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Clinical Trials: A Methodologic Perspective, 3rd Edition
  • 2020-11-16
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    • 978-1-118-95922-0
    ###-Book Description Begin-###
    -------如果这里没有任何信息,不是真没有,是我们懒!请复制书名上amazon搜索书籍信息。-------

    Clinical Trials: A Methodologic Perspective, 3rd Edition

    Steven Piantadosi

    ISBN: 978-1-118-95922-0 October 2017 928 Pages


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    DESCRIPTION

     

    Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies

     This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area.

    The authors bases current revisions...

    READ MORE

    Preface to the Third Edition xxv

    About the Companion Website xxviii

    1 Preliminaries 1

    1.1 Introduction 1

    1.2 Audiences 2

    1.3 Scope 3

    1.4 Other Sources of Knowledge 5

    1.5 Notation and Terminology 6

    1.6 Examples, Data, and Programs 9

    1.7 Summary 9

    2 Clinical Trials as Research 10

    2.1 Introduction 10

    2.2 Research 13

    2.3 Defining Clinical Trials 19

    2.4 Practicalities of Usage 29

    2.5 Nonexperimental Designs 35

    2.6 Summary 41

    2.7 Questions for Discussion 41

    3 Why Clinical Trials are Ethical 43

    3.1 Introduction 43

    3.2 Duality 47

    3.3 Historically Derived Principles of Ethics 57

    3.4 Contemporary Foundational Principles 65

    3.5 Methodologic Reflections 72

    3.6 Professional Conduct 79

    3.7 Summary 85

    3.8 Questions for Discussion 86

    4 Contexts for Clinical Trials 87

    4.1 Introduction 87

    4.2 Drugs 91

    4.3 Devices 95

    4.4 Prevention 99

    4.5 Complementary and Alternative Medicine 106

    4.6 Surgery and Skill-Dependent Therapies 116

    4.7 A Brief View of Some Other Contexts 130

    4.8 Summary 135

    4.9 Questions for Discussion 136

    5 Measurement 137

    5.1 Introduction 137

    5.2 Objectives 140

    5.3 Measurement Design 143

    5.4 Surrogate Outcomes 162

    5.5 Summary 170

    5.6 Questions for Discussion 171

    6 Random Error and Bias 172

    6.1 Introduction 172

    6.2 Clinical Bias 181

    6.3 Statistical Bias 188

    6.4 Summary 194

    6.5 Questions for Discussion 194

    7 Statistical Perspectives 196

    7.1 Introduction 196

    7.2 Differences in Statistical Perspectives 197

    7.3 Frequentist 202

    7.4 Bayesian 204

    7.5 Likelihood 210

    7.6 Statistics Issues 212

    7.7 Summary 215

    7.8 Questions for Discussion 216

    8 Experiment Design in Clinical Trials 217

    8.1 Introduction 217

    8.2 Trials As Simple Experiment Designs 218

    8.3 Goals of Experiment Design 223

    8.4 Design Concepts 225

    8.5 Design Features 230

    8.6 Special Design Issues 237

    8.7 Importance of the Protocol Document 244

    8.8 Summary 252

    8.9 Questions for Discussion 253

    9 The Trial Cohort 254

    9.1 Introduction 254

    9.2 Cohort Definition and Selection 255

    9.3 Modeling Accrual 264

    9.4 Inclusiveness, Representation, and Interactions 267

    9.5 Summary 275

    9.6 Questions for Discussion 275

    10 Development Paradigms 277

    10.1 Introduction 277

    10.2 Pipeline Principles and Problems 281

    10.3 A Simple Quantitative Pipeline 286

    10.4 Late Failures 292

    10.5 Summary 300

    10.6 Questions for Discussion 301

    11 Translational Clinical Trials 302

    11.1 Introduction 302

    11.2 Inferential Paradigms 308

    11.3 Evidence and Theory 312

    11.4 Translational Trials Defined 313

    11.5 Information From Translational Trials 317

    11.5.6 Sample Size for Translational Trials 324

    11.5.7 Validity 327

    11.6 Summary 328

    11.7 Questions for Discussion 328

    12 Early Development and Dose-Finding 329

    12.1 Introduction 329

    12.2 Basic Concepts 330

    12.3 Essential Concepts for Dose versus Risk 333

    12.4 Dose-Ranging 338

    12.5 Dose-Finding is Model Based 344

    12.6 General Dose-Finding Issues 354

    12.7 Summary 366

    12.8 Questions for Discussion 368

    13 Middle Development 370

    13.1 Introduction 370

    13.2 Characteristics of Middle Development 372

    13.3 Design Issues 375

    13.4 Middle Development Distills True Positives 379

    13.5 Futility and Nonsuperiority Designs 381

    13.6 Dose–Efficacy Questions 385

    13.7 Randomized Comparisons 386

    13.8 Cohort Mixtures 392

    13.9 Summary 395

    13.10 Questions for Discussion 396

    14 Comparative Trials 397

    14.1 Introduction 397

    14.2 Elements of Reliability 398

    14.3 Biomarker-Based Comparative Designs 402

    14.4 Some Special Comparative Designs 408

    14.5 Summary 411

    14.6 Questions for Discussion 412

    15 Adaptive Design Features 413

    15.1 Introduction 413

    15.2 Some Familiar Adaptations 418

    15.3 Biomarker Adaptive Trials 423

    15.4 Re-Designs 425

    15.5 Seamless Designs 427

    15.6 Barriers to the Use of AD 428

    15.7 Adaptive Design Case Study 428

    15.8 Summary 429

    15.9 Questions for Discussion 429

    16 Sample Size and Power 430

    16.1 Introduction 430

    16.2 Principles 431

    16.3 Early Developmental Trials 436

    16.4 Simple Estimation Designs 438

    16.5 Event Rates 451

    16.6 Staged Studies 455

    16.7 Comparative Trials 457

    16.8 Expanded Safety Trials 478

    16.9 Other Considerations 481

    16.10 Summary 489

    16.11 Questions for Discussion 490

    17 Treatment Allocation 492

    17.1 Introduction 492

    17.2 Randomization 494

    17.3 Constrained Randomization 500

    17.4 Adaptive Allocation 504

    17.5 Other Issues Regarding Randomization 507

    17.6 Unequal Treatment Allocation 514

    17.7 Randomization Before Consent 519

    17.8 Summary 520

    17.9 Questions for Discussion 520

    18 Treatment Effects Monitoring 522

    18.1 Introduction 522

    18.2 Administrative Issues in Trial Monitoring 527

    18.3 Organizational Issues Related to Monitoring 537

    18.4 Statistical Methods for Monitoring 545

    18.5 Summary 570

    18.6 Questions for Discussion 572

    19 Counting Subjects and Events 573

    19.1 Introduction 573

    19.2 Imperfection and Validity 574

    19.3 Treatment Nonadherence 575

    19.4 Protocol Nonadherence 580

    19.5 Data Imperfections 583

    19.6 Summary 588

    19.7 Questions for Discussion 589

    20 Estimating Clinical Effects 590

    20.1 Introduction 590

    20.2 Dose-Finding and Pharmacokinetic Trials 594

    20.3 Middle Development Studies 599

    20.4 Randomized Comparative Trials 606

    20.5 Problems With P-Values 616

    20.6 Strength of Evidence Through Support Intervals 620

    20.7 Special Methods of Analysis 622

    20.8 Exploratory Analyses 628

    20.9 Summary 639

    20.10 Questions for Discussion 640

    21 Prognostic Factor Analyses 644

    21.1 Introduction 644

    21.2 Model-Based Methods 647

    21.3 Adjusted Analyses of Comparative Trials 661

    21.4 PFAS Without Models 666

    21.5 Summary 669

    21.6 Questions for Discussion 669

    22 Factorial Designs 671

    22.1 Introduction 671

    22.2 Characteristics of Factorial Designs 672

    22.3 Treatment Interactions 675

    22.4 Examples of Factorial Designs 680

    22.5 Partial Fractional and Incomplete Factorials 682

    22.6 Summary 683

    22.7 Questions for Discussion 683

    23 Crossover Designs 684

    23.1 Introduction 684

    23.2 Advantages and Disadvantages 686

    23.3 Analysis 691

    23.4 Classic Case Study 696

    23.5 Summary 696

    23.6 Questions for Discussion 697

    24 Meta-Analyses 698

    24.1 Introduction 698

    24.2 A Sketch of Meta-Analysis Methods 700

    24.3 Other Issues 705

    24.4 Summary 707

    24.5 Questions for Discussion 708

    25 Reporting and Authorship 709

    25.1 Introduction 709

    25.2 General Issues in Reporting 710

    25.3 Clinical Trial Reports 715

    25.4 Authorship 726

    25.5 Other Issues in Disseminating Results 731

    25.6 Summary 732

    25.7 Questions for Discussion 733

    26 Misconduct and Fraud in Clinical Research 734

    26.1 Introduction 734

    26.2 Research Practices 741

    26.3 Approach to Allegations of Misconduct 743

    26.4 Characteristics of Some Misconduct Cases 747

    26.5 Lessons 754

    26.6 Clinical Investigators’ Responsibilities 757

    26.7 Summary 759

    26.8 Questions for Discussion 760

    Appendix A Data and Programs 761

    A.1 Introduction 761

    A.2 Design Programs 761

    A.3 Mathematica Code 763

    Appendix B Abbreviations 764

    Appendix C Notation and Terminology 769

    C.1 Introduction 769

    C.2 Notation 769

    C.3 Terminology and Concepts 772

    Appendix D Nuremberg Code 788

    D.1 Permissible Medical Experiments 788

    References 790

    Index 871

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    ###-Book Description End-###
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