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Global Clinical Trials: Effective Implementation and Management

Global Clinical Trials: Effective Implementation and Management Edited by Richard Chin and Menghis Bairu 501 pp, $124.95 London, United Kingdom, Academic Press, 2011 ISBN-13: 978-0-12-381537-8 A variety of factors are driving the phenomenon of global clinical trials, not all of them related to ethically and efficiently addressing the global or regional burden of disease. Adriana Petryna comprehensively and elegantly discussed the historical and philosophical dimensions of global clinical trials in When Experiments Travel (2009, Princeton University Press). Petryna highlighted the inequities of the outsourcing and offshoring of clinical research by multinational pharmaceutical corporations, in which clinical risk for patients (particularly in zones of crisis) becomes a resource traded for profit against the hope of indirect health benefits from association with trained foreign medical professionals. Jennifer Hawkins and Ezekiel Emanuel similarly edited Exploitation and Developing Countries: The Ethics of Clinical Research (2010, Princeton University Press) as a lively collection of essays and case studies by ethicists and clinicians. Global Clinical Trials, edited by Richard Chin and Menghis Bairu, has a more practical and positive focus; indeed, it can be considered a manual on how an ethical global clinical trial should be conducted. The pedigree of the editors fits this ambition. Chin is the chief executive officer of Institute for One World Health, the first US nonprofit pharmaceutical company, primarily funded by the Bill and Melinda Gates Foundation; Bairu was cofounder of a foundation donating medical equipment and materials to health care entities in developing and emerging nations. Introductory chapters by these editors set the context. For example, readers learn that according to a report from the Office of the Inspector General, as of 2008 some 80% of marketing applications for drugs and biologicals approved by the US Food and Drug Administration contained data from US clinical trials conducted outside of the United States. Drivers for this globalization of clinical trials include ease of recruitment (particularly of patients naive to therapy), location of diseases of interest, and improved quality of data. The International Conference on Harmonisation was a major factor, because it brought Global Cooperation Group regulations in line across the United States, Europe, and Japan. This has now resulted in the standardization of reporting requirements for suspected unexpected serious adverse reactions across clinical trials in all nations. A major source of divergence, however, is the fact that the United States no longer follows the ethical imperatives of the Declaration of Helsinki, chiefly because the politically powerful pharmaceutical lobby in that nation discerns commercial advantage in insisting it is ethical to administer a placebo when some form of active drug is available as a comparator. Chapters 3, 4, and 5 provide detailed expositions by experts familiar with the application of clinical trials regulations in the United States, Europe, and Japan, respectively. Section 2 involves chapters on the regulatory framework and practice of clinical trials in India (chapters 6 and 7), China (chapters 8 and 9), Taiwan (chapter 10), the Philippines (chapter 11), the Middle East and North Africa (chapter 12), South Africa (chapter 13), Latin America (chapter 14), and Central and Eastern Europe (chapter 15). Perhaps the most fascinating components of these chapters are the “Challenges and Opportunities” sections, which highlight unique features relevant to factors such as culture and the regulatory environment. Section 3 emphasizes the extent to which this is very much a how-to book. Chapter 16 deals in detail with the design of clinical trials in emerging countries. Recommendations emerging from this analysis involve enrolling patients from a mix of developed and emerging nations; planning by sponsors for the eventuality that investigators in emerging nations will demand posttrial access to the product for their patients; assessing the feasibility of the clinical trial within the emerging nation's health care environment; providing a budget for transportation and compensation for daily loss of wages for research participants to support retention; routinely using remote-access technologies; and carefully building relationships with particular investigators at particular sites. Chapters 17, 18, 19, and 20 likewise provide valuable insights on the practicalities of, respectively, study management; study documents and logistics; study conduct, monitoring, and data collection; and management and electronic capture. As the editors state in their foreword, Global Clinical Trials: Effective Implementation and Management is a landmark publication; it likely will stand as a standard reference book for global clinical trials for many years to come. Back to top Article Information Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported that he is an Australian Research Council Future Fellow investigating nanotechnology and global public health issues. The Australian Research Council had no role in writing this review. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Global Clinical Trials: Effective Implementation and Management

JAMA , Volume 307 (19) – May 16, 2012

Global Clinical Trials: Effective Implementation and Management

Abstract

Edited by Richard Chin and Menghis Bairu 501 pp, $124.95 London, United Kingdom, Academic Press, 2011 ISBN-13: 978-0-12-381537-8 A variety of factors are driving the phenomenon of global clinical trials, not all of them related to ethically and efficiently addressing the global or regional burden of disease. Adriana Petryna comprehensively and elegantly discussed the historical and philosophical dimensions of global clinical trials in When Experiments Travel (2009, Princeton University...
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Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.4820
Publisher site
See Article on Publisher Site

Abstract

Edited by Richard Chin and Menghis Bairu 501 pp, $124.95 London, United Kingdom, Academic Press, 2011 ISBN-13: 978-0-12-381537-8 A variety of factors are driving the phenomenon of global clinical trials, not all of them related to ethically and efficiently addressing the global or regional burden of disease. Adriana Petryna comprehensively and elegantly discussed the historical and philosophical dimensions of global clinical trials in When Experiments Travel (2009, Princeton University Press). Petryna highlighted the inequities of the outsourcing and offshoring of clinical research by multinational pharmaceutical corporations, in which clinical risk for patients (particularly in zones of crisis) becomes a resource traded for profit against the hope of indirect health benefits from association with trained foreign medical professionals. Jennifer Hawkins and Ezekiel Emanuel similarly edited Exploitation and Developing Countries: The Ethics of Clinical Research (2010, Princeton University Press) as a lively collection of essays and case studies by ethicists and clinicians. Global Clinical Trials, edited by Richard Chin and Menghis Bairu, has a more practical and positive focus; indeed, it can be considered a manual on how an ethical global clinical trial should be conducted. The pedigree of the editors fits this ambition. Chin is the chief executive officer of Institute for One World Health, the first US nonprofit pharmaceutical company, primarily funded by the Bill and Melinda Gates Foundation; Bairu was cofounder of a foundation donating medical equipment and materials to health care entities in developing and emerging nations. Introductory chapters by these editors set the context. For example, readers learn that according to a report from the Office of the Inspector General, as of 2008 some 80% of marketing applications for drugs and biologicals approved by the US Food and Drug Administration contained data from US clinical trials conducted outside of the United States. Drivers for this globalization of clinical trials include ease of recruitment (particularly of patients naive to therapy), location of diseases of interest, and improved quality of data. The International Conference on Harmonisation was a major factor, because it brought Global Cooperation Group regulations in line across the United States, Europe, and Japan. This has now resulted in the standardization of reporting requirements for suspected unexpected serious adverse reactions across clinical trials in all nations. A major source of divergence, however, is the fact that the United States no longer follows the ethical imperatives of the Declaration of Helsinki, chiefly because the politically powerful pharmaceutical lobby in that nation discerns commercial advantage in insisting it is ethical to administer a placebo when some form of active drug is available as a comparator. Chapters 3, 4, and 5 provide detailed expositions by experts familiar with the application of clinical trials regulations in the United States, Europe, and Japan, respectively. Section 2 involves chapters on the regulatory framework and practice of clinical trials in India (chapters 6 and 7), China (chapters 8 and 9), Taiwan (chapter 10), the Philippines (chapter 11), the Middle East and North Africa (chapter 12), South Africa (chapter 13), Latin America (chapter 14), and Central and Eastern Europe (chapter 15). Perhaps the most fascinating components of these chapters are the “Challenges and Opportunities” sections, which highlight unique features relevant to factors such as culture and the regulatory environment. Section 3 emphasizes the extent to which this is very much a how-to book. Chapter 16 deals in detail with the design of clinical trials in emerging countries. Recommendations emerging from this analysis involve enrolling patients from a mix of developed and emerging nations; planning by sponsors for the eventuality that investigators in emerging nations will demand posttrial access to the product for their patients; assessing the feasibility of the clinical trial within the emerging nation's health care environment; providing a budget for transportation and compensation for daily loss of wages for research participants to support retention; routinely using remote-access technologies; and carefully building relationships with particular investigators at particular sites. Chapters 17, 18, 19, and 20 likewise provide valuable insights on the practicalities of, respectively, study management; study documents and logistics; study conduct, monitoring, and data collection; and management and electronic capture. As the editors state in their foreword, Global Clinical Trials: Effective Implementation and Management is a landmark publication; it likely will stand as a standard reference book for global clinical trials for many years to come. Back to top Article Information Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported that he is an Australian Research Council Future Fellow investigating nanotechnology and global public health issues. The Australian Research Council had no role in writing this review.

Journal

JAMAAmerican Medical Association

Published: May 16, 2012

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