Global Clinical Trials

• Author : Richard Chin,Menghis Bairu
• Publisher : Academic Press
• Release : 06 May 2011

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

• Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : Jeffrey Cummings,Kate Zhong
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : Sara Gambril
• Publisher : Unknown
• Release : 01 April 2009

• Author : Menghis Bairu,Richard Chin
• Publisher : Academic Press
• Release : 12 June 2012

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

• Author : Menghis Bairu,Sidney A. Spector,Richard Chin
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : James (Dachao) Fan,Li Huafang,Jing Yin
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : Yoko Fujimoto,Takeshi Iwatsubo
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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.

• Author : Sidney A. Spector
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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,

• Author : Seong Yoon Kim
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : Nadina C. Jose,Lorne Cheeseman,Stephanie Danandjaja
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : Ricardo F. Allegri,Pablo Bagnati,Sonia Brucki,Ricardo Nitrini
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : Lynne Hughes,Spencer Guthrie
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : Tal Burt,Lynne Hughes,Amir Kalali,P. Murali Doraiswamy
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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

• Author : Michel Grothe,Jens Kurth,Harald Hampel,Bernd J. Krause,Stefan Teipel
• Publisher : Elsevier Inc. Chapters
• Release : 28 August 2013

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