Book Review

Economics and Ethics in Health Care

The Crisis in Clinical Research: Overcoming Institutional Obstacles

N Engl J Med 1993; 328:1361-1362May 6, 1993

Article

The Crisis in Clinical Research: Overcoming Institutional Obstacles
By Edward H. Ahrens, Jr. 236 pp. New York, Oxford University Press, 1992. $29.95. ISBN: 0-19-505156-4

There is a perception among medical scientists that clinical investigation is being threatened from all quarters. Fewer investigators are engaged in patient-oriented research, research funding has become increasingly difficult to obtain, and spectacular successes in molecular biology have led many scientists to believe that the study of whole human beings is no longer necessary. Although we may eventually understand most diseases at the molecular level, studies of animals and humans will always be needed to understand the pathophysiologic manifestations of molecular defects. The application of molecular findings to clinical medicine will require investigators who have an intimate understanding of human physiology and the ability to conduct carefully controlled trials. In his timely and thoughtful examination of the structure and conduct of clinical research in the United States, Dr. Edward Ahrens, Jr., clearly defines the many predicaments in clinical research and offers a range of recommendations to enhance the recruitment, training, and performance of young clinical investigators. In so doing, he presents a brief history of biomedical research in American medical schools and provides a lucid description of how the National Institutes of Health (NIH) reviews and processes grant applications. Ahrens makes a compelling case for restructuring medical schools by emphasizing the importance of clinical research and freeing the schools from competing in the health care-delivery marketplace.

The author delineates seven distinct categories of clinical research, ranging from basic patient-oriented research to applied research (such as drug studies) and to animal research, epidemiology, and health services research. Basic patient-oriented research includes studies of normal physiology and fundamental mechanisms of human disease. Ahrens warns that it is in danger of extinction because clinical investigators favor studies of disease management. This preference may be due to fear of the uncertainty that is inherent in basic clinical research.

Ahrens believes that basic patient-oriented research is the most difficult kind of biologic research because of the inherent difficulties and expenses involved in studies of humans. Most important, there are no clear-cut career paths and relatively few mentors for those who seek a career in this field. He suggests that each medical school support and fund pilot studies in basic patient-oriented research and that each institution appoint a full-time dean for clinical research. The more than 70 NIH-funded general clinical research centers that are located in medical schools and hospitals throughout the country should serve as educational centers for training medical and graduate students and postdoctoral fellows in the scientific method of this research. Young investigators should be provided with stable research funding for a long period, and they should be protected from the distractions of routine clinical care. Since it has become increasingly difficult for clinical investigation to compete with molecular biology for research-grant funding, Ahrens recommends that the NIH set aside a certain percentage of funds for basic patient-oriented research and that special study sections be formed to evaluate these grants. He calls for a new cooperation and collaboration between bench scientists with Ph.D.s and physicians, each lending his or her special expertise to the design of basic patient-oriented research. In addition, he urges the establishment of a national award for excellence in such research as further recognition of its vital importance. In fact, this year, for the first time, the American Federation for Clinical Research, the nation's largest organization of physician investigators, has established a separate young investigator award to recognize a scientist who is pursuing basic patient-oriented research.

To effect the changes needed to support this type of research, it will be necessary to educate the biomedical scientific community as well as the general public. Ahrens emphasizes that we have developed two cultures in biomedical research, epitomized on the one hand by the reductionist elegance of molecular genetics and, on the other, by the integrative work of physiology of the whole animal or human. Our efforts to comprehend biology and to cure disease can never succeed until cooperating scientists from each realm bring their knowledge to bear on the problems of basic human-oriented research. This effort will be extremely expensive, and the public will bear most of the cost. However, numerous opinion polls have shown that the public overwhelmingly supports funding biomedical and health research at higher levels than exist today, but it expects in return improvements in health and cures for disease. As Ahrens emphasizes, “doctors and medical scientists must make a serious effort to close ranks with the U.S. public and win back its confidence and moral support.” This goal can best be achieved by educating the public and the Congress about the importance of supporting the next generation of clinical investigators. Ahrens' book represents an important contribution to this educational effort.

Andrew R. Hoffman, M.D.
Palo Alto Veterans Affairs Medical Center, Palo Alto, CA 94304