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 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.
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 Relieving Pain in America written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-26 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chronic pain costs the nation up to $635 billion each year in medical treatment and lost productivity. The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In this report, the IOM offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. The IOM recommends that HHS develop a comprehensive plan with specific goals, actions, and timeframes. Better data are needed to help shape efforts, especially on the groups of people currently underdiagnosed and undertreated, and the IOM encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. Because pain varies from patient to patient, healthcare providers should increasingly aim at tailoring pain care to each person's experience, and self-management of pain should be promoted. In addition, because there are major gaps in knowledge about pain across health care and society alike, the IOM recommends that federal agencies and other stakeholders redesign education programs to bridge these gaps. Pain is a major driver for visits to physicians, a major reason for taking medications, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain in human lives, dollars, and social consequences, relieving pain should be a national priority.
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.
Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-07-19 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
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 Patient Centered Medicine written by Moira Stewart and published by CRC Press. This book was released on 2013-12-28 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: This long awaited Third Edition fully illuminates the patient-centered model of medicine, continuing to provide the foundation for the Patient-Centered Care series. It redefines the principles underpinning the patient-centered method using four major components - clarifying its evolution and consequent development - to bring the reader fully up-to-
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Download or read book The Future of Nursing written by Institute of Medicine and published by National Academies Press. This book was released on 2011-02-08 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Nursing explores how nurses' roles, responsibilities, and education should change significantly to meet the increased demand for care that will be created by health care reform and to advance improvements in America's increasingly complex health system. At more than 3 million in number, nurses make up the single largest segment of the health care work force. They also spend the greatest amount of time in delivering patient care as a profession. Nurses therefore have valuable insights and unique abilities to contribute as partners with other health care professionals in improving the quality and safety of care as envisioned in the Affordable Care Act (ACA) enacted this year. Nurses should be fully engaged with other health professionals and assume leadership roles in redesigning care in the United States. To ensure its members are well-prepared, the profession should institute residency training for nurses, increase the percentage of nurses who attain a bachelor's degree to 80 percent by 2020, and double the number who pursue doctorates. Furthermore, regulatory and institutional obstacles-including limits on nurses' scope of practice-should be removed so that the health system can reap the full benefit of nurses' training, skills, and knowledge in patient care. In this book, the Institute of Medicine makes recommendations for an action-oriented blueprint for the future of nursing.
Download or read book The CTSA Program at NIH written by Institute of Medicine and published by National Academies Press. This book was released on 2013-10-09 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country. The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.
Download or read book Priority Areas for National Action written by Institute of Medicine and published by National Academies Press. This book was released on 2003-04-10 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: A new release in the Quality Chasm Series, Priority Areas for National Action recommends a set of 20 priority areas that the U.S. Department of Health and Human Services and other groups in the public and private sectors should focus on to improve the quality of health care delivered to all Americans. The priority areas selected represent the entire spectrum of health care from preventive care to end of life care. They also touch on all age groups, health care settings and health care providers. Collective action in these areas could help transform the entire health care system. In addition, the report identifies criteria and delineates a process that DHHS may adopt to determine future priority areas.
Download or read book Publishing and Presenting Clinical Research written by Warren S. Browner and published by Lippincott Williams & Wilkins. This book was released on 2012-03-19 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publishing and Presenting Clinical Research, Fourth Edition is an excellent primer for investigators who wish to learn how to organize, present, and publish results of their research. Written by an experienced clinical researcher and editor, it uses hundreds of examples, tables and figures to show how to produce successful abstracts, posters, oral presentations, and manuscripts for publication. This book also serves as a companion to the popular text, Designing Clinical Research. This edition contains the latest: • Guidance on getting work accepted in medical journals and at scientific meetings • Examples of the do’s and don’ts of data presentation • Explanations of confusing statistical terminology • Templates to get started and avoid writers’ block • Tips for creating simple graphics and tables • Help for those who are not fluent in English • Suggestions about getting the most from a poster session • Checklists for each section of a manuscript or presentation • Advice about authorship and responding to reviewers’ comments Plus with this edition, there is access to a companion website with fully searchable text so you can access the content anytime, anywhere.
Download or read book Clinical Epidemiology written by R. Brian Haynes and published by Lippincott Williams & Wilkins. This book was released on 2012-03-29 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Third Edition of this popular text focuses on clinical-practice research methods. It is written by clinicians with experience in generating and answering researchable questions about real-world clinical practice and health care—the prevention, treatment, diagnosis, prognosis, and causes of diseases, the measurement of quality of life, and the effects of innovations in health services. The book has a problem-oriented and protocol-based approach and is written at an introductory level, emphasizing key principles and their applications. A bound-in CD-ROM contains the full text of the book to help the reader locate needed information.
Download or read book Biotechnology and Biopharmaceuticals written by and published by John Wiley & Sons. This book was released on 2013-12-16 with total page 744 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.
Download or read book Clinical Research Informatics written by Rachel Richesson and published by Springer Science & Business Media. This book was released on 2012-02-15 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.
Download or read book Whole Person Care written by Tom A. Hutchinson and published by Springer. This book was released on 2017-09-01 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book argues persuasively and passionately that patient care is best when the patient’s healing journey is as good as it can possibly be. That means the patient as a Whole Person – the self in all its physiological, emotional, social and even spiritual dimensions – should receive truly comprehensive patient-centered care. In Whole Person Care: Transforming Healthcare, the author, an expert in whole person care theory and practice, outlines the background of whole person care, explains and illustrates the key ideas, puts the growing movement of whole person care in the context of other recent developments in healthcare, and explores the implications of whole person care for individual practitioners, healthcare teams, and the organization of healthcare at the institutional and systems level. In addition, the author provides a compelling, coherent narrative, rich with clinical examples and vignettes, that clarifies for physicians, medical students and healthcare administrators the meaning of whole person care and its implications for the future of medical practice. An invaluable resource for all clinicians and personnel concerned with managing patients with acute and chronic illness, Whole Person Care: Transforming Healthcare is a major addition to the literature and a must-read for health practitioners and health administrators at every level.
