• Relatively few programs adequately prepare physicians and other health professionals to undertake research involving human subjects, and their successes are unproven.

  • Managed competition represents the new paradigm for the funding of health care. The development of this model is likely to lead to the formation of large organizations of provider groups or health plans, which in turn will contract with consortia of employer groups or alliances to provide health coverage for employees and their families. This change will have a major impact on the ability of academic health centers to support their academic missions and thus will have a direct effect on the support of research and education. Unless new approaches to the support of clinical investigators and academic health centers involving the participation of third-party payers are forthcoming, it is likely that this paradigm shift in health care financing will seriously compromise the translation of results from fundamental research into improved health care.

  • Funding for investigator-initiated human research is difficult to obtain. Whereas industry is obligated to conduct clinical trials during product development to meet regulatory conditions for market approval, there is no profit motive to support investigator-initiated studies on medical practice. The committee performed an analysis on a subset of R01 grants that were active in 1991. The purpose of that analysis was to determine the number of awards and amount of funding that were actually committed to patient-oriented research. Of the approximately 30 percent of all R01 grants indicating the use of humans or human materials, the committee determined that only one third (or about 10–12 percent of total R01s) of this grant pool actually involved human subjects. Although there are other mechanisms for funding human research, the R01 pool is the largest source of funds for investigator-initiated studies, both basic and clinical.

  • Clinical investigators devote months or years to developing the appropriate design for a clinical study. Barriers include the need to submit numerous protocols for approval within their institutions, the need to have adequate infrastructure and personnel for conducting a clinical study, the competing demands on their time to provide patient care as well as teaching and research, and the amount of funding available for investigator-initiated human research. The measures of scholarly productivity for clinical investigators are not well-defined, and to many university promotion committees, the research activities of clinical investigators may be considered nontraditional.

  • Responsibility for oversight of the nation's clinical research capacity is fragmented at every level, whether academic or governmental. Thus, there appears to be little prospective planning involving all interested parties to identify clinical research needs or new opportunities. As a consequence, no organized segment of society, public or private, focuses attention on the clinical investigator to ensure and encourage a career path(s) at so critical a phase in the history of human health.



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