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DNIA NEEDED FOR B~I'l'~K PROBLEM DEFINITION IN THE FUTURE Funding of Clinical Investigation In addition to those areas requiring better data identified in the Summary of Deliberations an] Recommendations, the following are areas in which the Committee felt that their deliberations were constrained owing to lack of data. 1. Dccumentation of the practice= of third-party payers (Medicare, Medicaid, private insurers) in support of clinical investigation. Documentation of the economic consequences for hospitals of their participation in clinical investigation (added costs associated with caring for patients on investigative protocols). Additional documentation of the adequacy of funding for clinical investigation (as defined in this report) and that of clinical investigators' difficulty with obtaining adequate funding support. Data as to the extent that clinical investigation is conducted in major teaching hospitals relative to other institutional settings and non-institutional settings. Data to analyze if the change in the indirect Medicare subsidy for teaching hospitals has affected the conduct of clinical investigation. 6. Data to document whether the shortened hospital stay has impacted clinical investigation An hospitals. Data to examine how the shift of Care from the inpatient to the ambulatory settings has affected clinical investigation. 8. Data to examine how the change In hospital patient mix (e.g. sicker and fewer patients) has affected clinical investigation. 9. Analysis of whether or not particular patient populations have been systemically excluded from participation in clinical investigation, including Medicare patients, Medicaid patients, children, . . . ~ munorl les, anc women. Training 1. Analysis of the number of clinical investigational trainees necessary in the United States to allow for approximately 1,000 new faculty each year. 20

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2. Data to document the record of Lruining programs Ln producing effective clinical investigators. Organization of Clinical Investigation 1. Analysis of the role played by the GCRC in clinical investigation. Analysis of the role of the GCRC in pro vidLng for training of young investigators. Relationship of the Pharmaceutical Industry and the Food and Drug Administration Analysis as to whether large scale clinical trials of a~=ptable scientific quality can be conducted outside the United States= at I-~= cost than that associated with such trials in the Uniter Stat=,=. Outcome Assessm at 1. Data giving the number of grants and contracts and the amount of money spent on those grants and contracts as well as intramural studies devoted to outcome assessment, by the NIH. 2. Data quantitated by the number and types of studies (e.g., randomized clinics] trials, versus non-experiment design of various kinds) devoted to outcomes assessment in the various Institutes of NIH and in the intramural program, by the NIH. 21

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AMIDIC A: Publications Consulted 22