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
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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 Institute 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
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Copyright 2011 by the National Academy of Sciences. All rights reserved.
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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.
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.
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
___________________
1Institute 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.
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
___________________
1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published meeting summary rests with the rapporteurs and the institution.
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
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
Although the reviewers listed have provided many constructive comments 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.
Contents
PANEL I: NCI AND THE COOPERATIVE GROUPS
NCI Perspective and Current Activities
Response of the NCI Community Clinical Oncology Program (CCOP)
Cooperative Group Leadership Perspective and Current Activities
Cooperative Group Chairs’ Perspective
Group Statisticians’ Perspective
Experience from the Consolidation of the Children’s Oncology Group (COG)
Consolidation of Cooperative Groups
Reducing NCI Oversight of the Cooperative Groups
Analysis of Cancer Clinical Trials Coverage
Determining the Standard of Care
Pharmaceutical Industry Perspective
Diagnostic Industry Perspective
Central IRB and Informed Consent
Partnerships Between Industry and the Cooperative Groups
Completeness Versus Flexibility
PANEL IV: CLINICAL TRIALS INVESTIGATORS AND PATIENT ADVOCATES
Academic Clinical Investigator Perspective
Community Cancer Center Perspective
Cooperative Group Patient Advocate Perspective
Research Foundation Perspective
Maintaining Engagement of Cooperative Group Investigators
B Executive Summary of A National Cancer Clinical Trials System for the 21st Century
BOXES, TABLES, AND FIGURES
BOX 1: Summary of the IOM Consensus Recommendations
BOX 3: NCCN Categories of Evidence and Consensus
BOX 4: CCOP Strategic Goals, 2010
TABLE 2: Overall Cooperative Group Funding Structure, Fiscal Year 2007
FIGURE 1: NCI’s proposed new organizational structure for the Cooperative Group Program
FIGURE 2: States with laws mandating clinical trials coverage