the escalating number of uninsured and underinsured people in the United States have thrown health issues into the policy arena at all levels of government. In medicine, highly subspecialized medical training, a declining interest by U.S. medical students in primary care training, and shortages of physicians willing to practice in rural or inner-city areas are all cited as symptoms of a worsening problem. The emergence of human immunodeficiency virus infection has demonstrated that new diseases can arise unexpectedly, and that a multifaceted approach spanning a variety of fields of research and a range of professional research scientists is needed to develop fundamental knowledge about a disease process, diagnosis, effective therapies, and prevention strategies and to assess the subsequent outcomes of health care practices. This can only be accomplished with highly talented and well-trained researchers in all areas of research, from basic to clinical research to outcomes and health services research.
Research is a highly social and political process of communication, interpersonal relationships, and scientific exchange that seeks to describe, explain, and modify biological and pathological processes. Researchers develop hypotheses and test them by collecting and analyzing data. The results add to existing knowledge. The unique feature of clinical research that distinguishes it from laboratory research is the direct involvement of human subjects. Although both laboratory and clinical research employ the same scientific principles for experimental procedures, the use of human subjects increases the complexities of scientific investigations. Whereas laboratory studies can more easily control for as many variables as possible to yield reproducible results, clinical research involves more heterogeneous populations, often is more expensive, takes longer to develop, requires long periods of time for data collection, and may be difficult to reproduce (Kimes et al., 1991). To advance medical care in patients, however, research must be performed in populations of patients with diseases.
Many research activities performed by a broad spectrum of professionals fall under the rubric of clinical research. Whereas many kinds of clinical research require similar skills and abilities, others may require different tools to achieve research objectives. Examples of how earlier investigations have influenced today's medical care are well known. Present research studies will improve tomorrow's medical practice, while future clinical research opportunities will affect care in the twenty-first century. What is the scope of clinical research, and what are the settings for conducting clinical research and the opportunities for future research?
Clinical research is a relatively new discipline. Although the American Society for Clinical Investigation was formed in 1908, clinical advances prior to the 1950s were often based on imprecise observations by practicing clinicians