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A01=Board on Health Care Services
A01=Board on Health Sciences Policy
A01=Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease
A01=Food and Nutrition Board
A01=Institute of Medicine
Age Group_Uncategorized
Age Group_Uncategorized
Author_Board on Health Care Services
Author_Board on Health Sciences Policy
Author_Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease
Author_Food and Nutrition Board
Author_Institute of Medicine
automatic-update
B01=Alison Mack
B01=Christine M. Micheel
B01=Erin Balogh
Category1=Non-Fiction
Category=M
Category=MJCL
COP=United States
Delivery_Delivery within 10-20 working days
Language_English
PA=Available
Price_€20 to €50
PS=Active
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Perspectives on Biomarker and Surrogate Endpoint Evaluation: 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.

Table of Contents
  • Front Matter
  • 1 Introduction
  • 2 Committee Findings and Recommendations
  • 3 FDA Perspectives
  • 4 National Institutes of Health Perspectives
  • 5 Industry Perspectives
  • 6 Public Health, Consumer, and Consulting Organization Perspectives
  • 7 Presentation by Thomas Fleming: Biomarkers and Surrogate Endpoints in Chronic Disease
  • 8 Key Themes, Challenges, and Opportunities
  • 9 Importance of the Biomarker Discussion Forum
  • References
  • Acronyms
  • Glossary
  • Appendix A: Discussion Forum Agenda
  • Appendix B: Summary from the Committee's Report *Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease*
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A01=Board on Health Care ServicesA01=Board on Health Sciences PolicyA01=Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic DiseaseA01=Food and Nutrition BoardA01=Institute of MedicineAge Group_UncategorizedAuthor_Board on Health Care ServicesAuthor_Board on Health Sciences PolicyAuthor_Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic DiseaseAuthor_Food and Nutrition BoardAuthor_Institute of Medicineautomatic-updateB01=Alison MackB01=Christine M. MicheelB01=Erin BaloghCategory1=Non-FictionCategory=MCategory=MJCLCOP=United StatesDelivery_Delivery within 10-20 working daysLanguage_EnglishPA=AvailablePrice_€20 to €50PS=Activesoftlaunch
Delivery/Collection within 10-20 working days
Product Details
  • Dimensions: 152 x 229mm
  • Publication Date: 12 Feb 2011
  • Publisher: National Academies Press
  • Publication City/Country: United States
  • Language: English
  • ISBN13: 9780309163248

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