Contemporary Issues For Protecting Patients In Cancer Research
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| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 125 |
| Release | : 2014-09-19 |
| Genre | : Medical |
| ISBN | : 0309306698 |
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 95 |
| Release | : 2013-06-20 |
| Genre | : Medical |
| ISBN | : 030926944X |
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 334 |
| Release | : 2009-03-24 |
| Genre | : Computers |
| ISBN | : 0309124999 |
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 455 |
| Release | : 2008-03-19 |
| Genre | : Medical |
| ISBN | : 0309134161 |
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 317 |
| Release | : 2010-07-08 |
| Genre | : Medical |
| ISBN | : 0309157870 |
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.
| Author | : Agency for Healthcare Research and Quality/AHRQ |
| Publisher | : Government Printing Office |
| Total Pages | : 385 |
| Release | : 2014-04-01 |
| Genre | : Medical |
| ISBN | : 1587634333 |
This 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 | : Peter Angelos |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 174 |
| Release | : 1999-12-31 |
| Genre | : Medical |
| ISBN | : 9780792377269 |
This book addresses a variety of ethical issues that arise in the care of oncology patients. Many volumes have been written on medical ethics in the past 30 years. However, few have focused on ethical issues specific to the care of cancer patients. This book brings together such a focused examination. The contributors are experienced clinicians, ethicists, medical humanists, and medical educators. The issues raised have direct relevance to the care of oncology patients in treatment as well as research settings. The chapters address issues that are central to contemporary medical practice and medical ethics inquiry. Any practicing clinician will be well aware of the problems of communication and how uncertainty, cross-cultural issues, and religious influences can impact patient care. The limits of care and the role of advance directives and palliative care are common issues that must be addressed in treating patients at the end of life. For oncologists and oncology patients, participation in clinical trials may be a thomy topic, especially when phase I clinical trials are being considered. The impact of managed care and reimbursement issues cannot be avoided in the contemporary patient care and similarly cannot be neglected when considering the ethical ramifications raised. No discussion of ethics in oncology can be complete without attention to the specific challenges raised by the pediatric patient with cancer. All of these topics are explored by the contributors to this book.
| Author | : Suzanne H. Reuben |
| Publisher | : DIANE Publishing |
| Total Pages | : 240 |
| Release | : 2010-10 |
| Genre | : Health & Fitness |
| ISBN | : 1437934218 |
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.
| Author | : Committee on Improving the Quality of Cancer Care: Addressing the Challenges of an Aging Population |
| Publisher | : National Academies Press |
| Total Pages | : 0 |
| Release | : 2014-01-10 |
| Genre | : Medical |
| ISBN | : 9780309286602 |
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.
| Author | : National Research Council |
| Publisher | : National Academies Press |
| Total Pages | : 142 |
| Release | : 2012-01-16 |
| Genre | : Medical |
| ISBN | : 0309222222 |
Motivated by the explosion of molecular data on humans-particularly data associated with individual patients-and the sense that there are large, as-yet-untapped opportunities to use this data to improve health outcomes, Toward Precision Medicine explores the feasibility and need for "a new taxonomy of human disease based on molecular biology" and develops a potential framework for creating one. The book says that a new data network that integrates emerging research on the molecular makeup of diseases with clinical data on individual patients could drive the development of a more accurate classification of diseases and ultimately enhance diagnosis and treatment. The "new taxonomy" that emerges would define diseases by their underlying molecular causes and other factors in addition to their traditional physical signs and symptoms. The book adds that the new data network could also improve biomedical research by enabling scientists to access patients' information during treatment while still protecting their rights. This would allow the marriage of molecular research and clinical data at the point of care, as opposed to research information continuing to reside primarily in academia. Toward Precision Medicine notes that moving toward individualized medicine requires that researchers and health care providers have access to very large sets of health- and disease-related data linked to individual patients. These data are also critical for developing the information commons, the knowledge network of disease, and ultimately the new taxonomy.
