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Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309042860
Category : Medical
Languages : en
Pages : 241

Book Description
The 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.

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309042860
Category : Medical
Languages : en
Pages : 241

Book Description
The 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.

Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334

Book Description
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Testing Treatments

Testing Treatments PDF Author: Imogen Evans
Publisher: Pinter & Martin Publishers
ISBN: 1905177488
Category : Health & Fitness
Languages : en
Pages : 187

Book Description
This work provides a thought-provoking account of how medical treatments can be tested with unbiased or 'fair' trials and explains how patients can work with doctors to achieve this vital goal. It spans the gamut of therapy from mastectomy to thalidomide and explores a vast range of case studies.

Clinical Practice Guidelines We Can Trust

Clinical Practice Guidelines We Can Trust PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030921646X
Category : Medical
Languages : en
Pages : 217

Book Description
Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

Book Description
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.

Evidence-Based Medicine and the Changing Nature of Health Care

Evidence-Based Medicine and the Changing Nature of Health Care PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309113695
Category : Medical
Languages : en
Pages : 202

Book Description
Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

Women's Health Research

Women's Health Research PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163374
Category : Medical
Languages : en
Pages : 439

Book Description
Even though slightly over half of the U.S. population is female, medical research historically has neglected the health needs of women. However, over the past two decades, there have been major changes in government support of women's health research-in policies, regulations, and the organization of research efforts. To assess the impact of these changes, Congress directed the Department of Health and Human Services (HHS) to ask the IOM to examine what has been learned from that research and how well it has been put into practice as well as communicated to both providers and women. Women's Health Research finds that women's health research has contributed to significant progress over the past 20 years in lessening the burden of disease and reducing deaths from some conditions, while other conditions have seen only moderate change or even little or no change. Gaps remain, both in research areas and in the application of results to benefit women in general and across multiple population groups. Given the many and significant roles women play in our society, maintaining support for women's health research and enhancing its impact are not only in the interest of women, they are in the interest of us all.

Cattle, Priests, and Progress in Medicine

Cattle, Priests, and Progress in Medicine PDF Author: Calvin W. Schwabe
Publisher: U of Minnesota Press
ISBN: 0816658676
Category : Medical
Languages : en
Pages : 294

Book Description
Cattle, Priests, and Progress in Medicine was first published in 1978. Minnesota Archive Editions uses digital technology to make long-unavailable books once again accessible, and are published unaltered from the original University of Minnesota Press editions. The author shows that over the centuries many of the most significant breakthroughs in improving humans health have been closely associated with observations and experiments on animals other than man. Because human medical progress has been so dependent on veterinary studies, he urges that schools of veterinary medicine assume a much greater role in the training of persons for research in human medicine. To illuminate the historical link between animals and man in medical progress, Professor Schwabe recounts highlights in the history of medicine from ancient times onward. He describes the early history of man in terms of animal cultures, focusing on the prehistoric Nile Valley, and points to similarities in medical knowledge between present-day "cattle" societies in Northeastern Africa and the ancient people of the Nile. He discusses the comparative healers of ancient Egypt, the comparative foundations of Greek medicine, the Arabic contribution, Sicily and the beginnings of modern medicine, and subsequent developments through the Renaissance .Bringing the history down to modern times, Professor Schwabe emphasizes the role of veterinary medicine in medical research. He outlines specific reforms in the curricula of schools and colleges of veterinary medicine which would provide for the education of medical investigators.

Innovation in Medical Technology

Innovation in Medical Technology PDF Author: Margaret L. Eaton
Publisher: JHU Press
ISBN: 9780801885266
Category : Law
Languages : en
Pages : 188

Book Description
This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.

Progress and Challenges in Precision Medicine

Progress and Challenges in Precision Medicine PDF Author: Mukesh Verma
Publisher: Academic Press
ISBN: 0128095024
Category : Medical
Languages : en
Pages : 344

Book Description
Progress and Challenges in Precision Medicine presents an insightful overview to the myriad factors of personalized and precision medicine. The availability of the human genome, large amounts of data on individual genetic variations, environmental interactions, influence of lifestyle, and cutting-edge tools and technologies for big-data analysis have led to the age of personalized and precision medicine. Bringing together a global range of experts on precision medicine, this book collects previously scattered information into one concise volume which covers the most important developments so far in precision medicine and also suggests the most likely avenues for future development. The book includes clinical information, informatics, public policy implications, and information on case studies. It is a useful reference and background work for students, researchers, and clinicians working in the biomedical and medical fields, as well as policymakers in the health sciences. Provides an overview of the growing field of precision medicine Contains chapters from geographically diverse experts in their field Explores important aspects of precision medicine, including applications, ethics, and development