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An Assessment of the NIH Women's Health Initiative
The National Institutes of Health Women's Health Initiative (WHI) is the largest research study ever funded by NIH ($625 million over 14 years) and is designed to test strategies to prevent cardiovascular disease, breast cancer, and osteoporotic fracturesâ€"leading causes of death, disability, and decreased quality of life for older women. Although the WHI has already begun, serious questions remain about its design, cost, and the likelihood that it can answer the questions it asks. This book evaluates whether the effort can be justified scientifically.
Clinical Practice Guidelines We Can Trust
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 ubiqu...
Evaluation of the Congressionally Directed Medical Research Programs Review Process
The medical research landscape in the United States is supported by a variety of organizations that spend billions of dollars in government and private funds each year to seek answers to complex medical and public health problems. The largest government funder is the National Institutes of Health (NIH), followed by the Department of Defense (DoD). Almost half of DoD's medical research funding is administered by the Congressionally Directed Medical Research Programs (CDMRP). The mission of CDMRP is to foster innovative approaches to medical research in response to the needs of its stakeholdersâ€"the U.S. military, their families, the American public, and Congress. CDMRP funds medical resea...
Finding What Works in Health Care
Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines...
Assessing the Value of Research in the Chemical Sciences
This book captures the messages from a workshop that brought together research managers from government, industry, and academia to review and discuss the mechanisms that have been proposed or used to assess the value of chemical research. The workshop focused on the assessment procedures that have been or will be established within the various organizations that carry out or fund research activities, with particular attention to the Government Performance and Results Act (GPRA). The book presents approaches and ideas from leaders in each area that were intended to identify new and useful ways of assessing the value and potential impact of research activities.
Sharing Clinical Trial Data
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 responsi...
Oversight and Review of Clinical Gene Transfer Protocols
Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Som...
Medicare
Health care for the elderly American is among our nation's more pressing social issues. Our society wishes to ensure quality health care for all older people, but there is growing concern about our ability to maintain and improve quality in the face of efforts to contain health care costs. Medicare: A Strategy for Quality Assurance answers the U.S. Congress' call for the Institute of Medicine to design a strategic plan for assessing and assuring the quality of medical care for the elderly. This book presents a proposed strategic plan for improving quality assurance in the Medicare program, along with steps and timetables for implementing the plan by the year 2000 and the 10 recommendations for action by Congress. The book explores quality of careâ€"how it is defined, measured, and improvedâ€"and reviews different types of quality problems. Major issues that affect approaches to assessing and assuring quality are examined. Medicare: A Strategy for Quality Assurance will be immediately useful to a wide audience, including policymakers, health administrators, individual providers, specialists in issues of the older American, researchers, educators, and students.
Responsible Conduct of Research
Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
