Technology Transfer at the National Institutes of Health


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Technology Transfer at the National Institutes of Health March 1982
NTIS order #PB82-202904

Library of Congress Catalog Card Number 82-600529
For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C, 20402

Preface
The quality and efficiency of health care and, ultimately, improved health of the population depend substantially on the timely and appropriate transfer of medical technologies from the research setting into medical practice. This spreading of technologies must be fast enough so that significant potential benefits are not denied to the population and yet sufficiently paced to assure that enough is known about the safety and appropriate conditions of use of the emerging technologies.
The flow of technologies from research and development (R&D), through evaluation, to their adoption and diffusion in health care settings is thus a crucial aspect of the lifecycle of technology. Congress and many other parties are concerned with how to blend accelerated transfer with informed transfer.
As background to an effort to develop improved policies toward the transfer of medical technologies, the House Committee on Energy and Commerce requested OTA to prepare an examination of current technology transfer and assessment activities of the National Institutes of Health (NIH). This technical memorandum is the result of that examination. It presents general information on biomedical R&D and its relationship to technology transfer, and on the processes of transferring medical technology and of assessing that technology. It discusses the current technology transfer activities of NIH and contains detailed looks at two specific institutes.
The National Cancer Institute has been the focus of substantial congressional concern, particularly over its research directions and its activities in bringing technologies to medical practice. OTA conferred with a large number of academic and other experts regarding these issues.
The National Heart, Lung, and Blood Institute (NHLBI) is also covered in depth. NHLBI has been the single most active institute in terms of an organized approach to technology transfer and the level of such activities.
The main finding of this study is that despite some problems in timely transfer of technologies the most critical problems are: 1) insufficient attention to the development of the basic science base necessary for development of effective technologies; and 2) insufficient attention to the careful, scientific evaluation of the potential benefits, risks, and costs of medical technologies.
Director
. .
Ill

Health Program Advisory Committee

Sidney S. Lee, Chairman Vice President, Michael Reese Hospital and Medical Center

Stuart H. Altman Dean, Florence Heller School Brandeis University
Robert M. Ball ]nstitute of Medicine National Academy of Sciences
Lewis H. Butler School of Medicine University of California, San Francisco
Kurt Deuschle Mount Sinai School of Medicine
Rashi Fein Center for Community Health and Health Care Harvard Medical School
Melvin A. Glasser Committee for National Health lnsurance
Patricia King Georgetown Law Center

Joyce C. Lashof School of Public Health University of California, Berkeley
Mark Lepper Vice President for InterInstitutional Affairs Rush Presbyterian-St. Luke’s Medical Center
Margaret Mahoney President The Commonwealth Fund
Frederick Mosteller School of Public Health Harvard University
Mitchell Rabkin Beth Israel Hospital
Frederick C. Robbins Institute of Medicine National Academy of Sciences
Rosemary Stevens Department of History and Sociology of Science University of Pennsylvania
Kerr L. White Rockefeller Foundation

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OTA Technology Transfer at NIH Project Staff
H. David Banta, Assistant Director, OTA Health and Life Sciences Division
Clyde J. Behney, Health Program Manager and Project Coordinator Anne Kesselman Burns, Analyst Hellen Gelband, Analyst Michael Gough, Senior Analyst Lawrence Miike, * Senior Analyst Kerry Britten Kemp, * Editor Mary E. Harvey, Secretary Pamela J. Simerly, Secretary
Virginia Cwalina, Administrative Assistant

OTA Publishing Staff

John Bergling

John C. Holmes, Publishing Officer Kathie S. Boss Debra M. Datcher

Joe Henson

Acknowledgments

OTA would like to thank the following individuals for their assistance during this project.

Lynne Alexander Office of Technology Assessment

Charles Lowe National Institutes of Health

Harold Amos Harvard Medical School

David McCallum Consultant in Health Policy

David Baltimore Massachusetts Institute of Technology

Jay Moskowitz National Heart, Lung, and Blood Institute

James Bowen M. D. Anderson Hospital and Tumor Institute

Norton Nelson New York University

Lester Breslow UCLA School of Public Health

Guy Newell M. D. Anderson Hospital and Tumor Institute

Irwin Bross Roswell Park Memorial Institute

Richard Peto Oxford University

Louis Carrese National Cancer Institute

Donald Pitcairn National Cancer Institute

Bruce Chabner National Cancer Institute

Henry Pitot McArdle Laboratory for Cancer Research

Sir Richard Doll Oxford University

Nathaniel Polster M. D. Anderson Hospital and Tumor Institute

Pony Feigl Fred Hutchinson Cancer Research Center

David Rail National Institute of Environmental Health Sciences

Leonard Fenninger American Medical Association

Benno Schmidt J. H. Whitney & Co.

James Fries Stanford University Medical Center

Marvin Schneiderman Clement Associates, Inc.

Peter Greenwald National Cancer Institute

Irving Selikoff Mt. Sinai School of Medicine

Maureen Henderson University of Washington

Charles Smart American College of Surgeons

Harry Holmes M. D. Anderson Hospital and Tumor Institute

Howard Temin McArdle Laboratory for Cancer Research

Anne Stuart Houser National Institutes of Health

William Terry National Cancer Institute

Douglas Hussey National Institutes of Health

Arthur Upton New York University

Itzhak Jacoby National Institutes of Health

Ernst Wynder American Health Foundation

Rose Kushner Kensington, Md.

John Young National Cancer Institute

Joshua Lederberg Rockefeller University

Marvin Zelen Sidney Farber Cancer Institute

Mark Lepper
Rush-Presbyterian-St. Luke’s Medical Center, Chicago

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Contents

Chapter

Page

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2. Biomedical Research and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3. The Process of Technology Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

4. Evaluation of Medical Technologies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

5. Technology Transfer at the National Institutes of Health. . . . . . . . . . . . . . . . . 37

6. Technology Transferal the National Cancer Institute. . . . . . . . . . . . . . . . . . . . 57

7. Technology Transfer at the National Heart, Lung, and Blood Institute. . . . . 93

8. Findings and Conclusions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........115

Appendixes A. Glossary of Acronyms. . . . . . . . . . . . . . . . . . . . . . . . . . ....................121 B. Background Material: Grants, Contracts, and Peer Review . ..............123 C. NHLBI Clinical Trials Briefing Document . . . . . . . . . . . . . . . ...............129

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......185

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Chapter 1
Introduction

Chapter 1
Introduction

The ultimate goal of biomedical research is a healthier population. The road to this end result, though, is made up of a great many intermediate goals: for example, improved understanding of basic biological processes; identification of the nature and causes of specific diseases and disabilities; development of ways to identify, prevent, diagnose, or treat diseases; exchange of relevant information; and delivery of services.
One important characteristic that most of the intermediate goals and objectives have in common is their dependence on science and technology. The Office of Technology Assessment (OTA) defines technology as the practical application of organized knowledge. Medical technology is defined as including drugs, devices, and medical and surgical procedures, and the systems in which such technologies are delivered (85). For example, prevention of disease is both a technology in itself and also depends on effective technologies (such as vaccination or public education) for its attainment. Thus, one of the principal outcomes of health-related research is the development and subsequent use of medical technologies.
The process through which technologies are brought to existence and employed in everyday medical practice is not a simple one. It involves, as will be covered later, a series of overlapping and often cyclical stages. For purposes of analysis, OTA divides the process into research and development (R&D), evaluation, diffusion, and use (delivery, financing, etc.).
Technology transfer is often thought of as involving primarily the diffusion stage—the spread of a new technology into common use. However, the success and appropriateness of any technology’s transfer or diffusion is heavily dependent on all the stages that precede use. Thus, technology truansfer-related activities are viewed in this report as involving R&D, evaluation, dissemination of pertinent information, and technology transfer (or diffusion) itself.
The timely and appropriate transfer of technologies from a research setting into medical

practice has important implications for the quality of health care, access to care, and the cost of care. For this reason, the transfer of biomedical knowledge into technologies, the assessment of the resulting technologies, and their spread into health care settings continue to be areas of congressional concern.
The National Institutes of Health (NIH) is the primary institution in the United States for the first two of the above processes (the development and the assessment of technologies) and one of the key actors in the third. Because NIH plays such a large and critical role in the substance and the quality of technology transfer, it exerts a powerful influence on the priority given to technology transfer by other groups, on the state of the art of assuring effective transfer, and on the generation and flow of information about technologies, especially their benefits, risks, costs, and readiness for widespread use.
The House Committee on Energy and Commerce requested that OTA examine the role of NIH in assessing and transferring medical technology. This technical memorandum, Technology Transfer at the National Institutes of Health, presents the results of that examination.
It was prepared during February and March of 1982. As with all OTA technical memoranda, it contains no policy options for congressional consideration. In response to the committee’s primary concerns, it covers NIH in regard to its R&D activities as they relate to the development of medical technologies, its demonstration and control programs and other activities related to transfer of technologies, its efforts to disseminate information on medical technology, and the extent and form of its assessment activities. It draws heavily on earlier OTA studies, especially Assessing tile Efficacy and Safety of Medical Technologies (85), The Implications of CostEffectiveness Analysis of Medical Technology (89), Development of Medical Technology Assessment: Opportunities for Assessment ( 8 8 ) , Strategies for Medical Technology Assessment (92), and Technologies for Determining Cancer Risks From the Environment (86).
3

4

ORGANIZATION OF THE REPORT
Chapters 2 through 5 cover NIH in general. Chapter 2 discusses biomedical R&D, providing background information on the process of biomedical science and its relation to technology development and transfer, on the Nation’s and NIH’s investment in biomedical research, and on the organization of NIH.
The third chapter presents a description of the process of technology transfer. It is designed to provide a context for the later examinations of current technology transfer activities at NIH. Chapter 4 highlights the role of evaluation of medical technologies as part of the R&D and transfer processes.
Chapter 5 presents and examines the current technology transfer activities engaged in or supported by NIH.
Because of their size, importance, and levels of relevant activities, the National Cancer Insti-

tute (NCI) and the National Heart, Lung, and Blood Institute (NHLBI) have been highlighted. A major share of attention has been devoted to NCI because of continuing congressional concern over the conflicting pressures on NCI related to transfer and assessment of technologies for preventing, diagnosing, and treating cancers. Chapter 6, therefore, is on NCI. NHLBI has been focused on because it is probably the single most active institute in technology transfer. It has devoted considerable thought and funds to such activities. Thus, chapter 7 covers NHLBI and its transfer and assessment activities.
Chapter 8 presents the findings and conclusions of the study.
Appendix A is a glossary of acronyms. The second appendix contains background material on NIH’s process of awarding grants and contracts, including a discussion of peer review. Appendix C is on NHLBI clinical trials.

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Technology Transfer at the National Institutes of Health