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Produktbild: Methods and Applications of Statistics in Clinical Trials

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

Aus der Reihe Methods and Applications of Statistics

257,99 €

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

03.02.2014

Herausgeber

N. Balakrishnan

Verlag

John Wiley & Sons

Seitenzahl

992

Maße (L/B/H)

26/18,3/5,7 cm

Gewicht

2022 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-1-118-30473-0

Beschreibung

Rezension

"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." ( Journal of Clinical Research Best Practices , 5 May 2015)

"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." ( Doody's , 13 February 2015)

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

03.02.2014

Herausgeber

N. Balakrishnan

Verlag

John Wiley & Sons

Seitenzahl

992

Maße (L/B/H)

26/18,3/5,7 cm

Gewicht

2022 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-1-118-30473-0

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: gpsr@libri.de

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  • Produktbild: Methods and Applications of Statistics in Clinical Trials
  • 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