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Produktbild: Data Monitoring Committees in Clinical Trials

Data Monitoring Committees in Clinical Trials A Practical Perspective

Aus der Reihe Statistics in Practice

136,99 €

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

22.03.2019

Verlag

John Wiley & Sons Inc

Seitenzahl

492

Maße (L/B/H)

23,5/15,7/3,1 cm

Gewicht

859 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-1-119-51265-3

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

22.03.2019

Verlag

John Wiley & Sons Inc

Seitenzahl

492

Maße (L/B/H)

23,5/15,7/3,1 cm

Gewicht

859 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-1-119-51265-3

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: GPSR Kontakt

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  • Produktbild: Data Monitoring Committees in Clinical Trials
  • Preface to the Second Edition xiii
     
    Preface to the First Edition xv
     
    1 Introduction 1
     
    1.1 Motivation 1
     
    1.2 History of data monitoring committees in government-sponsored trials 8
     
    1.3 Data monitoring committees in trials sponsored by the pharmaceutical industry 15
     
    1.4 Statistical methods for interim monitoring 18
     
    1.5 When are data monitoring committees needed? 21
     
    1.6 Models for data monitoring committees 22
     
    1.7 Where we are today 24
     
    1.8 Fundamental principles of data monitoring 25
     
    References 27
     
    2 Responsibilities of the Data Monitoring Committee and Motivating Illustrations 35
     
    2.1 Fundamental charges 36
     
    2.2 Specific tasks of the data monitoring committee 39
     
    2.2.1 Initial review 40
     
    2.2.1.1 Review of the study protocol 40
     
    2.2.1.2 Review of procedures to ensure quality of study conduct 45
     
    2.2.2 Evaluating the quality of ongoing study conduct 47
     
    2.2.3 Assessing safety and efficacy data 56
     
    2.2.3.1 Termination due to favorable benefit-to-risk 58
     
    2.2.3.2 Termination due to unfavorable benefit-to-risk 63
     
    2.2.3.3 Termination due to inability to answer trial questions 65
     
    2.2.3.4 Continuation of ongoing clinical trials 68
     
    2.2.3.5 Consideration of the overall picture: primary and secondary analyses 72
     
    2.2.3.6 Modifying sample sizes based on ongoing assessment of event rates 76
     
    2.2.4 Reviewing the final results 80
     
    2.3 The data monitoring committee charter 83
     
    References 84
     
    3 Composition of a Data Monitoring Committee 89
     
    3.1 Introduction 89
     
    3.2 Required areas of expertise 90
     
    3.3 Other relevant characteristics of committee members 96
     
    3.4 Committee size 98
     
    3.5 Selecting the committee chair 102
     
    3.6 Responsibility for appointing committee members 102
     
    3.7 Representation of other study components on the committee 104
     
    3.8 Preparation for service on a committee 106
     
    References 109
     
    4 Independence of the Data Monitoring Committee: Avoiding Conflicts of Interest 113
     
    4.1 Introduction 113
     
    4.2 Rationale for independence 114
     
    4.3 Financial independence 116
     
    4.3.1 Commercial sponsors 117
     
    4.3.2 Government sponsors 118
     
    4.3.3 Academic investigators 118
     
    4.4 Intellectual independence 125
     
    4.5 Emotional conflicts 131
     
    4.6 Best practices to address challenges to the DMC's independence 132
     
    4.6.1 Adequate training/experience in the DMC process 133
     
    4.6.2 Indemnification of DMC members 135
     
    4.6.3 Maintaining confidentiality of interim data 136
     
    4.6.4 Flexibility of procedures 138
     
    4.6.5 DMC meeting format 139
     
    4.6.6 Creating independent relationships and reducing conflicts of interest 141
     
    4.6.7 Adequately informative DMC reports 142
     
    4.7 Summary 143
     
    References 144
     
    5 Confidentiality Issues Relating to the Data Monitoring Committee 147
     
    5.1 Rationale 147
     
    5.2 Limits of confidentiality 159
     
    5.2.1 Interim analysis reports 159
     
    5.2.2 Access to aggregate data on efficacy and safety outcomes 161
     
    5.2.3 Providing access to interim data on a "need-to-know" basis 164
     
    5.2.4 Settings and procedures allowing broader unblinding of safety data 166
     
    5.2.5 Consequences of unblinding interim data for regulatory review in ongoing trials 168
     
    5.2.6 Some illustrations of broader unblinding 175
     
    5.2.7 The steering committee and maintaining confidentiality 1