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.
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 ...
other books by Richard Chin
Paperback|Nov 1 2005
Hardcover|Jun 18 2008
Paperback|Aug 19 2016
The following ISBNs are associated with this title:
ISBN - 10:012381538X
ISBN - 13:9780123815385
Preview Your Review
Your Review Has Been Submitted
Yes, I recommend this product.
No, I do not recommend this product.
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