Global Clinical Trials Playbook, 1st Edition

Key Features

* Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world

* Provides real world international examples which illustrate the practical translation of principles

* Includes forms, templates, and additional references for standardization in a number of global scenarios

Description

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.

Menghis Bairu

Menghis Bairu, M.D., EVP and General Manager, has primary responsibility for overseeing strategic opportunities for Elan. With more than two decades of international experience in the biopharmaceutical, global health, and non-profit arenas, his skills span the commercial, research and development, and managed-care sectors of the pharmaceutical industry. Dr Bairu’s particular emphasis is the clinical development and global implementation of important and cost-effective new therapies. Named Executive Vice President in 2007, Dr. Bairu served as Elan’s Chief Medical Officer and Head of Global Development through 2010. In this capacity, his responsibilities included Clinical Development, Biometrics, Regulatory, CMC, Quality/Compliance, Safety and Risk Management, Clinical Operations, and Medical Affairs. In May 2006, Dr. Bairu was appointed Senior Vice President and Head of Elan International for Biopharmaceutical activities. Since joining Elan in 2004, he has served as Vice President and Head of Global Medical Affairs and Senior Director in charge of the Regional Medical Scientists. Dr. Bairu worked at Genentech for five years in various commercial, clinical and managed care roles, and served as Medical Director for Fremont Health Corporation before joining Elan. He received his undergraduate degree in Business Administration from Instituto VII Tecnico Commerciale in Milan, Italy, and earned his M.D. at the Universita Statale, Facolta' di Medicina e Chirurgia (Faculty of Medicine & Surgery) in Milan.

Affiliations and Expertise

Executive Vice President and General Manager, Elan Pharmaceuticals, South San Francisco, CA, USA

Recent Publication

Global Clinical Trials Playbook, 1st Edition

See Details

Editors: Menghis Bairu & Richard Chin
Release Date: 30 May 2012
Global Clinical Trials Playbook, 1st Edition

Print Book:
GBP 76.00 GBP 38.00

Editors: Menghis Bairu & Richard Chin
Release Date: 30 May 2012

Richard Chin

Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a dozen drug registrations. His previous roles include CEO of a NASDAQ listed company, Senior Vice President of Global Development at Elan, and Head of Clinical Research for the Biotherapeutics Unit at Genentech. He was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned an M.D. from Harvard and the equivalent of a J.D. from Oxford, where he studied as a Rhodes Scholar.

Affiliations and Expertise

CEO, Oxigene San Francisco, CA, USA

View additional works by Richard Chin

Recent Publication

Global Clinical Trials Playbook, 1st Edition

See Details

Editors: Menghis Bairu & Richard Chin
Release Date: 30 May 2012
Global Clinical Trials Playbook, 1st Edition

Print Book:
GBP 76.00 GBP 38.00

Editors: Menghis Bairu & Richard Chin
Release Date: 30 May 2012

Global Clinical Trials Playbook, 1st Edition

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

Quotes and reviews

"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

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