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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

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.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

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

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.
”      

                                                —Goethe

image

INSTITUTE OF MEDICINE
              OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

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.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

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

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

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

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
×

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Implementing a National Cancer Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13154.
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Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research.

Thus, the Institute of Medicine's (IOM's) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation.

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