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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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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

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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THE NATIONAL ACADEMIES PRESS
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Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

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.

International Standard Book Number-13: 978-0-309-16324-8

International Standard Book Number-10: 0-309-16324-2

Additional copies of this report are available from the

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For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2011 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2011. Perspectives on biomarker and surrogate endpoint evaluation: Discussion forum summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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“Knowing is not enough; we must apply.

Willing is not enough; we must do.”

—Goethe

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine


The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.


The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.


The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.


The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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COMMITTEE ON QUALIFICATION OF BIOMARKERS AND SURROGATE ENDPOINTS IN CHRONIC DISEASE

JOHN R. BALL (Chair), Senior Advisor,

American Society for Clinical Pathology

MICHELLE A. ALBERT, Assistant Professor of Medicine, Associate Physician, and Director of Behavioral and Neurocardiovascular Cardiology,

Brigham and Women’s Hospital, Harvard Medical School

FRED APPLE, Medical Director,

Clinical Laboratories, Hennepin County Medical Center, and

Professor,

Laboratory Medicine and Pathology, University of Minnesota School of Medicine

ROBERT M. CALIFF, Vice Chancellor for Clinical Research and Professor of Medicine,

Cardiology, Duke University School of Medicine

VICTOR DE GRUTTOLA, Professor and Chair,

Biostatistics, Harvard School of Public Health

DAVID DEMETS, Professor,

Biostatistics & Medical Informatics, University of Wisconsin–Madison

ROBERT GERSZTEN, Research Director and Faculty Member,

Massachusetts General Hospital, and

Associate Professor of Medicine,

Harvard Medical School

WILLIAM HARLAN, JR., Consultant

ALLAN JAFFE, Professor of Medicine,

Mayo Clinic

RONALD KRAUSS, Director,

Atherosclerosis Research and

Senior Scientist,

Children’s Hospital Oakland Research Institute

HARLAN M. KRUMHOLZ, Harold H. Hines, Jr., Professor of Medicine

and Epidemiology and Public Health, Yale University School of Medicine

MARIA LOPES-VIRELLA, Professor,

Bioengineering, Medical University of South Carolina

ROBERTA NESS, Dean,

University of Texas Health Science Center, School of Public Health

JENNIFER VAN EYK, Professor,

Departments of Medicine and Biological Chemistry, Johns Hopkins University

JOHN A. WAGNER, Vice President,

Clinical Pharmacology, Merck & Co., Inc.

Consultant

ELIZABETH YETLEY, Consultant,

National Institutes of Health, Office of Dietary Supplements

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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Study Staff

CHRISTINE M. MICHEEL, Study Director

SHARYL NASS, Senior Program Officer

ERIN BALOGH, Associate Program Officer

CAIRA WOODS, Christine Mirzayan Science and Technology Policy Graduate Fellow (January to April 2010), Research Associate (April to July 2010)

ASHLEY MCWILLIAMS, Senior Program Assistant

PATRICK BURKE, Financial Associate

ROGER HERDMAN, Director,

Board on Health Care Services

LINDA MEYERS, Director,

Food and Nutrition Board

ANDREW POPE, Director,

Board on Health Sciences Policy

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report:

Douglas Balentine, Unilever

Thomas Fleming, University of Washington

Philip Greenland, Northwestern University

James Mayne, Pfizer, Inc.

Rebecca Miksad, Harvard Medical School

Jack Zakowski, Beckman Coulter, Inc.

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by Sharon B. Murphy, scholar-in-residence, Institute of Medicine. Appointed by the Institute of Medicine, she was responsible for making certain that an

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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authors and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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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.

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