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Methods and Applications of Statistics in Clinical Trials, Volume 1


Methods and Applications of Statistics in Clinical Trials, Volume 1

Concepts, Principles, Trials, and Designs
Methods and Applications of Statistics 1. Aufl.

von: Narayanaswamy Balakrishnan

181,99 €

Verlag: Wiley
Format: EPUB
Veröffentl.: 05.03.2014
ISBN/EAN: 9781118595916
Sprache: englisch
Anzahl Seiten: 992

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Beschreibungen

<p><b><i>A complete guide to the key statistical concepts essential for the design and construction of clinical trials</i></b></p> <p>As the newest major resource in the field of medical research, <i>Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs </i>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.</p> <p>Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the <i>Wiley Encyclopedia of Clinical Trials. </i>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. <i>Methods and Applications of</i> <i>Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs </i>also features:</p> <ul> <li>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</li> <li>Over 100 contributions from leading academics, researchers, and practitioners</li> <li>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</li> </ul> <p><i>Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs </i>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.</p>
<p>Contributors xxiii</p> <p>Preface xxix</p> <p>1 Absolute Risk Reduction 1</p> <p>2 Accelerated Approval 14</p> <p>3 AIDS Clinical Trials Group (ACTG) 27</p> <p>4 Algorithm-Based Designs 40 </p> <p>5 Alpha-Spending Function 53 </p> <p>6 Application of New Designs in Phase I Trials 65 </p> <p>7 ASCOT Trial 74</p> <p>8 Benefit/Risk Assessment in Prevention Trials 80 </p> <p>9 Biased Coin Randomization 90 </p> <p>10 Biological Assay, Overview 106 </p> <p>11 Block Randomization 125 </p> <p>12 Censored Data 139</p> <p>13 Clinical Data Coordination 146 </p> <p>14 Clinical Data Management 164 </p> <p>15 Clinical Significance 170</p> <p>16 Clinical Trial Misconduct 191</p> <p>17 Clinical Trials, Early Cancer and Heart Disease 205 </p> <p>18 Cluster Randomization 216 </p> <p>19 Coherence in Phase I Clinical Trials 230</p> <p>20 Compliance and Survival Analysis 240 </p> <p>21 Composite Endpoints in Clinical Trials 246</p> <p>22 Confounding 252 </p> <p>23 Control Groups 263</p> <p>24 Coronary Drug Project 273</p> <p>25 Covariates 285</p> <p>26 Crossover Design 300</p> <p>27 Crossover Trials 310</p> <p>28 Diagnostic Studies 320</p> <p>29 DNA Bank 340</p> <p>30 Up-and-Down and Escalation Designs 353</p> <p>31 Dose Ranging Crossover Designs 362</p> <p>32 Flexible Designs 383 </p> <p>33 Gene Therapy 399</p> <p>34 Global Assessment Variables 423</p> <p>35 Good Clinical Practice (GCP) 438</p> <p>36 Group-Randomized Trials 448</p> <p>37 Group Sequential Designs 467</p> <p>38 Hazard Ratio 483</p> <p>39 Large Simple Trials 500</p> <p>40 Longitudinal Data 510</p> <p>41 Maximum Duration and Information Trials 515</p> <p>42 Missing Data 522</p> <p>43 Mother to Child Human Immunodeficiency Virus Transmission Trials 536</p> <p>44 Multiple Testing in Clinical Trials 550</p> <p>45 Multicenter Trials 558</p> <p>46 Multiple Endpoints 570</p> <p>47 Multiple Risk Factor Intervention Trial 577</p> <p>48 N-of-1 Randomized Trials 587</p> <p>49 Noninferiority Trial 598</p> <p>50 Nonrandomized Trials 609 </p> <p>51 Open-Labeled Trials 619</p> <p>52 Optimizing Schedule of Administration in Phase I Clinical Trials 625</p> <p>53 Partially Balanced Designs 635</p> <p>54 Phase I/II Clinical Trials 658</p> <p>55 Phase II/III Trials 667</p> <p>56 Phase I Trials 682</p> <p>57 Phase II Trials 692</p> <p>58 Phase III Trials 700</p> <p>59 Phase IV Trials 711</p> <p>60 Phase I Trials in Oncology 719</p> <p>61 Placebos 725</p> <p>62 Planning a Group-Randomized Trial 736</p> <p>63 Postmenopausal Estrogen/Progestin Interventions Trial (PEPI) 744</p> <p>64 Preference Trials 759</p> <p>65 Prevention Trials 770</p> <p>66 Primary Efficacy Endpoint 779</p> <p>67 Prognostic Variables in Clinical Trials 789</p> <p>68 Randomization Procedures 799</p> <p>69 Randomization Schedule 813 </p> <p>70 Repeated Measurements 827</p> <p>71 Simple Randomization 841</p> <p>72 Subgroups 850</p> <p>73 Superiority Trials 867</p> <p>74 Surrogate Endpoints 878</p> <p>75 TNT Trial 887</p> <p>76 UGDP Trial 894</p> <p>77 Women's Health Initiative Hormone Therapy Trials 918</p> <p>78 Women's Health Initiative Dietary Modification Trial 931</p> <p>Index 945</p>
<p>“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.”  (<i>Journal of Clinical Research Best Practices</i>, 5 May 2015)</p> <p>“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.”  (<i>Doody’s</i>, 13 February 2015)</p> <p> </p>
<p><b>N. BALAKRISHNAN, PhD,</b> 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 <i>Encyclopedia of Statistical Sciences, Second Edition,</i> also published by Wiley.</p>
<p><b><i>A complete guide to the key statistical concepts essential for the design and construction of clinical trials</i></b></p> <p>As the newest major resource in the field of medical research, <i>Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs</i> presents a timely and authoritative review of the central statistical concepts used to build clinical trials that obtain the best results. The reference unveils modern approaches vital to understanding, creating, and evaluating data obtained throughout the various stages of clinical trial design and analysis.</p> <p>Accessible and comprehensive, the first volume in a two-part set includes newly written articles as well as established literature from the <i>Wiley Encyclopedia of Clinical Trials</i>. 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. <i>Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs</i> also features:</p> <ul> <li>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</li> <li>Over 100 contributions from leading academics, researchers, and practitioners</li> <li>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</li> </ul> <p><i>Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs</i> is an excellent reference for researchers, practitioners, and students in the fields of clinical trials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology, and public health.</p>

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