Global Clinical Trials for Alzheimers Disease: Design, Implementation, and Standardization

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 trialsA 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 areaIncludes 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 INDICE: 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

• ISBN: 978-0-12-411464-7
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Páginas: 432
• Fecha Publicación: 12/11/2013
• Nº Volúmenes: 1
• Idioma: Inglés