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Activating Clinical Trials: A Process Improvement Approach, Diego Martinez, Athanasios Tsalatsanis, Ali Yalcin, José L. Zayas-Castro, Benjamin Djulbegovic

Industrial and Management Systems Engineering Faculty Publications

Background: The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making.

Methods: We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July …