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.

Cover image for 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.

ISBN:

9780309163248

9780309163255

9781282976054

Title:

Author:

Mack, Alison, author.

Personal Author:

Mack, Alison, author.

Physical Description:

1 online resource (1 PDF file (ix, 129 pages)) : illustrations

General Note:

Title from PDF title page.

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.

Local Note:

eBooks on EBSCOhost

Title Subject:

Evaluation of biomarkers and surrogate endpoints in chronic disease.

Subject Term:

Biochemical markers -- Evaluation -- Congresses.

Drugs -- United States -- Testing -- Congresses.

Clinical trials -- Congresses.

Chronic diseases -- Congresses.

Biomarkers.

Chronic Disease.

Evidence-Based Practice.

Added Author:

Balogh, Erin,

Micheel, Christine,

Added Corporate Author:

Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease,

Added Conference Author:

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (Discussion forum) (2010 : Washington, D.C.)

Added Uniform Title:

Evaluation of biomarkers and surrogate endpoints in chronic disease.

Format:

Electronic Resources

Electronic Access:

Click here to view

Publication Date:

2011

Publication Information:

Washington, D.C. :

The National Academies Press,

[2011]

Available:*

Shelf Number	Material Type	Copy	Shelf Location	Status
610.28 22	1:E-BOOK	1	1:ONLINE	Searching... Unknown

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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.

Paula TrumboKathleen EllwoodMarc WaltonFederico GoodsaidRobert BeckerMichael LauerPaul CoatesDouglas BalentineMelissa Musiker and GroceryAndrew ShaoStephen WilliamsJames MayneJack ZakowskiRichard KuntzGuy JohnsonMary HagerIlene Heller

1 Introduction	p. 1
2 Committee Findings and Recommendations	p. 3
Charge to the Committee	p. 3
Definitions	p. 5
Recommendations	p. 7
3 FDA Perspectives	p. 29
Presentation	p. 31
Presentation	p. 33
Presentation	p. 34
Presentation	p. 37
Presentation	p. 39
4 National Institutes of Health Perspectives	p. 43
Presentation	p. 44
Presentation	p. 48
5 Industry Perspectives	p. 51
Presentation	p. 55
Presentation	p. 56
Presentation	p. 58
Presentation	p. 59
Presentation	p. 63
Presentation	p. 64
Presentation	p. 65
6 Public Health, Consumer, and Consulting Organization Perspectives	p. 69
Presentation	p. 69
Presentation	p. 71
Presentation	p. 72
7 Presentation Thomas Fleming: Biomarkers and Surrogate Endpoints in Chronic Disease	p. 75
A Correlate Does Not a Surrogate Make	p. 75
Validating Surrogate Endpoints	p. 80
A Biomarker Hierarchy	p. 83
Concluding Thoughts	p. 85
8 Key Themes, Challenges, and Opportunities	p. 87
Biomarker Evaluation Framework	p. 87
The Value of Biomarkers and Surrogate Endpoints	p. 90
Considerations for Food and Nutrition Applications	p. 91
Improving Communication and Understanding	p. 93
9 Importance of the Biomarker Discussion Forum	p. 97
References	p. 99
Acronyms	p. 103
Glossary	p. 107
Appendixes
A Discussion Forum Agenda	p. 113
B Summary from the Committee's Report	p. 115

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Summary

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Table of Contents