- Language: English
- 564 Pages
- Published: September 2014
- Region: Global
Global Clinical Trials Playbook
- ID: 2088836
- May 2012
- Region: Global
- 320 Pages
- Elsevier Science and Technology
Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium.
Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials.
Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world
- Provides real world international examples which illustrate the practical translation of principles
- Includes forms, templates, and additional references for standardization in a number of global scenarios
SECTION 1: Global Alzheimer's Disease Clinical Trials
1. Dementia and Neurodegenerative Diseases: Global and Local Public Health Burden 2. Developing a National Plan to Address Alzheimer's Disease 3. Preventing Alzheimer's Disease
SECTION 2: Global Alzheimer's Disease Clinical Trials
4. Overview of Global Clinical trials: Drivers/Issues/Opportunities of Globalization
SECTION 3: Challenges and Opportunities to conduct Global Alzheimer's Disease Clinical Trials
5. Challenges and Opportunities to conduct Global Alzheimer's Disease Clinical Trials 6. Lessons learned from Significant Clinical trials conducted over the past decades 7. Treatment for Alzheimer's Disease: What's behind the negative studies?
SECTION 4: Global Regulatory Environment Surrounding Alzheimer's Disease Trials
8. The Regulatory Environment Surrounding Alzheimer's Disease Research: FDA and EMA Guidance SECTION 5: Standardization of Diagnostic and Outcome Measures in Global AD Trials
9. Standardization of Volumetric and Amyloid Imaging
SECTION 6: Operationalization of Global Alzheimer's Disease Trials
10. Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization 11. AD Mortality and patient retention in clinical trials: the impact of Alzheimer's Disease on Mortality 12. Minimizing AD Global Trial costs by Accelerating/Improving Enrollment/Retention SECTION 7: Enhancing Low and Middle Income Countries capacity and capability to Conduct Alzheimer's Disease Trials
13. Latin America's AD clinical trial experience 14. India's AD clinical trial experience 15. China's AD clinical trial experience 16. Eastern European countries' AD clinical trial experience 17. Turkey's AD clinical trial experience 18. Japan's AD Clinical Trials Experience 19. Korea's AD Clinical Trials Experience
SECTION 8: Pharmacogenetics and pharmacogenomics considerations 20. Pharmacogenomics in Developing Countries: Challenges and Opportunities 21. Translation of Pharmacogenomics Into Global Alzheimer's Disease Clinical Trials: Ethical Implications
SECTION 9: Human Resources Planning
22. Human Resources Planning
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.
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.