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Clinical Trial Registries A Practical Guide for Sponsors and Researchers of Medicinal Products

:	Mary-Ann Foote
:	MaryAnn Foote
:	Clinical Trial Registries A Practical Guide for Sponsors and Researchers of Medicinal Products
:	Birkhäuser Basel
:	9783764375836
:	1
:	CHF 47.50
:

:	Pharmazie
:	English

:	194
:	Wasserzeichen/DRM
:	PC/MAC/eReader/Tablet
:	PDF

ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results.

	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