Full Product Details
Author: Richard Chin (CEO, Oxigene<br>San Francisco, CA, USA) ,
Menghis Bairu (President and CEO, Speranza Therapeutics, Dublin, Ireland and Chief Medical Officer and Head of Global Development, Elan Pharmaceuticals, Cambridge, Massachusetts)
Publisher: Elsevier Science Publishing Co Inc
Imprint: Academic Press Inc
Dimensions:
Width: 15.20cm
, Height: 2.50cm
, Length: 22.90cm
Weight: 0.900kg
ISBN: 9780123815378
ISBN 10: 0123815371
Pages: 522
Publication Date: 06 July 2011
Audience:
Professional and scholarly
,
Professional & Vocational
Format: Hardback
Publisher's Status: Unknown
Availability: In Print
Limited stock is available. It will be ordered for you and shipped pending supplier's limited stock.
Reviews
First published in 2011, Global Clinical Trials: Effective Implementation and Management gives a global overview of conducting clinical trials. Its introductory chapter provides bioethical consideration of clinical trials in emerging regions, together with sections on conducting trials in the more traditional regions. US, EU and Japanese regulations are all considered in this section. Although the harmonisation of GCP across the three major developed markets has been a significant advance in drug development and immensely aided the growth of global clinical trials, the International Conference on Harmonisation (ICH) must continue to be developed further. Regulations are not completely harmonised, since every region can add additional requirements, and in many regions these requirements are being added on a regular basis. For this reason it is necessary to keep in touch on an almost daily basis with the regulatory authorities in countries in which you might be wishing to carry out these trials. This is particularly relevant in the developing nations, which are dealt with in subsequent chapters. Bioethical considerations for trials in developing countries are discussed in section 2, concentrating in particular on India, China, Taiwan, Philippines, Middle East and North Africa, South Africa, Latin America and central and eastern Europe. While many readers will be familiar with the regulations and conditions of running clinical trials in eastern Europe and perhaps India, the sections on less well known countries will be of particular use. The final section of the book addresses the logistics of conducting clinical trials in multiple countries. In particular it focuses on the design, management and documentation of clinical trials for emerging countries, and how best these studies can be monitored and conducted. In the final chapter, data collection, data management and electronic data capture are also considered. One particularly important consideration that the book recommends is to recognise the opportunities and challenges in effectively designing and conducting clinical trials in emerging countries. Post-trial design and conduct must be carried out so as to maximise the advantages and above all minimise the risks associated with these emerging countries. The specifics of a trial will certainly influence protocol design and trial planning, and issues relating to conducting clinical trials in emerging regions are normally universally applicable, whether this country be in South America, sub-Saharan Africa or South East Asia. What is particularly impressive in this book is the fine level of detail that is laid out in terms of regulatory affairs and other considerations for virtually every region considered. The authors are drawn from both industry and academia, and address critical issues often seen in global clinical trials. The scope is comprehensive, covering virtually every continent. The book is impressively up-to-date, with references dating up to the end of 2010. With an increasing number of clinical trials being conducted on a global basis this book is very timely, particularly because studies in developing countries often pose specific challenges, so advice on addressing these will be particularly welcome to the clinical trial community. Global Clinical Trials may prove to be a landmark publication and a standard reference book for many years to come. The only reservation one might have is that regulations are constantly evolving, so its coverage may soon become out-of-date. We would certainly expect and indeed look forward to future, updated editions. Found at: http://www.samedanltd.com/magazine/11/issue/168/article/3198
Global Clinical Trials: Effective Implementation and Management is probably the most comprehensive book written to date on the topic.The book includes contributions from 59 authors, with coverage of many countries engaged in clinical research. -Review by Norman M. Goldfarb in Journal of Clinical Research Best Practices, May 2012
Author Information
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. 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.
