Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)

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ABSTRACT The conduct of clinical trials, particularly in infants and children, is complex, time consuming and expensive. Much of this inefficiency stems from slow and ineffective trial start-up and conduct. Duke University and Vanderbilt University propose to develop the Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT) to improve trial efficiencies, reduce the costs of multi-site clinical trials, optimize study quality, and in doing so, advance health in our country. Duke and Vanderbilt Universities are uniquely poised to establish the Trial Innovation Center (TIC) infrastructure in response to this CTSA funding opportunity. Duke will leverage the capacity, track record, and the pediatrics clinical trials program of the world’s largest Academic Research Organization, Duke Clinical Research Institute (DCRI), with Vanderbilt’s renowned biomedical informatics enterprise to meld high quality multi-center trial management with sophisticated informatics solutions supporting trial processes. Duke will capitalize on the world’s largest NIH-sponsored multicenter pediatric clinical trials program to support research in this underserved population. TRIDENT will not only transform trial quality and efficiency at CTSA sites, but will leverage TRIDENT infrastructure and resources to reach well beyond the CTSAs, given DCRI’s established site network throughout the world. To achieve this vision, we will establish three cores that will develop and implement innovative strategies across the design and conduct of trials. The Study Design core will use innovative methods and work directly with the CTSA Recruitment Innovation Centers and study investigators to develop robust protocols and feasible study budgets. The Study Start-up Core will engage interoperable IT systems, employ standardized study documents, assess site capabilities, establish Master Clinical Trial Agreements, facilitate e-consent, and oversee a central IRB thereby improving time to first participant enrolled. The Study Conduct core will then track study progress and quality, provide regulatory support, and develop materials to maximize public health impact. We will expand RedCap capabilities to facilitate collection of study documents via a web based portal, and collect, measure and act upon trial metrics. From the initial design of the trial until dissemination of the results, investigators will be partnered with operational and research methods experts. This partnership facilitates ongoing innovation via self-learning and frequent assessment. Key goals of this effort will be to implement a novel multi-site clinical trials platform combined with state of the art clinical trial operations to increase multi-site trial quality and efficiency across the CTSA.