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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

DEVELOPING BIOMARKER-BASED TOOLS FOR Cancer Screening, Diagnosis, and Treatment

The State of the Science, Evaluation, Implementation, and Economics

WORKSHOP SUMMARY

National Cancer Policy Forum

Margie Patlak and Sharyl Nass, Rapporteurs

INSTITUTE OF MEDICINE OF THE NATIONAL ACADMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Contract Nos. HHSH25056133, HHSN261200611002C, 200-2005-13434, HHSM-500-2005-00179P, HHSP23320042509XI, and 223-01-2460 between the National Academy of Sciences and the Department of Health and Human Services. 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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International Standard Book Number-13 978-0-309-10134-9

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 2006 by the National Academy of Sciences. All rights reserved.

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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:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

“Knowing is not enough; we we must apply.

Willing is not enough; we must do.”

—Geothe

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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. Wm. A. Wulf 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. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

NATIONAL CANCER POLICY FORUM

HAROLD L. MOSES, MD (Chair), Professor of Cancer Biology, Medicine, and Pathology, Director Emeritus,

Vanderbilt-Ingram Comprehensive Cancer Center, Vanderbilt University Medical Center

PETER BACH, MD, MAPP, Senior Advisor,

Office of the Administrator, Centers for Medicare & Medicaid Services

EDWARD BENZ, JR., MD, President,

Dana-Farber Cancer Center

THOMAS BURISH, PhD, Chair,

ACS Board and Provost, Notre Dame University

MARK CLANTON, MD, MPH, Deputy Director,

Cancer Delivery Systems, National Cancer Institute

BETTY FERRELL, PhD, RN, FAAN, Research Scientist,

City of Hope National Medical Center

JOSEPH FRAUMENI, JR., MD, Director,

Division of Cancer Epidemiology and Genetics, National Cancer Institute

STEPHEN FRIEND, MD, PhD, Executive Vice President,

Oncology, Merck

PATRICIA GANZ, MD, ASCO Board Member and Professor of Medicine,

University of California, Los Angeles

THOMAS KEAN, MPH, Executive Director,

C-Change

WILLIAM LAWRENCE, MD, MS, Director,

Center for Outcomes and Evidence, Agency for Healthcare Research and Quality

LYNN MATRISIAN, PhD, Chair,

Division of Cancer Biology, Vanderbilt University

DAVID R. PARKINSON, MD, Senior Vice President,

Oncology Research and Development, Biogen Idec

EDITH PEREZ, MD, Director,

Cancer Clinical Study Unit, Mayo Clinic

SCOTT RAMSEY, MD, PhD, Full Member,

Fred Hutchinson Cancer Research Center

EDDIE REED, MD, Director,

Division of Cancer Prevention and Control, Centers for Disease Control and Prevention

WILLIAM ROBINSON, MD, MPH, Director,

Office of Minority Health and Health Disparities, Health Resources and Services Administration

CHARLES SAWYERS, MD, Chairman,

Human Oncology and Pathogenesis Program, Memorial Sloan-Kettering Cancer Center

Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

MARGARET SPITZ, MD, Chair of Epidemiology,

M.D. Anderson Cancer Center

ELLEN STOVALL, President and CEO,

National Coalition for Cancer Survivorship

JANET WOODCOCK, MD, Deputy Commissioner for Operations,

Food and Drug Administration

Staff

SHARYL NASS, PhD, Study Director

ROGER HERDMAN, MD, Director,

ALIZA NORWOOD, Research Assistant

MARY ANN PRYOR, Senior Program Assistant

Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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 (NRC’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 deliberative process. We wish to thank the following individuals for their review of this report:

Margaret Pepe, PhD, University of Washington School of Public Health

G. Gregory Raab, PhD, Consultant, Raab & Associates, Inc.

David Ransohoff, MD, University of North Carolina, Chapel Hill

Howard Schulman, PhD, Pharmaceutical Product Development, Inc. (PPD), Biomarker Discovery Sciences

Janet Warrington, PhD, Affymetrix, 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 Melvin Worth, MD. Appointed by the NRC, he was responsible for making certain that an

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×

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 rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
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Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
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Suggested Citation:"Front Matter." Institute of Medicine. 2006. Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11768.
×
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Research has long sought to identify biomarkers that could detect cancer at an early stage, or predict the optimal cancer therapy for specific patients. Fueling interest in this research are recent technological advances in genomics, proteomics, and metabolomics that can enable researchers to capture the molecular fingerprints of specific cancers and fine-tune their classification according to the molecular defects they harbor. The discovery and development of new markers of cancer could potentially improve cancer screening, diagnosis, and treatment. Given the potential impact cancer biomarkers could have on the cost effectiveness of cancer detection and treatment, they could profoundly alter the economic burden of cancer as well.

Despite the promise of cancer biomarkers, few biomarker-based cancer tests have entered the market, and the translation of research findings on cancer biomarkers into clinically useful tests seems to be lagging. This is perhaps not surprising given the technical, financial, regulatory, and social challenges linked to the discovery, development, validation, and incorporation of biomarker tests into clinical practice.

To explore those challenges and ways to overcome them, the National Cancer Policy Forum held the conference "Developing Biomarker-Based Tools for Cancer Screening, Diagnosis and Treatment: The State of the Science, Evaluation, Implementation, and Economics" in Washington, D.C., from March 20 to 22, 2006.

At this conference, experts gave presentations in one of six sessions. In addition, seven small group discussions explored the policy implications surrounding biomarker development and adoption into clinical practice. Developing Biomarker-based Tools for Developing Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics-Workshop Summary presents the conference proceedings and will be used by an Institute of Medicine (IOM) committee to develop consensus-based recommendations for moving the field of cancer biomarkers forward.

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