Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease - Softcover

Committee On Qualifications Of Biomarkers And Surrogate Endpoints In Chronic Disease; Institute Of Medicine

Softcover

ISBN 10: 0309151295 ISBN 13: 9780309151290

Publisher: National Academies Press, 2010

Synopsis

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. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease recommends a new framework to consistently and transparently judge the appropriateness and validity of the scientific benchmarks used in studies that companies provide to support health and safety claims for their products. The book states that the same rigour be applied to evaluating the science behind claims of foods' and nutritional supplements' health benefits as is devoted to assessing medication and medical technology approvals. Agencies have been hampered in their ability to assess the proliferation of health claims being made by food and supplement manufacturers in part because they lack a process broadly accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid and appropriate measurements to substitute for clinical outcomes. The book focuses on the use of biomarkers. Because it can be time consuming and difficult to test products against actual clinical outcomes - such as whether they cure or reduce the risk of a disease - companies often conduct studies measuring effects on biomarkers, which are used as biological yardsticks or substitutes for clinical outcomes. Biomarkers can enable faster, more efficient clinical trials for life-saving and health-promoting interventions and can help improve the understanding of healthy dietary choices, help public health professionals to identify and track health concerns, and help health care practitioners and their patients make decisions about patient care. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease recommends a framework for the evaluation of biomarkers. The framework is meant for use in research; clinical; product, and claim development in the food, drug, and device industries; and public health settings. The book also suggests strategies for implementing the evaluation framework, supporting the use of evidence-based regulation and the protection and promotion of public health.

Edition details

• Publisher: National Academies Press
• Publication date: 2010
• Language: English
• ISBN 10: 0309151295
• ISBN 13: 9780309151290
• Binding: Paperback
• Number of pages: 336
• Editor: Christine M. Micheel, John R. Ball