The Value of Transnational Medical Research

The Value of Transnational Medical Research

Author: Ann H. Kelly

Publisher: Routledge

Published: 2013-09-13

Total Pages: 145

ISBN-13: 1135759200

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What is the value of medical research? With contributions from anthropologists, sociologists and activists, this approach brings into focus the forms of value – social, epistemic, and economic – that are involved in medical research practices and how these values intersect with everyday living. Though their work covers wide empirical ground –from HIV trials in Kenya and drug donation programs in Tanzania to industry-academic collaborations in the British National Health Service – the authors share a commitment to understanding the practices of medical research as embedded in both local social worlds and global markets. Their collective concern is to rethink the conventional ethical demarcations betwweenpaid and unpaid research services in light of the social and material organisation of medical research practices. . Rather than warn against economic incursions into medical knowledge and health practice, or, alternatively, the reduction of local experience to the standards of bioethics, we hope to illuminate the array of practices, knowledges, and techniques through which the value of medical research is brought into being. This book was originally published as a special issue of Journal of Cultural Economy.


Book Synopsis The Value of Transnational Medical Research by : Ann H. Kelly

Download or read book The Value of Transnational Medical Research written by Ann H. Kelly and published by Routledge. This book was released on 2013-09-13 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: What is the value of medical research? With contributions from anthropologists, sociologists and activists, this approach brings into focus the forms of value – social, epistemic, and economic – that are involved in medical research practices and how these values intersect with everyday living. Though their work covers wide empirical ground –from HIV trials in Kenya and drug donation programs in Tanzania to industry-academic collaborations in the British National Health Service – the authors share a commitment to understanding the practices of medical research as embedded in both local social worlds and global markets. Their collective concern is to rethink the conventional ethical demarcations betwweenpaid and unpaid research services in light of the social and material organisation of medical research practices. . Rather than warn against economic incursions into medical knowledge and health practice, or, alternatively, the reduction of local experience to the standards of bioethics, we hope to illuminate the array of practices, knowledges, and techniques through which the value of medical research is brought into being. This book was originally published as a special issue of Journal of Cultural Economy.

Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 334

ISBN-13: 0309124999

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In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.


Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Translational Medicine - What, Why and How

Translational Medicine - What, Why and How

Author: Barbara Alving

Publisher: Karger Medical and Scientific Publishers

Published: 2012-12-01

Total Pages: 136

ISBN-13: 3318022845

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This book is the first to provide an aerial view, as well as detailed information, on 'how' activities in translational medicine are under development in countries such as the USA, China, the UK, and Taiwan. Institutions in each country are training investigators to work as sophisticated interdisciplinary teams. Investigators from 11 US academic health centers explain how they are incentivizing collaborations through pilot project programs, forming partnerships with business schools to promote efficient management of basic and clinical research, creating ethical, high- value public-private (industry) partnerships, improving efficiency with utilization of informatics, and engaging the community in research. The essential role of evaluation is explained in a clear and concise manner. The readers will also learn about the role of private funding in Taiwan and the vision of the government in China in developing multiple translational research centers. The UK is developing methodical approaches to patient needs across their lifespans; ongoing innovation is encouraged through incubator programs. With the emphasis on open innovation and sharing, the concepts and practice of translational medicine are spreading rapidly on an international scale.


Book Synopsis Translational Medicine - What, Why and How by : Barbara Alving

Download or read book Translational Medicine - What, Why and How written by Barbara Alving and published by Karger Medical and Scientific Publishers. This book was released on 2012-12-01 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first to provide an aerial view, as well as detailed information, on 'how' activities in translational medicine are under development in countries such as the USA, China, the UK, and Taiwan. Institutions in each country are training investigators to work as sophisticated interdisciplinary teams. Investigators from 11 US academic health centers explain how they are incentivizing collaborations through pilot project programs, forming partnerships with business schools to promote efficient management of basic and clinical research, creating ethical, high- value public-private (industry) partnerships, improving efficiency with utilization of informatics, and engaging the community in research. The essential role of evaluation is explained in a clear and concise manner. The readers will also learn about the role of private funding in Taiwan and the vision of the government in China in developing multiple translational research centers. The UK is developing methodical approaches to patient needs across their lifespans; ongoing innovation is encouraged through incubator programs. With the emphasis on open innovation and sharing, the concepts and practice of translational medicine are spreading rapidly on an international scale.

Sharing Clinical Trial Data

Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 304

ISBN-13: 0309316324

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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.


Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Envisioning a Transformed Clinical Trials Enterprise in the United States

Envisioning a Transformed Clinical Trials Enterprise in the United States

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-09-13

Total Pages: 248

ISBN-13: 0309253187

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There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.


Book Synopsis Envisioning a Transformed Clinical Trials Enterprise in the United States by : Institute of Medicine

Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

Ethical and Policy Issues in International Research

Ethical and Policy Issues in International Research

Author: United States. National Bioethics Advisory Commission

Publisher:

Published: 2001

Total Pages: 388

ISBN-13:

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Book Synopsis Ethical and Policy Issues in International Research by : United States. National Bioethics Advisory Commission

Download or read book Ethical and Policy Issues in International Research written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-10-22

Total Pages: 151

ISBN-13: 0309163358

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An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.


Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine

Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Evidence-Based Medicine and the Changing Nature of Health Care

Evidence-Based Medicine and the Changing Nature of Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2008-09-06

Total Pages: 202

ISBN-13: 0309113695

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Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.


Book Synopsis Evidence-Based Medicine and the Changing Nature of Health Care by : Institute of Medicine

Download or read book Evidence-Based Medicine and the Changing Nature of Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2008-09-06 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

Measuring the Gains from Medical Research

Measuring the Gains from Medical Research

Author: Kevin M. Murphy

Publisher: University of Chicago Press

Published: 2010-04-15

Total Pages: 270

ISBN-13: 0226551792

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In 1998, health expenditures in the United States accounted for 12.9% of national income-the highest share of income devoted to health in the developed world. The United States also spends more on medical research than any other country-in 2000, the federal government dedicated $18.4 billion to it, compared with only $3.7 billion for the entire European Union. In this book, leading health economists ask whether we are getting our money's worth. From an economic perspective, they find, the answer is a resounding "yes": in fact, considering the extraordinary value of improvements to health, we may even be spending too little on medical research. The evidence these papers present and the conclusions they reach are both surprising and convincing: that growth in longevity since 1950 has been as valuable as growth in all other forms of consumption combined; that medical advances producing 10% reductions in mortality from cancer and heart disease alone would add roughly $10 trillion-a year's GDP-to the national wealth; or that the average new drug approved by the FDA yields benefits worth many times its cost of development. The papers in this book are packed with these and many other surprising revelations, their sophisticated analysis persuasively demonstrating the massive economic benefits we can gain from investments in medical research. For anyone concerned about the cost and the value of such research-from policy makers to health care professionals and economists-this will be a landmark book.


Book Synopsis Measuring the Gains from Medical Research by : Kevin M. Murphy

Download or read book Measuring the Gains from Medical Research written by Kevin M. Murphy and published by University of Chicago Press. This book was released on 2010-04-15 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1998, health expenditures in the United States accounted for 12.9% of national income-the highest share of income devoted to health in the developed world. The United States also spends more on medical research than any other country-in 2000, the federal government dedicated $18.4 billion to it, compared with only $3.7 billion for the entire European Union. In this book, leading health economists ask whether we are getting our money's worth. From an economic perspective, they find, the answer is a resounding "yes": in fact, considering the extraordinary value of improvements to health, we may even be spending too little on medical research. The evidence these papers present and the conclusions they reach are both surprising and convincing: that growth in longevity since 1950 has been as valuable as growth in all other forms of consumption combined; that medical advances producing 10% reductions in mortality from cancer and heart disease alone would add roughly $10 trillion-a year's GDP-to the national wealth; or that the average new drug approved by the FDA yields benefits worth many times its cost of development. The papers in this book are packed with these and many other surprising revelations, their sophisticated analysis persuasively demonstrating the massive economic benefits we can gain from investments in medical research. For anyone concerned about the cost and the value of such research-from policy makers to health care professionals and economists-this will be a landmark book.

International Ethical Guidelines for Health-Related Research Involving Humans

International Ethical Guidelines for Health-Related Research Involving Humans

Author: Council for International Organizations of Medical Sciences (CIOMS)

Publisher: World Health Organization

Published: 2017-01-31

Total Pages: 0

ISBN-13: 9789290360889

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"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.


Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.