Transforming Clinical Research in the United States

Author: Forum on Drug Discovery, Development, and Translation
Publisher: National Academies Press
ISBN: 0309153328
Format: PDF, ePub, Docs
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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: Forum on Drug Discovery, Development, and Translation
Publisher: National Academies Press
ISBN: 0309253160
Format: PDF, Docs
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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.

Crossing the Quality Chasm

Author: Committee on Quality of Health Care in America
Publisher: National Academies Press
ISBN: 0309072808
Format: PDF, ePub, Docs
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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.

Neuroscience Trials of the Future

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442559
Format: PDF, Docs
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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.

Public Engagement and Clinical Trials New Models and Disruptive Technologies

Author: Forum on Drug Discovery, Development, and Translation
Publisher: National Academies Press
ISBN: 0309219299
Format: PDF, ePub
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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.

Principles and Practice of Clinical Trial Medicine

Author: Richard Chin
Publisher: Elsevier
ISBN: 9780080557939
Format: PDF
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Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

Relieving Pain in America

Author: Committee on Advancing Pain Research, Care, and Education
Publisher: National Academies Press
ISBN: 030921484X
Format: PDF, Kindle
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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.

A National Cancer Clinical Trials System for the 21st Century

Author: Committee on Cancer Clinical Trials and the NCI Cooperative Group Program
Publisher: National Academies Press
ISBN: 0309151864
Format: PDF
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The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.

Key Advances in Clinical Informatics

Author: Aziz Sheikh
Publisher: Academic Press
ISBN: 0128095253
Format: PDF, Mobi
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Key Advances in Clinical Informatics: Transforming Health Care through Health Information Technology provides a state-of-the-art overview of the most current subjects in clinical informatics. Leading international authorities write short, accessible, well-referenced chapters which bring readers up-to-date with key developments and likely future advances in the relevant subject areas. This book encompasses topics such as inpatient and outpatient clinical information systems, clinical decision support systems, health information technology, genomics, mobile health, telehealth and cloud-based computing. Additionally, it discusses privacy, confidentiality and security required for health data. Edited by internationally recognized authorities in the field of clinical informatics, the book is a valuable resource for medical/nursing students, clinical informaticists, clinicians in training, practicing clinicians and allied health professionals with an interest in health informatics. Presents a state-of-the-art overview of the most current subjects in clinical informatics. Provides summary boxes of key points at the beginning of each chapter to impart relevant messages in an easily digestible fashion Includes internationally acclaimed experts contributing to chapters in one accessible text Explains and illustrates through international case studies to show how the evidence presented is applied in a real world setting

Medical Proofs Social Experiments

Author: Tiago Moreira
Publisher: Ashgate Publishing, Ltd.
ISBN: 1409492753
Format: PDF, Mobi
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Clinical trials have become key technologies for decision making in the contemporary world. Their results shape medical practice and determine priorities across health care systems, but the work that goes into producing credible data is often hidden. Medical Proofs, Social Experiments draws upon detailed case studies to argue that to understand their value, we need to pay more attention to the contexts for these modern medical experiments, recovering the diverse ways in which they involve doctors, patients and the public, the local practices that contribute to their completion, and the complex negotiation of their results in professional and statutory institutions. Presenting research from the UK, USA, Sweden and The Netherlands, the ethnographic perspective adopted by the authors provides a space to explore the investments of different state, market, professional and other actors in particular forms of evaluation, and the ways in which trial methodologies may be re-designed or re-imagined to satisfy social and political expectations. As such, this volume will be of interest to those working in the fields of science and technology studies, the sociology and anthropology of medicine and researchers of policy and organisation in health care.