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Contemporary Issues for Protecting Patients in Cancer Research

Contemporary Issues for Protecting Patients in Cancer Research PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309306698
Category : Medical
Languages : en
Pages : 125

Book Description
In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges.

Contemporary Issues for Protecting Patients in Cancer Research

Contemporary Issues for Protecting Patients in Cancer Research PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309306698
Category : Medical
Languages : en
Pages : 125

Book Description
In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges.

Cancer Care for the Whole Patient

Cancer Care for the Whole Patient PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309134161
Category : Medical
Languages : en
Pages : 455

Book Description
Cancer care today often provides state-of-the-science biomedical treatment, but fails to address the psychological and social (psychosocial) problems associated with the illness. This failure can compromise the effectiveness of health care and thereby adversely affect the health of cancer patients. Psychological and social problems created or exacerbated by cancer-including depression and other emotional problems; lack of information or skills needed to manage the illness; lack of transportation or other resources; and disruptions in work, school, and family life-cause additional suffering, weaken adherence to prescribed treatments, and threaten patients' return to health. Today, it is not possible to deliver high-quality cancer care without using existing approaches, tools, and resources to address patients' psychosocial health needs. All patients with cancer and their families should expect and receive cancer care that ensures the provision of appropriate psychosocial health services. Cancer Care for the Whole Patient recommends actions that oncology providers, health policy makers, educators, health insurers, health planners, researchers and research sponsors, and consumer advocates should undertake to ensure that this standard is met.

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.

Delivering Affordable Cancer Care in the 21st Century

Delivering Affordable Cancer Care in the 21st Century PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030926944X
Category : Medical
Languages : en
Pages : 95

Book Description
Rising health care costs are a central fiscal challenge confronting the United States. National spending on health care currently accounts for 18 percent of gross domestic product (GDP), but is anticipated to increase to 25 percent of GDP by 2037. The Bipartisan Policy Center argues that "this rapid growth in health expenditures creates an unsustainable burden on America's economy, with far-reaching consequences". These consequences include crowding out many national priorities, including investments in education, infrastructure, and research; stagnation of employee wages; and decreased international competitiveness.In spite of health care costs that far exceed those of other countries, health outcomes in the United States are not considerably better. With the goal of ensuring that patients have access to high-quality, affordable cancer care, the Institute of Medicine's (IOM's) National Cancer Policy Forum convened a public workshop, Delivering Affordable Cancer Care in the 21st Century, October 8-9, 2012, in Washington, DC. Delivering Affordable Cancer Care in the 21st Century summarizes the workshop.

Delivering High-Quality Cancer Care

Delivering High-Quality Cancer Care PDF Author: Committee on Improving the Quality of Cancer Care: Addressing the Challenges of an Aging Population
Publisher: National Academies Press
ISBN: 9780309286602
Category : Medical
Languages : en
Pages : 0

Book Description
In the United States, approximately 14 million people have had cancer and more than 1.6 million new cases are diagnosed each year. However, more than a decade after the Institute of Medicine (IOM) first studied the quality of cancer care, the barriers to achieving excellent care for all cancer patients remain daunting. Care often is not patient-centered, many patients do not receive palliative care to manage their symptoms and side effects from treatment, and decisions about care often are not based on the latest scientific evidence. The cost of cancer care also is rising faster than many sectors of medicine--having increased to $125 billion in 2010 from $72 billion in 2004--and is projected to reach $173 billion by 2020. Rising costs are making cancer care less affordable for patients and their families and are creating disparities in patients' access to high-quality cancer care. There also are growing shortages of health professionals skilled in providing cancer care, and the number of adults age 65 and older--the group most susceptible to cancer--is expected to double by 2030, contributing to a 45 percent increase in the number of people developing cancer. The current care delivery system is poorly prepared to address the care needs of this population, which are complex due to altered physiology, functional and cognitive impairment, multiple coexisting diseases, increased side effects from treatment, and greater need for social support. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis presents a conceptual framework for improving the quality of cancer care. This study proposes improvements to six interconnected components of care: (1) engaged patients; (2) an adequately staffed, trained, and coordinated workforce; (3) evidence-based care; (4) learning health care information technology (IT); (5) translation of evidence into clinical practice, quality measurement and performance improvement; and (6) accessible and affordable care. This report recommends changes across the board in these areas to improve the quality of care. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis provides information for cancer care teams, patients and their families, researchers, quality metrics developers, and payers, as well as HHS, other federal agencies, and industry to reevaluate their current roles and responsibilities in cancer care and work together to develop a higher quality care delivery system. By working toward this shared goal, the cancer care community can improve the quality of life and outcomes for people facing a cancer diagnosis.

A National Cancer Clinical Trials System for the 21st Century

A National Cancer Clinical Trials System for the 21st Century PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157870
Category : Medical
Languages : en
Pages : 317

Book Description
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.

Reducing Environmental Cancer Risk

Reducing Environmental Cancer Risk PDF Author: Suzanne H. Reuben
Publisher: DIANE Publishing
ISBN: 1437934218
Category : Health & Fitness
Languages : en
Pages : 240

Book Description
Though overall cancer incidence and mortality have continued to decline in recent years, cancer continues to devastate the lives of far too many Americans. In 2009 alone, 1.5 million American men, women, and children were diagnosed with cancer, and 562,000 died from the disease. There is a growing body of evidence linking environmental exposures to cancer. The Pres. Cancer Panel dedicated its 2008¿2009 activities to examining the impact of environmental factors on cancer risk. The Panel considered industrial, occupational, and agricultural exposures as well as exposures related to medical practice, military activities, modern lifestyles, and natural sources. This report presents the Panel¿s recommend. to mitigate or eliminate these barriers. Illus.

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151

Book Description
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.

Cancer in Sub-Saharan Africa

Cancer in Sub-Saharan Africa PDF Author: D. M. Parkin
Publisher: IARC Scientific Publications
ISBN: 9789283222200
Category : History
Languages : en
Pages : 0

Book Description
The Cancer in Sub-Saharan Africa volume brings together population-based cancer incidence data from 25 cancer registries in 20 sub-Saharan African countries that are part of the African Cancer Registry Network. The compiled data in this volume, presented and commented upon by covered population and by anatomical site, are of tremendous value to the assessment of the pattern and evolution of cancer in Africa, as a means of elucidating, confirming, and evaluating causes of the disease.

Ethics in Pharmacy Practice: A Practical Guide

Ethics in Pharmacy Practice: A Practical Guide PDF Author: Dennis M. Sullivan
Publisher: Springer Nature
ISBN: 3030721698
Category : Philosophy
Languages : en
Pages : 234

Book Description
This textbook offers a unique and accessible approach to ethical decision-making for practicing pharmacists and student pharmacists. Unlike other texts, it gives clear guidance based on the fundamental principles of moral philosophy, explaining them in simple language and illustrating them with abundant clinical examples and case studies. The strength of this text is in its emphasis on normative ethics and critical thinking, and that there is truly a best answer in the vast majority of cases, no matter how complex. The authors place high trust in a pharmacist’s moral judgment. This teaches the reader how to think, based on ethical principles, not necessarily what to think. This means navigating between the two extremes of overly theoretical and excessively prescriptive. The cogent framework given in this text uses the language of competing duties, identifying the moral principles at stake that create duties for the pharmacist. This is the balancing act of normative ethics, and of deciding which duties should prevail in a given clinical situation. This work presents a clear-cut pathway for resolving ethical dilemmas encountered by pharmacists, based on foundational principles and critical thinking. Presents a clear-cut pathway for resolving the ethical dilemmas encountered by pharmacists, based on foundational principles and critical thinking. Jon E. Sprague, RPh, PhD, Director of Science and Research for the Ohio Attorney General