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Methods and Applications of Statistics in Clinical Trials, Volume 2


Methods and Applications of Statistics in Clinical Trials, Volume 2

Planning, Analysis, and Inferential Methods
Methods and Applications of Statistics 1. Aufl.

von: Narayanaswamy Balakrishnan

177,99 €

Verlag: Wiley
Format: EPUB
Veröffentl.: 16.06.2014
ISBN/EAN: 9781118595961
Sprache: englisch
Anzahl Seiten: 960

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Beschreibungen

<p><i>Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods</i> includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features:</p> <p>• Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems</p> <p>• Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index</p> <p>• Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials</p>
Contributors xix <p>Preface xxiii</p> <p>1 Analysis of Over- and Underdispersed Data 1</p> <p>2 Analysis of Variance (ANOVA) 10</p> <p>3 Assessment of Health-Related Quality of Life 26</p> <p>4 Bandit Processes and Response-Adaptive Clinical Trials: The Art of Exploration Versus Exploitation 40</p> <p>5 Bayesian Dose-Finding Designs in Healthy Volunteers 51</p> <p>6 Bootstrap 62</p> <p>7 Conditional Power in Clinical Trial Monitoring 102</p> <p>8 Cost-Effectiveness Analysis 111</p> <p>9 Cox-Type Proportional Hazards Models 126</p> <p>10 Empirical Likelihood Methods in Clinical Experiments 146</p> <p>11 Frailty Models 166</p> <p>12 Futility Analysis 174</p> <p>13 Imaging Science in Medicine I: Overview 187</p> <p>14 Imaging Science in Medicine, II: Basics of X-Ray Imaging 213</p> <p>15 Imaging Science in Medicine, III: Digital (21st Century) X-Ray Imaging 264</p> <p>16 Intention-to-Treat Analysis 313</p> <p>17 Interim Analyses 323</p> <p>18 Interrater Reliability 334</p> <p>19 Intrarater Reliability 340</p> <p>20 Kaplan-Meier Plot 357</p> <p>21 Logistic Regression 365</p> <p>22 Metadata 380</p> <p>23 Microarray 392</p> <p>24 Multi-Armed Bandits, Gittins Index, and Its Calculation 416</p> <p>25 Multiple Comparisons 436</p> <p>26 Multiple Evaluators 446</p> <p>27 Noncompartmental Analysis 457</p> <p>28 Nonparametric ROC Analysis for Diagnostic Trials 483</p> <p>29 Optimal Biological Dose for Molecularly Targeted Therapies 496</p> <p>30 Over- and Underdispersion Models 506</p> <p>31 Permutation Tests in Clinical Trials 527</p> <p>32 Pharmacoepidemiology, Overview 536</p> <p>33 Population Pharmacokinetic and Pharmacodynamic Methods 551</p> <p>34 Proportions: Inferences and Comparisons 570</p> <p>35 Publication Bias 595</p> <p>36 Quality of Life 608</p> <p>37 Relative Risk Modeing 622</p> <p>38 Sample Size Considerations for Morbidity/Mortality Trials 633</p> <p>39 Sample Size for Comparing Means 642</p> <p>40 Sample Size for Comparing Proportions 653</p> <p>41 Sample Size for Comparing Time-to-Event Data 664</p> <p>42 Sample Size for Comparing Variabilities 672</p> <p>43 Screening, Models of 689</p> <p>44 Screening Trials 721</p> <p>45 Secondary Efficacy End Points 731</p> <p>46 Sensitivity, Specificity, and Receiver Operator Characteristic (ROC) Methods 740</p> <p>47 Software for Genetics/Genomics 752</p> <p>48 Stability Study Designs 778</p> <p>49 Subgroup Analysis 793</p> <p>50 Survival Analysis, Overview 802</p> <p>51 The FDA and Regulatory Issues 815</p> <p>52 The Kappa Index 836</p> <p>53 Treatment Interruption 846</p> <p>54 Trial Reports: Improving Reporting, Minimizing Bias, and Producing Better Evidence-Based Practice 860</p> <p>55 U.S. Department of Veterans Affairs Cooperative Studies Program 876</p> <p>56 Women's Health Initiative: Statistical Aspects and Selected Early Results 901</p> <p>57 World Health Organization (WHO): Global Health Situation 914</p> <p>Index 925</p>
<p>“This book provides a good overview on most relevant topics for clinical trials.”  (<i>Biometrical Journal</i>, 1 October 2015)</p> <p> </p> <p> </p>
<p><b>N. BALAKRISHNAN, P<small>H</small>D,</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>An essential guide to planning the next steps in clinical trial design, management, and data analysis</i></b></p> <p>The second volume in a comprehensive two-part set, <i>Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods</i> provides the next steps of planning, analyzing, and managing clinical data. After <i>Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs</i> establishes the key principles behind clinical trials, the second volume concentrates on methods of planning, designing, data analysis, and statistical inference in clinical trials.</p> <p><i>Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods</i> includes updates of established literature from the <i>Wiley Encyclopedia of Clinical Trials</i> as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features:</p> <ul> <li>Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems</li> <li>Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index</li> <li>Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials</li> </ul> <p><i>Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods</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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