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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. : National Academies Press, c2011.
description
x, 129 p. : charts, 23 cm.
ISBN
0309163242 (pbk.), 9780309163248 (pbk.)
format(s)
Book
Holdings
More Details
imprint
Washington, D.C. : National Academies Press, c2011.
isbn
0309163242 (pbk.)
9780309163248 (pbk.)
contents note
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.
general note
Summary of a discussion forum held June 21-22, 2010 in Washington, DC.
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.
catalogue key
8276802
 
Includes bibliographical references.
A Look Inside
Reviews
This item was reviewed in:
Reference & Research Book News, October 2011
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Summaries
Description for Bookstore
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.
Main Description
Summary of a discussion forum that took place in Washington, DC on June 21-22, 2010.
Table of Contents
Introductionp. 1
Committee Findings and Recommendationsp. 3
Charge to the Committeep. 3
Definitionsp. 5
Recommendationsp. 7
FDA Perspectivesp. 29
Presentationp. 31
Presentationp. 33
Presentationp. 34
Presentationp. 37
Presentationp. 39
National Institutes of Health Perspectivesp. 43
Presentationp. 44
Presentationp. 48
Industry Perspectivesp. 51
Presentationp. 55
Presentationp. 56
Presentationp. 58
Presentationp. 59
Presentationp. 63
Presentationp. 64
Presentationp. 65
Public Health, Consumer, and Consulting Organization Perspectivesp. 69
Presentationp. 69
Presentationp. 71
Presentationp. 72
Presentation Thomas Fleming: Biomarkers and Surrogate Endpoints in Chronic Diseasep. 75
A Correlate Does Not a Surrogate Makep. 75
Validating Surrogate Endpointsp. 80
A Biomarker Hierarchyp. 83
Concluding Thoughtsp. 85
Key Themes, Challenges, and Opportunitiesp. 87
Biomarker Evaluation Frameworkp. 87
The Value of Biomarkers and Surrogate Endpointsp. 90
Considerations for Food and Nutrition Applicationsp. 91
Improving Communication and Understandingp. 93
Importance of the Biomarker Discussion Forump. 97
Referencesp. 99
Acronymsp. 103
Glossaryp. 107
Appendixes
Discussion Forum Agendap. 113
Summary from the Committee's Reportp. 115
Table of Contents provided by Ingram. All Rights Reserved.

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