Optimizing the Research Administrative Infrastructure to Support an Increase of Clinical Trials at Wake Forest Baptist Medical Center
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In late 2017, Wake Forest Baptist Medical Center (WFBMC) created a Clinical Trials Task Force to identify ways of increasing their volume of industry-sponsored clinical trials. Increasing the number of industry-sponsored clinical trials provides many benefits, including: (1) offering more cutting-edge treatment options to its patients, (2) growing its research portfolio, (3) expanding the reach of its research across the entire WFBMC network, and (4) providing additional opportunities for revenue. The author is a member of this task force and capitalized on the opportunity to use this capstone project to help generate information and ideas that were presented to WFMBC leadership in March of 2018. In order for WFBMC to build capacity to increase its volume of clinical trials, workflows must be improved in order to have a research infrastructure capable of facilitating clinical trial agreements (CTAs) in a timely manner. For this capstone project, the author examined a new improvement initiative, the 60-Day Challenge, and conducted a literature search to determine what other institutions consider best practices in this area. The author also conducted interviews with senior leadership to identify potential research infrastructure improvement strategies that could be implemented at WFBMC. The research done for this capstone project led the author to make ten recommendations from the findings. These recommendations included continuing the 60-Day Challenge to allow for parallel submission and review of the budget, contract, and regulatory documents; incorporating previously approved contract language and master agreements whenever possible to help facilitate faster contract negotiations; and creating a focused pool of dedicated CTA processing staff. These recommendations can help WFBMC become more efficient at processing CTAs and become more attractive to sponsors, which will promote and support an increase in clinical trials.