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- 2011378635 abstract "In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.-- Source other than Library of Congress.".
- 2011378635 contributor B12247831.
- 2011378635 contributor B12247832.
- 2011378635 created "c2011.".
- 2011378635 date "2011".
- 2011378635 date "c2011.".
- 2011378635 dateCopyrighted "c2011.".
- 2011378635 description "In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.-- Source other than Library of Congress.".
- 2011378635 description "Includes bibliographical references.".
- 2011378635 description "Introduction -- Committee findings and recommendations -- FDA perspectives -- National institutes of health perspectives -- Industry perspectives -- Public health, consumer, and consulting organization perspectives -- Presentation by Thomas Fleming: biomarkers and surrogate endpoints in chronic disease -- Key themes, challenges, and opportunities -- Importance of the biomarker discussion forum.".
- 2011378635 extent "x, 129 p. :".
- 2011378635 identifier "0309163242 (pbk.)".
- 2011378635 identifier "9780309163248 (pbk.)".
- 2011378635 issued "2011".
- 2011378635 issued "c2011.".
- 2011378635 language "eng".
- 2011378635 publisher "Washington, D.C. : National Academies Press,".
- 2011378635 spatial "United States".
- 2011378635 subject "Biochemical markers Evaluation.".
- 2011378635 subject "Chronic diseases.".
- 2011378635 subject "Clinical trials.".
- 2011378635 subject "Drugs United States Testing.".
- 2011378635 subject "R853.B54 P47 2011".
- 2011378635 tableOfContents "Introduction -- Committee findings and recommendations -- FDA perspectives -- National institutes of health perspectives -- Industry perspectives -- Public health, consumer, and consulting organization perspectives -- Presentation by Thomas Fleming: biomarkers and surrogate endpoints in chronic disease -- Key themes, challenges, and opportunities -- Importance of the biomarker discussion forum.".
- 2011378635 title "Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / Alison Mack, Erin Balogh, and Christine M. Micheel, rapporteurs ; Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Board on Health Care Services, Board on Health Sciences Policy, Food and Nutrition Board, Institute of Medicine of the National Academies.".
- 2011378635 type "text".