Clinical Research: Elements for a Prognosis

CLINICAL RESEARCH: ELEMENTS FOR A PROGNOSIS RICHARD L. LANDAU* Medically speaking, a prognosis is impossible without a diagnosis. With an annual expenditure by the National Institutes of Health of $4 billion for biomedical research and additional millions from industry and private sources supporting similar endeavors, is it even possible that clinical research could be ailing? To the original planners of the conference—Daniel X. Freedman, a psychiatrist; Leon I. Goldberg, a clinical pharmacologist; and Richard L. Landau, an endocrinologist— the answer was a resounding yes! The idea of having a conference sprang from conversations in the spring of 1978, probably because each of the three professors at the University of Chicago had developed in his own way an active interest in the national politics of medicine and medical science. As the conference idea took hold, Bernard Meltzer, a law professor, and Ann Grahn, from the university's Center for Policy Studies, joined the conversations. They had to be persuaded that there was even a problem—that there might be more than the malaise that President Carter believes is afflicting the entire nation. The logical questioning ofthese wise and persistent colleagues led to a tentative formulation which convinced them that there was indeed a definable disease affecting clinical research. If they could be convinced, it should have been relatively easy to convince persons more directly interested in the field. It was. As the outline for the conference took shape, the group was encouraged and helped by consultations with many colleagues and friends across the country. John Sherman, Julius Comroe, Robert Glaser, Don Whedon, and William Hubbard were especially helpful. The private foundations which backed the conference required no convincing. All seemed aware that clinical research was indeed in trouble. Medical academicians who had lived through the 1950s and 1960s, when clinical research flourished as never before, knew there had been a *Department of Medicine, University of Chicago Pritzker School of Medicine, 950 East 59th Street, Chicago, Illinois 60637.© 1980 by The University of Chicago. 0031-5982/80/2322-0150$01.00 Perspectives in Biology and Medicine · Winter 1980 · Part 2 | S3 change. However, Meltzer and Grahn insisted that impressions needed to be buttressed by more facts—anecdotes and personal experiences were not enough. Key questions had to be addressed: Do clinical scientists obtain competitive research grants from the National Institutes of Health (NIH) with no more difficulty than nonclinical biologists? How difficult is it for young clinical scientists to win research grants? Carl Douglass and his associates from the NIH Division of Research Grants and Don Whedon and Carl Leventhal of the National Institute of Arthritis , Metabolism, and Digestive Diseases (NIAMDD) were interested and offered their help in obtaining data. We were able to convince Arley Bever, Jr., formerly of the Division of Research Grants, that carrying out a quantitative analysis of clinical research support would be interesting and worthwhile. This study was slated to be the foundation on which the pathogenesis and the diagnosis of the disorder would be built. It was agreed that Bever's research should, because of time constriction , be confined to the Institute for Arthritis, Metabolism, and Digestive Diseases and utilize the data resources of NIH and NIAMDD. Bever's primary task was to quantitate fundamental clinical research supported by the institute in 4 selected years spanning the period 1970-1978. The arbitrary definition of "fundamental clinical research" given to Bever was the equivalent philosophically ofwhat the laboratory scientists would term "basic." It would encompass a major portion ofthat research which could result in the elucidation of diseases and their pathogenesis, the development of innovative therapy, the mechanisms ofdrug action, and the broadening of human physiology. The results of Bever's study were a surprise. Fundamental clinical research at the NIAMDD held steady or increased slightly throughout the decade, whether one counted numbers of grants, financial support, or number of principal investigators who were physicians. This was the case despite a sharp, late rise in politically dictated "service" and targeted research supported by the institute. Clearly there was no evidence of a decline in this institute's support of fundamental clinical research, even though in the NIH as a whole there was substantial evidence that proportionately...