Perspectives on biomarker and surrogate endpoint evaluation
Subtitle: discussion forum summary
By: 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
Contributors: Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease; Institute of Medicine (U.S.). Board on Health Care Services; Institute of Medicine (U.S.). Board on Health Sciences Policy; Institute of Medicine (U.S.). Food and Nutrition Board; National Academies Press (U.S.)
Publisher: National Academies Press
Published: 2011
Place of publication: Washington, D.C
Language: eng
Number of pages: 129
ISBN-13: 9780309163248
Subjects: Biochemical markers; Chronic diseases; Clinical trials; Drugs; Testing; Evaluation
Description: 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.
Notes: Summary of a discussion forum that took place in Washington, DC on June 21-22, 2010.

Includes bibliographical references.
Table of contents: title: Introduction; title: Committee findings and recommendations; title: FDA perspectives; title: National institutes of health perspectives; title: Industry perspectives; title: Public health, consumer, and consulting organization perspectives; title: Presentation by Thomas Fleming: biomarkers and surrogate endpoints in chronic disease; title: Key themes, challenges, and opportunities; title: Importance of the biomarker discussion forum.