Editorial: For Clinical Research: A Formula for Improved Prognosis

PERSPECTIVES IN BIOLOGY AND MEDICINE Volume 31 · Number 1 · Autumn 1987 EDITORIAL: FOR CLINICAL RESEARCH: A FORMULA FOR IMPROVED PROGNOSIS In 1980 thisjournal published, as a supplement, the proceedings of a national conference entitled "Clinical Research: Elements for a Prognosis " [23, 2, part 2]. The perception of those who planned the meeting was that research centered on the patient and normal human subject was diminishing at a disturbing rate in the United States. This evaluation, shared by most of the participating academic physicians, was based in the main on personal observations within institutions and on impressions gained from reading scientific publications. There had been a shift in the research interests and style of clinical researchers, a fact emphasized by statistical reports from the National Institutes of Health (NIH). During the 12 years from 1966 to 1978, the percentage of new principal investigators with an M.D. degree had dropped steadily from 45 percent to 30 percent. New investigators with a Ph.D. degree only had risen from 53 percent to 67 percent of the total. In absolute numbers the M.D.'s remained constant at about 300 per year despite an increase in the number of medical schools and academic physicians. The Ph.D.'s rose from 400 to about 700. Perhaps more telling was the fact that postdoctoral fellowship awards to M.D.'s dropped from 46 percent ofthe total in 1968 to 21 percent in 1977. The latter point was the most worrisome; this was evidence that bright young physicians were becoming less interested in postdoctoral research fellowships. Since that conference was held, many observers have been convinced that the situation has worsened. It is true that there has been a considerable amount of clinical pharmacologic investigation sponsored by pharmaceutical firms and the National Cancer Institute, but this has been mosdy phase III studies—research with protocols fixed by the sponsoring agency. Such studies are important, but it must be pointed out that this is not the sort of innovative research that should parallel original laboratory investigation. An NIH panel member from a specialty that traditionally carries out a considerable amount of such research has told Perspectives in Biology and Medicine, 31, 1 ¦ Autumn 1987 | 1 us that now patient-centered proposals constitute a small minority of all grant proposals reviewed. There is no reason to doubt that this sample is representative. It is our conviction that the declining interest in patient-centered clinical research is a social rather than a scientific phenomenon. Despite the natural reductionist tendencies of all biological research, many fundamental problems in human biology and medicine can be studied adequately only in the intact organism. The view that clinical research programs are mainly suggested by laboratory science is depreciatory and inaccurate. The AIDS story is an example of the reverse situation. In addition to the philosophic attractiveness of the reductionist approach , there are other factors contributing to the declining interest in clinical studies. Increased competitiveness within the research community has been a factor that has drawn investigators to "the bench" from which more papers can be produced per year. There is also an underlying feeling that important patient-centered research is no longer accomplished easily. In part this may be due to community-imposed "regulation ," the need to have all protocols and their revisions approved by institutional review boards. Most important, there is at this time a widespread perception that the NIH panels and councils do not look with favor on such clinical research programs and will not approve them. The belief by some excellent young physicians that an academic future requires an emphasis on bench research distant from the patient has discouraged their embarking on a research and teaching career. Approximately one-third of our medical schools do not have clinical research centers; as a matter of fact, there are about as many research beds in the NIH's Clinical Center as there are in all the rest of the country. There are, and will always be, some medical schools that are more research intensive. We are convinced, however, that all medical schools should provide a clinical research environment for developing physicians at all levels, from student to senior house staff. It should...