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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 the report were chosen for their special competencies and with regard for appropriate balance.
Support for this project was provided by the Health Care Financing Administration (Contract No. 500-98-0275). The views presented in this report are those of the Institute of Medicine Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries and are not necessarily those of the funding agencies.
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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.
THE NATIONAL ACADEMIES
National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
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. Bruce M. Alberts 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. William A. Wulf 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.
COMMITTEE ON ROUTINE PATIENT CARE COSTS IN CLINICAL TRIALS FOR MEDICARE BENEFICIARIES
HENRY J. AARON, Ph.D. (Chair),
The Brookings Institution, Washington, D.C.
ROBERT M. CALIFF, M.D.,
Duke University Medical Center
KAY DICKERSIN, Ph.D.,
Brown University School of Medicine
BERTIE A. FORD, M.S, R.N., O.C.N.,
Amgen, inc., Columbus, Ohio
PETER D. FOX, Ph.D.,
PDF Inc., Chevy Chase, Md.
LANCE LIEBMAN, L.L.B.,
Columbia Law School
JOHN M. LUDDEN, M.D.,
Harvard Medical School
ROBERT S. McDONOUGH, M.D., J.D.,
Aetna U.S. Health care, Hartford, Conn.
WILLIAM T. McGIVNEY, Ph.D.,
National Comprehensive Cancer Network, Rockledge, Pa.
ROSEMARY ROSSO, J.D.,
Baltimore/Washington Breast Cancer Advocacy Group, National Breast Cancer Coalition, Washington, D.C.
ELIZABETH STONER, M.D.,
Merck & Co., Inc., Rahway, N.J.
ROBERT THOMPSON, M.S., M.A.,
Medtronic, Minneapolis, Minn.
PETER J. WHITEHOUSE, M.D., Ph.D.,
Case Western Reserve University School of Medicine
Study Staff
HELLEN GELBAND, Study Director
ELLEN JOHNSON, Administrative Assistant
ANNIKA OLSSON, Research Assistant
ROBERT M. COOK-DEEGAN, Director,
National Cancer Policy Board
Consultants
ALLEN DOBSON, The Lewin Group, Fairfax, Va.
ERON STURM, The Lewin Group, Fairfax, Va.
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 Institute of Medicine in making the 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. The committee wishes to thank the following individuals for their participation in the review of this report:
WADE AUBRY, M.D., The Lewin Group and University of California at San Francisco
TOM AULT, Health Policy Alternatives, Washington, D.C.
PATRICIA A. BARR, J.D., Barr, Sternberg, and Moss, Bennington, Vt.
NORMAN DANIELS, Ph.D., Newton, Mass.
OLGA JONASSON, M.D., F.A.C.S., The American College of Surgeons, Chicago
ALAN S. LICHTER, M.D., University of Michigan Medical School
JAN PLATNER, J.D., JRI Health/Justice Resource Institute, Boston
HELEN L. SMITS, M.D., Ivoryton, Conn.
ROBERT YOUNG, M.D., Fox Chase Cancer Center, Philadelphia
Although 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 authors and the Institute of Medicine.
Acknowledgments
We thank the following people for providing information or other assistance during the course of this project.
Wade Aubry |
University of California at San Francisco |
Grant P. Bagley |
Health Care Financing Administration |
Carmella Bocchino |
American Association of Health Plans |
Charles A. Coltman, Jr. |
San Antonio Cancer Institute |
Chuck Cutler |
Prudential Health Care |
Ronald Herberman |
Association of American Cancer Institutes |
Doug Kamerow |
Agency for Health Care Policy and Research |
Deborah Kamin |
American Society of Clinical Oncology |
Allen S. Lichter |
University of Michigan School of Medicine |
Joanne R. Less |
Food and Drug Administration |
Sridhar Mani |
Montefiore Medical Center, Albert Einstein College of Medicine |
Mary McCabe |
National Cancer Institute |
Alexa McCray |
National Library of Medicine |
Charles J. McDonald |
American Cancer Society |
Stephen J. Northrup |
Medical Device Manufacturers Association |
Michael O'Conneil |
Mayo Clinic Cancer Center |
Arnold Potosky |
National Cancer Institute |
Richard Rettig |
Rand Corporation |
Richard L. Schilsky |
University of Chicago Cancer Research Center |
Ellen M. Smith |
General Accounting Office |
Fran Visco |
National Breast Cancer Coalition |
Judith L. Wagner |
Congressional Budget Office |
Robert C. Young |
Fox Chase Cancer Center |