The Crisis in Clinical Research: Overcoming Institutional Obstacles

The current crisis in clinical research cannot be fully appreciated unless the underlying economic, sociological and motivational problems in American medicine are fully understood. Accordingly, this important book describes the evolution of biomedical research in relation to changes in institutional perceptions of the importance of each of the three roles that U.S. medical schools play--teaching, research and service to patients. Ahrens meticulously analyzes seven very different kinds of research activity that are included under the term "clinical research." He describes the profound shift in emphasis from patient-oriented research to research at the cellular and molecular level. This shift has created an imbalance between two contrasting research approaches to the problems of human disease--reductionism and integrative research. In searching out the reasons for this change, Ahrens carefully examines institutional supports for clinical research--the medical school environment in which the research is carried out and the main funding source, the National Institutes of Health. This timely work identifies the fundamental differences between reductionism and integrative research and provides clear evidence that if both modes are to prosper in the future, as they must, then patient-oriented research must receive far stronger support from U.S. medical schools and the N.I.H. Ahrens masterfully argues that changes must be made in the special training of clinical investigators and in their funding requirements, and that new working partnerships between clinically skilled M.D.s and technically trained Ph.D.s are urgently needed in order to restore patient-oriented research to full productivity and to accomplish a re-balancing that most effectively assures quality research in the future.