Global Clinical Trials: Effective Implementation and Management

Other | May 6, 2011

byRichard Chin, Richard Chin, Menghis Bairu

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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

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From the Publisher

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 ...

Menghis Bairu, M.D.-physician, editor, author, philanthropist and healthcare business executive-has more than two decades of international experience in the biotechnology, pharmaceutical, global health and non-profit arenas. Dr. Bairu serves as Executive Vice President, Chief Medical Officer and Head of Global Development at Elan. His ...

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Format:OtherDimensions:522 pages, 1 × 1 × 1 inPublished:May 6, 2011Publisher:Academic PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:012381538X

ISBN - 13:9780123815385

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Table of Contents

Section I: OverviewChapter 1 Background Chapter 2: Ethics Chapter 3: Regulatory and Legal Requirements Chapter 4: United States Regulations Chapter 5: Indian Regulations Chapter 6: Chinese Regulations Chapter 7: African Regulations Chapter 8: Middle Eastern Regulations Chapter 9: Southeast Asian Regulations Chapter 10: South American Regulations Chapter 11: WHO and prequalification

Section II: Clinical Study and LogisticsChapter 12: Design of Clinical Trials Chapter 13: Study Management Chapter 14: CRO Qualification, Selection, and Management Chapter 15: Logistics Chapter 16: Partner Management Chapter 17: Site Selection and Capacity Building Chapter 18: Study Conduct and Monitoring Chapter 19: Data Collection and ManagementSection III: Special Considerations in Conducting Trials in Developing CountriesChapter 20: Conducting Studies in India Chapter 21: Conducting Studies in China Chapter 22: Conducting Studies in Africa Chapter 23: Conducting Studies in Eastern Europe Chapter 24: Vaccine Trials

Section IV: Analysis of ResultsChapter 25: Basic Statistics Chapter 26: Data Analysis Chapter 27: Confounding, Interactions, and Multivariate Analysis Chapter 28: Common Misinterpretations Chapter 29: Regulatory Filings

Section V: AppendicesAppendix A: Sample Protocol Appendix B: Sample Consent Form Appendix C: Sample Investigator's Brochure Appendix C: Sample Case Report Form Appendix D: Sample Statistical Analysis Plan Appendix D: ICH Guideline Appendix E: Glossary