eBook Global Clinical Trials for Alzheimer’s Disease, 1st Edition

  • Published By:
  • ISBN-10: 0124115306
  • ISBN-13: 9780124115309
  • DDC: 616.8
  • Grade Level Range: College Freshman - College Senior
  • 432 Pages | eBook
  • Original Copyright 2013 | Published/Released June 2014
  • This publication's content originally published in print form: 2013
  • Price:  Sign in for price

About

Overview

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.

Table of Contents

Front Cover.
Title Page.
Copyright Page.
International Editorial Advisors.
Contents.
Preface.
About the Editors.
List of Contributors.
Dedication.
1: Alzheimer's Disease: The Twenty-First Century Epidemic.
2: The Epidemiology and Prevention of Alzheimer's Disease and Projected Burden of Disease.
3: Developing a National Plan to Address Alzheimer's Disease.
4: Preventing Alzheimer's Disease.
5: Global Alzheimer's Disease: Clinical Trials.
6: Overview of Global Clinical Trials: Drivers/Issues/Opportunities of Globalization.
7: Challenges and Opportunities to Conduct Global Alzheimer's Disease Clinical Trials.
8: Challenges and Opportunities to Conduct Global Alzheimer's Disease Clinical Trials.
9: Lessons Learned from Major Clinical Trials Conducted Over the Past Decades.
10: Why the Negative Studies in Alzheimer's Disease?.
11: Global Regulatory Environment Surrounding Alzheimer's Disease Trials.
12: The Regulatory Environment Surrounding Alzheimer's Disease Research: FDA and EMA Guidance.
13: Standardization of Diagnostic and Outcome Measures in Global Alzheimer's Disease Trials.
14: Standardization of MRI and Amyloid Imaging.
15: Operationalization of Global Alzheimer's Disease Trials.
16: Operationalization of Global Alzheimer's Disease Trials.
17: Alzheimer's Disease Mortality and Patient Retention in Clinical Trials.
18: Minimizing Trial Costs by Accelerating and Improving Enrollment and Retention.
19: Enhancing Low and Middle Income Countries' Capacity and Capability to Conduct Alzheimer's Disease Trials.
20: South America's AD Clinical Trials Experience:Lessons Learned from Argentina and Brazil.
21: Dementia Clinical Research in India.
22: Alzheimer's Disease Clinical Trials in China.
23: Lessons Learned: Alzheimer's Disease Clinical Trials in Eastern Europe.
24: Experience in Alzheimer's Disease Clinical Trials in Turkey.
25: Strengthening/Building Alzheimer's Disease Global Clinical Trial Site Capabilities and Capacity in and for Emerging Markets. Lessons Learned from Japan.
26: Strengthening/Building Alzheimer's Disease Global Clinical Trial Site Capabilities and Capacity in and for Developing/Emerging Markets. Lessons Learned from Korea†.
27: Pharmacogenetics and Pharmacogenomics Considerations.
28: Pharmacogenomics in Developing Countries: Challenges and Opportunities.
29: Application of Pharmacogenomics in Global Alzheimer's Disease Clinical Trials and Ethical Implications.
30: Human Resources Planning.
31: Long-Term Human Resources Planning for Alzheimer's Disease Trials.
Index.