Global Clinical Trials for Alzheimer s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780124115309

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Global Clinical Trials for Alzheimer s Disease Excerpt :

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 Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2013-09-18
  • Genre: Medical
  • Pages : 407
  • ISBN 10 : 0124114644

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Global Clinical Trials for Alzheimer s Disease Excerpt :

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 Book
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Global Clinical Trials Playbook


  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2012-06-12
  • Genre: Medical
  • Pages : 320
  • ISBN 10 : 9780124158603

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Global Clinical Trials Playbook Excerpt :

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 s Disease Drug Development Book

Alzheimer s Disease Drug Development


  • Author : Jeffrey L. Cummings
  • Publisher : Unknown
  • Release Date : 2021
  • Genre: Alzheimer's disease
  • Pages : null
  • ISBN 10 : 1108975755

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Alzheimer s Disease Drug Development Excerpt :

"Alzheimer's Disease Drug Development: A Research and Development Ecosystem captures the complexity of Alzheimer's disease (AD) drug develop and provides a comprehensive set of perspectives from the many stakeholders involved in discovering and developing new therapies for AD. There is no greater unmet therapeutic need for humanity than effective therapies for brain disorders. The suffering caused by these conditions and other neurodegenerative disorders is overwhelming and is burdened with substantial stigma. Therefore, I have devoted my professional life to changing the way brain disorders such as schizophrenia, depression, AD, among others are not only treated, but also viewed by society. From my time with the National Institutes of Health, Janssen and Johnson & Johnson where I serve as the Global Head of Science for Minds, my colleagues and I recognize there is still much to uncover about brain disorders due to the rich complexity of the brain and the challenges in accessing it. But that is not a reason to stop - especially as we enter the golden age of neuroscience, driven largely by scientific breakthroughs and accelerated regulatory pathways"--

Global Clinical Trials Book

Global Clinical Trials


  • Author : Richard Chin
  • Publisher : Academic Press
  • Release Date : 2016-07-14
  • Genre: Medical
  • Pages : 522
  • ISBN 10 : 0128103558

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Global Clinical Trials Excerpt :

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

Re Engineering Clinical Trials Book

Re Engineering Clinical Trials


  • Author : Peter Schueler
  • Publisher : Academic Press
  • Release Date : 2014-12-16
  • Genre: Medical
  • Pages : 360
  • ISBN 10 : 9780128007907

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Re Engineering Clinical Trials Excerpt :

The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

Global Clinical Trials for Alzheimer   s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Jeffrey Cummings
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070406

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Global Clinical Trials for Alzheimer s Disease Excerpt :

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 Book

Global Clinical Trials for Alzheimer s Disease


  • Author : James (Dachao) Fan
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070505

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Global Clinical Trials for Alzheimer s Disease Excerpt :

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.

Global Clinical Trials for Alzheimer   s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Seong Yoon Kim
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070543

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Global Clinical Trials for Alzheimer s Disease Excerpt :

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 Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Sidney A. Spector
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070567

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Global Clinical Trials for Alzheimer s Disease Excerpt :

Decades ago, pharmacogenetic research established that one’s genetic profile might predict efficacy and safety of medicines. Polymorphic expression of isoenzymes of the cytochrome P-450 enzyme system explains a significant amount of the variability of inter-individual responses to medicines. In Alzheimer’s disease, the highly variable clinical response to cholinesterase inhibitors metabolized by the liver is explained on this basis. More recently, translation of basic pharmacogenomic research through the drug development process has led to the approval of ”personalized“ medicines, for example, in the field of oncology, cardiology and psychiatry, based on an individual’s underlying genotypic variance of phenotypically expressed pathogenic targets and pathways. Translational pharmacogenomic research in Alzheimer’s disease has emerged as a viable alternative to the study of large populations with similar phenotypic expression of symptoms through stratification of sub-groups based on ApoE carrier status in clinical trials. When initiating a global research protocol, it is incumbent upon sponsors to actively engage stakeholders in developing and underdeveloped countries, including local government authorities, regulatory bodies, ethics review boards, community representatives and participants, to address all aspects of the clinical trial, especially informed consent, which may be more challenging in countries where local customs and practices dictate the need for innovative approaches. Implementation of pharmacogenomics in the clinical trial requires further attention to ethical detail related to what kind of informed consent is needed for use of stored DNA samples for future, unforeseen related or unrelated research, whether and to whom to disclose current and future study results, and ways by which the benefits of current and future discoveries are shared by stakeholders in developed and underdeveloped or developing countries.

Global Clinical Trials for Alzheimer   s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Ricardo F. Allegri
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070482

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Global Clinical Trials for Alzheimer s Disease Excerpt :

Dementia is seriously disabling for those who have it and is often devastating for their caregivers and families. There are 7.7 million new cases of dementia each year, implying that there is a new case of dementia somewhere in the world every four seconds. The growth of dementia in the next 20 years will be much more acute in those countries with low and medium salaries. The World Health Organization wrote a report about dementia, calling on all governments to define dementia as a public health priority. Dementia clinical studies are becoming more and more complex with the number of enrolled patients increasing. Historically, the majority of patients recruited into clinical trials for medicine development have been from Western Europe and the US. However, clinical trials are increasingly recruiting patients from more countries, including developing countries. South America has larger urban populations than other emerging regions and could provide treatment-naïve patients for clinical trials.

Global Clinical Trials for Alzheimer   s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Yoko Fujimoto
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070536

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Global Clinical Trials for Alzheimer s Disease Excerpt :

Considering the difficulty of clinical development for Alzheimer’s Disease (AD), understanding each country’s specific situation is an important first step in reducing the operational burden on clinical trials while maintaining the quality of the study. In this chapter, the long history of clinical development for AD in Japan is introduced. There has been a lot of experience in Japan of AD clinical development from the time of developing donepezil to the current global development of AD disease-modifying drugs. However, this experience has not always been a success story and has often been the cause of much frustration, such as the failure of Phase III studies, high regulatory requirements, development and implementation of neuropsychological tests, influence of ethnic factors, etc. However, all of these points provide us with a good source from which we can learn about the challenges of the clinical trials and discuss how to strengthen the quality and efficiency. It’s important to take advantage of this experience for future success in the clinical development of AD, especially in emerging markets.

Global Clinical Trials for Alzheimer   s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Tal Burt
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070499

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Global Clinical Trials for Alzheimer s Disease Excerpt :

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 Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Lynne Hughes
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070451

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Global Clinical Trials for Alzheimer s Disease Excerpt :

This chapter reviews significant recent clinical trials involving potential disease-modifying drugs, including active immunotherapy, passive immunotherapy, γ-secretase inhibitors and modulators, β-secretase inhibitors, and amyloid-beta (Aβ) anti-aggregants. The challenges and opportunities involved in global trials are then discussed, such as variability in diagnosis and patient selection; patient endpoints for both symptomatic therapies and disease-modifying drugs; rater training and global validation of rating scales; competition to recruit the pool of patients available for clinical trials; and emerging logistical concerns related to the use of biomarkers.

Global Clinical Trials for Alzheimer   s Disease Book

Global Clinical Trials for Alzheimer s Disease


  • Author : Yağız Üresin
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Genre: Medical
  • Pages : 432
  • ISBN 10 : 9780128070529

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Global Clinical Trials for Alzheimer s Disease Excerpt :

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 exports. Investments by foreign companies have increased since 1984 and 19 foreign capital firms have entered the Turkish pharmaceuticals market since 1990. Today, there are approximately 300 entities operating in Turkey. Turkey has a long tradition of providing clinical trial legislation, regulation and guidelines; the country has taken major steps towards harmonizing its legislation with those of the European Union in the field of clinical research. Currently Turkish regulations are completely in line with EC Directives. Clinical trials performed in the field of Alzheimer’s disease in Turkey since 1997, including their rationale, design, summary, and outcomes, are discussed in this chapter.