Description
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
Table of Contents
Section I – Global Alzheimer's Disease Clinical TrialsCh 1 – Introduction and Overview of Global Clinical TrialsCh 2 – Dementia and Neurodegenerative Diseases: Global and Local Public Health BurdenSection II – Challenges and Opportunities to conduct Alzheimer's Disease TrialsCh 3 – Global Issues in Drug DevelopmentCh 4 – Patient Populations and Evolution of Diagnostic and Therapeutic StandardsCh 5 – Opportunities for Standardization of Diagnostic and Outcome MeasuresSection III – Operationalization of Global Alzheimer's Disease TrialsCh 6 - The Increasing Competition for Clinical Trial Sites and Traditional Markets – Issues and OpportunitiesSection IV – Enhancing Low and Middle Income Countries CapacitiesCh 7 – Strengthening/Building AD Global Clinical Trial Sites – Lessons LearnedSection V – Pharmacogenomics and Ethical ConsiderationsCh 8 – DefinitionsCh 9 – Pharmacogenomics in Clinical TrialsCh 10 – Pharmacogenomics in AD Clinical TrialsCh 11 – Conduct of Global Clinical Trials in Vulnerable Populations (Ethical Considerations)Ch 12 – Next Steps Towards Global Clinical Trials of CNS DiseaseSection VI – Human Resources PlanningCh 13 – Talent ManagementSection VII – AppendicesCh 14 – Useful Online Appendices
