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Global Clinical Trials
Effective Implementation and Management
Comprehensive guide to design and development of effective clinical trials around the world
Richard Chin (Edited by), Menghis Bairu (Edited by)
9780128103555, Elsevier Science
Paperback, published 19 August 2016
522 pages
22.9 x 15.1 x 3.2 cm, 0.86 kg
"...can be considered a manual on how an ethical global clinical trial should be conducted....a landmark publication; it likely will stand as a standard reference book for global clinical trials for many years to come." --Journal of the American Medical Association, May 2012 "Global Clinical Trials: Effective Implementation and Management? is probably the most comprehensive book written to date on the topic…The book includes contributions from 59 authors, with coverage of many countries engaged in clinical research." --Journal of Clinical Research Best Practices, May 2012
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.
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
Subject Areas: Genetics [non-medical PSAK]
