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 countries
Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting
Case studies outline successes, failures, lessons learned and prospects for future collaboration
Includes country-specific guidelines for the most utilized countries
Foreword by David Feigel, former Head of CDRH at FDA
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"...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 16, 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. -Review by Norman M. Goldfarb in Journal of Clinical Research Best Practices, May 2012About the Author:
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., EVP and General Manager, has primary responsibility for overseeing strategic opportunities for Elan. With more than two decades of international experience in the biopharmaceutical, global health, and non-profit arenas, his skills span the commercial, research and development, and managed-care sectors of the pharmaceutical industry. Dr Bairu's particular emphasis is the clinical development and global implementation of important and cost-effective new therapies. Named Executive Vice President in 2007, Dr. Bairu served as Elan's Chief Medical Officer and Head of Global Development through 2010. In this capacity, his responsibilities included Clinical Development, Biometrics, Regulatory, CMC, Quality/Compliance, Safety and Risk Management, Clinical Operations, and Medical Affairs. In May 2006, Dr. Bairu was appointed Senior Vice President and Head of Elan International for Biopharmaceutical activities. Since joining Elan in 2004, he has served as Vice President and Head of Global Medical Affairs and Senior Director in charge of the Regional Medical Scientists. Dr. Bairu worked at Genentech for five years in various commercial, clinical and managed care roles, and served as Medical Director for Fremont Health Corporation before joining Elan. He received his undergraduate degree in Business Administration from Instituto VII Tecnico Commerciale in Milan, Italy, and earned his M.D. at the Universita Statale, Facolta' di Medicina e Chirurgia (Faculty of Medicine & Surgery) in Milan.
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