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INIK)WCr1CN hi In Air ur~tar~i~ of both the nor and airman furx~ioni~ of the human body frmn the cellular too We Ear leered, carbines win ad~var~ ~ biot~logy, have led us to He point where a Ear of major clip: not yet conquers are within Air grasp to prevent or Are (1~. Be possibility of vaccines to prevent malaria or h~patitis-B viral infection, and of gene transfer therapy to Acre inborn errors of metabolism are but a few examples of scientific Alvarez that may <]ramati~ly affect Be natural c~r~;e of human At; .~. At this them of unprecedented progress in Air increase in kneeled In the bic~i~a~ science= deal ing with dish of human beings, there is growing cordon that progress in translating r cations into clinically useful products, devise and pro will be sacked or even stomped entirely because of serials pebble; facing clinical irnrestigation and clinical investigators In the United States (2-7, 12, 14, 17, 18, 21, 22, 24~. These pebble: include: a) an inadequate supply Indoor inadequately trained clinical investigators, b) lack of funding for clinical m He ~ igation, and c) fat ure to achieve methodological advances, particularly in clinical trials, that take into account both resource limitations and expanding cpportuniti~c for studies of new interventions. -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 Static; (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 p emblems were suggested. For ocher areas, it was clear to the Committee that easy answers are not currently identifiable. In some instances this was, in part, bPrall== of lack of appropriate and adequate data Oboe pp. 20-2l). It was the unanimous Opinion of the Committee that The problems outlined most be thoughtfully and vigorously addressed to prevent serious deterioration In clinical investigation in this country. DE:F~S For the purposes of the Cbmmittee's deliberations, the National Institutes of Health (NIH) provided the following definitions: Clinical investigation is defined as that segment of clinical research for which an investigator directly interacts with patients in either an outpatient or inpatient setting. This definition excludes studies for which material of human origin is obtained through a third party and for which an investigator has had no direct interaction with Be patient. 3