Clinical Trial Registries (eBook)

Contents 4
List of contributors 6
Preface 8
Clinical trial registries and publication of results – a primer 13
Introduction 13
Regulatory agency actions Europe 16
USA 17
Journal editor actions 18
International pharmaceutical industry association actions 19
Discussion 20
Acknowledgements 22
References 22
The journal editor’s perspective 25
Introduction 25
Why did ICMJE call for mandatory clinical trial registration? 26
How did ICMJE develop a trial registration policy? 26
The future clinical trials and medical journals 28
Which trials should be registered? 30
Which registration database can be used? 31
What data should be entered in the registration database? 32
Which journals subscribe to the trial registration policy? 33
Discussion 35
References 37
Industry perspective on public clinical trial registries and results databases 39
Introduction 39
Clinical trial registries 40
Clinical trial results databases 50
Future directions 54
Acknowledgements 56
References 56
Public and patient usage and expectations for clinical trial registries 59
Introduction 59
Methdology to assess public and patient usage 61
Profile of respondents 61
Usage of registries 62
Assessment of information quality, scope and usefulness 63
How registry information is being used 65
Conclusions 66
References 70
Building a global culture of trial registration 71
Introduction 71
Perspectives from the Canadian Institutes of Health Research 73
Internal oversight: The need for increased accountabil-ity, quality control, and transparency in CIHR- funded trials 74
Randomized controlled trial database 75
Registration of CIHR-funded trials in an international register 76
CIHR vision regarding trial registration 78
The Ottawa Group and Ottawa Statement 79
The Ottawa Statement Part 1 80
The Ottawa Statement Part 2 82
The impact of the Ottawa Group and the Ottawa Statement 84
The WHO International Clinical Trials Registry Platform 84
Interactions between CIHR, Ottawa Group, and the WHO trial registration project 89
Conclusion 91
References 92
The Japanese perspective on registries and a review of clinical trial process in Japan 95
Introduction 95
Regulations for clinical trials in Japan 95
Clinical trials for NDA submission 96
Clinical trials not for NDA submission 104
Number of clinical trials conducted in Japan 104
Publication of clinical trials in Japan Clinical trials for NDA submission 107
Clinical trials not for NDA submission 109
Status of clinical trial registration 110
Clinical Trial Registries in Japan 111
UMIN-CTR 112
Issues in clinical trial registration in Japan 113
Necessity of mandatory registration 113
Reinforcing education on clinical trials 114
Future of Japanese clinical trial registration scheme 115
References 116
Transparency and validity of pharmaceutical research 119
Introduction 119
The process of drug development in the United States 120
Clinical trial registration 123
Obtaining transparency 125
Clinicalstudyresults.org 125
The data set element issue 126
Summary 129
References 129
A project management approach to the planning and execution of clinical trial registries 131
Introduction 131
Defining a project 132
Lilly’s approach 133
Project phases 133
Initiation 133
Planning 135
Execution 140
Monitoring and control 141
Closeout 142
Conclusions 143
References 144
Biopharmaceutical companies tackle clinical trial transparency 146
Introduction 146
Demand for transparency grows 149
Transparency increases 151
Industry response divided 151
Resources applied 155
Challenges for the future 157
References 159
In search of “Clinical Trial Register – Version 2.0” 161
Introduction 161
The difference between register and registry 162
The case for registering information from concluded trials 163
Increasing stakeholder and government interest 163
Highlights of key websites that aggregate clinical trial data ClinicalStudyResults. org 165
ClinicalTrials.gov 166
Current controlled trials (ControlledTrials.com) 166
The Clinical Trial Registry Platform (http://www.who. int/ ictrp/ en/) 166
Thomson CenterWatch (centerwatch.com) 167
From attributes to content to benefits: It’s all about the user 167
Assessing user needs and the competitive environment 169
Capturing eyeballs, contending for time 171
Driving clinical trial register use and reliance 173
References 175
Appendix 177
Clinical trial registries and study results databases 178
Annotated bibliography of important papers 185
Index 199