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OCR for page R1
IMPLEMENTING A
NATIONAL CANCER
CLINICAL TRIALS SYSTEM
FOR THE 21ST CENTURY
Workshop Summary
An American Society of Clinical Oncology and
Institute of Medicine Workshop
Alison Mack and Sharyl J. Nass, Rapporteurs
National Cancer Policy Forum
Board on Health Care Services
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. 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 Insti-
tute of Medicine. The members of the committee responsible for planning the workshop
were chosen for their special competences and with regard for appropriate balance.
This project was sponsored by the American Society of Clinical Oncology. The National
Cancer Policy Forum is supported by Contract Nos. HHSN261200900003C and 200-
2005-13434 TO #1 between the National Academy of Sciences and the National Cancer
Institute and the Centers for Disease Control and Prevention, respectively. This project
was also supported by the American Association for Cancer Research, the American
Cancer Society, the Association of American Cancer Institutes, Bristol-Myers Squibb,
C-Change, the CEO Roundtable on Cancer, Novartis Oncology, and the Oncology
Nursing Society. 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: 978-0-309-21268-7
International Standard Book Number-10: 0-309-21268-5
Additional copies of this report are available from the National Academies Press, 500
Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202)
334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.
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. Implementing a National Cancer
Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The
National Academies Press.
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“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
— Goethe
Advising the Nation. Improving Health.
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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 man-
date 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
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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
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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,
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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
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WORKSHOP PLANNING COMMITTEE1
RICHARD L. SCHILSKY (Chair), Professor of Medicine and Section
Chief, Hematology/Oncology, University of Chicago Medical Center,
Chicago, Illinois
JAN C. BUCKNER, Professor of Oncology, Mayo Clinic College of
Medicine, and Group Chair, North Central Cancer Treatment Group,
Rochester, Minnesota
MICHAEL A. CALIGIURI, Director, Ohio State Comprehensive Cancer
Center, Columbus, Ohio
WILLIAM DALTON, President, Chief Executive Officer, and Center
Director, Moffitt Cancer Center, Tampa, Florida
JAMES H. DOROSHOW, Director, Division of Cancer Treatment and
Diagnosis, National Cancer Institute, Bethesda, Maryland
ROY S. HERBST, Chief of Medical Oncology, Yale Cancer Center,
New Haven, Connecticut
JOHN HOHNEKER, Senior Vice President and Head, Global Development,
Integrated Hospital Care, Novartis Pharma AG, Basel, Switzerland
JOHN MENDELSOHN, President, M.D. Anderson Cancer Center,
Houston, Texas
SHARON B. MURPHY, Scholar-in-Residence, Institute of Medicine,
Washington, DC
GEORGE W. SLEDGE, JR., Ballve-Lantero Professor of Medicine, Indiana
University School of Medicine, and Co-leader, Breast Cancer Program,
Indiana University Simon Cancer Center, Indianapolis, Indiana
MARY LOU SMITH, Co-founder, Research Advocacy Network, Naperville,
Illinois
Institute of Medicine Project Staff
SHARYL J. NASS, Director, National Cancer Policy Forum
ERIN BALOGH, Associate Program Officer
MICHAEL PARK, Senior Program Assistant
ROGER HERDMAN, Director, Board on Health Care Services
American Society of Clinical Oncology Staff
SUANNA BRUINOOGE, Director, Research Policy Division, ASCO Cancer
Policy and Clinical Affairs Department
1 Institute of Medicine planning committees are solely responsible for organizing the
workshop, identifying topics, and choosing speakers. The responsibility for the published
workshop summary rests with the workshop rapporteurs and the institution.
v
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NATIONAL CANCER POLICY FORUM1
JOHN MENDELSOHN (Chair), President, M.D. Anderson Cancer Center,
Houston, Texas
PATRICIA A. GANZ (Vice Chair), Professor, University of California at
Los Angeles (UCLA) School of Medicine & Public Health, Division of
Cancer Prevention & Control Research, Jonsson Comprehensive Cancer
Center, Los Angeles, California
AMY ABERNETHY, Associate Professor of Medicine, Duke University
School of Medicine, and Director, Duke Cancer Care Research Program,
Durham, North Carolina
FRED APPELBAUM, Director, Clinical Research Division, Fred
Hutchinson Cancer Research Center, Seattle, Washington
PETER B. BACH, Associate Attending Physician, Memorial Sloan-Kettering
Cancer Center, New York
EDWARD BENZ, JR., President, Dana-Farber Cancer Institute, and
Director, Harvard Cancer Center, Harvard University Medical School,
Boston, Massachusetts
MONICA BERTAGNOLLI, Professor of Surgery, Harvard University
Medical School, Boston, Massachusetts
THOMAS G. BURISH, Provost, Notre Dame University, South Bend,
Indiana, and Past Chair, American Cancer Society Board of Directors
MICHAEL A. CALIGIURI, Director, Ohio State Comprehensive Cancer
Center, Columbus, Ohio, and President, Association of American
Cancer Institutes
RENZO CANETTA, Vice President, Oncology Global Clinical Research,
Bristol-Myers Squibb, Wallingford, Connecticut
MICHAELE CHAMBLEE CHRISTIAN, Retired, Washington, DC
WILLIAM DALTON, President, Chief Executive Officer, and Center
Director, Moffitt Cancer Center, Tampa, Florida, and Chair, AACR
Committee on Science Policy and Legislative Affairs
WENDY DEMARK-WAHNEFRIED, Associate Director for Cancer
Prevention and Control, University of Alabama at Birmingham
Comprehensive Cancer Center, Birmingham, Alabama
ROBERT ERWIN, President, Marti Nelson Cancer Foundation, Davis,
California
1 Institute of Medicine forums and roundtables do not issue, review, or approve indi-
vidual documents. The responsibility for the published meeting summary rests with the
rapporteurs and the institution.
vi
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ROY S. HERBST, Chief of Medical Oncology, Yale Cancer Center,
New Haven, Connecticut
JOHN HOHNEKER, Senior Vice President and Head, Global Development,
Integrated Hospital Care, Novartis Pharma AG, Basel, Switzerland
THOMAS J. KEAN, Executive Director, C-Change, Washington, DC
DOUGLAS R. LOWY, Deputy Director, National Cancer Institute,
Bethesda, Maryland
DANIEL R. MASYS, Affiliate Professor, Department of Medical Education
and Biomedical Informatics, University of Washington, Seattle,
Washington
MARTIN J. MURPHY, Chief Executive Officer, CEO Roundtable on
Cancer, Durham, North Carolina
BRENDA NEVIDJON, Clinical Professor and Specialty Director, Nursing
& Healthcare Leadership, Duke University School of Nursing, Durham,
North Carolina, and Past President, Oncology Nursing Society
STEVEN PIANTADOSI, Director, Samuel Oschin Comprehensive Cancer
Institute, Cedars-Sinai Medical Center, Los Angeles, California
LISA C. RICHARDSON, Associate Director for Science, Division of
Cancer Prevention and Control, Centers for Disease Control and
Prevention, Atlanta, Georgia
YA-CHEN TINA SHIH, Director, Program in the Economics of Cancer,
University of Chicago, Chicago, Illinois
ELLEN SIGAL, Chairperson and Founder, Friends of Cancer Research,
Washington, DC
JOHN A. WAGNER, Vice President, Clinical Pharmacology, Merck and
Company, Inc., Rahway, New Jersey
RALPH R. WEICHSELBAUM, Chair, Radiation and Cellular Oncology,
and Director, Ludwig Center for Metastasis Research, The University of
Chicago Medical Center, Chicago, Illinois
JANET WOODCOCK, Director, Center for Drug Evaluation and Research,
Food and Drug Administration, Rockville, Maryland
National Cancer Policy Forum Staff
SHARYL J. NASS, Director, National Cancer Policy Forum
LAURA LEVIT, Program Officer
CHRISTINE MICHEEL, Program Officer
ERIN BALOGH, Associate Program Officer
MICHAEL PARK, Senior Program Assistant
PATRICK BURKE, Financial Associate
SHARON B. MURPHY, Scholar-in-Residence
ROGER HERDMAN, Director, Board on Health Care Service
vii
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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 deliberative process. We wish to thank the following
individuals for their review of this report:
Bettye Green, Chair, ACOSOG Patient Advocates, South Bend,
Indiana
Michael Katz, Chair, Patient Advisory Board, Coalition of Cancer
Cooperative Groups, Bayside, New York
Heidi Nelson, Fred C. Andersen Professor of Surgery, Division of
Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota,
and Group Co-Chair, ACOSOG
Edith A. Perez, Deputy Director, Mayo Clinic Cancer Center,
Serene M. and Frances C. Durling Professor of Medicine, Mayo
Clinic Florida, Jacksonville, Florida, and Breast Committee
Chair, NCCTG
ix
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x REVIEWERS
Although the reviewers listed have provided many constructive com-
ments and suggestions, they were not asked to endorse the conclusions or
recommendations nor did they see the final draft of this report before its
release. The review of this report was overseen by Melvin Worth. Appointed
by the Institute of Medicine, he was responsible for making certain that
an 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.
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Contents
INTRODUCTION, 1
PANEL I: NCI AND THE COOPERATIVE GROUPS, 4
NCI Perspective and Current Activities, 4
Overview of the NCI Response, 4
Response of the NCI Community Clinical Oncology
Program (CCOP), 19
Cooperative Group Leadership Perspective and Current Activities, 22
Cooperative Group Chairs’ Perspective, 22
Group Statisticians’ Perspective, 26
Experience from the Consolidation of the Children’s
Oncology Group (COG), 27
Panel Discussion, 30
Consolidation of Cooperative Groups, 30
Encouraging Collaboration, 32
Reducing NCI Oversight of the Cooperative Groups, 34
Going Forward, 36
PANEL II: PAYORS, 36
Payor Policies, 37
An Insurer’s Perspective, 37
Kaiser Permanente’s Dual Role, 39
Medicare and Medicaid Support of Clinical Trials, 40
Demonstrating Utility to Payors, 40
xi
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xii CONTENTS
Analysis of Cancer Clinical Trials Coverage, 42
Coverage of Phase I Trials, 44
Determining the Standard of Care, 48
Establishing New Common Procedural Terminology (CPT)
Codes for Care of Patients Enrolled in Clinical Trials, 48
PANEL III: INTERACTIONS BETWEEN INDUSTRY,
THE FDA, AND THE PUBLICLY FUNDED CANCER
CLINICAL TRIALS SYSTEM, 50
Pharmaceutical Industry Perspective, 51
Diagnostic Industry Perspective, 52
FDA Perspective, 54
Central IRB and Informed Consent, 57
Partnerships Between Industry and the Cooperative Groups, 59
Informatics, 64
Vendor Perspective, 64
Completeness Versus Flexibility, 66
PANEL IV: CLINICAL TRIALS INVESTIGATORS AND
PATIENT ADVOCATES, 69
Clinical Trials Investigators, 69
CCOP Physician Perspective, 69
Academic Clinical Investigator Perspective, 74
Community Cancer Center Perspective, 76
Patient Advocates, 78
Cooperative Group Patient Advocate Perspective, 78
Research Foundation Perspective, 80
Panel Discussion, 81
Maintaining Engagement of Cooperative Group Investigators, 81
Measuring Success, 82
Open Trial Enrollment, 84
Selection of Trial Sites, 85
Funding Clinical Trials, 86
CLOSING REMARKS, 87
REFERENCES, 91
ACRONYMS, 95
APPENDIXES
A Workshop Agenda, 99
B Executive Summary of A National Cancer Clinical Trials System
for the 21st Century, 105
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xiii
CONTENTS
BOXES, TABLES, AND FIGURES
BOX 1: Summary of the IOM Consensus Recommendations, 3
BOX 2: Timeline for Implementing a New Funding Opportunity
Announcement for the Cooperative Group Program, 14
BOX 3: NCCN Categories of Evidence and Consensus, 38
BOX 4: CCOP Strategic Goals, 2010, 71
TABLE 1: Progress by NCI Toward Goals and Recommendations of the
IOM Report A National Cancer Clinical Trials System for the 21st
Century (2010), 6
TABLE 2: Overall Cooperative Group Funding Structure, Fiscal Year
2007, 24
TABLE 3: Rates of Approval for Coverage of Care in a Cancer Clinical
Trial, by Insurance Provider, at Johns Hopkins University Hospital,
from July 2003 to July 2008, 45
FIGURE 1: NCI’s proposed new organizational structure for the
Cooperative Group Program, 17
FIGURE 2: States with laws mandating clinical trials coverage, 44
FIGURE 3: Distribution of the 63 CCOP and Minority CCOP sites
across the United States and in Puerto Rico, as of June 2010, 71
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