Narayanaswamy (McMaster University, Hamilton, Canada) Balakrishnan,
N Balakrishnan
John Wiley & Sons
e druk, 2014
9781118790786
Methods and Applications of Statistics in Clinical Trials, Volume 1 and Volume 2 – Concepts, Principles, Trials, and Designs Set
Concepts, Principles, Trials, and Designs
Specificaties
Gebonden, 1952 blz.
|
Engels
John Wiley & Sons |
e druk, 2014
ISBN13: 9781118790786
Rubricering
Onderdeel van serie
Methods and Applications of Statistics
Verwachte levertijd ongeveer 16 werkdagen
Samenvatting
This set includes Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs & Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods.
Volume 1
Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs successfully upholds the goals of the Wiley Encyclopedia of Clinical Trials by combining both previously–published and newly developed contributions written by over 100 leading academics, researchers, and practitioners in a comprehensive, approachable format. The result is a succinct reference that unveils modern, cutting–edge approaches to acquiring and understanding data throughout the various stages of clinical trial design and analysis.
Volume 2
Featuring newly–written material as well as established literature from the Wiley Encyclopedia of Clinical Trials, this book provides a timely and authoritative review of techniques for planning clinical trials as well as the necessary inferential methods for analyzing collected data. This comprehensive volume features established and newly–written literature 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. Examples of ongoing, cutting–edge clinical trials from today′s research such as early cancer & heart disease, mother to child human immunodeficiency virus transmission, women′s health initiative dietary, and AIDS clinical trials are also explored.
Specificaties
Inhoudsopgave
<p>VOLUME 1</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>VOLUME 2</p>
<p>Contributors xix</p>
<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>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>VOLUME 2</p>
<p>Contributors xix</p>
<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>