A complete guide to the key statistical concepts essential for the design and construction of clinical trialsAs the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis.Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features:* Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials* Over 100 contributions from leading academics, researchers, and practitioners* An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials GroupMethods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.

Contributors xxiiiPreface xxix1 Absolute Risk Reduction 12 Accelerated Approval 143 AIDS Clinical Trials Group (ACTG) 274 Algorithm-Based Designs 405 Alpha-Spending Function 536 Application of New Designs in Phase I Trials 657 ASCOT Trial 748 Benefit/Risk Assessment in Prevention Trials 809 Biased Coin Randomization 9010 Biological Assay, Overview 10611 Block Randomization 12512 Censored Data 13913 Clinical Data Coordination 14614 Clinical Data Management 16415 Clinical Significance 17016 Clinical Trial Misconduct 19117 Clinical Trials, Early Cancer and Heart Disease 20518 Cluster Randomization 21619 Coherence in Phase I Clinical Trials 23020 Compliance and Survival Analysis 24021 Composite Endpoints in Clinical Trials 24622 Confounding 25223 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 38333 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 60951 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 81370 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