Global Clinical Trials: Effective Implementation and Management

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 countriesProvides hands-on tools for regulatory and legal requirements and qualification, design, management, and reportingCase studies outline successes, failures, lessons learned and prospects for future collaborationIncludes country-specific guidelines for the most utilized countriesForeword by David Feigel, former Head of CDRH at FDA

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