Global Clinical Trials: Effective Implementation and Management [Hardcover] Author: Richard Chin Menghis Bairu | Language: English | ISBN:
0123815371 | Format: PDF, EPUB
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This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials.
Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries
Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting
Case studies outline successes, failures, lessons learned and prospects for future collaboration
Includes country-specific guidelines for the most utilized countries
Foreword by David Feigel, former Head of CDRH at FDA
Books with free ebook downloads available Global Clinical Trials: Effective Implementation and Management [Hardcover]
- Hardcover: 522 pages
- Publisher: Academic Press; 1 edition (June 6, 2011)
- Language: English
- ISBN-10: 0123815371
- ISBN-13: 978-0123815378
- Product Dimensions: 1 x 5.9 x 8.9 inches
- Shipping Weight: 2 pounds (View shipping rates and policies)
- Amazon Best Sellers Rank: #1,300,137 in Books (See Top 100 in Books)
This is a very comprehensive book. It covers a lot of countries, and is great if you need a succinct chapter on a country written by someone who is knowledgeable about that country. You will still need to rely on in-country expert if you actually run the study in the country but great for planning purposes and for feasibility assessment. The chapters on China and India are more in depth.
By Norman Cohen
Physicians, investigators, and institutions interested in global clinical trials will be absolutely delighted by this important new source of information in one place. This volume is a "must read" for people working with or in global clinical trials of all types
By Michael W Weiner
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