MAS Clinical Trials v1

Herausgegeben von Balakrishnan, N.

• Gebundenes Buch

Produktbeschreibung

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. It discusses the various kinds of trials that can be found in today's clinical setting including open-labeled trials, multicentered trials, and superiority trials. It also explores such ongoing, cutting-edge trials as early cancer & heart disease, mother to child human immunodeficiency virus transmission, women's health initiative dietary, and AIDS.

---

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.

Produktdetails

• Methods and Applications of Statistics
• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 992
• Erscheinungstermin: 3. Februar 2014
• Englisch
• Abmessung: 260mm x 183mm x 57mm
• Gewicht: 2022g
• ISBN-13: 9781118304730
• ISBN-10: 111830473X
• Artikelnr.: 38478514

Autorenporträt

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.

Inhaltsangabe

Contributors xxiii Preface xxix 1 Absolute Risk Reduction 1 References 11
Further Reading 12 2 Accelerated Approval 14 References 25 Further Reading
26 3 AIDS Clinical Trials Group (ACTG) 27 References 37 4 Algorithm-Based
Designs 40 References 51 5 Alpha-Spending Function 53 References 61 Further
Reading 63 6 Application of New Designs in Phase I Trials 65 References 72
Further Reading 73 7 ASCOT Trial 74 References 78 8 Benefit/Risk Assessment
in Prevention Trials 80 References 87 9 Biased Coin Randomization 90
References 104 10 Biological Assay, Overview 106 References 122 Further
Reading 124 11 Block Randomization 125 References 136 Further Reading 138
12 Censored Data 139 References 141 13 Clinical Data Coordination 146
References 162 14 Clinical Data Management 164 References 169 15 Clinical
Significance 170 References 185 16 Clinical Trial Misconduct 191 References
202 17 Clinical Trials, Early Cancer and Heart Disease 205 References 213
18 Cluster Randomization 216 References 228 19 Coherence in Phase I
Clinical Trials 230 References 238 20 Compliance and Survival Analysis 240
References 244 21 Composite Endpoints in Clinical Trials 246 References 251
22 Confounding 252 References 261 23 Control Groups 263 References 271 24
Coronary Drug Project 273 References 282 Further Reading 284 25 Covariates
285 References 296 26 Crossover Design 300 References 308 27 Crossover
Trials 310 References 317 28 Diagnostic Studies 320 References 338 Further
Reading 339 29 DNA Bank 340 References 350 30 Up-and-Down and Escalation
Designs 353 References 359 Further Reading 361 31 Dose Ranging Crossover
Designs 362 References 379 Further Reading 382 32 Flexible Designs 383
References 396 33 Gene Therapy 399 References 411 Further Reading 422 34
Global Assessment Variables 423 References 435 35 Good Clinical Practice
(GCP) 438 References 446 Further Reading 446 36 Group-Randomized Trials 448
References 462 37 Group Sequential Designs 467 References 479 38 Hazard
Ratio 483 Further Reading 499 References 499 39 Large Simple Trials 500
References 506 Further Reading 508 40 Longitudinal Data 510 References 514
Further Reading 514 41 Maximum Duration and Information Trials 515
References 521 42 Missing Data 522 References 533 43 Mother to Child Human
Immunodeficiency Virus Transmission Trials 536 References 545 Further
Reading 549 44 Multiple Testing in Clinical Trials 550 References 556
Further Reading 557 45 Multicenter Trials 558 Readings 569 References 569
46 Multiple Endpoints 570 References 575 47 Multiple Risk Factor
Intervention Trial 577 References 583 Further Reading 586 48 N-of-1
Randomized Trials 587 References 596 49 Noninferiority Trial 598 References
605 50 Nonrandomized Trials 609 References 617 51 Open-Labeled Trials 619
References 623 Further Reading 624 52 Optimizing Schedule of Administration
in Phase I Clinical Trials 625 References 632 53 Partially Balanced Designs
635 References 655 54 Phase I/II Clinical Trials 658 References 665 55
Phase II/III Trials 667 References 679 Further Reading 680 56 Phase I
Trials 682 References 688 57 Phase II Trials 692 References 697 Further
Reading 699 58 Phase III Trials 700 References 709 59 Phase IV Trials 711
References 717 Further Reading 718 60 Phase I Trials in Oncology 719
References 723 Further Reading 724 61 Placebos 725 References 732 62
Planning a Group-Randomized Trial 736 References 743 63 Postmenopausal
Estrogen/Progestin Interventions Trial (PEPI) 744 References 754 Further
Reading 756 64 Preference Trials 759 References 768 Further Reading 769 65
Prevention Trials 770 References 776 66 Primary Efficacy Endpoint 779
References 786 Further Reading 788 67 Prognostic Variables in Clinical
Trials 789 References 797 68 Randomization Procedures 799 References 810 69
Randomization Schedule 813 References 825 Further Reading 826 70 Repeated
Measurements 827 References 838 71 Simple Randomization 841 References 849
Further Reading 849 72 Subgroups 850 References 865 73 Superiority Trials
867 References 877 Further Reading 877 74 Surrogate Endpoints 878
References 885 75 TNT Trial 887 References 892 Further Reading 893 76 UGDP
Trial 894 References 914 77 Women's Health Initiative Hormone Therapy
Trials 918 References 928 78 Women's Health Initiative Dietary Modification
Trial 931 References 943 Index 945