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A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms

Hellen Gelband

Prepared for the National Cancer Policy Board

Institute of Medicine

National Research Council

Washington, D.C.

February 1999



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A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms Hellen Gelband Prepared for the National Cancer Policy Board Institute of Medicine National Research Council Washington, D.C. February 1999

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A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms INSTITUTE OF MEDICINE • 2101 Constitution Avenue, N.W. • Washington, DC 20418 NOTICE: This project 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 author of the report was chosen for competency and lack of bias. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I.Shine is president of the Institute of Medicine. This study was supported under Contract Number N02-CO-71024. The views presented in this paper are those of the author and not necessarily those of the funding organization. Additional copies of A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms are available in limited quantities from the Institute of Medicine, National Cancer Policy Board, 2101 Constitution Avenue, N.W., Washington, DC 20418. The full text of this publication is available on line at: www.nap.edu. Copyright 1999 by the National Academy of Sciences. All rights reserved.

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A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms Preface This report for the National Cancer Policy Board (NCPB) describes the procedures currently in place in the United States for approving and monitoring clinical trials of cancer treatments. Virtually all cancer clinical trials are funded by agencies of the federal government or the pharmaceutical industry, so the focus is on the requirements for each of these groups. The paper is intended as a jumping off point for the NCPB to consider some of the pressing policy issues surrounding clinical trials in cancer, though as yet, no specific follow-on projects have been initiated. This project came about as a result of NCPB deliberations at an April 1998 meeting, during which payment of patient care costs in cancer treatment trials was identified as a policy issue of great concern, in particular under the Medicare Program, which insures the majority of cancer patients. The common policy of insurers, including Medicare through the Health Care Financing Administration (HCFA), has been to consider all treatment in clinical trials to be, by definition, experimental, and therefore, not eligible for reimbursement. This has been the case whether the patient receives standard care (e.g., in a “usual treatment” arm) or a truly experimental treatment, and despite the fact that most patients would be receiving some form of treatment eligible for reimbursement if they were not in the trial. Before exploring the payment issues in more detail, the NCPB commissioned this review to lay out the range of cancer clinical trial sponsors in the United States, and what the requirements are for review and monitoring of clinical trials initiated by each type of sponsor. This purely descriptive document does not imply the NCPB’s endorsement of the status quo, or a belief that only government and industry are capable of appropriately reviewing and carrying out clinical trials. The NCPB is, in fact, concerned that a review process be open to innovation from outside existing channels without sacrificing rigor. This document merely describes the major systems now in place, and can be the basis for developing criteria that might be applied to judging the appropriateness of non-government, non-industry funded trials from the perspective of the insurer who is asked to pay for the costs of patient care. The NCPB intends to issue statements in the future on coverage of participation in clinical trials, following an effort to gather information pertinent to the policy issues. This document contains no recommendations, but future statements will contain recommendations for government and private payers.

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A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms Report Reviewers This report was 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 assist the Institute of Medicine in making the final 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. The author wishes to thank the following individuals for their participation in the review of this report: Paul F.Griner, M.D., Vice President and Director, Center for the Assessment and Management of Change in Academic Medicine, Association of American Medical Colleges, Washington, D.C.; Ada Sue Hinshaw, Ph.D., R.N., Dean, School of Nursing, University of Michigan; Barbara S.Hulka, M.D., M.P.H., Kenan Professor, Department of Epidemiology, University of North Carolina at Chapel Hill; Brent C.James, M.D., Executive Director, Institute for Health Care Delivery Research, and Vice President, Medical Research, Intermountain Health Care, Salt Lake City, Utah; and Robert I.Levy, M.D., Senior Vice President, Science and Technology, American Home Products Corporation, Madison, N.J. While the individuals listed above have provided constructive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the author and the Institute of Medicine.

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A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms Contents     SUMMARY   1     INTRODUCTION   4     ELIGIBILITY OF MEDICARE PATIENTS FOR CANCER CLINICAL TRIALS   5     CRITERIA AND PROCEDURES FOR APPROVING AND MONITORING CLINICAL TRIALS   6     The Two Prongs of Clinical Trial Protocol Review and Monitoring,   6     The National Cancer Institute,   7     Department of Veterans Affairs,   11     INSTITUTIONAL REVIEW BOARDS   13     THE FOOD AND DRUG ADMINISTRATION   16     The Commercial IND Application,   16     Noncommercial INDs,   17     Protection of Human Subjects,   18     COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA   18     Reviews for Scientific Merit,   18     Reviews and Procedures to Ensure the Safety and Rights of Participants,   19     REFERENCES   19