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.
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Multi-Center Phase III Clinical Trials and NCI Cooperative Groups WORKSHOP SUMMARY Margie Patlak, Sharyl Nass, and Christine Micheel, Rapporteurs National Cancer Policy Forum

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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 Gov- erning Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engi- neering, 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, find- ings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agen- cies 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 Clini- cal Trials and NCI Cooperative Groups: 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 mandate that requires it to advise the federal govern- ment 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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 pro- viding 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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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. v

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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. vi

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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 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 pub- lished 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 construc- tive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was over- seen by Melvin Worth, M.D. Appointed by the Institute of Medicine, he ix

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x REVIEWERS 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 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 xi

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xii CONTENTS 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