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Produktbild: Randomised Clinical Trials

Randomised Clinical Trials Design, Practice and Reporting

119,99 €

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

26.07.2021

Verlag

John Wiley & Sons Inc

Seitenzahl

560

Maße (L/B/H)

24,1/17,3/3,3 cm

Gewicht

1021 g

Auflage

2. Auflage

Sprache

Englisch

ISBN

978-1-119-52464-9

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

26.07.2021

Verlag

John Wiley & Sons Inc

Seitenzahl

560

Maße (L/B/H)

24,1/17,3/3,3 cm

Gewicht

1021 g

Auflage

2. Auflage

Sprache

Englisch

ISBN

978-1-119-52464-9

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  • Produktbild: Randomised Clinical Trials

  • Preface xiii

    Part I Basic Considerations 1

    1 Introduction 3

    1.1 Introduction 3

    1.2 Some completed trials 4

    1.3 Choice of design 13

    1.4 Practical constraints 18

    1.5 Influencing clinical practice 20

    1.6 History 20

    1.7 How do trials arise? 22

    1.8 Ethical considerations 24

    1.9 Regulatory requirements 24

    1.10 Focus 25

    1.11 Further reading 25

    2 Design Features 27

    2.1 Introduction 27

    2.2 The research question 29

    2.3 Patient selection 30

    2.4 The consent process 32

    2.5 Choice of interventions 33

    2.6 Choice of design 35

    2.7 Assigning the interventions 37

    2.8 Making the assessments 38

    2.9 Analysis and reporting 38

    2.10 Technical details 42

    2.11 Guidelines 43

    2.12 Further reading 44

    3 The Trial Protocol 45

    3.1 Introduction 45

    3.2 Abstract 47

    3.3 Background 49

    3.4 Research objectives 49

    3.5 Design 52

    3.6 Intervention details 53

    3.7 Eligibility 56

    3.8 Randomisation 58

    3.9 Assessment and data collection 61

    3.10 Statistical considerations 63

    3.11 Ethical issues 66

    3.12 Organisational structure 69

    3.13 Publication policy 69

    3.14 Trial forms 70

    3.15 Appendices 71

    3.16 Regulatory requirements 72

    3.17 Guidelines 74

    3.18 Protocols 74

    4 Measurement and Data Capture 77

    4.1 Introduction 77

    4.2 Types of measures 78

    4.3 Measures and endpoints 80

    4.4 Making the observations 91

    4.5 Baseline measures 92

    4.6 Data recording 93

    4.7 Technical notes 101

    4.8 Guidelines 101

    5 Randomisation 103

    5.1 Introduction 103

    5.2 Rationale 104

    5.3 Mechanics 104

    5.4 Application 113

    5.5 Carrying out randomisation 115

    5.6 Documentation 119

    5.7 Unacceptable methods 120

    5.8 Guidelines 120

    6 Trial Initiation 121

    6.1 Introduction 121

    6.2 Trial organisation 122

    6.3 Data collection and processing 130

    6.4 Internal data monitoring 132

    6.5 Ethical and regulatory requirements 133

    6.6 Launching the trial 134

    6.7 Trial registries 134

    6.8 Guidelines 135

    7 Trial Conduct and Completion 137

    7.1 Introduction 137

    7.2 Regular feedback 137

    7.3 Publicity 141

    7.4 Protocol modifications 142

    7.5 Preparing the publication(s) 142

    7.6 The next trial? 145

    7.7 Protocol 146

    8 Basics for Analysis 147

    8.1 Introduction 147

    8.2 The standard Normal distribution 148

    8.3 Confidence intervals 149

    8.4 Statistical tests 150

    8.5 Examples of analysis 152

    8.6 Regression methods 169

    8.7 Other issues 179

    8.8 Practice 182

    8.9 Technical details 183

    9 Trial Size 185

    9.1 Introduction 185

    9.2 Significance level and power 186

    9.3 The fundamental equation 188

    9.4 Specific situations 190

    9.5 Practical considerations 198

    9.6 Further topics 203

    9.7 Guideline 206

    9.8 Software 206

    10 Data and Safety Monitoring 209

    10.1 Introduction 209

    10.2 The DSMB 211

    10.3 Early reviews 214

    10.4 Interim reviews 219

    10.5 Protocols 228

    11 Reporting 229

    11.1 Introduction 229

    11.2 Publication 230

    11.3 Responsibilities 233

    11.4 Background 235

    11.5 Methods 236

    11.6 Findings 248

    11.7 When things go wrong 258

    11.8 Conclusions 259

    11.9 Guidelines 260

    Part II Adaptions of the Basic Design 263

    12 More Than Two Interventions 265

    12.1 Introduction 265

    12.2 Unstructured comparisons 266

    12.3 Comparisons with placebo (or standard) 270

    12.4 Dose-response designs 275

    12.5 Factorial trials 280

    12.6 Complex structure comparisons 289

    13 Paired and Matched Designs 293

    13.1 Matched-pair trials 293

    13.2 Cross-over trials 305

    13.3 Split-mouth designs 311

    13.4 Guidelines 317

    14 Repeated Measures Design 319

    14.1 Introduction 319

    14.2 Simplified analysis 322

    14.3 Regression models 329

    14.4 Auto-correlation 331

    14.5 Accounting for auto-correlation 334

    14.6 The design effect (DE) 338

    14.7 Trial size 344

    14.8 Practicalities 347

    14.9 Reporting 350

    14.10 Matched organs receiving the same intervention 354

    15 Non-Inferiority and Equivalence Trials 357

    15.1 Introduction 357

    15.2 Non-inferiority 358

    15.3 Analysis 361

    15.4 Trial size 366

    15.5 Equivalence 370

    15.6 Reporting 373

    15.7 Practical Issues 373

    15.8 Guidelines 373

    16 Cluster Designs 375

    16.1 Design features 375

    16.2 Procedures 376

    16.3 Regression models 379

    16.4 Intra-class correlation 380

    16.5 Trial size 381

    16.6 Analysis 386

    16.7 Practicalities 388

    16.8 Reporting 388

    16.9 Further reading 389

    17 Stepped Wedge Designs 391

    17.1 Introduction 391

    17.2 Notation 392

    17.3 Basic structure 396

    17.4 Randomisation 398

    17.5 Cross-sectional design 398

    17.6 Closed cohort design 408

    17.7 Practicalities 413

    Part III Further Topics 415

    18 Genomic Targets 417

    18.1 Introduction 417

    18.2 Predictive markers 418

    18.3 Enrichment design 420

    18.4 Biomarker-Stratified Designs 422

    18.5 Adaptive threshold designs 431

    19 Feasibility and Pilot Studies 435

    19.1 Introduction 435

    19.2 Feasibility studies 436

    19.3 External-pilot studies 437

    19.4 Considerations across external-pilot and main trial 444

    19.5 Internal-pilot studies 445

    19.6 Other preliminary studies 447

    19.7 Reporting 449

    20 Further Topics 451

    20.1 Introduction 451

    20.2 Adaptive approaches 452

    20.3 Large simple trials 461

    20.4 Bayesian methods 463

    20.5 Interim analyses 467

    20.6 Zelen randomised consent designs 472

    20.7 Systematic overviews 476

    Statistical Tables 483

    Glossary 493

    References 503

    Index 523