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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.