This report summarizes the deliberations and recommendations of the Institute of Medicine Committee for the Study on Resources for Clinical Investigation. Four major areas of concern were identified. These areas were: (1) funding of clinical investigation in the United States; (2) training of the young clinical investigator in the United States; (3) resource considerations and necessary organization and structure of clinical investigation; and (4) outcome assessment research. Where the Committee felt it was appropriate, possible solutions to the problems were suggested. For other areas, it was clear to the Committee that easy answers are not currently identifiable. In some instances this was, in part, because of lack of appropriate and adequate data (see pp. 20-21). It was the unanimous opinion of the Committee that the problems outlined must be thoughtfully and vigorously addressed to prevent serious deterioration in clinical investigation in this country.

Contents

• Committee for the Study of Resources for Clinical Investigation
• STAFF
• MANDATE OF THE COMMITTEE
• PROCESS USED BY COMMITTEE
• INTRODUCTION
• DEFINITIONS
• ISSUE 1: FUNDING OF CLINICAL INVESTIGATION IN THE UNITED STATES
  • Recommendations
• ISSUE 2: TRAINING OF THE YOUNG CLINICAL INVESTIGATOR IN THE UNITED STATES
  • Recommendations
• ISSUE 3: RESOURCE CONSIDERATIONS AND NECESSARY ORGANIZATION AND STRUCTURE OF CLINICAL INVESTIGATION
  • Recommendations
• ISSUE 4: OUTCOME ASSESSMENT RESEARCH
  • Recommendations
• REFERENCES
• DATA NEEDED FOR BETTER PROBLEM DEFINITION IN THE FUTURE
  • Funding of Clinical Investigation
  • Training
  • Organization of Clinical Investigation
  • Relationship of the Pharmaceutical Industry and the Food and Drug Administration
  • Outcome Assessment
• APPENDIX A: Publications Consulted
• APPENDIX B: Position Papers by Committee Members

Support for this project was provided by the National Institutes of Health, Department of Health and Human Services, pursuant to Contract No. NO1-OD-8-2108.

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.

This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

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 advisor to the federal government and its own initiative in identifying issues of medical, research, and education.