N. BALAKRISHNAN, PhD, is Professor in the Department of Mathematics and Statistics at McMaster University, Canada. He is the author of over twenty books and is the coeditor of Encyclopedia of Statistical Sciences, Second Edition, also published by Wiley.

“Methods and Applications of Statistics in Clinical Trials is a comprehensive, in-depth and up-to-date guide to statistics in clinical research.  Most readers will have more than an introductory understanding of statistics.”  (Journal of Clinical Research Best Practices, 5 May 2015)“This book provides an excellent description of the methods and applications of statistics to design clinical trials and to understand and evaluate data at different stages of clinical trials. It is strongly recommended for researchers, practitioners, and students.”  (Doody’s, 13 February 2015)

• Contributors xxiiiPreface xxix1 Absolute Risk Reduction 12 Accelerated Approval 143 AIDS Clinical Trials Group (ACTG) 274 Algorithm-Based Designs 40 5 Alpha-Spending Function 53 6 Application of New Designs in Phase I Trials 65 7 ASCOT Trial 748 Benefit/Risk Assessment in Prevention Trials 80 9 Biased Coin Randomization 90 10 Biological Assay, Overview 106 11 Block Randomization 125 12 Censored Data 13913 Clinical Data Coordination 146 14 Clinical Data Management 164 15 Clinical Significance 17016 Clinical Trial Misconduct 19117 Clinical Trials, Early Cancer and Heart Disease 205 18 Cluster Randomization 216 19 Coherence in Phase I Clinical Trials 23020 Compliance and Survival Analysis 240 21 Composite Endpoints in Clinical Trials 24622 Confounding 252 23 Control Groups 26324 Coronary Drug Project 27325 Covariates 28526 Crossover Design 30027 Crossover Trials 31028 Diagnostic Studies 32029 DNA Bank 34030 Up-and-Down and Escalation Designs 35331 Dose Ranging Crossover Designs 36232 Flexible Designs 383 33 Gene Therapy 39934 Global Assessment Variables 42335 Good Clinical Practice (GCP) 43836 Group-Randomized Trials 44837 Group Sequential Designs 46738 Hazard Ratio 48339 Large Simple Trials 50040 Longitudinal Data 51041 Maximum Duration and Information Trials 51542 Missing Data 52243 Mother to Child Human Immunodeficiency Virus Transmission Trials 53644 Multiple Testing in Clinical Trials 55045 Multicenter Trials 55846 Multiple Endpoints 57047 Multiple Risk Factor Intervention Trial 57748 N-of-1 Randomized Trials 58749 Noninferiority Trial 59850 Nonrandomized Trials 609 51 Open-Labeled Trials 61952 Optimizing Schedule of Administration in Phase I Clinical Trials 62553 Partially Balanced Designs 63554 Phase I/II Clinical Trials 65855 Phase II/III Trials 66756 Phase I Trials 68257 Phase II Trials 69258 Phase III Trials 70059 Phase IV Trials 71160 Phase I Trials in Oncology 71961 Placebos 72562 Planning a Group-Randomized Trial 73663 Postmenopausal Estrogen/Progestin Interventions Trial (PEPI) 74464 Preference Trials 75965 Prevention Trials 77066 Primary Efficacy Endpoint 77967 Prognostic Variables in Clinical Trials 78968 Randomization Procedures 79969 Randomization Schedule 813 70 Repeated Measurements 82771 Simple Randomization 84172 Subgroups 85073 Superiority Trials 86774 Surrogate Endpoints 87875 TNT Trial 88776 UGDP Trial 89477 Women's Health Initiative Hormone Therapy Trials 91878 Women's Health Initiative Dietary Modification Trial 931Index 945

N. BALAKRISHNAN, PhD, is Professor in the Department of Mathematics and Statistics at McMaster University, Canada. He is the author of over twenty books and is the coeditor of Encyclopedia of Statistical Sciences, Second Edition, also published by Wiley.

“Methods and Applications of Statistics in Clinical Trials is a comprehensive, in-depth and up-to-date guide to statistics in clinical research.  Most readers will have more than an introductory understanding of statistics.”  (Journal of Clinical Research Best Practices, 5 May 2015)“This book provides an excellent description of the methods and applications of statistics to design clinical trials and to understand and evaluate data at different stages of clinical trials. It is strongly recommended for researchers, practitioners, and students.”  (Doody’s, 13 February 2015)

• Contributors xxiiiPreface xxix1 Absolute Risk Reduction 12 Accelerated Approval 143 AIDS Clinical Trials Group (ACTG) 274 Algorithm-Based Designs 40 5 Alpha-Spending Function 53 6 Application of New Designs in Phase I Trials 65 7 ASCOT Trial 748 Benefit/Risk Assessment in Prevention Trials 80 9 Biased Coin Randomization 90 10 Biological Assay, Overview 106 11 Block Randomization 125 12 Censored Data 13913 Clinical Data Coordination 146 14 Clinical Data Management 164 15 Clinical Significance 17016 Clinical Trial Misconduct 19117 Clinical Trials, Early Cancer and Heart Disease 205 18 Cluster Randomization 216 19 Coherence in Phase I Clinical Trials 23020 Compliance and Survival Analysis 240 21 Composite Endpoints in Clinical Trials 24622 Confounding 252 23 Control Groups 26324 Coronary Drug Project 27325 Covariates 28526 Crossover Design 30027 Crossover Trials 31028 Diagnostic Studies 32029 DNA Bank 34030 Up-and-Down and Escalation Designs 35331 Dose Ranging Crossover Designs 36232 Flexible Designs 383 33 Gene Therapy 39934 Global Assessment Variables 42335 Good Clinical Practice (GCP) 43836 Group-Randomized Trials 44837 Group Sequential Designs 46738 Hazard Ratio 48339 Large Simple Trials 50040 Longitudinal Data 51041 Maximum Duration and Information Trials 51542 Missing Data 52243 Mother to Child Human Immunodeficiency Virus Transmission Trials 53644 Multiple Testing in Clinical Trials 55045 Multicenter Trials 55846 Multiple Endpoints 57047 Multiple Risk Factor Intervention Trial 57748 N-of-1 Randomized Trials 58749 Noninferiority Trial 59850 Nonrandomized Trials 609 51 Open-Labeled Trials 61952 Optimizing Schedule of Administration in Phase I Clinical Trials 62553 Partially Balanced Designs 63554 Phase I/II Clinical Trials 65855 Phase II/III Trials 66756 Phase I Trials 68257 Phase II Trials 69258 Phase III Trials 70059 Phase IV Trials 71160 Phase I Trials in Oncology 71961 Placebos 72562 Planning a Group-Randomized Trial 73663 Postmenopausal Estrogen/Progestin Interventions Trial (PEPI) 74464 Preference Trials 75965 Prevention Trials 77066 Primary Efficacy Endpoint 77967 Prognostic Variables in Clinical Trials 78968 Randomization Procedures 79969 Randomization Schedule 813 70 Repeated Measurements 82771 Simple Randomization 84172 Subgroups 85073 Superiority Trials 86774 Surrogate Endpoints 87875 TNT Trial 88776 UGDP Trial 89477 Women's Health Initiative Hormone Therapy Trials 91878 Women's Health Initiative Dietary Modification Trial 931Index 945