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Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine by Annetine C. Gel-ijns International Fellow A Paper to the Committee on Technological Innovation in Medicine Institute of Medicine National Academy of Sciences National Academy Press Washington, D.C. 1989

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The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions for 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 in IS63 by its congressional charter to advise the federal government and, upon its own initiative, to study problems and issues of medical care, research, and education. The Committee on Technological Innovation in Medicine was established in 198S, as a joint effort by the Council on Health Care Technology and the Forum on Drug Development and Regulation, to provide and disseminate a more fundamental knowledge of the process by which research findings are translated into clinical practice. This paper was prepared as background material for a workshop, "Improving the Translation of Research Findings into Clinical Practice: the Potential and Problems of Modern Methods of Clinical Investigation," conducted May 3-4, 1989 by the Committee on Technological Innovation in Medicine of the Institute of Medicine. The observations and conclusions in this publication are solely those of the author. This publication and the workshop are supported by endowment funds provided from the Howard Hughes Medical Institute to the Institute of Medicine and by a grant from the National Center for Health Services Research to the Council. Copies of this publication are available without charge from: The Committee on Technological Innovation in Medicine Institute of Medicine 2101 Constitution Avenue, N.W Washington, D.C. 20418 . Printed in the United States of America

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Committee on Technological Innovation in Medicine Gerald D. Laubach, Ph.D., Chairman President, Pfizer, Inc. Susan Bartlett Foote, J.D. Assistant Professor, School of Business Administration, University of California at Berkeley . . . Benjamin L. Holmes Ace President and General Manager, Medical Products Group, Hewlett-Packard Company William N. Hubbard? Jr., M.D. Chainnan, Council on Health Care Technology Robert I. Levy, M.D. Chairman, Forum on Drug Development and Regulation President, Sandoz Research Institute Kenneth L. Melmon, M.D. Arthur L. Bloomfiel`d Professor of Medicine and Pharmacology, Department of Medicine, Stanford University, School of Medicine . Paul D. Parkman, M.D. Director, Center for Biologics Evaluation and Research, The Food and Drug Administration John E. Wennberg, M.D. Professor of Epidemiology, Department of Community and Family Medicine, Dartmouth Medical School

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Acknowledgments ~ would like to acknowledge the careful review and invaluable insights provided by the Committee on Technological Innovation in Medicine, especially by its chairman Dr. Gerald D. Laubach. ~ am grateful to Samuel Thier, President of the Institute of Medicine, for sharing his knowledge and enthusiasm for this activity. In addition, would like to thank the following colleagues at the Institute of Medicine for their stimulating discussions, critique and genera] support of this paper: Sharon Baratz, Queta Bond, Steve Bongard, Ruth Bulger, Holly Dawkins, Paul Friedman, Cliff Goodman, Maria Elena Lara, May Naddaf, Dick Rettig, and Don Tiller. ~ am also indebted to Wallace Waterfall for his careful editing of the manuscript. However, the views expressed in this paper are not necessarily those of the reviewers and are solely my responsibility. Special thanks are due to May Naddaf and Holly Dawkins for the many hours spent in producing the paper, and for their resourcefulness in bringing about the workshop for which this paper is a background document. Annetine C. Gelijns Washington, D.C. 1989