Produktbild: Randomised Clinical Trials

Randomised Clinical Trials Design, Practice and Reporting

121,99 €

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Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

27.05.2021

Verlag

John Wiley & Sons Inc

Seitenzahl

552

Maße (L/B/H)

24,4/17/2,8 cm

Gewicht

870 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-1-119-52464-9

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

27.05.2021

Verlag

John Wiley & Sons Inc

Seitenzahl

552

Maße (L/B/H)

24,4/17/2,8 cm

Gewicht

870 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-1-119-52464-9

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: GPSR Kontakt

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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
    &nb