In lieu of an abstract, here is a brief excerpt of the content:

INSTITUTIONAL OBSTACLES TO CLINICAL RESEARCH EDWARD H. AHRENSJR.* We need look no further for evidence of today's declining interest in clinical research than the programs of the 1992 "clinical meetings" in Baltimore (the prestigious Tri-Society Meetings of the Association of American Physicians, American Society of Clinical Investigation, and American Federation of Clinical Research): reports on patient-oriented research (POR) were minimally represented during those three days' speeches, most of which involved "high science" but not patients. In examining the sea-changes in the research interests of U.S. physician -scientists over the last two decades, it is important to be clear about our terms. Clinical research (a term synonymous with experimental medicine , clinical science, and clinical investigation) encompasses a vast terrain of different objectives, trainings, laboratory skills, and technical facilities. Comroe and Dripps [1] in 1976 said: "We define research as clinically oriented, even if it is performed entirely on animals, tissues, cells or subcellular particles if the author mentions even briefly [emphasis mine] an interest in the diagnosis, treatment, or prevention of a clinical disorder, or in explaining the [underlying] mechanisms of a sign or symptom of the disease itself." Because the term describes so many different activities, I have divided this terrain into seven regions, so as to plot the changes over time in attention paid to each of these areas of research by investigators and by funding agencies. My taxonomy has been patterned on that of Bever and Landau, published in 1980 [2]. Seven Categories of Clinical Research Category 1. Studies of Mechanisms in Human Disease.—In these studies, the investigator seeks to refine current characterizations of disease proThis article is based on several sections of the author's recently published book, The Crisis in Clinical Research: Overcoming Institutional Obstacles (New York: Oxford University Press, 1992), with permission of the publisher. *The Rockefeller University, 1230 York Avenue, New York, New York 10021.© 1993 by The University of Chicago. All rights reserved. 003 1 -5982/93/3602-08 14$0 1 .00. 194 Edward H. Ahrens, Jr. ¦ Obstacles to Clinical Research cesses (or health) and to explore unresolved questions in the understanding of human disease by controlled observations or manipulations (or both) of patients or volunteers and their environments (by variations of such extrinsic factors as diet, exercise, sleep, study setting, stress, drugs, etc.). Category 2. Studies ofManagement ofDisease.—In these studies, the investigator , working directly with patients or volunteers, prospectively conducts controlled observations of an incompletely tested new diagnostic or therapeutic technique or device, usually in comparison with an accepted one. Category 3. In Vitro Studies on Materiah ofHuman Origin.—These strictly laboratory studies are conducted in relation to a stated or strongly implied clinical issue, in which the patients or volunteers providing such materials as blood, tissues, or excreta are not directly managed or experimentally manipulated by the investigators whose laboratory work requires those materials. Category 4. Modeh of Human Health or Disease.—In these mechanistic or management studies, the investigator sets up animal, mathematical, or computer models in order to simulate normal or diseased human processes. Category 5. Field Studies.—Here the investigator or teams of investigators carry out studies in open population groups, either descriptively or through active manipulations (i.e., passive or active epidemiologic studies). Category 6. Development ofNew Technologies.—In these studies, the development of new diagnostic and therapeutic methods (bioassays, scanning techniques, biostatistical methods, vaccines, etc.) is clearly distinguished from their application in management of disease (which is Category 2). Category 7. Assessment ofHealth Care Delivery.—In these studies, investigators examine the societal and/or economic consequences of health management practices, or study the infrastructure of health care delivery systems. This field has come to be called "health sciences research." Nonclinical Research Nonclinical biomedical research is performed in many disciplines, from physics to behavior. If those studies are not directly related to clinical issues, or do not stem from stated or implied questions dealing with human health or disease, such research is called nonclinical research, in order to distinguish it from the seven categories of clinical research. This large body of biomedical research often contributes significantly to new understandings of human biologic processes, but it does not as yet...

pdf

Share