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Informationen zum Autor 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. Klappentext 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. Zusammenfassung This comprehensive book features both new and established material on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data. Inhaltsverzeichnis Contributors xxiii Preface xxix 1 Absolute Risk Reduction 1 2 Accelerated Approval 14 3 AIDS Clinical Trials Group (ACTG) 27 4 Algorithm-Based Designs 40 5 Alpha-Spending Function 53 6 Application of New Designs in Phase I Trials 65 7 ASCOT Trial 74 8 Benefit/Risk Assessment in Prevention Trials 80 9 Biased Coin Randomization 90 10 Biological Assay, Overview 106 11 Block Randomization 125 12 Censored Data 139 13 Clinical Data Coordination 146 14 Clinical Data Management 164 15 Clinical Significance 170 16 Clinical Trial Misconduct 191 17 Clinical Trials, Early Cancer and Heart Disease 205 18 Cluster Randomization 216 19 Coherence in Phase I Clinical Trials 230 20 Compliance and Survival Analysis 240 21 Composite Endpoints in Clinical Trials 246 22 Confounding 252 23 Control Groups 263 24 Coronary Drug Project 273 25 Covariates 285 26 Crossover Design 300 27 Crossover Trials 310 28 Diagnostic Studies 320 29 DNA Bank 340 30 Up-and-Down and Escalation Designs 353 31 Dose Ranging Crossover Designs 362 32 Flexible Designs 383 33 Gene Therapy 399 34 Global Assessment Variables 423
