Global Clinical Trials
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Global Clinical Trials
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Author : Richard Chin
language : en
Publisher: Academic Press
Release Date : 2011-05-06
Global Clinical Trials written by Richard Chin and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-05-06 with Science categories.
This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA
Global Clinical Trials Playbook
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Author : Menghis Bairu
language : en
Publisher: Academic Press
Release Date : 2012-04-20
Global Clinical Trials Playbook written by Menghis Bairu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-20 with Medical categories.
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. 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
Global Clinical Trials Playbook
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Author : Menghis Bairu
language : en
Publisher:
Release Date :
Global Clinical Trials Playbook written by Menghis Bairu and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on with Clinical trials categories.
Global Clinical Trials For Alzheimer S Disease
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Author : Menghis Bairu
language : en
Publisher: Academic Press
Release Date : 2013-08-28
Global Clinical Trials For Alzheimer S Disease written by Menghis Bairu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-08-28 with Medical categories.
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
Multiregional Clinical Trials For Simultaneous Global New Drug Development
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Author : Joshua Chen
language : en
Publisher: CRC Press
Release Date : 2016-04-21
Multiregional Clinical Trials For Simultaneous Global New Drug Development written by Joshua Chen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-21 with Mathematics categories.
In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in
Global Clinical Trials
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Author : Richard Chin
language : en
Publisher: Academic Press
Release Date : 2011-06-06
Global Clinical Trials written by Richard Chin and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-06-06 with Science categories.
This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA
Global Clinical Trials For Alzheimer S Disease
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Author : James (Dachao) Fan
language : en
Publisher: Elsevier Inc. Chapters
Release Date : 2013-08-28
Global Clinical Trials For Alzheimer S Disease written by James (Dachao) Fan and has been published by Elsevier Inc. Chapters this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-08-28 with Medical categories.
China has the largest number of people with dementia and the incidence is projected to increase much faster than in the developed world. There is a great demand for new drugs that can prevent or treat the disease and great potential for conducting Alzheimer’s disease clinical trials. The majority of Alzheimer’s disease trials that have been conducted in China are local trials. In early years, there were deficiencies in trial design and implementation; however, with more attention from the government and concerted efforts among Alzheimer’s disease experts, the standards for conducting Alzheimer’s disease clinical trials have improved. There are currently 159 clinical trial institutions capable of conducting Alzheimer’s disease trials in China, offering good facilities, experienced investigators and easily accessible patient pools. Recently a few global pharmaceutical companies have expanded their Alzheimer’s disease trials into China. It is expected that with increasing exposure to global standards and improved training, China’s capacity and capability to conduct Alzheimer’s disease trials will be strengthened.
The Comparative Impact Of Globalization Of Clinical Trials In India And China
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Author : Ginika Egesimba
language : en
Publisher: GRIN Verlag
Release Date : 2013-05-02
The Comparative Impact Of Globalization Of Clinical Trials In India And China written by Ginika Egesimba and has been published by GRIN Verlag this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-02 with Medical categories.
Master's Thesis from the year 2013 in the subject Medicine - Hospital Environment, Clinical Medicine, Walden University, course: Clinical Research and Administration- General concentration, language: English, abstract: India and China have been identified by pharmaceutical companies as the future markets that would support drug research and development in a cost efficient manner. This has become necessary as resources to conduct clinical studies dwindle, coupled with the fact that pharmaceutical industries are under pressure to deliver quality medicine, on time, to the public. Exploring and examining India and China’s potential in a stepwise fashion provides the opportunity to dissect the good, the bad and the ugly of globalization in a comparative approach. This paper will cover areas like ethics in the conduct of studies, good clinical practice (GCP), economic realities, ICH influence, intellectual property security and the role of government in global clinical trial.
Global Clinical Trials For Alzheimer S Disease
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Author : Menghis Bairu
language : en
Publisher: Elsevier Inc. Chapters
Release Date : 2013-08-28
Global Clinical Trials For Alzheimer S Disease written by Menghis Bairu and has been published by Elsevier Inc. Chapters this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-08-28 with Medical categories.
A rapid increase in the globalization of clinical trials is being driven by a need for lower cost, greater speed, and higher quality. Increasing costs—approximately 20% per year—account for much of this effort. Trials in developing countries—done with rigorous controls and safeguards—can lower the cost of drugs, distribute modern science and medicine, and enhance the health of patients around the world. Lesser developed countries offer a large pool of willing, treatment-naïve patients. Globalization of clinical trials introduces potential issues: for example, ethical concerns, harmonization, logistical challenges. Researchers must take into account potential ethnic, genetic, and other differences which can make extrapolation from one geographical region to another problematic. Differences between populations and geographies are divided into intrinsic and extrinsic differences. Historically, these differences have not resulted in changes to the risk–benefit ratio of outsourcing clinical trials.
When Experiments Travel
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Author : Adriana Petryna
language : en
Publisher: Princeton University Press
Release Date : 2009-04-27
When Experiments Travel written by Adriana Petryna and has been published by Princeton University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-04-27 with Social Science categories.
The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.