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Author: Institute of Medicine
Publisher: National Academies Press
Published: 2011-04-03
Total Pages: 442
ISBN-13: 0309158060
DOWNLOAD EBOOKRare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1990-02-01
Total Pages: 241
ISBN-13: 0309042860
DOWNLOAD EBOOKThe very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
Published: 2014-04-01
Total Pages: 385
ISBN-13: 1587634333
DOWNLOAD EBOOKThis User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1988-01-01
Total Pages: 203
ISBN-13: 0309038472
DOWNLOAD EBOOKIn the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2011-11-25
Total Pages: 318
ISBN-13: 0309212421
DOWNLOAD EBOOKMedical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1991-02-01
Total Pages: 225
ISBN-13: 030904491X
DOWNLOAD EBOOKAmericans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: James Beck
Publisher: Law Journal Press
Published: 2004
Total Pages: 982
ISBN-13: 9781588521217
DOWNLOAD EBOOKThis timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Author: Jeanne Lenzer
Publisher: Little, Brown
Published: 2017-12-12
Total Pages: 306
ISBN-13: 0316343781
DOWNLOAD EBOOKDid you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc. The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial. In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment. His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies. In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare. "Before you get anything implanted in your body, read this book."-Shannon Brownlee, author of Overtreated
Author: Kerm Henriksen
Publisher:
Published: 2005
Total Pages: 526
ISBN-13:
DOWNLOAD EBOOKv. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Author: Joris C. Verster
Publisher: Springer Science & Business Media
Published: 2012-07-06
Total Pages: 569
ISBN-13: 1461433754
DOWNLOAD EBOOKDrug abuse and addiction are common in clinical practice. Often they interfere with patient treatment or require an alternative approach. Drug Abuse and Addiction in Medical Illness: Causes, Consequences, and Treatment is a major contribution to the literature, a gold standard title offering a comprehensive range of topics for those who care for patients with addiction, conduct research in this area, or simply have an interest in the field. Offering state-of-the-art information for all those working with drug abusing or addicted patients, or for those interested in this topic from other research perspectives, the volume is a first of its kind book -- rich, comprehensive, yet focused, addressing the needs of the very active theoretical, basic, and clinical research in the field. Comprised of 46 chapters organized in four sections and developed by the leading international experts, Drug Abuse and Addiction in Medical Illness: Causes, Consequences, and Treatment covers virtually every core, as well as contemporary, topic on addiction, from the established theories to the most modern research and development in the field. Enhancing the educational value of the volume, every chapter includes an abstract and two boxes summarizing learning objectives and directions for future research. Drug Abuse and Addiction in Medical Illness: Causes, Consequences, and Treatment discusses the topic in a authoritative, systematic manner and is an indispensable reference for all clinicians and researchers interested in this rapidly changing field.
