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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
Multi-Center Phase III Clinical Trials and NCI Cooperative Groups
WORKSHOP SUMMARY
Margie Patlak, Sharyl Nass, and Christine Micheel, Rapporteurs
National Cancer Policy Forum
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
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.
This study was supported by Contract Nos. HHSN261200611002C, 200-2005-13434 TO #1, HHSP233200700373P, and 223-01-2460 TO #27, between the National Academy of Sciences and the National Cancer Institute, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, and the Food and Drug Administration, respectively. This study was also supported by the American Cancer Society, the American Society for Clinical Oncology, C-Change, and the Association of American Cancer Institutes. 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: 978-0-309-12867-4
International Standard Book Number-10: 0-309-12867-6
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 2009 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). 2009. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington, DC: The National Academies Press.
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
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
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
WORKSHOP PLANNING COMMITTEE1
JOHN MENDELSOHN, M.D. (Chair), President,
M. D. Anderson Cancer Center
ROBERT CALIFF, M.D., Professor of Cardiology, Vice Chancellor for Clinical Research, and Director,
Duke Translational Medicine Institute, Duke University
DAVID DILTS, Ph.D., Professor of Operations Management,
Owen Graduate School of Management, Vanderbilt University and
co-director of the Center for Management Research in Healthcare
JAMES DOROSHOW, M.D., Director,
Division of Cancer Treatment and Diagnosis, National Cancer Institute
HAROLD MOSES, M.D., Professor of Molecular Oncology,
Cancer Biology, Medicine, and Pathology;
Director Emeritus,
Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center
DAVID PARKINSON, M.D., President and CEO,
Nodality, Inc.
RICHARD SCHILSKY, M.D., Professor of Medicine and Associate Dean for Clinical Research,
University of Chicago
Project Staff
ROGER HERDMAN, M.D., Director,
National Cancer Policy Forum and Board on Health Care Services
SHARYL NASS, Ph.D., Study Director
CHRISTINE MICHEEL, Ph.D., Program Officer
LAURA LEVIT, J.D., Senior Program Associate
ERIN BALOGH, M.P.H., Research Associate
MICHAEL PARK, Senior Program Assistant
MARGIE PATLAK, M.S., Science Writer
1
IOM 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.
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
NATIONAL CANCER POLICY FORUM1
HAROLD MOSES, M.D. (Chair), Director Emeritus,
Vanderbilt-Ingram Cancer Center
FRED APPELBAUM, M.D., Director,
Clinical Research Division, Fred Hutchinson Cancer Research Center
PETER B. BACH, M.D., M.A.P.P., Associate Attending Physician,
Memorial Sloan-Kettering Cancer Center
EDWARD BENZ, Jr., M.D., President,
Dana Farber Cancer Institute and
Director,
Harvard Cancer Center, Harvard School of Medicine
THOMAS G. BURISH, Ph.D., Past-Chair,
American Cancer Society Board of Directors and
Provost,
Notre Dame University
MICHAELE CHAMBLEE CHRISTIAN, M.D., Retired,
Division of Cancer Treatment and Diagnosis, National Cancer Institute
ROBERT ERWIN, M.S., President,
Marti Nelson Cancer Foundation
BETTY R. FERRELL, Ph.D., R.N., F.A.A.N., Research Scientist,
City of Hope National Medical Center
JOSEPH F. FRAUMENI, Jr., M.D., Director,
Division of Cancer Epidemiology and Genetics, National Cancer Institute
PATRICIA A. GANZ, M.D., Professor,
University of California, Los Angeles Schools of Medicine and Public Health, Division of Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center
ROBERT R. GERMAN, Dr.P.H., M.P.H., Associate Director for Science (Acting),
Division of Cancer Prevention and Control, Centers for Disease Control and Prevention
ROY S. HERBST, M.D., Ph.D., Chief,
Thoracic/Head and Neck, Medical Oncology, M. D. Anderson Cancer Center
THOMAS J. KEAN, M.P.H., Executive Director,
C-Change
JOHN MENDELSOHN, M.D., President,
M. D. Anderson Cancer Center
JOHN E. NIEDERHUBER, M.D., Director,
National Cancer Institute
DAVID R. PARKINSON, M.D., President and CEO,
Nodality, Inc.
SCOTT RAMSEY, M.D., Ph.D., Full Member,
Cancer Prevention Program, Fred Hutchinson Cancer Research Center
JOHN WAGNER, M.D., Ph.D., Executive Director,
Clinical Pharmacology, Merck and Company, Inc.
JANET WOODCOCK, M.D., Deputy Commissioner and Chief Medical Officer,
Food and Drug Administration
1
IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
Forum Staff
ROGER HERDMAN, M.D., Director,
National Cancer Policy Forum and Board on Health Care Services
SHARYL NASS, Ph.D., Senior Program Officer
CHRISTINE MICHEEL, Ph.D., Program Officer
LAURA LEVIT, J.D., Senior Program Associate
ERIN BALOGH, M.P.H., Research Associate
MICHAEL PARK, Senior Program Assistant
ASHLEY McWILLIAMS, Senior Program Assistant
ADAM SCHICKEDANZ, Christine Mirzayan Science and Technology Policy Graduate Fellow
SHARON MURPHY, M.D., Scholar in Residence
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
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:
Jan C. Buckner, M.D., Mayo Clinic
Gwendolyn Fyfe, M.D., Genentech
Heidi Nelson, M.D., American College of Surgeons Oncology Group and Mayo Clinic
Ellen Stovall, National Coalition for Cancer Survivorship
Marcy Waldinger, M.H.S.A., University of Michigan Comprehensive Cancer Center
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Melvin Worth, M.D. Appointed by the Institute of Medicine, he
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
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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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
Contents
Introduction
1
Adapting the Cooperative Groups in a Changing Clinical Environment,
3
Session 1A:
Organization of the NCI Clinical Trials System
5
The NCI’s Clinical Trials System,
5
Mayo Clinic and North Central Cancer Treatment Group,
12
Radiation Therapy Oncology Group,
14
Improving Clinical Trial Start-Up Times,
17
IRB Issues,
25
Session 1B:
Lessons from Non-Cooperative Group Multi-Center Clinical Trials
27
Organization of Multi-Center Clinical Trials,
27
Industry-Sponsored Multi-Center Clinical Trials,
31
Private Physician Perspective on Multi-Center Clinical Trials,
35
Session 2:
Barriers to Patient Recruitment and Physician Participation
41
Academic Challenges,
43
Insurance Barriers,
47
Academic Recognition for Clinical Trialists,
50
CCOP Perspective on Patient Accrual,
54
Perspective from a National Health Care System,
59
Patient Perspective,
61
Session 3:
Data Collection Standards and Monitoring
65
The NCI Perspective,
65
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary
Industry Perspective,
67
Cooperative Groups Perspective,
70
FDA Perspective,
71
Session 4:
Costs of Cooperative Group Clinical Trials
75
Cooperative Groups Cost Analysis,
75
Clinical Trial Cost Management,
77
Regulatory Costs,
82
CMS Perspective,
84
Private Health Insurer Perspective,
86
Summary and Wrap-Up
91
Possible Paths Forward,
93
References
97
Abbreviations and Acronyms
103
Glossary
105
Appendixes
A
Workshop Agenda
111
B
Workshop Speakers
117
C
Letter from John Niederhuber, Director of the National Cancer Institute, to Members of the National Cancer Policy Forum
119
