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Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization

Editat de Menghis Bairu, Michael Weiner
en Limba Engleză Hardback – 24 noi 2013
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
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Specificații

ISBN-13: 9780124114647
ISBN-10: 0124114644
Pagini: 432
Ilustrații: 25 illustrations
Dimensiuni: 152 x 229 x 33 mm
Greutate: 0.82 kg
Editura: ELSEVIER SCIENCE

Public țintă

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.

Cuprins

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

Recenzii

"Written and edited by internationally recognized clinician-scientists, this useful book is a welcome addition to the field…This is a practical and useful reference for conducting international clinical trials in Alzheimer's disease. Researchers that are planning and conducting global clinical trials would benefit from having access to this excellent reference." Rating: 3 Stars --Doody.com, April 11, 2014