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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.
Imprint Washington, D.C. : The National Academies Press, [2011]

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Description 1 online resource (1 PDF file (ix, 129 pages)) : illustrations.
Note Title from PDF title page.
Bibliog. Includes bibliographical references.
Note Available only to authorized UTEP users.
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.
Subject Evaluation of biomarkers and surrogate endpoints in chronic disease.
Biochemical markers -- Evaluation -- Congresses.
Drugs -- United States -- Testing -- Congresses.
Clinical trials -- Congresses.
Chronic diseases -- Congresses.
Biomarkers.
Chronic Disease.
Evidence-Based Practice.
United States.
Genre Congresses.
Conference papers and proceedings.
Contents 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.
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.
Other Author 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.)
Other Title Print version: Perspectives on biomarker and surrogate endpoint evaluation. Washington, D.C. : National Academies Press, ©2011 9780309163248
Other Title Evaluation of biomarkers and surrogate endpoints in chronic disease.