Global Clinical Trials for Alzheimer

Global Clinical Trials for Alzheimer's 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.

Audience

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.

Hardbound, 432 Pages

Published: September 2013

Imprint: Academic Press

ISBN: 978-0-12-411464-7

Contents

  • 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

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