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MESS USE;L) ~ ~ The goal of this study ~ s to identify and analyze near and long berm national needs for NIH-supporbed research involving patients. m is assessment was to be done by considering recent advances ~ science, changes in the health care system and other factors that influence motivation, ability, and opportunity to carry out this type of research. A Remittee of 15 Norse; with expertise in medicine, surgery, pediatrics, psychiatry, h~lff1 care financing, university and ho~it=1 . . . a~r~stratlon, ~n~rs~ng resmrm, health care ser~ri~, male~lar biology arx] ird~try research a~inistuation was appointed by the president of the Institute of Medicine with He co~urr~e of the president of He Nations Academy of Science;. Rogers were active In clinical investigation. meet with the campsite so as to ensure the broadest range of Ives. me majority of the (bests were invited to Grouse of the Complexity of the issues to be considers arm the Short time ally for He Depletion of the task, two activities were Pertain prior to the first meeting. Each Peer of the committee was ashy to define in writing a personal priority list of the leading issues In clinical investigation arx] the rationale for th~o choices. In ablution, each was asked to suggest approaches to these priority issues as well as key references in the literature that cculd be distributed to the committee. From the responses, an outline of these issues was assembled by the committee chair. A request for more data and analyses was made of the staff and of the National Institutes of H-a1ffh. In response to a question of the chair, NIH also provided a definition of clinical investigation and of clinical trials to be use] by the committee in its deliberations. frees committee members, the data from the NIH and from the staff, and hey publications were distributed to the committee prior to their first meeting. Extensive discussions by the committee members at the first meeting led to the affection of four areas to be considered during the informal workshop held as the second meeting. The areas were (1) funding of clinical investigation in the United Static; (2) training of the young clinical investigator ~ the United States; (3) organizational structure of clinical investigation; and (4) issues related to ouboome assessment and cost-effectiveness analysis. Prior to the second meeting the committee members prepared written papers to serve as the Harris of the ~n_denth discussions of the four issues which had been selected. The written letters and pacers m e written papers were distributed to the members and guests in advance of the meeting along with the publications which the members had requested and were discussed in depth by the group. me papers are included in the Appendix of this report. me C;ommit~e divided into 5~1 grate; to prepare a spry of He deliberations and rations relays to each of the fair major issues as identified in this report. Fred on the deliberations of these ~r~, a full Remittee discussion of these issue-oriented sentries and rations took place. 2