Also intertwined in this labyrinth of clinical research funding is the role of third-party payers. Although third-party payers, particularly Medicare, have underwritten some of the costs of medical education, the costs of experimental or investigational therapies have not generally been allowed as reimbursable, even though the results of clinical studies will define future standards for medical care. The growing concerns about cost-containment and a shift toward managed care are having an effect on what insurers will cover, even in the use of standard therapy (Antman et al., 1988 and 1989; Wittes 1987b). The committee is concerned that these coverage decisions might not be based on the best and most up-to-date information. Furthermore, cost-containment decisions might encourage the use of outmoded therapies rather than foster the timely introduction of truly novel or innovative therapies that could lead to long-term savings. Some feel that insurers and other third-party payers have a fundamental interest in and responsibility for supporting evaluative, patient-oriented clinical research to engage in coverage decisions and to facilitate the adoption of more cost-effective care (leaf, 1989; Newcomer, 1990). The total costs of clinical research cannot be shifted to insurers, but they are participants in providing care and should support and promote definitive studies that will define standards of care, assess the effectiveness of current therapies, and provide new effective therapies. Thus, the committee includes here a section on the roles and responsibilities of third-party payers.
Realizing how critical funding is to successful research careers, particularly the perception by clinical scientists of their inability to garner funds for patient-oriented studies, the committee devoted time to develop a clearer understanding of the research funding base. Many of the commissioned papers included some reference to the tenuous nature of research funding, and the committee sponsored an invitational workshop, "Clinical Research and Training: Spotlight on Funding," in June 1992. This chapter explores trends in research funding by the various sectors. Because of inadequate data collection methods by research sponsors, it was frequently impossible to disaggregate research funds devoted to patient-oriented clinical research from other research funds. When possible, however, the trends in funding for patient-related research are elaborated. Since academic research careers are closely intertwined with the investigator-initiated, peer-reviewed grant system in the Public Health Service, including the National Institutes of Health (NIH) (and previously the Alcohol, Drug Abuse and Mental Health Administration [ADAMHA]), the committee focused considerable attention on this process.
Prior to World War II, health research was sponsored primarily by industry, academic institutions, and private individuals (Ginzberg and Dutka, 1989).