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Global Clinical Trials

Author: Richard Chin
Publisher: Academic Press
ISBN: 9780123815385
Size: 59.81 MB
Format: PDF
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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 Playbook

Author: Menghis Bairu
Publisher: Academic Press
ISBN: 0124157874
Size: 30.98 MB
Format: PDF, ePub, Mobi
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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 For Alzheimer S Disease

Author: Menghis Bairu
Publisher: Academic Press
ISBN: 0124115306
Size: 80.48 MB
Format: PDF, ePub, Mobi
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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

A Practical Guide To Managing Clinical Trials

Author: JoAnn Pfeiffer
Publisher: CRC Press
ISBN: 1315299771
Size: 21.43 MB
Format: PDF, ePub, Docs
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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

Clinical Trials

Author: Tom Brody
Publisher: Academic Press
ISBN: 0128042583
Size: 30.22 MB
Format: PDF, Kindle
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Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Research Training In The Biomedical Behavioral And Clinical Research Sciences

Author: National Research Council
Publisher: National Academies Press
ISBN: 0309209935
Size: 10.34 MB
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Comprehensive research and a highly-trained workforce are essential for the improvement of health and health care both nationally and internationally. During the past 40 years the National Research Services Award (NRSA) Program has played a large role in training the workforce responsible for dramatic advances in the understanding of various diseases and new insights that have led to more effective and targeted therapies. In spite of this program, the difficulty obtaining jobs after the postdoc period has discouraged many domestic students from pursuing graduate postdoc training. In the United States, more than 50 percent of the postdoc workforce is made up of individuals who obtained their Ph.D.s from other countries. Indeed, one can make a strong argument that the influx of highly trained and creative foreigners has contributed greatly to U.S. science over the past 70 years. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences discusses a number of important issues, including: the job prospects for postdocs completing their training; questions about the continued supply of international postdocs in an increasingly competitive world; the need for equal, excellent training for all graduate students who receive NIH funding; and the need to increase the diversity of trainees. The book recommends improvements in minority recruiting, more rigorous and extensive training in the responsible conduct of research and ethics, increased emphasis on career development, more attention to outcomes, and the requirement for incorporating more quantitative thinking in the biomedical curriculum.

Global Telehealth 2014

Author: A.J. Maeder
Publisher: IOS Press
ISBN: 1614994560
Size: 76.38 MB
Format: PDF, ePub, Docs
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Although telehealth (one component of ehealth) continues to be implemented around the world, sound evidence of its value to healthcare systems remains limited and the tipping point at which its universal adoption will be assured has yet to be reached. On the other hand, the spontaneous growth of mobile healthcare solutions and applications offered by smart phones have become more common amongst healthcare providers, and the creation of Web-based wellness promotion and health management tools has opened up a whole new area in which telehealth can provide future benefits. This book presents selected full papers from Global Telehealth 2014 (GT2014), held in Durban, South Africa, in November 2014. This was the third international conference in the series, and this year’s theme was "Integrated, Innovative, Scalable and Sustainable Solutions"; emphasizing the importance of these aspects in achieving wider acceptance and adoption of ehealth and telehealth. The book will be of interest to all those involved in the global telehealth community.

Global Mental Health Trials

Author: Graham Thornicroft
Publisher: OUP Oxford
ISBN: 0191501646
Size: 23.25 MB
Format: PDF, ePub, Docs
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Global mental health is a dynamic field of global health; a core aspect of the story which has led to its emergence has been the conduct of randomised controlled trials (RCTs) evaluating innovative delivery systems of packages of care for mental disorders in low-resource settings. Global Mental Health Trials brings together many of the world's leading researchers active in the fields of RCTs in low- and medium-resource countries and settings related to improving mental health care. It presents clear and practical information about how to conduct such trials in these settings, along with critical methodological and ethical issues related to such trials, learning from the positive and negative experiences of expert scientists in many countries worldwide who have completed such trials. This book serves as a valuable resource for practitioners in mental health - psychiatrists, psychiatric nurses nursing, psychologists, social workers, and occupational therapists - as well as researchers in the areas of psycho-social treatments in mental health, mental health services research, and programme and systems evaluation.

Tuberculosis E Book

Author: H. Simon Schaaf
Publisher: Elsevier Health Sciences
ISBN: 1437711065
Size: 59.49 MB
Format: PDF, Docs
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This book provides all the vital information you need to know about tuberculosis, especially in the face of drug-resistant strains of the disease. Coverage includes which patient populations face an elevated risk of infection, as well as which therapies are appropriate and how to correctly monitor ongoing treatment so that patients are cured. Properly administer screening tests, interpret their results, and identify manifestations of the disease, with authoritative guidance from expert clinicians from around the world. Discusses screening tests for tuberculosis so you can interpret their results and identify not only common manifestations of the disease, but also those that are comparatively rare—such as tuberculosis in pregnant women. Covers all clinical aspects of tuberculosis in children, including current practices on managing those infected with HIV. Provides details on how best to interact with the public health system in both industrialized and developing countries. Addresses the social aspects of tuberculosis and presents the latest advances on new and potential vaccines against tuberculosis. Offers the expertise of internationally recognized tuberculosis clinicians to provide you with well-rounded, global coverage. Features numerous illustrations to provide clear and detailed depictions of rare manifestations of tuberculosis.

A Manager S Guide To The Design And Conduct Of Clinical Trials

Author: Phillip I. Good
Publisher: John Wiley & Sons
ISBN: 0471930873
Size: 31.68 MB
Format: PDF, Docs
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This newly updated edition of the benchmark guide tocomputer-assisted clinical trials provides a comprehensive primerfor prospective managers. It covers every critical issue of thedesign and conduct of clinical trials, including study design,organization, regulatory agency liaison, data collection andanalysis, as well as recruitment, software, monitoring, andreporting. Keeping the same user-friendly format as the original, this SecondEdition features new examples and the latest developments inregulatory guidelines, such as e-submission procedures andcomputerized direct data acquisition. The new edition also reflectsthe increasing globalization of clinical trial activities, andincludes new information about international standards andprocedures, including the Common Technical Document and CDISCstandards. This step-by-step guide is supported by handy checklists andextracts from submitted protocols. Experienced author andconsultant Phillip Good incorporateshumorous yet instructiveanecdotes to illustrate common pitfalls. Based on the provenindustrial formula of planning, implementing, and finallyperforming essential checks, the book's three sections-"Plan,""Do," and "Check"-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design andanalysis of clinical experiments, along with clinical researchassociates, biostatisticians, and students in public health willfind A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stopsbeing concise and well written . . . a book worth a read . .." -Statistics in Medicine "The book is very prescriptive and full of lists and tables withwhich to guide managers in making effective decisions in usingcomputer-assisted clinical trials in pharmaceutical studies."-Technometrics "This book is must-have reading for anyone in the business . .." -Clinical Chemistry