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Produktbild: Methods and Applications of Statistics in Clinical Trials, Volume 1 and Volume 2

Methods and Applications of Statistics in Clinical Trials, Volume 1 and Volume 2 Concepts, Principles, Trials, and Designs

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

27.05.2014

Verlag

Wiley

Seitenzahl

1952

Maße (L/B/H)

26,7/18,8/9,7 cm

Gewicht

1860 g

Sprache

Englisch

ISBN

978-1-118-79078-6

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

27.05.2014

Verlag

Wiley

Seitenzahl

1952

Maße (L/B/H)

26,7/18,8/9,7 cm

Gewicht

1860 g

Sprache

Englisch

ISBN

978-1-118-79078-6

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  • Produktbild: Methods and Applications of Statistics in Clinical Trials, Volume 1 and Volume 2

  • VOLUME 1

    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

    VOLUME 2

    Contributors xix

    Preface xxiii

    1 Analysis of Over- and Underdispersed Data 1

    2 Analysis of Variance (ANOVA) 10

    3 Assessment of Health-Related Quality of Life 26

    4 Bandit Processes and Response-Adaptive Clinical Trials: The Art of Exploration Versus Exploitation 40

    5 Bayesian Dose-Finding Designs in Healthy Volunteers 51

    6 Bootstrap 62

    7 Conditional Power in Clinical Trial Monitoring 102

    8 Cost-Effectiveness Analysis 111

    9 Cox-Type Proportional Hazards Models 126

    10 Empirical Likelihood Methods in Clinical Experiments 146

    11 Frailty Models 166

    12 Futility Analysis 174

    13 Imaging Science in Medicine I: Overview 187

    14 Imaging Science in Medicine, II: Basics of X-Ray Imaging 213

    15 Imaging Science in Medicine, III: Digital (21st Century) X-Ray Imaging 264

    16 Intention-to-Treat Analysis 313

    17 Interim Analyses 323

    18 Interrater Reliability 334

    19 Intrarater Reliability 340

    20 Kaplan-Meier Plot 357

    21 Logistic Regression 365

    22 Metadata 380

    23 Microarray 392

    24 Multi-Armed Bandits, Gittins Index, and Its Calculation 416

    25 Multiple Comparisons 436

    26 Multiple Evaluators 446

    27 Noncompartmental Analysis 457

    28 Nonparametric ROC Analysis for Diagnostic Trials 483

    29 Optimal Biological Dose for Molecularly Targeted Therapies 496

    30 Over- and Underdispersion Models 506

    31 Permutation Tests in Clinical Trials 527

    32 Pharmacoepidemiology, Overview 536

    33 Population Pharmacokinetic and Pharmacodynamic Methods 551

    34 Proportions: Inferences and Comparisons 570

    35 Publication Bias 595

    36 Quality of Life 608

    37 Relative Risk Modeing 622

    38 Sample Size Considerations for Morbidity/Mortality Trials 633

    39 Sample Size for Comparing Means 642

    40 Sample Size for Comparing Proportions 653

    41 Sample Size for Comparing Time-to-Event Data 664

    42 Sample Size for Comparing Variabilities 672

    43 Screening, Models of 689

    44 Screening Trials 721

    45 Secondary Efficacy End Points 731

    46 Sensitivity, Specificity, and Receiver Operator Characteristic (ROC) Methods 740

    47 Software for Genetics/Genomics 752

    48 Stability Study Designs 778

    49 Subgroup Analysis 793

    50 Survival Analysis, Overview 802

    51 The FDA and Regulatory Issues 815

    52 The Kappa Index 836

    53 Treatment Interruption 846

    54 Trial Reports: Improving Reporting, Minimizing Bias, and Producing Better Evidence-Based Practice 860

    55 U.S. Department of Veterans Affairs Cooperative Studies Program 876

    56 Women's Health Initiative: Statistical Aspects and Selected Early Results 901

    57 World Health Organization (WHO): Global Health Situation 914

    Index 925