Clinical Trials And Human Research
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A Practical Guide To Human Research And Clinical Trials
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Author : M. U. R. Naidu
language : en
Publisher: CRC Press
Release Date : 2013-01-29
A Practical Guide To Human Research And Clinical Trials written by M. U. R. Naidu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-01-29 with Medical categories.
Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines. Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.
Clinical Trials And Human Research
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Author : Fay A. Rozovsky
language : en
Publisher: Jossey-Bass
Release Date : 2003-06-10
Clinical Trials And Human Research written by Fay A. Rozovsky and has been published by Jossey-Bass this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-06-10 with Medical categories.
This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.
Human Experimentation And Research
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Author : George F. Tomossy
language : en
Publisher: Routledge
Release Date : 2017-07-12
Human Experimentation And Research written by George F. Tomossy and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-12 with Medical categories.
This title was first published in 2003: As new medical technologies and treatments develop with increasing momentum, the legal and ethical implications of research involving human participants are being called into question as never before. Human Experimentation and Research explores the philosophical foundations of research ethics, ongoing regulatory dilemmas, and future challenges raised by the rapid globalisation and corporatisation of the research endeavour. This volume brings together some of the most significant published essays in the field. The editors also provide an informative introduction, summarizing the area and the relevance of the articles chosen.
When Experiments Travel
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Author : Adriana Petryna
language : en
Publisher: Princeton University Press
Release Date : 2009-04-27
When Experiments Travel written by Adriana Petryna and has been published by Princeton University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-04-27 with Social Science categories.
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.
The Ethical Challenges Of Human Research
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Author : Franklin G. Miller
language : en
Publisher: Oxford University Press
Release Date : 2012-11-15
The Ethical Challenges Of Human Research written by Franklin G. Miller and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-11-15 with Law categories.
This book contains 22 essays on the ethics of research involving human subjects written over a 15-year period. Topics addressed include the ethics of clinical trials, controversial study designs, and informed consent.
The Use Of Human Beings In Research
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Author : S.F. Spicker
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
The Use Of Human Beings In Research written by S.F. Spicker and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
This volume, which has developed from the Fourteenth Trans Disciplinary Symposium on Philosophy and Medicine, September 5-8, 1982, at Tel Aviv University, Israel, contains the contributions of a group of distinguished scholars who together examine the ethical issues raised by the advance of biomedical science and technology. We are, of course, still at the beginning of a revolution in our understanding of human biology; scientific medicine and clinical research are scarcely one hundred years old. Both the sciences and the technology of medicine until ten or fifteen years ago had the feeling of the 19th century about them; we sense that they belonged to an older time; that era is ending. The next twenty-five to fifty years of investigative work belong to neurobiology, genetics, and reproductive biology. The technologies of information processing and imaging will make diagnosis and treatment almost incomprehensible by my generation of physicians. Our science and technology will become so powerful that we shall require all of the art and wisdom we can muster to be sure that they remain dedicated, as Francis Bacon hoped four centuries ago, "to the uses of life." It is well that, as philosophers and physicians, we grapple with the issues now when they are relatively simple, and while the pace of change is relatively slow. We require a strategy for the future; that strategy must be worked out by scientists, philosophers, physicians, lawyers, theologians, and, I should like to add, artists and poets.
The Oxford Textbook Of Clinical Research Ethics
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Author : Ezekiel J. Emanuel
language : en
Publisher: Oxford University Press
Release Date : 2008-04-18
The Oxford Textbook Of Clinical Research Ethics written by Ezekiel J. Emanuel and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-18 with Medical categories.
The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Clinical And Translational Science
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Author : David Robertson
language : en
Publisher: Academic Press
Release Date : 2016-11-25
Clinical And Translational Science written by David Robertson and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-25 with Science categories.
Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs
The Fundamentals Of Clinical Research
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Author : P. Michael Dubinsky
language : en
Publisher: John Wiley & Sons
Release Date : 2022-01-26
The Fundamentals Of Clinical Research written by P. Michael Dubinsky and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-26 with Medical categories.
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
Principles And Practice Of Clinical Research
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Author : John I. Gallin
language : en
Publisher: Academic Press
Release Date : 2012-05-31
Principles And Practice Of Clinical Research written by John I. Gallin and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-31 with Medical categories.
This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.