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Global Clinical Trials For Alzheimers Disease

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Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer s Disease Book
Author : Menghis Bairu,Michael Weiner
Publisher : Academic Press
Release : 2013-08-28
ISBN : 0124115306
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Menghis Bairu,Richard Chin
Publisher : Academic Press
Release : 2012-04-20
ISBN : 0124157874
Language : En, Es, Fr & De

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Book Description :

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

Alzheimer s Disease Drug Development Book
Author : Jeffrey Cummings,Jefferson Kinney,Howard Fillit
Publisher : Cambridge University Press
Release : 2022-03-31
ISBN : 1108838669
Language : En, Es, Fr & De

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Book Description :

Provides a definitive overview of the complex ecosystem facilitating Alzheimer's Disease drug research and development. Demonstrates a drug's journey from in the lab, clinical trial testing, regulatory review, and marketing by pharmaceutical companies. Details the use of artificial intelligence, clinical trial management, and financing models.

Global Clinical Trials

Global Clinical Trials Book
Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Release : 2016-07-14
ISBN : 9780128103555
Language : En, Es, Fr & De

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Book Description :

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

Re Engineering Clinical Trials Book
Author : Peter Schueler,Brendan Buckley
Publisher : Academic Press
Release : 2014-12-16
ISBN : 0128007907
Language : En, Es, Fr & De

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Book Description :

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 Mental Health Trials

Global Mental Health Trials Book
Author : Graham Thornicroft,Vikram Patel
Publisher : Oxford University Press, USA
Release : 2014
ISBN : 0199680469
Language : En, Es, Fr & De

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Book Description :

Brings together many of the world's leading researchers active in the fields of randomized controlled trials (RCTs) in low- and medium-resource counties and settings related to improving mental health care to present clear and practical information about how to conduct such trials.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Jeffrey Cummings,Kate Zhong
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070404
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : James (Dachao) Fan,Li Huafang,Jing Yin
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070501
Language : En, Es, Fr & De

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Book Description :

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

Global Clinical Trials for Alzheimer   s Disease Book
Author : Seong Yoon Kim
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070544
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Sidney A. Spector
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070560
Language : En, Es, Fr & De

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Book Description :

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

Global Clinical Trials for Alzheimer   s Disease Book
Author : Ricardo F. Allegri,Pablo Bagnati,Sonia Brucki,Ricardo Nitrini
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 012807048X
Language : En, Es, Fr & De

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Book Description :

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

Global Clinical Trials for Alzheimer   s Disease Book
Author : Yoko Fujimoto,Takeshi Iwatsubo
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070536
Language : En, Es, Fr & De

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Book Description :

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

Global Clinical Trials for Alzheimer   s Disease Book
Author : Tal Burt,Lynne Hughes,Amir Kalali,P. Murali Doraiswamy
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070498
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Lynne Hughes,Spencer Guthrie
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070455
Language : En, Es, Fr & De

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Book Description :

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.

Alzheimer Disease

Alzheimer Disease Book
Author : Robert Becker,Ezio Giacobini
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 1461241162
Language : En, Es, Fr & De

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Book Description :

Download Alzheimer Disease book written by Robert Becker,Ezio Giacobini, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070528
Language : En, Es, Fr & De

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Book Description :

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.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Nadina C. Jose,Lorne Cheeseman,Stephanie Danandjaja
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070579
Language : En, Es, Fr & De

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Book Description :

The incidence of Alzheimer’s disease is increasing worldwide. The need to fortify global resources conducting clinical trials becomes of paramount importance for sponsors to ensure less delay in marketing their products. This chapter provides a concise and practical approach to building capacity and capability in emerging or developing markets. Lessons learned from countries like China and India, where the top 12 pharmaceutical and biotech companies have become deeply entrenched in the last 10 years, serve as important benchmarks which can be referenced as new emerging markets like Vietnam, Indonesia, and the Philippines establish themselves as available and capable areas for clinical trials. Referenced case studies describe actual events from which valuable practical pearls can be adapted in other settings. Sponsors need to recognize that investing early on in developing project teams that can support these trials creates a better landscape for success.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : H. Michael Arrighi
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070463
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Muriel O’ Byrne,Menghis Bairu
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070439
Language : En, Es, Fr & De

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Book Description :

Data from clinical trials in emerging markets are becoming a standard component of the regulatory package being provided to support pharmaceutical marketing authorizations including the FDA New Drug Application (NDA) and the EMA Marketing Authorization Application (MAA). In this chapter, the highlights of the requirements for Alzheimer’s disease interventions are summarized, including a review of trial enrichment strategies. The topic of acceptance of foreign clinical data is also reviewed.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Michel Grothe,Jens Kurth,Harald Hampel,Bernd J. Krause,Stefan Teipel
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070447
Language : En, Es, Fr & De

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Book Description :

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 preclinical through predementia to clinically manifest stages of AD. However, a widespread clinical use of these imaging biomarkers is hampered by considerable multi-centric variability related to differences in scanner hardware and acquisition protocols, but also by the lack of internationally agreed upon standards for analytic design and employed quantitative metrics. Several strategies for reducing multicenter variability in imaging measures have been proposed, including homogenization of the acquisition settings across scanner platforms, stringent quality assurance procedures, and artifact removal by means of post-acquisition image processing techniques. In addition, selection of appropriate statistical models to account for remaining multicenter variability in the data can further improve the accuracy and reproducibility of study results. The first projects for international standardization of image analysis methods and derived quantitative metrics have emerged recently for volumetric MRI measures. In contrast, the standardization and establishment of DTI-derived measures within a multicenter context are less well developed. Although molecular imaging techniques are already widely used in multicenter settings, sources of variability across sites and appropriate methods to reduce multicenter effects are still not explored in detail. Comparability of neuroimaging measures as AD biomarkers in worldwide clinical settings will finally depend on the establishment of internationally agreed upon standards for image acquisition, quality assurance, and employed quantitative metrics.