Presents the results of the first year of a two-year project to evaluate the role of NIH-supported General Clinical Research Centers in clinical trials. To provide a context for the evaluation, the authors conducted a literature review and interviews with about 100 people, and developed a broad characterization of clinical trials, their problems, and tentative solutions. A key distinction between clinical trials and other clinical research is the extensive information processing that the trials require. Thus, special emphasis was placed on information processing problems, which include the administrative, organizational, and operational problems relating to the communication and manipulation of information. Future clinical trials would benefit from increased attention to planning (particularly the nonmedical aspects), the availability of trained support staff and appropriate information processing resources, improved technical communication among professional and support staffs, better personnel management, and a framework for communicating trial methodology and findings to researchers, health care practitioners, and the public.
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