DEVELOPING BIOMARKER-BASED TOOLS FOR Cancer Screening, Diagnosis, and Treatment
The State of the Science, Evaluation, Implementation, and Economics
WORKSHOP SUMMARY
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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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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.
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
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
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
