Global Clinical Trials Playbook

Written By Menghis Bairu
Global Clinical Trials Playbook
  • Publsiher : Academic Press
  • Release : 24 June 2021
  • ISBN : 0124157874
  • Pages : 310 pages
  • Rating : /5 from reviews
GET THIS BOOKGlobal Clinical Trials Playbook


Download or read book entitled Global Clinical Trials Playbook by author: Menghis Bairu which was release on 24 June 2021 and published by Academic Press with total page 310 pages . This book available in PDF, EPUB and Kindle Format. 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

Global Clinical Trials Playbook

Global Clinical Trials Playbook
  • Author : Menghis Bairu,Richard Chin
  • Publisher : Academic Press
  • Release Date : 2012
  • Total pages : 310
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

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
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : James (Dachao) Fan,Li Huafang,Jing Yin
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

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
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Yoko Fujimoto,Takeshi Iwatsubo
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

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
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Menghis Bairu,Sidney A. Spector,Richard Chin
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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, ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Lynne Hughes
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : This chapter provides an overview of the increasingly important role of emerging markets in Alzheimer’s disease trials, particularly Eastern Europe, where there is a robust population of accurately diagnosed subjects for trial participation, and recruitment rates are on a par with those in Western Europe and the USA. Some ...

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
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Hans J. Möbius
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : Regulatory approval of the first rational AD therapeutic tacrine occurred in 1993, followed by the approval of three other, AChEIs, and the NMDA antagonist memantine in 2002 (EMA) and 2003 (FDA) respectively. Since then, despite an enormous research and development effort, the past 10 years have seen a series of failures to translate pathophysiological ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Lynne Hughes,Spencer Guthrie
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Tiia Ngandu,Francesca Mangialasche,Miia Kivipelto
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : Today there are more than 36 million demented persons worldwide. With the aging of populations, the prevalence of dementia and Alzheimer’s disease (AD) is expected to more than triple in the coming 40 years. Besides high age and genetic factors, evidence from observational studies shows that many modifiable vascular and lifestyle-related ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Ricardo F. Allegri,Pablo Bagnati,Sonia Brucki,Ricardo Nitrini
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease
  • Author : Muriel O’ Byrne,Menghis Bairu
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • Total pages : 432
  • ISBN : 0124157874
GET BOOK

Summary : 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 ...