Marilyn J. Field

Conflict of Interest in Medical Research, Education, and Practice

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the publics trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

The Future of Disability in America

The future of disability in America will depend on how well the U.S. prepares for and manages the demographic, fiscal, and technological developments that will unfold during the next two to three decades. Building upon two prior studies from the Institute of Medicine (the 1991 Institute of Medicines report Disability in America and the 1997 report Enabling America), The Future of Disability in America examines both progress and concerns about continuing barriers that limit the independence, productivity, and participation in community life of people with disabilities. This book offers a comprehensive look at a wide range of issues, including the prevalence of disability across the lifespan; disability trends the role of assistive technology; barriers posed by health care and other facilities with inaccessible buildings, equipment, and information formats; the needs of young people moving from pediatric to adult health care and of adults experiencing premature aging and secondary health problems; selected issues in health care financing (e.g., risk adjusting payments to health plans, coverage of assistive technology); and the organizing and financing of disability-related research. The Future of Disability in America is an assessment of both principles and scientific evidence for disability policies and services. This books recommendations propose steps to eliminate barriers and strengthen the evidence base for future public and private actions to reduce the impact of disability on individuals, families, and society.

Medical Practice Guidelines: Current Activities and Future Directions

OBJECTIVE To examine the state of the art in the field of medical practice guidelines, to identify limitations, and to suggest future directions. DESIGN Informal descriptive survey using a questionnaire administered by telephone, supplemented by comments, by opinions, and by examples solicited from the participating organizations. PARTICIPANTS Eight prominent organizations representing prototypic approaches to guideline development; these organizations included three medical societies, two health care organizations, two insurers, and one private health benefits management company. RESULTS Improving the quality of medical care was a stated goal of all eight surveyed organizations. However, their objectives have not been stated in operational terms, reflecting the lesser emphasis placed on methods and means for both implementing guidelines and evaluating their impact on health practices and outcomes. In contrast, several systematic methods for developing guidelines exist. They differ in the stress placed on formal literature reviews, reliance on local as opposed to national experts, and formal methods of group judgment, but no evidence exists on which approaches produce sounder and more usable guidelines. CONCLUSIONS Guidelines are being vigorously promoted as a means to improve the effectiveness of the health care system. Current initiatives show both strengths and weaknesses. In particular, the attention now paid to the development of guidelines needs to be matched by attention to implementation strategies and to the scientific evaluation of their effectiveness in real clinical settings. Also, more agreement is needed on acceptable methods for developing guidelines, assessing their content, and evaluating their impact on professional behavior, patient outcomes, and health care costs. Fortunately, several initiatives to bring greater order and quality to this field are under way.

Telemedicine: A guide to assessing telecommunications in healthcare

Telemedicine--the use of information and telecommunications technologies to provide and support health care when distance separates the participants--is receiving increasing attention not only in remote areas where health care access is troublesome but also in urban and suburban locations. Yet the benefits and costs of this blend of medicine and digital technologies must be better demonstrated before todays cautious decisionmakers invest significant funds in its development. Telemedicine presents a framework for evaluating patient care applications of telemedicine. The book identifies managerial, technical, policy, legal, and human factors that must be taken into account in evaluating a telemedicine program. The committee reviews previous efforts to establish evaluation frameworks and reports on results from several completed studies of image transmission, consulting from remote locations, and other telemedicine programs. The committee also examines basic elements of an evaluation and considers relevant issues of quality, accessibility, and cost of health care. Telemedicine will be of immediate interest to anyone with interest in the clinical application of telemedicine.

Ethical Conduct of Clinical Research Involving Children

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Tuberculosis in the Workplace

Summary Introduction Risks to Health Care and Other Workers Overview of Report Responses to Resurgent Tuberculosis The Broader Public Health Context: Eliminating Tuberculosis in the United States and Worldwide Conclusion Basics of Tuberculosis Transmission and Development of Latent Tuberculosis Infection and Active Tuberculosis Detection and Treatment of Latent Tuberculosis Infection Diagnosis and Treatment of Active Tuberculosis Conclusion Occupational Safety and Health Regulation in Context Strategies for Reducing Workplace Hazards The Occupational Safety and Health Act of 1970 and Its Administration Conclusion Comparison of CDC Guidelines and Proposed OSHA Rule CDC Guidelines on Preventing Transmission of Tuberculosis in Health Care Facilities Proposed OSHA Rule on Occupational Exposure to Tuberculosis Comparison of Guidelines and Proposed Rule: Administrative Controls Comparison of Guidelines and Proposed Rule: Engineering Controls Comparison of Guidelines and Proposed Rule: Personal Respiratory Protections Conclusion Occupational Risk of Tuberculosis Concepts and Definitions Historical Perspectives on the Occupational Risk of Tuberculosis More Recent Information on the Community and Occupational Risk of Tuberculosis Committee Conclusions Summary Implementation and Effects of CDC Guidelines Implementation of Tuberculosis Control Guidelines Effects of Implementing Tuberculosis Control Measures Committee Conclusions Summary Regulation and the Future of Tuberculosis in the Workplace Potential Effects of an OSHA Standard on Occupational Tuberculosis The Workplace and the Community References Appendixes A Study Origins and Activities B The Tuberculin Skin Test C The Occupational Tuberculosis Risk of Health Care Workers D Effects of CDC Guidelines on Tuberculosis Control in Health Care Facilities E OSHA in a Health Care Context F Respiratory Protection and Control of Tuberculosis in Health Care Facilities G Recommendations of the Institute of Medicine Committee on Eliminating Tuberculosis in the United States H Committee Biographies Index

IOM Review of FDA-Approved Biologics Labeled or Studied for Pediatric Use

BACKGROUND: Studies have examined the extent to which public policies such as the Best Pharmaceuticals for Children Act have increased pediatric information in drug labeling. Little attention has focused on pediatric labeling of biologics. This analysis examines the extent to which biologics are labeled for pediatric use or have been studied in children. METHODS: The analysis covers the 96 biologics (excluding vaccines) that were first licensed by the Food and Drug Administration between 1997 and 2010 and were still marketed as of 2010. Product labeling was consulted for information on approved pediatric uses, pediatric studies, or pediatric safety warnings based on analyses of adverse events. The online database ClinicalTrials.gov was searched for registered pediatric studies of these biologics. A separate analysis examined labeling and studies for 55 vaccines. RESULTS: For ∼60% of the 96 biologics, labeling shows approved pediatric use or pediatric study information or both. Approximately 85% of the biologics have ≥1 registered pediatric trial completed, underway, or planned. Overall, ∼90% are labeled for pediatric use, have pediatric information in the label, have a registered pediatric study, or have some combination of these characteristics. For the 55 analyzed vaccines, the corresponding figure is 95%. CONCLUSIONS: A majority of biologics approved in the past 15 years include some pediatric information in their labeling, and pediatric trials have been registered for a substantial majority of these products.

Rare Diseases and Orphan Products

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Safe and Effective Medicines for Children

Beginning in the 1990s and continuing into 2010, the federal government has acted to increase the study of drugs in children and thereby reduce a serious deficit in the data on drug safety and efficacy for young patients. One step was to offer economic incentives for the conduct of pediatric studies. A second step was to require such studies in specific situations. These policies—in their current form, the Best Pharmaceuticals for Children Act (BPCA; which provides the incentives) and the Pediatric Research Equity Act (PREA; which provides the requirements)—seek to expand the information available to clinicians who prescribe medications to children and, as a consequence, to improve clinical care and health outcomes for children of all ages. Consistent with legislative provisions adopted in 2007 and 2010, the Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to examine pediatric studies requested under BPCA (or its predecessor policies) or required under PREA (or its predecessor policies) and to consider the incentives for pediatric studies of biologics. A committee appointed by the IOM reviewed and assessed a representative sample of labeling changes and other FDA actions related to requested or required studies for the period from July 1, 1998, through December 31, 2010. The assessments covered the use of extrapolation and alternative endpoints for pediatric populations, neonatal assessments, ethical issues, and safety

Responsible Research Involving Children

Each year, advances in biomedical science save the lives of tens of thousands of children worldwide, prevent or limit disease or disability in many more, and improve the quality of life for countless others. Still, pediatricians and others have long argued that infants, children, and adolescents have not shared equally with adults in biomedical progress. In particular, many drugs that are prescribed for children have not been tested with children. This gap puts them at risk for dosing miscalculations and preventable harms related to metabolic and other differences between children and adults.