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Public Engagement And Clinical Trials
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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.
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.
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 236 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.
Book Synopsis Public Engagement and Clinical Trials by : Institute of Medicine
Download or read book Public Engagement and Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2012-03-17 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309452880 Total Pages :329 pages Book Rating :4.3/5 (94 download)
Book Synopsis Human Genome Editing by : National Academies of Sciences, Engineering, and Medicine
Download or read book Human Genome Editing written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-08-13 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309442583 Total Pages :111 pages Book Rating :4.3/5 (94 download)
Book Synopsis Neuroscience Trials of the Future by : National Academies of Sciences, Engineering, and Medicine
Download or read book Neuroscience Trials of the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-11-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
Book Synopsis Testing Treatments by : Imogen Evans
Download or read book Testing Treatments written by Imogen Evans and published by Pinter & Martin Publishers. This book was released on 2011 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work provides a thought-provoking account of how medical treatments can be tested with unbiased or 'fair' trials and explains how patients can work with doctors to achieve this vital goal. It spans the gamut of therapy from mastectomy to thalidomide and explores a vast range of case studies.
Book Synopsis Cross-Cultural and Religious Critiques of Informed Consent by : Joseph Tham
Download or read book Cross-Cultural and Religious Critiques of Informed Consent written by Joseph Tham and published by Routledge. This book was released on 2021-11-28 with total page 119 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the challenges of informed consent in medical intervention and research ethics, considering the global reality of multiculturalism and religious diversity. Even though informed consent is a gold standard in research ethics, its theoretical foundation is based on the conception of individual subjects making autonomous decisions. There is a need to reconsider autonomy as relational—where family members, community and religious leaders can play an important part in the consent process. The volume re-evaluates informed consent in multicultural contexts and features perspectives from Buddhism, Confucianism, Hinduism, Christianity, Judaism and Islam. It is valuable reading for scholars interested in bioethics, healthcare ethics, research ethics, comparative religions, theology, human rights, law and sociology.
Book Synopsis Public Engagement and Social Science by : Stella Maile
Download or read book Public Engagement and Social Science written by Stella Maile and published by Policy Press. This book was released on 2014 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on social science conversations at a lively café in Bristol, this highly original book explores the value of public engagement in a wider social science context. The chapters range from themes such as the dialogic character of the social sciences, pragmatism in responses, and the underpinnings of managerial approaches to the restructuring of higher education. The first part reflects upon the different social and political inflections of public engagement. It is followed by chapters based upon talks at the café that were concerned with public engagement and the contribution of social science to a reflexive understanding of the dilemmas and practices of daily life. Together, the contributors offer a refreshing look at the role of social science in the societies it examines.--
Author :Linda R. Tropp Publisher :American Psychological Association (APA) ISBN 13 :9781433828249 Total Pages :0 pages Book Rating :4.8/5 (282 download)
Book Synopsis Making Research Matter by : Linda R. Tropp
Download or read book Making Research Matter written by Linda R. Tropp and published by American Psychological Association (APA). This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume shows researchers how to bring their scholarship to a broader audience. Contributors explain how to talk to the media, testify as an expert witness, approach governmental organizations, work with schools and students, and influence public policy.
Book Synopsis Critical Thinking in Clinical Research by : Felipe Fregni
Download or read book Critical Thinking in Clinical Research written by Felipe Fregni and published by Oxford University Press. This book was released on 2018 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.
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.
Book Synopsis The Ethics and Politics of Community Engagement in Global Health Research by : Lindsey Reynolds
Download or read book The Ethics and Politics of Community Engagement in Global Health Research written by Lindsey Reynolds and published by Routledge. This book was released on 2020-06-09 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on a growing consensus about the importance of community representation and participation for ethical research, community engagement has become a central component of scientific research, policy-making, ethical review, and technology design. The diversity of actors involved in large-scale global health research collaborations and the broader ‘background conditions’ of global inequality and injustice that frame the field have led some researchers, funders, and policy-makers to conclude that community engagement is nothing less than a moral imperative in global health research. Rather than taking community engagement as a given, the contributions in this edited volume highlight how processes of community engagement are shaped by particular local histories and social and political dynamics, and by the complex social relations between different actors involved in global public health research. By interrogating the everyday politics and practices of engagement across diverse contexts, the book pushes conversations around engagement and participation beyond their conventional framings. In doing so, it raises radical questions about knowledge, power, expertise, authority, representation, inclusivity, and ethics and to make recommendations for more transformative, inclusive, and meaningful community engagement. This book was originally published as a special issue of the Critical Public Health journal.
Book Synopsis The Morehouse Model by : Ronald L. Braithwaite
Download or read book The Morehouse Model written by Ronald L. Braithwaite and published by Johns Hopkins University Press. This book was released on 2020-06-16 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: How can the example of Morehouse School of Medicine help other health-oriented universities create ideal collaborations between faculty and community-based organizations? Among the 154 medical schools in the United States, Morehouse School of Medicine stands out for its formidable success in improving its surrounding communities. Over its history, Morehouse has become known as an institution committed to community engagement with an interest in closing the health equity gap between people of color and the white majority population. In The Morehouse Model, Ronald L. Braithwaite and his coauthors reveal the lessons learned over the decades since the school's founding—lessons that other medical schools and health systems will be eager to learn in the hope of replicating Morehouse's success. Describing the philosophical, cultural, and contextual grounding of the Morehouse Model, they give concrete examples of it in action before explaining how to foster the collaboration between community-based organizations and university faculty that is essential to making this model of care and research work. Arguing that establishing ongoing collaborative projects requires genuineness, transparency, and trust from everyone involved, the authors offer a theory of citizen participation as a critical element for facilitating behavioral change. Drawing on case studies, exploratory research, surveys, interventions, and secondary analysis, they extrapolate lessons to advance the field of community-based participatory research alongside community health. Written by well-respected leaders in the effort to reduce health inequities, The Morehouse Model is rooted in social action and social justice constructs. It will be a touchstone for anyone conducting community-based participatory research, as well as any institution that wants to have a positive effect on its local community.
Book Synopsis Circadian and Visual Neuroscience by :
Download or read book Circadian and Visual Neuroscience written by and published by Elsevier. This book was released on 2022-08-05 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Circadian and Visual Neuroscience, Volume 273 in the Methods in Enzymology series, highlights new advances in the field with this new volume presenting interesting chapters on topics including Optical set-ups, Psychophysics of Luminance and Color Vision, Psychophysics of non-visual photoreception PRC/IRC/DRC/Spectral Sensitivity, Circadian and visual photometry, Modelling (retina), Modelling (circadian), Techniques for examining vision at the cellular level, Advanced techniques for characterizing the world hyperspectrally, Circadian physiology in mice: Melanopsin, Circadian physiology in mice: Color and cones, Translational aspects of animal studies, Retinal clocks, Primate non-visual physiology, Light and mood in animal models, and much more. - Provides the authority and expertise of leading contributors from an international board of authors - Presents the latest release in Progress in Brain Research series - Updated release includes the latest information on Circadian and Visual Neuroscience
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 2012-10-13 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.
Book Synopsis Decision Making in a World of Comparative Effectiveness Research by : Howard G. Birnbaum
Download or read book Decision Making in a World of Comparative Effectiveness Research written by Howard G. Birnbaum and published by Adis. This book was released on 2018-07-29 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past decade there has been a worldwide evolution in evidence-based medicine that focuses on real-world Comparative Effectiveness Research (CER) to compare the effects of one medical treatment versus another in real world settings. While most of this burgeoning literature has focused on research findings, data and methods, Howard Birnbaum and Paul Greenberg (both of Analysis Group) have edited a book that provides a practical guide to decision making using the results of analysis and interpretation of CER. Decision Making in a World of Comparative Effectiveness contains chapters by senior industry executives, key opinion leaders, accomplished researchers, and leading attorneys involved in resolving disputes in the life sciences industry. The book is aimed at 'users' and 'decision makers' involved in the life sciences industry rather than those doing the actual research. This book appeals to those who commission CER within the life sciences industry (pharmaceutical, biologic, and device manufacturers), government (both public and private payers), as well as decision makers of all levels, both in the US and globally.
