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.
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.
Download or read book Sharing Clinical Research Data written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-07 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.
Download or read book Engineering a Learning Healthcare System written by National Academy of Engineering and published by National Academies Press. This book was released on 2011-07-14 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving our nation's healthcare system is a challenge which, because of its scale and complexity, requires a creative approach and input from many different fields of expertise. Lessons from engineering have the potential to improve both the efficiency and quality of healthcare delivery. The fundamental notion of a high-performing healthcare system-one that increasingly is more effective, more efficient, safer, and higher quality-is rooted in continuous improvement principles that medicine shares with engineering. As part of its Learning Health System series of workshops, the Institute of Medicine's Roundtable on Value and Science-Driven Health Care and the National Academy of Engineering, hosted a workshop on lessons from systems and operations engineering that could be applied to health care. Building on previous work done in this area the workshop convened leading engineering practitioners, health professionals, and scholars to explore how the field might learn from and apply systems engineering principles in the design of a learning healthcare system. Engineering a Learning Healthcare System: A Look at the Future: Workshop Summary focuses on current major healthcare system challenges and what the field of engineering has to offer in the redesign of the system toward a learning healthcare system.
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.
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
Download or read book Clinical Data as the Basic Staple of Health Learning written by Institute of Medicine and published by National Academies Press. This book was released on 2011-01-14 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. As part of its Learning Health System Series, the Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss expanding the access to and use of clinical data as a foundation for care improvement.
Download or read book The Role of Purchasers and Payers in the Clinical Research Enterprise written by Institute of Medicine and published by National Academies Press. This book was released on 2002-06-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
Download or read book Bridging Disciplines in the Brain Behavioral and Clinical Sciences written by Institute of Medicine and published by National Academies Press. This book was released on 2000-09-24 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: Interdisciplinary research is a cooperative effort by a team of investigators, each an expert in the use of different methods and concepts, who have joined in an organized program to attack a challenging problem. Each investigator is responsible for the research in their area of discipline that applies to the problem, but together the investigators are responsible for the final product. The need for interdisciplinary training activities has been detailed over the last 25 years in both public and private reports. The history of science and technology has even shown the important advances that arose from interdisciplinary research, including plate tectonics which brought together geologists, oceanographers, paleomagnetists, seismologists, and geophysicists to advance the ability to forecast earthquakes and volcanic eruptions. In recognition of this, the need to train scientists who can address the highly complex problems that challenge us today and fully use new knowledge and technology, and the fact that cooperative efforts have proved difficult, the National Institute of Mental Health (NIMH), the National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR), the National Institute on Nursing Research (NINR), and the National Institute on Aging (NIA) requested that an Institute of Medicine (IOM) Committee be created to complete several tasks including: examining the needs and strategies for interdisciplinary training in the brain, behavioral, social, and clinical sciences, defining necessary components of true interdisciplinary training in these areas, and reviewing current educational and training programs to identify elements of model programs that best facilitate interdisciplinary training. Bridging Disciplines in the Brain, Behavioral, and Clinical Sciences provides the conclusions and recommendations of this committee. Due to evaluations of the success of interdisciplinary training programs are scarce, the committee could not specify the "necessary components" or identify the elements that "best facilitate" interdisciplinary training. However, after reviewing existing programs and consulting with experts, the committee identified approaches likely to be successful in providing direction for interdisciplinary endeavors at various career stages. This report also includes interviews, training programs, and workshop agendas used.
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1993 with total page 1628 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
Download or read book Overview written by United States. Dept. of Health, Education, and Welfare. Commission on the Control of Huntington's Disease and its Consequences and published by . This book was released on 1977 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register written by and published by . This book was released on 1978-12 with total page 1992 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Nuclear Science Applictions Se written by Yosh Maruyama and published by CRC Press. This book was released on 1991 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Artificial Intelligence and Machine Learning in Health Care and Medical Sciences written by Gyorgy J. Simon and published by Springer Nature. This book was released on with total page 824 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Departments of Labor and Health Education and Welfare and Related Agencies Appropriations for Fiscal Year 1976 written by United States. Congress. Senate. Committee on Appropriations and published by . This book was released on 1975 with total page 1488 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Monthly Catalog of United States Government Publications written by and published by . This book was released on 1988 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Anthropology in Medical Education written by Iveris Martinez and published by Springer Nature. This book was released on 2021-03-04 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume reflects on how anthropologists have engaged in medical education and aims to positively influence the future careers of anthropologists who are currently engaged or are considering a career in medical education. The volume is essential for medical educators, administrators, researchers, and practitioners, those interested in the history of medicine, global health, sociology of health and illness, medical and applied anthropology. For over a century, anthropologists have served in many roles in medical education: teaching, curriculum development, administration, research, and planning. Recent changes in medical education focusing on diversity, social determinants of health, and more humanistic patient-centered care have opened the door for more anthropologists in medical schools. The chapter authors describe various ways in which anthropologists have engaged and are currently involved in training physicians, in various countries, as well as potential new directions in this field. They address critical topics such as: the history of anthropology in medical education; humanism, ethics, and the culture of medicine; interprofessional and collaborative clinical care; incorporating patient perspectives in practice; addressing social determinants of health, health disparities, and cultural competence; anthropological roles in planning and implementation of medical education programs; effective strategies for teaching medical students; comparative analysis of systems of care in Japan, Uganda, France, United Kingdom, Mexico, Canada and throughout the United States; and potential new directions for anthropological engagement with medicine. The volume overall emphasizes the important role of anthropology in educating physicians throughout the world to improve patient care and population health.
