
Global Clinical Trials for Alzheimer's Disease
Design, Implementation, and Standardization
- 1st Edition - September 18, 2013
- Editors: Menghis Bairu, Michael Weiner
- Language: English
- Hardback ISBN:9 7 8 - 0 - 1 2 - 4 1 1 4 6 4 - 7
- eBook ISBN:9 7 8 - 0 - 1 2 - 4 1 1 5 3 0 - 9
Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book… Read more

Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease.
- Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials
- A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area
- Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries
Targets those individuals worldwide who are involved in clinical trials in AD, dementia and other neurodegenerative diseases, including scientists, physicians, regulators, safety officers, biostatisticians, data managers and more who plan and execute Alzheimer’s Disease clinical trials in and for developing companies.
Section I – Global Alzheimer’s Disease Clinical Trials
Ch 1 – Introduction and Overview of Global Clinical Trials
Ch 2 – Dementia and Neurodegenerative Diseases: Global and Local Public Health Burden
Section II – Challenges and Opportunities to conduct Alzheimer’s Disease Trials
Ch 3 – Global Issues in Drug Development
Ch 4 – Patient Populations and Evolution of Diagnostic and Therapeutic Standards
Ch 5 – Opportunities for Standardization of Diagnostic and Outcome Measures
Section III – Operationalization of Global Alzheimer’s Disease Trials
Ch 6 - The Increasing Competition for Clinical Trial Sites and Traditional Markets – Issues and Opportunities
Section IV – Enhancing Low and Middle Income Countries Capacities
Ch 7 – Strengthening/Building AD Global Clinical Trial Sites – Lessons Learned
Section V – Pharmacogenomics and Ethical Considerations
Ch 8 – Definitions
Ch 9 – Pharmacogenomics in Clinical Trials
Ch 10 – Pharmacogenomics in AD Clinical Trials
Ch 11 – Conduct of Global Clinical Trials in Vulnerable Populations (Ethical Considerations)
Ch 12 – Next Steps Towards Global Clinical Trials of CNS Disease
Section VI – Human Resources Planning
Ch 13 – Talent Management
Section VII – Appendices
Ch 14 – Useful Online Appendices
- Edition: 1
- Published: September 18, 2013
- Language: English
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Menghis Bairu
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.
MW