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9783764375782

Clinical Trial Registries

by
  • ISBN13:

    9783764375782

  • ISBN10:

    3764375787

  • Edition: 1st
  • Format: Paperback
  • Copyright: 2006-10-04
  • Publisher: Birkhauser

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Summary

Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products is a necessary addition to the library of all researchers who plan to publish their results in top-tier, peer-reviewed journals. ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects and some countries and regions also require this information, as well as timely publication of study results. 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. More than 25 current Web addresses for registries are provided as well as a comprehensive annotated bibliography of papers on the topic of clinical trial registries. This book is a valuable source of information for all sponsors of medicinal products.

Table of Contents

List of contributors
vii
Preface ix
Clinical trial registries and publication of results -- a primer
1(12)
Mary Ann Foote
The journal editor's perspective
13(14)
Ana Marusic
Charlotte Haug
Industry perspective on public clinical trial registries and results databases
27(20)
Tracy Beck
Public and patient usage and expectations for clinical trial registries
47(12)
Kenneth Getz
Building a global culture of trial registration
59(24)
Karmela Krleza-Jeric
The Japanese perspective on registries and a review of clinical trial process in Japan
83(24)
Hisako Matsuba
Takahiro Kiuchi
Kuchiro Tstutani
Eiji Uchida
Yasuo Ohashi
Transparency and validity of pharmaceutical research
107(12)
Alan Goldhammer
A project management approach to the planning and execution of clinical trial registries
119(16)
Mark Jungemann
Biopharmaceutical companies tackle clinical trial transparency
135(16)
Dan McDonald
Steve Zisson
In search of ``Clinical Trial Register -- Version 2.0''
151(40)
Lawrence E. Liberti
Lucy Erdelac
Jean Papaj
Appendix
Clinical trial registries and study results databases
169(8)
Mary Ann Foote
Annotated bibliography of important papers
177(14)
Tim Peoples
Susan Siefert
Index 191

Supplemental Materials

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

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