Concepts, principles, trials, and designs

Author(s)

• Balakrishnan, N.

Bibliographic Information

Concepts, principles, trials, and designs

（Wiley series in methods and applications of statistics / advisory editor, N. Balakrishnan, . Methods and applications of statistics in clinical trials / edited by N. Balakrishnan ; v. 1）

Wiley, c2014

Other Title

MAS clinical trials

Note

Includes bibliographical references and index

Description and Table of Contents

Description

A complete guide to the key statistical concepts essential for the design and construction of clinical trials As 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 Group Methods 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.

Table of Contents

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 35 Good Clinical Practice (GCP) 438 36 Group-Randomized Trials 448 37 Group Sequential Designs 467 38 Hazard Ratio 483 39 Large Simple Trials 500 40 Longitudinal Data 510 41 Maximum Duration and Information Trials 515 42 Missing Data 522 43 Mother to Child Human Immunodeficiency Virus Transmission Trials 536 44 Multiple Testing in Clinical Trials 550 45 Multicenter Trials 558 46 Multiple Endpoints 570 47 Multiple Risk Factor Intervention Trial 577 48 N-of-1 Randomized Trials 587 49 Noninferiority Trial 598 50 Nonrandomized Trials 609 51 Open-Labeled Trials 619 52 Optimizing Schedule of Administration in Phase I Clinical Trials 625 53 Partially Balanced Designs 635 54 Phase I/II Clinical Trials 658 55 Phase II/III Trials 667 56 Phase I Trials 682 57 Phase II Trials 692 58 Phase III Trials 700 59 Phase IV Trials 711 60 Phase I Trials in Oncology 719 61 Placebos 725 62 Planning a Group-Randomized Trial 736 63 Postmenopausal Estrogen/Progestin Interventions Trial (PEPI) 744 64 Preference Trials 759 65 Prevention Trials 770 66 Primary Efficacy Endpoint 779 67 Prognostic Variables in Clinical Trials 789 68 Randomization Procedures 799 69 Randomization Schedule 813 70 Repeated Measurements 827 71 Simple Randomization 841 72 Subgroups 850 73 Superiority Trials 867 74 Surrogate Endpoints 878 75 TNT Trial 887 76 UGDP Trial 894 77 Women's Health Initiative Hormone Therapy Trials 918 78 Women's Health Initiative Dietary Modification Trial 931 Index 945

by "Nielsen BookData"

Details

• NCID: BB1662188X
• ISBN:
  • 9781118304730
• LCCN: 2013034342
• Country Code: us
• Title Language Code: eng
• Text Language Code: eng
• Place of Publication: Hoboken, N.J.
• Pages/Volumes: xxx, 961 p.
• Size: 26 cm
• Classification:
  • LCC : R853.C55
  • NLM : QV 771.4
  • DC23 : 610.72/4
  • DC20 : 610.724
• Subject Headings:
  • MESH : Clinical Trials as Topic
  • MESH : Statistics as Topic
• Parent Bibliography ID:
  • BB0157854X