Global Clinical Trials Playbook

Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Page : 522 pages
File Size : 43,5 Mb
Release : 2011-05-06
Category : Science
ISBN : 012381538X

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Global Clinical Trials by Richard Chin,Menghis Bairu Pdf

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

Author : Menghis Bairu,Richard Chin
Publisher : Academic Press
Page : 320 pages
File Size : 43,9 Mb
Release : 2012-06-12
Category : Medical
ISBN : 9780124158603

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Global Clinical Trials Playbook by Menghis Bairu,Richard Chin Pdf

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

Author : Menghis Bairu,Richard Y. Chin
Publisher : Unknown
Page : 332 pages
File Size : 40,8 Mb
Release : 2024-06-26
Category : Clinical trials
ISBN : OCLC:794547299

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Global Clinical Trials Playbook by Menghis Bairu,Richard Y. Chin Pdf

Author : Menghis Bairu,Richard Yoonsik Chin
Publisher : Unknown
Page : 128 pages
File Size : 42,9 Mb
Release : 2012
Category : Electronic
ISBN : OCLC:1132121848

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Global clinical trials playbook : management and implementation when resources are limited by Menghis Bairu,Richard Yoonsik Chin Pdf

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

Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Page : 522 pages
File Size : 46,7 Mb
Release : 2011-06-06
Category : Science
ISBN : 0123815371

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Global Clinical Trials by Richard Chin,Menghis Bairu Pdf

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

Author : Menghis Bairu,Michael Weiner
Publisher : Academic Press
Page : 432 pages
File Size : 43,5 Mb
Release : 2013-08-28
Category : Medical
ISBN : 9780124115309

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Global Clinical Trials for Alzheimer's Disease by Menghis Bairu,Michael Weiner Pdf

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

Author : Joshua Chen,Hui Quan
Publisher : CRC Press
Page : 375 pages
File Size : 54,9 Mb
Release : 2016-04-21
Category : Mathematics
ISBN : 9781498701488

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Multiregional Clinical Trials for Simultaneous Global New Drug Development by Joshua Chen,Hui Quan Pdf

In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in

Author : Adriana Petryna
Publisher : Princeton University Press
Page : 271 pages
File Size : 54,8 Mb
Release : 2009-04-27
Category : Social Science
ISBN : 9781400830824

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When Experiments Travel by Adriana Petryna Pdf

The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.

Author : Peter Schueler,Brendan Buckley
Publisher : Academic Press
Page : 360 pages
File Size : 44,5 Mb
Release : 2014-12-16
Category : Medical
ISBN : 9780128007907

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Re-Engineering Clinical Trials by Peter Schueler,Brendan Buckley Pdf

The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1247 pages
File Size : 47,6 Mb
Release : 2009-06-17
Category : Science
ISBN : 9780470466353

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Clinical Trials Handbook by Shayne Cox Gad Pdf

Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.

Author : Cemal Cingi,Nuray Bayar Muluk
Publisher : Springer
Page : 237 pages
File Size : 45,6 Mb
Release : 2016-11-15
Category : Medical
ISBN : 9783319443447

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Quick Guide to Good Clinical Practice by Cemal Cingi,Nuray Bayar Muluk Pdf

This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.

Author : Harry Yang,Binbing Yu
Publisher : CRC Press
Page : 191 pages
File Size : 46,5 Mb
Release : 2021-01-11
Category : Mathematics
ISBN : 9780429676826

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Real-World Evidence in Drug Development and Evaluation by Harry Yang,Binbing Yu Pdf

Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise

Author : Ann Raven,Frank Wells
Publisher : CRC Press
Page : 128 pages
File Size : 55,5 Mb
Release : 2018-05-08
Category : Medical
ISBN : 9781315345987

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Clinical Trials by Ann Raven,Frank Wells Pdf

This volume provides an introduction to the process of clinical drug development. It demystifies the way new medicines are discovered, tested and regulated. This book is intended for those who wich to understand the background of clinical trials from a pharmaceutical company perspective, and is suitable for clinical trials supplies technicians and pharmacists, data management staff, information officers, medical secretaries and all support staff. This second edition is updated and includes information on the practical implications of recent EC legislation.

Author : John I. Gallin,Frederick P Ognibene,Laura Lee Johnson
Publisher : Academic Press
Page : 824 pages
File Size : 52,9 Mb
Release : 2017-11-17
Category : Science
ISBN : 9780128499047

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Principles and Practice of Clinical Research by John I. Gallin,Frederick P Ognibene,Laura Lee Johnson Pdf

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

Author : P. Michael Dubinsky,Karen A. Henry
Publisher : John Wiley & Sons
Page : 554 pages
File Size : 42,8 Mb
Release : 2022-01-26
Category : Medical
ISBN : 9781118949597

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The Fundamentals of Clinical Research by P. Michael Dubinsky,Karen A. Henry Pdf

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources