e \u003cp\u003e18 Traditional Chinese Medicine 733\u003c\/p\u003e \u003cp\u003e18.1 Introduction, 733\u003c\/p\u003e \u003cp\u003e18.2 Fundamental Differences, 734\u003c\/p\u003e \u003cp\u003e18.3 Basic Considerations of TCM Clinical Trials, 741\u003c\/p\u003e \u003cp\u003e18.4 Other Issues in TCM Research and Development, 744\u003c\/p\u003e \u003cp\u003e18.5 Consortium for Globalization of Traditional Chinese Medicine, 751\u003c\/p\u003e \u003cp\u003e18.6 Discussion, 752\u003c\/p\u003e \u003cp\u003ePART VI CONDUCT OF CLINICAL TRIALS\u003c\/p\u003e \u003cp\u003e19 Preparation and Implementation of a Clinical Protocol 755\u003c\/p\u003e \u003cp\u003e19.1 Introduction, 755\u003c\/p\u003e \u003cp\u003e19.2 Structure and Components of a Protocol, 756\u003c\/p\u003e \u003cp\u003e19.3 Points to be Considered and Common Pitfalls During Development\u003c\/p\u003e \u003cp\u003eand Preparation of a Protocol, 762\u003c\/p\u003e \u003cp\u003e19.4 Common Departures for Implementation of a Protocol, 765\u003c\/p\u003e \u003cp\u003e19.5 Monitoring, Audit, and Inspection, 771\u003c\/p\u003e \u003cp\u003e19.6 Quality Assessment of a Clinical Trial, 775\u003c\/p\u003e \u003cp\u003e19.7 Discussion, 777\u003c\/p\u003e \u003cp\u003e20 Data Management of a Clinical Trial 779\u003c\/p\u003e \u003cp\u003e20.1 Introduction, 779\u003c\/p\u003e \u003cp\u003e20.2 Regulatory Requirements, 781\u003c\/p\u003e \u003cp\u003e20.3 Development of Case Report Forms, 783\u003c\/p\u003e \u003cp\u003e20.4 Database Development, 787\u003c\/p\u003e \u003cp\u003e20.5 Data Entry, Query, and Correction, 788\u003c\/p\u003e \u003cp\u003e20.6 Data Validation and Quality, 791\u003c\/p\u003e \u003cp\u003e20.7 Database Lock, Archive, and Transfer, 792\u003c\/p\u003e \u003cp\u003e20.8 Critical Issues, 795\u003c\/p\u003e \u003cp\u003eReferences 799\u003c\/p\u003e \u003cp\u003eAppendix A 845\u003c\/p\u003e \u003cp\u003eIndex 851\u003c\/p\u003e \u003cp\u003e�In summary, this third edition is an impressive expansion beyond a remarkable second edition. This book would be good reference for biostatisticians, clinical researchers, and pharmaceutical scientists in clinical research and development.�  (\u003ci\u003eJournal of Biopharmaceutical Statistics\u003c\/i\u003e, 1 July 2014)\u003c\/p\u003e\u003cp\u003e\"\u003ci\u003eDesign and Analysis of Clinical Trials: Concepts and Methodologies, Third Edition\u003c\/i\u003e is a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite...Essential reading for clinical research professionals.\" (\u003ci\u003eJournal of Clinical Research Best Practice\u003c\/i\u003e February 2014)\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eSHEIN-CHUNG CHOW, PhD,\u003c\/b\u003e is Professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eJEN-PEI LIU, PhD,\u003c\/b\u003e is Professor in the Department of Agronomy and Institute of Epidemiology and Preventive Medicine at the National Taiwan University. He has authored multiple articles and books on clinical trials and been involved in clinical trials as a biostatistician for more than twenty-five years.\u003c\/p\u003e  \u003cp\u003ePraise for the \u003ci\u003eSecond Edition\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003ci\u003e\". . . a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.\"\u003cbr\u003e \u003c\/i\u003e—Journal of Clinical Research Best Practices\u003c\/p\u003e \u003cp\u003eThe \u003ci\u003eThird Edition\u003c\/i\u003e of \u003ci\u003eDesign and Analysis of Clinical Trials\u003c\/i\u003e provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this \u003ci\u003eThird Edition\u003c\/i\u003e include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eNew chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine\u003c\/li\u003e \u003cli\u003eA balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies\u003c\/li\u003e \u003cli\u003ePractical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts\u003c\/li\u003e \u003cli\u003eNew sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT\/QTc prolongation\u003c\/li\u003e \u003cli\u003eA complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines\u003c\/li\u003e \u003cli\u003eAn update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eDesign and Analysis of Clinical Trials, Third Edition\u003c\/i\u003e continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists\/researchers, statisticians, and graduate-level students.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989042774245,"sku":"NP9780470887653","price":171.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470887653.jpg?v=1761782555","url":"https:\/\/k12savings.com\/products\/design-and-analysis-of-clinical-trials-isbn-9780470887653","provider":"K12savings","version":"1.0","type":"link"}