Global Clinical Trials

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

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  • Author : Richard Chin
  • Publisher : Academic Press
  • Pages : 522 pages
  • ISBN : 9780123815385
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKGlobal Clinical Trials

Global Clinical Trials

Global Clinical Trials
  • Author : Richard Chin,Menghis Bairu
  • Publisher : Academic Press
  • Release : 06 May 2011
GET THIS BOOKGlobal Clinical Trials

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

Global Clinical Trials Playbook

Global Clinical Trials Playbook
  • Author : Menghis Bairu,Richard Chin
  • Publisher : Academic Press
  • Release : 26 February 2021
GET THIS BOOKGlobal Clinical Trials Playbook

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

Multiregional Clinical Trials for Simultaneous Global New Drug Development

Multiregional Clinical Trials for Simultaneous Global New Drug Development
  • Author : Taylor & Francis Group
  • Publisher : CRC Press
  • Release : 18 December 2020
GET THIS BOOKMultiregional Clinical Trials for Simultaneous Global New Drug Development

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, industry, and health organizations address various aspects of the important problems in global clinical development and MRCTs. The book first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
  • Author : Menghis Bairu,Michael Weiner
  • Publisher : Academic Press
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer's Disease

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

When Experiments Travel

When Experiments Travel
  • Author : Adriana Petryna
  • Publisher : Princeton University Press
  • Release : 27 April 2009
GET THIS BOOKWhen Experiments Travel

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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : James (Dachao) Fan,Li Huafang,Jing Yin
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Turkey straddles the continents of Europe and Asia, and this unique geographical location steers its economy. On the world economic scale, as an exceptional emerging economy, Turkey is the 16th largest economy in the world and the sixth largest economy as compared with the European Union countries, according to gross domestic product. The Turkish pharmaceutical sector is ranked 16th in terms of market value, and it is 36th in terms of the clinical research conducted and the volume of pharmaceutical

Global clinical trials playbook : management and implementation when resources are limited

Global clinical trials playbook : management and implementation when resources are limited
  • Author : Menghis Bairu,Richard Yoonsik Chin
  • Publisher : Unknown Publisher
  • Release : 26 February 2021
GET THIS BOOKGlobal 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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Michel Grothe,Jens Kurth,Harald Hampel,Bernd J. Krause,Stefan Teipel
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

In-vivo imaging markers of neuronal changes related to Alzheimer’s disease (AD) are ideally suited to be employed as diagnostic markers for early and differential diagnosis of AD as well as for the assessment of neurobiological effects of medical treatments in clinical trials. Novel molecular imaging techniques enable in-vivo detection of cerebral amyloid pathology, whereas magnetic resonance imaging (MRI)-based techniques, such as volumetric MRI and diffusion tensor imaging (DTI), provide structural lesion markers that allow tracking disease progression from

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Jeffrey Cummings,Kate Zhong
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Globalization is increasingly common as a means of more rapidly recruiting patients, shortening clinical trials, abbreviating clinical development cycle times, and preparing for marketing in non-US markets. Globalization refers to the inclusion of trial sites in three or more international regions. Globalization is common and most drug development programs include both US and non-US sites. There has been limited evaluation of the transnational performance of clinical trial instrumentation used in drug development programs. The performance across nations, languages and cultures

Global Clinical Trials

Global Clinical Trials
  • Author : Richard Chin,Menghis Bairu
  • Publisher : Academic Press
  • Release : 06 May 2011
GET THIS BOOKGlobal Clinical Trials

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

Oncology Clinical Trials

Oncology Clinical Trials
  • Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
  • Publisher : Demos Medical Publishing
  • Release : 22 December 2009
GET THIS BOOKOncology Clinical Trials

Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
  • Author : Richard Chin,Bruce Y Lee
  • Publisher : Elsevier
  • Release : 25 July 2008
GET THIS BOOKPrinciples and Practice of Clinical Trial Medicine

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting

Design and Analysis of Bridging Studies

Design and Analysis of Bridging Studies
  • Author : Jen-pei Liu,Shein-Chung Chow,Chin-Fu Hsiao
  • Publisher : CRC Press
  • Release : 26 July 2012
GET THIS BOOKDesign and Analysis of Bridging Studies

As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the

Envisioning a Transformed Clinical Trials Enterprise in the United States

Envisioning a Transformed Clinical Trials Enterprise in the United States
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher : National Academies Press
  • Release : 13 September 2012
GET THIS BOOKEnvisioning a Transformed Clinical Trials Enterprise in the United States

There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery,