BN.com Gift Guide

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

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 ...

See more details below
Hardcover
$86.76
BN.com price
(Save 13%)$99.95 List Price
Other sellers (Hardcover)
  • All (9) from $62.31   
  • New (7) from $80.34   
  • Used (2) from $62.31   
Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization

Available on NOOK devices and apps  
  • NOOK Devices
  • Samsung Galaxy Tab 4 NOOK 7.0
  • Samsung Galaxy Tab 4 NOOK 10.1
  • NOOK HD Tablet
  • NOOK HD+ Tablet
  • NOOK eReaders
  • NOOK Color
  • NOOK Tablet
  • Tablet/Phone
  • NOOK for Windows 8 Tablet
  • NOOK for iOS
  • NOOK for Android
  • NOOK Kids for iPad
  • PC/Mac
  • NOOK for Windows 8
  • NOOK for PC
  • NOOK for Mac
  • NOOK for Web

Want a NOOK? Explore Now

NOOK Book (eBook)
$56.99
BN.com price
(Save 42%)$99.95 List Price

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.

  • 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
Read More Show Less

Editorial Reviews

From the Publisher
"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
Doody's Review Service
Reviewer: Michael Joel Schrift, D.O., M.A.(University of Illinois at Chicago College of Medicine)
Description: Alzheimer's disease is a rapidly growing public health problem that poses a huge social burden. The prevalence has been estimated to be about 10% overall among persons over 65 and almost 50% among those 85 and older. In the United States there are approximately 4.5 million persons with Alzheimer's disease and this number is expected to double by 2030. This important new reference, geared for researchers who are planning and conducting international clinical trials for Alzheimer's disease, is a step towards tackling this urgent problem. Written and edited by internationally recognized clinician-scientists, this useful book is a welcome addition to the field.
Purpose: The purpose of the book, according to the editors, is to address, "...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." Indeed, the editors and chapter authors have produced a very useful and practical reference.
Audience: The intended audience is researchers who are planning and conducting international clinical trials in dementia and Alzheimer's disease.
Features: The book features 407 pages divided into 9 sections containing 22 chapters. The first section focuses on the epidemiology and risk factors as well as strategies for developing a plan to address Alzheimer's disease. This is followed by an overview of global clinical trials in Alzheimer's disease. The next section summarizes the challenges as well as the opportunities in conducting international clinical trials. The issues regarding the regulatory environment from an international perspective are addressed in section 4. The use of standardized diagnostic and outcome measures such as MRI and amyloid imaging and amyloid PET in global clinical trials are addressed in section 5. Issues specific to conducting clinical trials in Argentina and Brazil, India, China, Turkey, Japan, and Korea are described in section 7. Pharmacogenics and the ethical implications involved in global clinical trials are detailed in section 8. The issue of planning human resources is covered in the final section, focusing on the challenges of emerging markets, optimizing the workforce and ensuring the continuity of the trial. Each chapter concludes with relevant and timely citations of the scientific literature. The index was particularly helpful.
Assessment: 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.
Read More Show Less

Product Details

  • ISBN-13: 9780124114647
  • Publisher: Elsevier Science
  • Publication date: 10/2/2013
  • Pages: 432
  • Sales rank: 1,452,742
  • Product dimensions: 6.00 (w) x 9.10 (h) x 1.20 (d)

Meet the Author

Menghis Bairu, M.D.-physician, editor, author, philanthropist and healthcare business executive-has more than two decades of international experience in the biotechnology, pharmaceutical, global health and non-profit arenas. Dr. Bairu serves as Executive Vice President, Chief Medical Officer and Head of Global Development at Elan. His responsibilities include, but are not limited to clinical development, biometrics, regulatory, CMC, QA, safety-and-risk management, clinical operations and medical affairs. Previously he served as head of Onclave Therapeutics, a wholly Elan-owned oncology biotech company.

He lectures extensively on global health and biopharmaceutical issues with particular focus on Emerging Markets (e.g. India, China, Latin America, Singapore, Middle East, South East Asia and Africa). He served as editor and co-author of Global Clinical Trials: Effective Implementation and Management (Elsevier, 2011), a textbook designed to help researchers develop and implement effective and ethical international clinical trials. Dr. Bairu is also editor/co-author of Global Clinical Trials Playbook: Management and Implementation (Elsevier, 2012), and Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization (Elsevier, 2013).

Prior to joining Elan, Dr. Bairu worked at Genentech for more than five years in a number of managed care, medical and commercial (Oncology, Immunology, and Cardiovascular) roles. He served as managed care Medical Director for Fremont Health Corporation/II before joining Genentech. He served on the board of directors for One World Health, a nonprofit drug development company funded by the Bill and Melinda Gates Foundation and A-Cube, a privately held pharma startup.
In 2013, Dr. Bairu was named to the boards of directors of Dubai-based NewBridge Pharmaceuticals (he also serves as chairman of NewBridge’s science and technology committee), and ADVentura Capital SL, a Barcelona, Spain-based venture capital firm focused on funding and mentoring promising healthcare, IT and GreenTech companies. In 2011, Dr. Bairu joined the advisory board of the China Trials 5, a global clinical trials development summit focusing on China and north Asia. He currently serves as Adjunct Faculty at the University of California San Francisco School of Medicine where he lectures on global clinical trials’ design, development and conduct.

Dr. Weiner attended Johns Hopkins University and the State University of New York, and worked at Mount Sinai Hospital in New York (Resident), and Yale University (Fellow). After service in the US Air Force, in 1971 at the University of Wisconsin he was awarded a VA Research Associate at the Madison VA. Subsequently he was awarded a VA Clinical Investigatorship and relocated to the Palo Alto VA/Stanford University, where he subsequently received the Young Investigator Award of the American College of Cardiology in 1976. In 1980 he performed the first experiment using implanted coils to obtain 31P NMR spectra from the kidney of living rats, beginning his work using NMR/MRI for research. Since1980 he has been at the San Francisco VA/UCSF. He is currently Director of the Center for Imaging of Neurodegenerative Diseases. He is Professor of Radiology, Medicine, Psychiatry, and Neurology at UCSF. He has published over 600 peer reviewed scientific papers. His grants include studies of Alzheimer’s disease, vascular dementia, frontotemporal dementia, HIV/AIDS, gulf war illness, posttraumatic stress disorder, traumatic brain injury, amyotrophic lateral sclerosis, epilepsy, and other neurodegenerative conditions. He is the Principal Investigator of: the NIA funded Alzheimer’s Disease Neuroimaging Initiative (ADNI)/Grand Opportunities (GO) Grant, and the renewal of ADNI (total funding over $150 million for these 3 grants). Recently he was awarded a grant from the DOD entitled Effects of traumatic brain injury and post traumatic stress disorder on Alzheimer’s disease (AD) in Veterans using ADNI. In 2006 Dr. Weiner was awarded the Middleton Award, for outstanding research in the VA. In 2010 he was awarded the Gold Medal of Paul Sabatier University in Toulouse France, and the Gold Medal of the city of Toulouse, France. In 2011 he accepted the Ronald and Nancy Reagan Research Award from the Alzheimer’s Association on behalf of ADNI. In 2013, he is being awarded the Potamkin Prize for Research in Pick’s, Alzheimer’s, and Related Diseases from The American Academy of Neurology and The American Brain Foundation.

Read More Show Less

Table of 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

Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star

(0)

4 Star

(0)

3 Star

(0)

2 Star

(0)

1 Star

(0)

Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation

Reminder:

  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

 
Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)