Committee on Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment's Books

Cancer Biomarkers

The Promises and Challenges of Improving Detection and Treatment

By: Institute of Medicine,Committee on Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment

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Cancer Biomarkers

The Promises and Challenges of Improving Detection and Treatment

By: Institute of Medicine,Committee on Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment

Many cancer patients are diagnosed at a stage in which the cancer is too far advanced to be cured, and most cancer treatments are effective in only a minority of patients undergoing therapy. Thus, there is tremendous opportunity to improve the outcome for people with cancer by enhancing detection and treatment approaches. Biomarkers will be instrumental in making that transition. Advances in biotechnology and genomics have given scientists new hope that biomarkers can be used to improve cancer screening and detection, to improve the drug development process, and to enhance the effectiveness and safety of cancer care by allowing physicians to tailor treatment for individual patients—an approach known as personalized medicine. However, progress overall has been slow, despite considerable effort and investment, and there are still many challenges and obstacles to overcome before this paradigm shift in oncology can become a reality.

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Page Count

250

Publisher

National Academies Press

Published Date

ISBN 10

0309133998

ISBN 13

9780309133999

Geographic Adjustment in Medicare Payment

Phase I: Improving Accuracy

By: Institute of Medicine,Board on Health Care Services,Committee on Geographic Adjustment Factors in Medicare Payment

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Geographic Adjustment in Medicare Payment

Phase I: Improving Accuracy

By: Institute of Medicine,Board on Health Care Services,Committee on Geographic Adjustment Factors in Medicare Payment

Medicare is the largest health insurer in the United States, providing coverage for 39 million people aged 65 and older and 8 million people with disabilities, and reaching more than an estimated $500 billion in payments in 2010. Although Medicare is a national program, it adjusts fee-for-service payments according to the geographic location of a practice. While there is widespread agreement about the importance of providing accurate payments to providers, there is disagreement about how best to adjust payment based on geographic location. At the request of Congress and the Department of Health and Human Services (HHS), the Institute of Medicine (IOM) examined ways to improve the accuracy of data sources and methods used for making the geographic adjustments to payments. The IOM recommends an integrated approach that includes moving to a single source of wage and benefits data; changing to one set of payment areas; and expanding the range of occupations included in the index calculations. The first of two reports, Geographic Adjustment in Medicare Payment: Phase I: Improving Accuracy, assesses existing practices in regards to accuracy, criteria consistency, evidence for adjustment, sound rationale, transparency, and separate policy adjustments to reform the current payment system. Adopting the recommendations outlined in this report will mean a change in the way that the indexes are calculated, and will require a combination of legislative, rule-making, and administrative actions, as well as a period of public comment. Geographic Adjustment in Medicare Payment will inform the work of government agencies such as HHS, the Centers for Medicare and Medicaid Services, congressional members and staff, the health care industry, national professional organizations and state medical and nursing societies, and Medicare advocacy groups.

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Page Count

236

Publisher

National Academies Press

Published Date

ISBN 10

0309211492

ISBN 13

9780309211499

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

By: Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease

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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

By: Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease

Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

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Page Count

335

Publisher

National Academies Press

Published Date

ISBN 10

0309157277

ISBN 13

9780309157278

Scientific Standards for Studies on Modified Risk Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

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Scientific Standards for Studies on Modified Risk Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

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