Global Clinical Trials Playbook book cover

Global Clinical Trials Playbook

Management and Implementation when resources are limited

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium.

Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries.  This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. 

Audience

Professionals in biotechnology and pharmaceutical companies, government, NGOs, contract research organizations and foundations including physicians, regulators, safety officers, clinical coordinators, data managers, and business managers who are planning and executing clinical trials in developing countries.

Hardbound, 320 Pages

Published: April 2012

Imprint: Academic Press

ISBN: 978-0-12-415787-3

Reviews

  • "Contributors mostly from outside of Europe and the US explore various elements required for successfully implementing clinical trials in poor countries that will be used as evidence to license drugs in rich countries."--Reference and Research Book News, August 2013
    "The book brings together a panoply of academics, registration professionals, safety officers and other experts from the pharmaceutical industry and CROs… [and] uses real-life examples to present the tools available to build and enhance human capacity in order to execute clinical trials throughout the world, and is recommended for anybody interested in expanding their knowledge of international clinical trials."--Samedan LTD Pharmaceutical Publishers, Autumn 2012
    "Global Clinical Trials: Effective Implementation and Management is probably the most comprehensive book written to date on the topic. In 2008, 97 (80%) of 121 FDA marketing applications for drug and biological products included non-U.S. data, including 10 (8%) with no U.S. data. The book includes contributions from 59 authors, with coverage of many countries engaged in clinical research"--Clinical Research Best Practices
    "This is indeed a valuable resource with a broad range of regional experiences in clinical trials and touching a wide array of topics increasing the potential of target readers. I have truly found it quite informative."--Dr. Michael Makanga, Director South-South Cooperation and Head of Africa Office, European & Developing Countries Clinical Trials Partnership (EDCTP), South Africa
    "Global Clinical Trials Playbook is a treatise in self-learning, and a must read for researchers in academia, CROs, and NGOs involved in funding and conducting clinical trials. It is a vital reference for those interested in capacity building in clinical research, especially in developing countries."--
    Professor S. D. Seth, MD, FAMS, FNASc, FIPS, FCAI, FISCD, Advisor of Clinical Trials Registry - India, National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India
    "This is an important book that comprehensively addresses capacity building across the globe. The breadth of the book and the broad array of geographies covered are impressive. This is a major publication that will push the field forward."--
    Dr. Dan Zhang, MD, PhD, Chairman & CEO of Fountain Medical Group, Shangai, China
    "Dr. Bairu and colleagues have produced the definitive reference guide to undertaking clinical trials around the world. I am sure that the Global Clinical Trials Playbook will instantly become an indispensable resource for funders and organisers of clinical trials who wish to stay up to date with the latest thinking in this fast moving field."--
    Dr. Rubin Minhas, M.B.Ch.B, Editor-in-Chief: ‘Clinical Evidence’, ‘Best Practice’ & Clinical Director, BMJ Evidence Centre
    "This book covers a broad range of topics important in global clinical trials and will be a welcome and comprehensive resource for professionals who are engaged in clinical trial related capacity building. It is a practical guide to conduct clinical trials in the new and uprising parts of the drug development world including Eastern Europe, Turkey, Singapore, India and China. The book goes hand in hand with global efforts to develop one global training concept for global drug development, the PharmaTrain Project. Learning by reading and doing for improved competency."--Fritz R. Bühler, Coordinator of IMI PharmaTrain, University of Basel, Switzerland Carl C. Peck, University of California San Francisco, UCSF, USA.Both Founders of the European, American and Chinese Courses in Drug Development and Regulatory Sciences


Contents

  • SECTION 1: Global Alzheimer’s Disease Clinical Trials

    1. Dementia and Neurodegenerative Diseases: Global and Local Public Health Burden
    2. Developing a National Plan to Address Alzheimer's Disease
    3. Preventing Alzheimer’s Disease

    SECTION 2: Global Alzheimer's Disease Clinical Trials

    4. Overview of Global Clinical trials: Drivers/Issues/Opportunities of Globalization

    SECTION 3: Challenges and Opportunities to conduct Global Alzheimer's Disease Clinical Trials

    5. Challenges and Opportunities to conduct Global Alzheimer’s Disease Clinical Trials
    6. Lessons learned from Significant Clinical trials conducted over the past decades
    7. Treatment for Alzheimer's Disease: What's behind the negative studies?

    SECTION 4:  Global Regulatory Environment Surrounding Alzheimer's Disease Trials

    8. The Regulatory Environment Surrounding Alzheimer's Disease Research: FDA and EMA Guidance
     
    SECTION 5: Standardization of Diagnostic and Outcome Measures in Global AD Trials

    9. Standardization of  Volumetric and Amyloid Imaging

    SECTION 6: Operationalization of Global Alzheimer's Disease Trials

    10. Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization 
    11. AD Mortality and patient retention in clinical trials: the impact of Alzheimer's Disease on Mortality
    12. Minimizing AD Global Trial costs by Accelerating/Improving Enrollment/Retention
     
    SECTION 7: Enhancing Low and Middle Income Countries capacity and capability to Conduct Alzheimer's Disease Trials

    13. Latin America’s AD clinical trial experience
    14. India's  AD clinical trial experience 
    15. China’s  AD clinical trial experience
    16. Eastern European countries’ AD clinical trial experience
    17. Turkey’s AD clinical trial experience
    18. Japan’s AD Clinical Trials Experience
    19. Korea’s AD Clinical Trials Experience

    SECTION 8: Pharmacogenetics and pharmacogenomics considerations
    20. Pharmacogenomics in Developing Countries:  Challenges and Opportunities
    21. Translation of Pharmacogenomics Into Global Alzheimer's Disease Clinical Trials: Ethical Implications

    SECTION 9: Human Resources Planning

    22. Human Resources Planning

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