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Public Engagement And Clinical Trials
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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.
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 Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop by : National Academies Of Sciences Engineeri
Download or read book Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop written by National Academies Of Sciences Engineeri and published by National Academies Press. This book was released on 2022-08-09 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands. Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.
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.
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 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 Principles and Practice of Clinical Research by : John I. Gallin
Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
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.--
Book Synopsis Public Engagement and Clinical Trials by :
Download or read book Public Engagement and Clinical Trials written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309494885 Total Pages :127 pages Book Rating :4.3/5 (94 download)
Book Synopsis Virtual Clinical Trials by : National Academies of Sciences, Engineering, and Medicine
Download or read book Virtual Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-11-16 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Making clinical trials more patient-centered using digital interactive e-consent tools by : Barbara Bowles Biesecker
Download or read book Making clinical trials more patient-centered using digital interactive e-consent tools written by Barbara Bowles Biesecker and published by RTI Press. This book was released on 2019-10-20 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research participants are required to give their consent to participate in clinical trials and nonexempt government-funded studies. The goal is to facilitate participant understanding of the intent of the research, its voluntary nature, and the potential benefits and harms. Ideally, participants make an informed choice whether to participate; one that is based on having sufficient relevant knowledge and that is consistent with their values and preferences. Achieving this objective can be challenging, and as such, many scholars have declared the consent process flawed or “broken.” Moreover, clinical trials are complex studies, and compelling evidence suggests that current consent processes are inadequate in achieving informed choice. E-consent offers a dynamic, engaging consent delivery mode that can effectively support making informed decisions about whether to participate in a trial.
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.
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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309499720 Total Pages :121 pages Book Rating :4.3/5 (94 download)
Book Synopsis Health Literacy in Clinical Research by : National Academies of Sciences, Engineering, and Medicine
Download or read book Health Literacy in Clinical Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-05-28 with total page 121 pages. Available in PDF, EPUB and Kindle. Book excerpt: Because of the individualized nature of drug and therapeutic treatments, clinical trials require participants who represent the diversity of the patient base. If early trials do not have a broad patient base, it can be difficult to know who may or may not benefit from or respond to a treatment later. In addition to diversity in recruitment, informed consent during participation is also crucial. If participants do not fully understand what they are signing up for, they may become confused, mistrustful, or drop out of a trial altogether, confusing investigators and possibly affecting the generalizability of a study. To explore the incorporation of health literacy practices into clinical trials, the Roundtable on Health Literacy convened a workshop titled Clinical Trials: Practice and Impact on April 11, 2019, in Washington, DC. The workshop presentations and discussion centered around issues related to the challenges or barriers for diverse populations' participation in clinical trials, best practices for clinical trial sites and researchers incorporating health literacy practices, and effective health literacy strategies for clear communication with participants. This publication summarizes the presentation and discussion of the workshop.
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: 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309443601 Total Pages :85 pages Book Rating :4.3/5 (94 download)
Book Synopsis Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials by : National Academies of Sciences, Engineering, and Medicine
Download or read book Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-08-24 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop.
