Modeling clinical trials workflow in community practice settings.

Clinical research is vital to the translation of biomedical knowledge into standard clinical practice. Efforts are underway under the NIH Roadmap initiative to re-engineer the national research enterprise to sustain the rapid pace of innovation in the biomedical domain. As part of these efforts, we have embarked on an empirical evaluation of clinical research workflow in community practice settings. The reasons for this focus are three-fold. First, there is an increasing tendency by trial sponsors to conduct clinical trials in community, rather than academic, settings. Second, understanding workflow is critical to developing re-engineering strategies. Third, workflow associated with the conduct of clinical research in community practices have received virtually no attention in the scientific literature. In this paper, we describe a pilot study using time-motion observations, to determine the workflow of clinical research coordinators, the tools they use to conduct the constituent activities of those workflows, and their ultimate outcomes. The preliminary findings provide insights and understanding of clinical research workflow in community practice settings - knowledge that may significantly impact the way in which information technology based re-engineering can be deployed in such an environment.