Full Description
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.
Contents
Section I: Overview
Chapter 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 Logistics
Chapter 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 Management
Section III: Special Considerations in Conducting Trials in Developing Countries
Chapter 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 Results
Chapter 25: Basic Statistics
Chapter 26: Data Analysis
Chapter 27: Confounding, Interactions, and Multivariate Analysis
Chapter 28: Common Misinterpretations
Chapter 29: Regulatory Filings
Section V: Appendices
Appendix 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
