Global Clinical Trials for Alzheimeras 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 Alzheimeras 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 Alzheimeras disease. Written by leading experts with hands-on experience in designing and running global Alzheimeras 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 Alzheimeras disease global clinical trials in emerging markets and developing countriesIn the EU, the EMA adopted a reflection paper in 2010  to address the agencya#39;s thinking on the acceptability of data from clinical ... drug (IND), the required investigator documentation and financial dis- closure forms will be required irrespective of the geography in which the study is being conducted. ... [ cited June 2013].
|Title||:||Global Clinical Trials for Alzheimer's Disease|
|Author||:||Menghis Bairu, Michael Weiner|
|Publisher||:||Academic Press - 2013-08-28|