Comprehensive guide to design and development of effective clinical trials around the world
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
Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a dozen drug registrations. His previous roles include CEO of a NASDAQ listed company, Senior Vice President of Global Development at Elan, and Head of Clinical Research for the Biotherapeutics Unit at Genentech. He was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned an M.D. from Harvard and the equivalent of a J.D. from Oxford, where he studied as a Rhodes Scholar. 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 responsibilities include, but are not limited to clinical development, biometrics, regulatory, CMC, QA, safety-and-risk management, clinical operations and medical affairs. Previously he served as head of Onclave Therapeutics, a wholly Elan-owned oncology biotech company. He lectures extensively on global health and biopharmaceutical issues with particular focus on Emerging Markets (e.g. India, China, Latin America, Singapore, Middle East, South East Asia and Africa). He served as editor and co-author of Global Clinical Trials: Effective Implementation and Management (Elsevier, 2011), a textbook designed to help researchers develop and implement effective and ethical international clinical trials. Dr. Bairu is also editor/co-author of Global Clinical Trials Playbook: Management and Implementation (Elsevier, 2012), and Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization (Elsevier, 2013). Prior to joining Elan, Dr. Bairu worked at Genentech for more than five years in a number of managed care, medical and commercial (Oncology, Immunology, and Cardiovascular) roles. He served as managed care Medical Director for Fremont Health Corporation/II before joining Genentech. He served on the board of directors for One World Health, a nonprofit drug development company funded by the Bill and Melinda Gates Foundation and A-Cube, a privately held pharma startup. In 2013, Dr. Bairu was named to the boards of directors of Dubai-based NewBridge Pharmaceuticals (he also serves as chairman of NewBridge's science and technology committee), and ADVentura Capital SL, a Barcelona, Spain-based venture capital firm focused on funding and mentoring promising healthcare, IT and GreenTech companies. In 2011, Dr. Bairu joined the advisory board of the China Trials 5, a global clinical trials development summit focusing on China and north Asia. He currently serves as Adjunct Faculty at the University of California San Francisco School of Medicine where he lectures on global clinical trials' design, development and conduct.
"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." -Review by Norman M. Goldfarb in Journal of Clinical Research Best Practices, May 2012
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