December 5, 2020

Download Ebook Free Global Clinical Trials For Alzheimer’s Disease

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
Author : Menghis Bairu,Michael Weiner
Publisher : Academic Press
Release Date : 2013-08-28
Category : Medical
Total pages :432
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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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
Author : Jeffrey Cummings,Kate Zhong
Publisher : Elsevier Inc. Chapters
Release Date : 2013-08-28
Category : Medical
Total pages :432
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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 of the ADAS-Cog, Clinical Dementia Rating, Neuropsychiatric Inventory, quality of life measures, pharmacoeconomic measures, and activities of daily living tools has been inadequately researched. The creation of a library of well-tested and shared instruments would be of value in globalized trials. The approach to diagnosis of Alzheimer’s disease may vary across trial sites and create undesirable heterogeneity within clinical trials. Biological factors such as differences in liver metabolism enzymes, diet, education and head size may all create differences in treatment response in different ethnic settings. Sites across the globe may differ in terms of experience, and institutional review boards may also perform variably with regard to informed consent and human safety. These require vigilance by sponsors performing globalized trials. International efforts such as the Alzheimer’s Disease Neuroimaging Initiative provide data that will help reduce the variance and improve clinical trial quality. Improved understanding of the effects of globalization will enhance clinical trials and speed the development of new medications for patients with AD.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
Author : Seong Yoon Kim
Publisher : Elsevier Inc. Chapters
Release Date : 2013-08-28
Category : Medical
Total pages :432
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Prevalence of dementia in Korea is 9.1% of the elderly population, and those with dementia are thus estimated to be nearly 750,000. Dementia due to Alzheimer’s disease (AD) accounts for 45–75% of all dementia syndromes, whereas vascular dementia accounts for about 12–37%. Clinical research on AD has been greatly expanded in volume and quality in the last 10 years in Korea, partly due to public and governmental awareness of the increase of the elderly population. The national drug market for dementia in 2020 is estimated to be US$ 1,700 million. Past experiences in clinical research or drug trials for AD have taught us several lessons: 1) cognitive tests and function measurements need careful interpretation due to the unstable educational system in Korea between 1940 and 1970, and the rapid industrialization of modern Korean society; 2) in a governmental drive to encourage clinical research, several national collaborative research networks will work as a solid base for future clinical trials; 3) recent revision of clinical research-related regulations, and a change in the general public's views on drug trials, can be both an advantage and a disadvantage for drug trials at the same time.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
Author : Tal Burt,Lynne Hughes,Amir Kalali,P. Murali Doraiswamy
Publisher : Elsevier Inc. Chapters
Release Date : 2013-08-28
Category : Medical
Total pages :432
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There is considerable interest, both nationally and internationally, in conducting dementia research in India. Motivated by a rapid increase in the aging population and a desire for indigenous, self-sufficient healthcare and medical research, dementia research in India is on course for rapid growth in the coming years. Several challenges will have to be overcome along the way. A solid and general clinical research culture and a supportive healthcare system, both tailored to the specific needs of the dementia field and its vulnerable patient population, will have to be established through careful guidance of government regulators and collaborations with academic, industry and public stakeholders both in and outside India.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
Author : H. Michael Arrighi
Publisher : Elsevier Inc. Chapters
Release Date : 2013-08-28
Category : Medical
Total pages :432
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Alzheimer’s disease (AD) confers an additional risk of death. The magnitude of this impact is related to the person’s underlying mortality and current AD stage. When planning clinical trials, estimating the number of deaths prior to study initiation, and periodically during the study as participants are enrolled, assists in providing an informative context, particularly if there are few life events. Additionally, deaths have the potential to introduce a bias, thus, equal follow-up needs to ensure for participants assigned to either active or placebo, particularly if the period of observation for safety events extends beyond the end of the study. During AD clinical trials, patients discontinue for reasons other than death and at substantially high rates, which has the potential to introduce significant bias. Planning and incorporating strategies to improve retention and identify successful techniques should be an integral part of the study process.

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
Author : Menghis Bairu,Michael Weiner
Publisher : Academic Press
Release Date : 2013-08-28
Category : Medical
Total pages :432
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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

Global Clinical Trials Playbook

Global Clinical Trials Playbook
Author : Menghis Bairu,Richard Chin
Publisher : Academic Press
Release Date : 2012-06-12
Category : Medical
Total pages :320
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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

Alzheimer Disease

Alzheimer Disease
Author : Robert Becker,Ezio Giacobini
Publisher : Springer Science & Business Media
Release Date : 2012-12-06
Category : Medical
Total pages :614
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Trial Designs and Outcomes in Dementia Therapeutic Research

Trial Designs and Outcomes in Dementia Therapeutic Research
Author : Kenneth Rockwood,Serge Gauthier
Publisher : CRC Press
Release Date : 2005-11-23
Category : Medical
Total pages :324
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Given the increased attention by clinicians, researchers and the pharmaceutical industry to the management and treatment of dementia not only in the elderly but also in increasingly younger populations, the demands for effective evidence-based pharmaceutical control of dementia and quantitative assessment of outcomes have increased. Since some firs

Global Clinical Trials

Global Clinical Trials
Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Release Date : 2011-05-06
Category : Science
Total pages :522
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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

Mental Disorders: New Insights for the Healthcare Professional: 2013 Edition

Mental Disorders: New Insights for the Healthcare Professional: 2013 Edition
Author : Anonim
Publisher : ScholarlyEditions
Release Date : 2013-07-22
Category : Psychology
Total pages :387
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Mental Disorders: New Insights for the Healthcare Professional: 2013 Edition is a ScholarlyEditions™ book that delivers timely, authoritative, and comprehensive information about Diagnosis and Screening. The editors have built Mental Disorders: New Insights for the Healthcare Professional: 2013 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Diagnosis and Screening in this book to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Mental Disorders: New Insights for the Healthcare Professional: 2013 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Global Clinical Trials

Global Clinical Trials
Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Release Date : 2011-06-06
Category : Science
Total pages :522
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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

Evidence-based Dementia Practice

Evidence-based Dementia Practice
Author : Nawab Qizilbash,Lon S. Schneider,Henry Brodaty,Pierre Tariot,Jeffrey Kaye,Helena Chui,Timo Erkinjuntti
Publisher : John Wiley & Sons
Release Date : 2008-04-15
Category : Medical
Total pages :928
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The era of therapeutic nihilism in dementia has ended, with the emergence of agents for symptomatic treatment, those that delay the course of the disease or prevent the onset of dementia, and new methods to manage symptoms. With the expansion of therapies, there is a clear danger of being overwhelmed by the volume of data. This book is designed to collect this information, distil what is relevant and reliable, and present it in a format that is useful to clinicians who manage and treat people with dementia. The book is designed to bring together the latest, best and practical evidence on all aspects of management, from diagnosis and therapy to social and ethical considerations. The editors are all dynamic clinicians involved in the care of patients with dementia and the evaluation of therapies. Two of the editors are the leaders of the Cochrane Collaboration for the examination of therapies for dementia. There are no other books that take such a practical and problem-oriented or approach to the diagnosis and management of dementia. Furthermore none but this can be described as truely evidence-based.

Developing Therapeutics for Alzheimer's Disease

Developing Therapeutics for Alzheimer's Disease
Author : Michael S. Wolfe
Publisher : Academic Press
Release Date : 2016-05-27
Category : Medical
Total pages :676
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Developing Therapeutics for Alzheimer's Disease: Progress and Challenges provides a thorough overview of the latest advances toward the development of therapeutics for Alzheimer’s disease, along with the major hurdles that still must be overcome and potential solutions to these problems. Despite the lack of progress toward developing therapeutics that can slow or stop the progression of this disease, important discoveries have been made and many promising approaches are advancing in preclinical studies and clinical trials. This book outlines the special challenges related to specific targets and approaches, while presenting a realistic, comprehensive and balanced view of drug discovery and development in this area. Written by international leaders in the field, the book assesses prospects for the emergence of effective agents and allows readers to better understand the challenges, failures, and future potential for research in Alzheimer’s disease. This book is a valuable resource to academic scientists carrying out translational research in Alzheimer’s disease, industrial scientists engaged in Alzheimer's drug discovery, executives in biopharmaceutical companies making strategic decisions regarding the direction of internal research and potential outside partnerships, and graduate-level students pursuing courses on Alzheimer's therapeutics. Provides a realistic but promising assessment of the potential of various therapeutic approaches to Alzheimer’s disease Focuses primarily on neuroprotective agents and cognitive enhancers, as well as approaches to targeting the amyloid B-peptide, tau and Apolipoprotein E Discusses alternative approaches, preclinical and clinical development issues, related biomarkers and diagnostics, and prevention and nonpharmacological approaches

Public Engagement and Clinical Trials

Public Engagement and Clinical Trials
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release Date : 2012-03-17
Category : Medical
Total pages :140
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Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.