November 24, 2020

Download Ebook Free Global Clinical Trials Playbook

Global Clinical Trials Playbook

Global Clinical Trials Playbook
Author : Menghis Bairu,Richard Chin
Publisher : Academic Press
Release Date : 2012-06-12
Category : Medical
Total pages :320
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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 : management and implementation when resources are limited

Global clinical trials playbook : management and implementation when resources are limited
Author : Menghis Bairu,Richard Yoonsik Chin
Publisher : Unknown
Release Date : 2012
Category :
Total pages :129
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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

Global Clinical Trials

Global Clinical Trials
Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Release Date : 2011-05-06
Category : Science
Total pages :522
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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

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
Category : Medical
Total pages :432
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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

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
Category : Medical
Total pages :432
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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.

A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials
Author : Delva Shamley,Brenda Wright
Publisher : Academic Press
Release Date : 2017-06-07
Category : Medical
Total pages :210
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A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

The Role of the Pharmacist in Patient Care

The Role of the Pharmacist in Patient Care
Author : Abdul Kader Mohiuddin
Publisher : Universal-Publishers
Release Date : 2020
Category : Medical
Total pages :690
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The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on the expanded role of the pharmacists in total patient care including prescribing, dispensing, compounding, administering and monitoring of drugs at home, hospital, community, hospice, critical care, changeover and other care settings. The sector is emerging in both developed and under-developed countries. Overburdened by patient loads and the explosion of new drugs physicians turned to pharmacists more and more for drug information especially within institutional settings. And today’s patient care pharmacists are taking more interests in medication review and reconciliation, patient education and counseling, creating drug therapy regimen and monitoring compliance. The purpose of this book is to guide the pharmacists in their daily interactions with patients and to ensure collaboration with other health professionals. The contents are mostly based on recently published articles related to patient care, with most recent ideas and activities followed by the patient care pharmacists around the globe. However, a pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. Along with professional guidelines, the book discusses the concepts and best practices of patient interaction, patient rights, and ethical decision-making for the professional pharmacist, apprentice and student. In every chapter, the role of pharmacists in that chapter specific issues are detailed explicitly so that a professional pharmacist or a student can figure out his or her do’s and don’ts in that specific situation. Moreover, further reading references are listed as future recommendations. So, the book is an archive of potential references too. Among so many books about patient care, either doctors’ or nurses’ roles are highlighted. The proposed book highlights the pharmacists’ roles and responsibilities to the most, separated from those of doctors and nurses, with the most recent information obtained from most publications in several journals, books, bulletins, newsletter, magazines etc.

Bad Science

Bad Science
Author : Ben Goldacre
Publisher : McClelland & Stewart
Release Date : 2010-10-12
Category : Science
Total pages :304
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The informative and witty expose of the "bad science" we are all subjected to, called "one of the essential reads of the year" by New Scientist. We are obsessed with our health. And yet — from the media's "world-expert microbiologist" with a mail-order Ph.D. in his garden shed laboratory, and via multiple health scares and miracle cures — we are constantly bombarded with inaccurate, contradictory, and sometimes even misleading information. Until now. Ben Goldacre masterfully dismantles the questionable science behind some of the great drug trials, court cases, and missed opportunities of our time, but he also goes further: out of the bullshit, he shows us the fascinating story of how we know what we know, and gives us the tools to uncover bad science for ourselves. From the Hardcover edition.

Cytokine Storm Syndrome

Cytokine Storm Syndrome
Author : Randy Q. Cron,Edward M. Behrens
Publisher : Springer Nature
Release Date : 2019-09-09
Category : Medical
Total pages :617
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Cytokine Storm Syndromes, including HLH and MAS, are frequently fatal disorders, particularly if not recognized early and treated during presentation. The genetics of Cytokine Storm Syndromes are being defined with many of the risk alleles giving rise to mutations in the perforin-mediated cytolytic pathway used by CD8 cytotoxic T cells and natural killer cells. These are being studied using murine models. Up to 10% of the general population may carry risk alleles for developing Cytokine Storm Syndromes, and Cytokine Storm Syndromes are being increasingly recognized around the world in pediatric and adult hospitals. A variety of infectious, rheumatic, and oncologic triggers are commonly associated with Cytokine Storm Syndromes, but understanding this disorder is critical for all researchers and physicians to ensure timely and appropriate therapy. This textbook, the first of its kind, addresses all aspects of the disorder – from genetics, pathophysiology, and ongoing research, to clinical presentations, risk factors, and treatment.

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
Author : Richard Chin,Bruce Y Lee
Publisher : Elsevier
Release Date : 2008-07-25
Category : Medical
Total pages :560
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Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

Ghost-Managed Medicine

Ghost-Managed Medicine
Author : SERGIO. SISMONDO
Publisher : Unknown
Release Date : 2018-07-23
Category :
Total pages :234
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Ghost-Managed Medicine probes the pharmaceutical industry and its agents as they work to shape medicine and createmarkets for drugs. The book traces paths of information about drugs, from the extraction of data from experimental bodies to articles ghostwritten for researchers to manifold infl uences of doctors and consumers.

Implementation Research in Health

Implementation Research in Health
Author : David H. Peters,Nhan T. Tran,Taghreed Adam,World Health Organization
Publisher : World Health Organization
Release Date : 2013
Category : Medical
Total pages :67
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Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.

Social and Interpersonal Dynamics in Pain

Social and Interpersonal Dynamics in Pain
Author : Tine Vervoort,Kai Karos,Zina Trost,Kenneth M. Prkachin
Publisher : Springer
Release Date : 2018-07-18
Category : Psychology
Total pages :532
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This groundbreaking analysis moves our knowledge of pain and its effects from the biomedical model to one accounting for its complex psychosocial dimensions. Starting with its facial and physical display, pain is shown in its manifold social contexts—in the lifespan, in a family unit, expressed by a member of a gender and/or race—and as observed by others. These observations by caregivers and family are shown as vital to the social dynamic of pain—as observers react to sufferers’ pain, and as these reactions affect those suffering. The book’s findings should enhance practitioners’ understanding of pain to develop more effective individualized treatments for clients’ pain experience, and inspire researchers as well. Among the topics covered: Why do we care? Evolutionary mechanisms in the social dimension of pain. When, how, and why do we express pain? On the overlap between physical and social pain. Facing others in pain: why context matters. Caregiving impact upon sufferers’ cognitive functioning. Targeting individual and interpersonal processes in therapeutic interventions for chronic pain. Social and Interpersonal Dynamics in Pain will be a valuable resource for clinicians who deal in pain practice and management, as well as for students and researchers interested in the social, interpersonal, and emotional variables that contribute to pain, the processes with which pain is associated, and the psychology of pain in general.

Rituals and Practices in World Religions

Rituals and Practices in World Religions
Author : David Bryce Yaden,Yukun Zhao,Kaiping Peng,Andrew B. Newberg
Publisher : Springer Nature
Release Date : 2020-02-03
Category : Social Science
Total pages :230
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This book codifies, describes, and contextualizes group rituals and individual practices from world religious traditions. At the interface of religious studies, psychology, and medicine, it elucidates the cultural richness of practices and rituals from numerous world religions. The book begins by discussing the role that religious rituals and practices may play in the well-being of humans and the multi-dimensional cultural and psychological complexity of religious rituals and practices. It then discusses rituals and practices within a number of religions, including Christian, Islamic, Jewish, Buddhist, Taoist, Sikh, Hindu, Confucian, and other traditions. There is a need for a more inclusive collection of religious rituals and practices, as some practices are making headlines in contemporary society. Mindfulness is one of the fastest-growing psychological interventions in healthcare and Yoga is now practiced by tens of millions of people in the U.S.A. These practices have been examined in thousands of academic publications spanning neuroscience, psychology, medicine, sociology, and religious studies. While Mindfulness and Yoga have recently received widespread scientific and cultural attention, many rituals and practices from world religious traditions have remained underexplored in scholarly, scientific, and clinical contexts. This book brings more diverse rituals and practices into this academic discourse while providing a reference guide for clinicians and students of the topic.

The Global Industrial Complex

The Global Industrial Complex
Author : Steven Best
Publisher : Lexington Books
Release Date : 2011
Category : Political Science
Total pages :315
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The Global Industrial Complex: Systems of Domination, is a groundbreaking collection of essays by leading scholars from wide scholarly and activist backgrounds who examine the entangled array of contemporary industrial complexes—what the editors refer to as "the power complex"—that was first analyzed by C. Wright Mills in his 1956 classic work,The Power Elite.