PERSPECTIVES ON BIOMARKER AND SURROGATE ENDPOINT EVALUATION
Discussion Forum Summary
Alison Mack, Erin Balogh, and Christine M. Micheel, Rapporteurs
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
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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.
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Suggested citation: IOM (Institute of Medicine). 2011. Perspectives on biomarker and surrogate endpoint evaluation: Discussion forum summary. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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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
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,
RONALD KRAUSS, Director,
Atherosclerosis Research and
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.
ELIZABETH YETLEY, Consultant,
National Institutes of Health, Office of Dietary Supplements
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
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