Hidden Bibliographic Details
| Other uniform titles: | Evaluation of biomarkers and surrogate endpoints in chronic disease.
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| Other authors / contributors: | Balogh, Erin, author.
Micheel, Christine, author.
Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, author.
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (Discussion forum) (2010 : Washington, D.C.)
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| ISBN: | 9780309163248
0309163242
9780309163255
0309163250
1282976052
9781282976054
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| Notes: | Title from PDF title page.
Includes bibliographical references.
This study was supported by Contract No. HHSF223200810020I between the National Academy of Sciences and the Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
Version viewed Sept. 10, 2014.
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| Summary: | 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.
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| Other form: | Print version: Perspectives on biomarker and surrogate endpoint evaluation. Washington, D.C. : National Academies Press, ©2011 9780309163248
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