Envisioning A Transformed Clinical Trials Enterprise In The United States

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Envisioning a Transformed Clinical Trials Enterprise in the United States

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 248 pages
File Size : 53,7 Mb
Release : 2012-09-13
Category : Medical
ISBN : 9780309253185

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Envisioning a Transformed Clinical Trials Enterprise in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop

Author : National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation
Publisher : National Academies Press
Page : 128 pages
File Size : 48,9 Mb
Release : 2022-08-09
Category : Medical
ISBN : 0309269288

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Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop by National Academies Of Sciences Engineeri,National Academies of Sciences Engineering and Medicine,Health And Medicine Division,Board On Health Sciences Policy,Forum on Drug Discovery Development and Translation Pdf

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.

Transforming Clinical Research in the United States

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 151 pages
File Size : 45,8 Mb
Release : 2010-10-22
Category : Medical
ISBN : 9780309163354

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Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Envisioning a Transformed Clinical Trials Enterprise in the United States

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 248 pages
File Size : 45,8 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309253154

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Envisioning a Transformed Clinical Trials Enterprise in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Virtual Clinical Trials

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 127 pages
File Size : 43,6 Mb
Release : 2019-11-16
Category : Medical
ISBN : 9780309494885

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Virtual Clinical Trials by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

The Science of Health Disparities Research

Author : Irene Dankwa-Mullan,Eliseo J. Pérez-Stable,Kevin L. Gardner,Xinzhi Zhang,Adelaida M. Rosario
Publisher : John Wiley & Sons
Page : 548 pages
File Size : 44,8 Mb
Release : 2021-03-16
Category : Science
ISBN : 9781119374817

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The Science of Health Disparities Research by Irene Dankwa-Mullan,Eliseo J. Pérez-Stable,Kevin L. Gardner,Xinzhi Zhang,Adelaida M. Rosario Pdf

Integrates the various disciplines of the science of health disparities in one comprehensive volume The Science of Health Disparities Research is an indispensable source of up-to-date information on clinical and translational health disparities science. Building upon the advances in health disparities research over the past decade, this authoritative volume informs policies and practices addressing the diseases, disorders, and gaps in health outcomes that are more prevalent in minority populations and socially disadvantaged communities. Contributions by recognized scholars and leaders in the field—featuring contemporary research, conceptual models, and a broad range of scientific perspectives—provide an interdisciplinary approach to reducing inequalities in population health, encouraging community engagement in the research process, and promoting social justice. In-depth chapters help readers better understand the specifics of minority health and health disparities while demonstrating the importance of advancing theory, refining measurement, improving investigative methods, and diversifying scientific research. In 26 chapters, the book examines topics including the etiology of health disparities research, the determinants of population health, research ethics, and research in African American, Asians, Latino, American Indian, and other vulnerable populations. Providing a unified framework on the principles and applications of the science of health disparities research, this important volume: Defines the field of health disparities science and suggests new directions in scholarship and research Explains basic definitions, principles, and concepts for identifying, understanding and addressing health disparities Provides guidance on both conducting health disparities research and translating the results Examines how social, historical and contemporary injustices may influence the health of racial and ethnic minorities Illustrates the increasing national and global importance of addressing health disparities Discusses population health training, capacity-building, and the transdisciplinary tools needed to advance health equity A significant contribution to the field, The Science of Health Disparities Research is an essential resource for students and basic and clinical researchers in genetics, population genetics, and public health, health care policymakers, and epidemiologists, medical students, and clinicians, particularly those working with minority, vulnerable, or underserved populations.

Sharing Clinical Trial Data

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 52,5 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

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Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

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.

Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise

Author : National Academies of Sciences, Engineering, and Medicine,National Academies Of Sciences Engineeri,Health and Medicine Division,Board on Health Sciences Policy,Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise
Publisher : Unknown
Page : 150 pages
File Size : 47,6 Mb
Release : 2022-08-03
Category : Medical
ISBN : 0309271487

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Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise by National Academies of Sciences, Engineering, and Medicine,National Academies Of Sciences Engineeri,Health and Medicine Division,Board on Health Sciences Policy,Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise Pdf

The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.

Transforming Clinical Research in the United States

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 150 pages
File Size : 42,8 Mb
Release : 2010-11-22
Category : Medical
ISBN : 9780309153324

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Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Returning Individual Research Results to Participants

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories
Publisher : National Academies Press
Page : 399 pages
File Size : 42,7 Mb
Release : 2018-09-23
Category : Medical
ISBN : 9780309475174

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Returning Individual Research Results to Participants by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Pdf

When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

The Master Adaptive Learner

Author : William Cutrer,Martin Pusic,Larry D Gruppen,Maya M. Hammoud,Sally A. Santen
Publisher : Elsevier Health Sciences
Page : 242 pages
File Size : 51,5 Mb
Release : 2019-09-29
Category : Medical
ISBN : 9780323711128

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The Master Adaptive Learner by William Cutrer,Martin Pusic,Larry D Gruppen,Maya M. Hammoud,Sally A. Santen Pdf

Tomorrow’s best physicians will be those who continually learn, adjust, and innovate as new information and best practices evolve, reflecting adaptive expertise in response to practice challenges. As the first volume in the American Medical Association’s MedEd Innovation Series, The Master Adaptive Learner is an instructor-focused guide covering models for how to train and teach future clinicians who need to develop these adaptive skills and utilize them throughout their careers. Explains and clarifies the concept of a Master Adaptive Learner: a metacognitive approach to learning based on self-regulation that fosters the success and use of adaptive expertise in practice. Contains both theoretical and practical material for instructors and administrators, including guidance on how to implement a Master Adaptive Learner approach in today’s institutions. Gives instructors the tools needed to empower students to become efficient and successful adaptive learners. Helps medical faculty and instructors address gaps in physician training and prepare new doctors to practice effectively in 21st century healthcare systems. One of the American Medical Association Change MedEd initiatives and innovations, written and edited by members of the ACE (Accelerating Change in Medical Education) Consortium – a unique, innovative collaborative that allows for the sharing and dissemination of groundbreaking ideas and projects.

The Future of Nursing

Author : Institute of Medicine,Committee on the Robert Wood Johnson Foundation Initiative on the Future of Nursing, at the Institute of Medicine
Publisher : National Academies Press
Page : 700 pages
File Size : 42,7 Mb
Release : 2011-02-08
Category : Medical
ISBN : 9780309208956

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The Future of Nursing by Institute of Medicine,Committee on the Robert Wood Johnson Foundation Initiative on the Future of Nursing, at the Institute of Medicine Pdf

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.

The Future of Nursing 2020-2030

Author : National Academies of Sciences Engineering and Medicine,Committee on the Future of Nursing 2020-2030
Publisher : Unknown
Page : 128 pages
File Size : 55,9 Mb
Release : 2021-09-30
Category : Electronic
ISBN : 0309685060

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The Future of Nursing 2020-2030 by National Academies of Sciences Engineering and Medicine,Committee on the Future of Nursing 2020-2030 Pdf

The decade ahead will test the nation's nearly 4 million nurses in new and complex ways. Nurses live and work at the intersection of health, education, and communities. Nurses work in a wide array of settings and practice at a range of professional levels. They are often the first and most frequent line of contact with people of all backgrounds and experiences seeking care and they represent the largest of the health care professions. A nation cannot fully thrive until everyone - no matter who they are, where they live, or how much money they make - can live their healthiest possible life, and helping people live their healthiest life is and has always been the essential role of nurses. Nurses have a critical role to play in achieving the goal of health equity, but they need robust education, supportive work environments, and autonomy. Accordingly, at the request of the Robert Wood Johnson Foundation, on behalf of the National Academy of Medicine, an ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine conducted a study aimed at envisioning and charting a path forward for the nursing profession to help reduce inequities in people's ability to achieve their full health potential. The ultimate goal is the achievement of health equity in the United States built on strengthened nursing capacity and expertise. By leveraging these attributes, nursing will help to create and contribute comprehensively to equitable public health and health care systems that are designed to work for everyone. The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity explores how nurses can work to reduce health disparities and promote equity, while keeping costs at bay, utilizing technology, and maintaining patient and family-focused care into 2030. This work builds on the foundation set out by The Future of Nursing: Leading Change, Advancing Health (2011) report.

The Handbook of Applied Communication Research

Author : H. Dan O'Hair,Mary John O'Hair
Publisher : John Wiley & Sons
Page : 1100 pages
File Size : 55,7 Mb
Release : 2020-04-24
Category : Language Arts & Disciplines
ISBN : 9781119399872

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The Handbook of Applied Communication Research by H. Dan O'Hair,Mary John O'Hair Pdf

An authoritative survey of different contexts, methodologies, and theories of applied communication The field of Applied Communication Research (ACR) has made substantial progress over the past five decades in studying communication problems, and in making contributions to help solve them. Changes in society, human relationships, climate and the environment, and digital media have presented myriad contexts in which to apply communication theory. The Handbook of Applied Communication Research addresses a wide array of contemporary communication issues, their research implications in various contexts, and the challenges and opportunities for using communication to manage problems. This innovative work brings together the diverse perspectives of a team of notable international scholars from across disciplines. The Handbook of Applied Communication Research includes discussion and analysis spread across two comprehensive volumes. Volume one introduces ACR, explores what is possible in the field, and examines theoretical perspectives, organizational communication, risk and crisis communication, and media, data, design, and technology. The second volume focuses on real-world communication topics such as health and education communication, legal, ethical, and policy issues, and volunteerism, social justice, and communication activism. Each chapter addresses a specific issue or concern, and discusses the choices faced by participants in the communication process. This important contribution to communication research: Explores how various communication contexts are best approached Addresses balancing scientific findings with social and cultural issues Discusses how and to what extent media can mitigate the effects of adverse events Features original findings from ongoing research programs and original communication models and frameworks Presents the best available research and insights on where current research and best practices should move in the future A major addition to the body of knowledge in the field, The Handbook of Applied Communication Research is an invaluable work for advanced undergraduate students, graduate students, and scholars.

The Future of Health Services Research

Author : National Academy of Medicine
Publisher : Unknown
Page : 0 pages
File Size : 40,5 Mb
Release : 2023-09-03
Category : Electronic
ISBN : 0309705223

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The Future of Health Services Research by National Academy of Medicine Pdf

Health services research is "the multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and personal behaviors affect access to health care and the quality and cost of health care." Since the 1960s, health services research has provided the foundation for progress, effectiveness, and value in health care. Ironically, at a time in which appreciation has never been higher for both the need and potential from health services research, the political and financial support for sustenance and growth appear to be weakening. With funding support from AcademyHealth, the American Association of Colleges of Nursing, the American Board of Family Medicine, the American Society of Anesthesiologists, the Association of American Medical Colleges, the Federation of American Hospitals, and the Robert Wood Johnson Foundation, this National Academy of Medicine Special Publication identifies the range of issues that health services research must consider, address, and potentially overcome to transform the field to meet the needs of a 21st-century health care system. These issues are broad, multidisciplinary, and will require a coordinated effort to address?as well as dedicated and sustainable funding. Federal support for health services research has never been more critical. Now is a critical time for the field to articulate its priorities, demonstrate its utility, and transform to meet the needs of a 21st-century health care system. The physical and financial health of the nation is at stake.