Results from the TrialNet Pathway to Prevention (PTP) and the type 1 diabetes (T1D) prevention trials indicate potential for success in decreasing the autoimmune destruction of beta cells in individuals destined to develop T1D. The ultimate goal is preservation of sufficient beta cell mass to prevent overt T1D. To accomplish that long-term goal, there is a critical need to identify enough individuals at risk for T1D and to remove both time- and travel-related barriers to participation in T1D prevention trials. The specific objective in this application is to create a Clinical Center and Affiliate Network that wil expand the reach of TrialNet to an under-represented region that is within 4-5 hours of Kansas City, MO. In collaboration with other Clinical Centers and Affiliates, we will help improve identification of subjects at risk for T1D at a rate sufficient to fulfill the enrollment requiremets of current and future trials designed to preserve beta cell mass in subjects at risk for development of T1D, and provide easy access to prevention trials for all subjects at risk in our region. We have commitments for new and existing Affiliates that will target about 3370 families of pediatric patients with existing T1D and almost 470 families/yr of pediatric patients with new onset T1D within a 3 hr radius of Kansas City. In that same region, we have commitments for new Affiliates that will target about 4300 families of adults with existing T1D and 440 families/yr of adults with new onset T1D. To improve the effectiveness of screening and retention, we will deploy a comprehensive business model that has been previously validated to maximize the performance of clinical trials for therapies in other disease states and will apply a novel real-tie informatics-driven system (StudyHawk) to identify qualified candidates for participation in PTP. To improve the efficiency of screening, we will leverage real-time event processing (StudyHawk) to maximize recruitment per hour spent recruiting and will apply Quality Improvement methods to identify and respond to poor performing sites. The ultimate outcome of a Clinical Center in Kansas City will be expanded access to TrialNet and prevention trials in an underserved region, a Midwest network of Clinical Centers, and increased identification of subjects at risk, increased participation in clinical trials, through development of new approaches to increase productivity that will be shared with all of TrialNet.
We propose creating a Trialnet Clinical Center in the Children's Mercy Hospital network. This will bring a clinical center much closer to many Midwest cities, making these trials more accessible to an underserved region. We use innovative methods to increase trial recruitment: 1) a formal business model, 2) real-time informatics to automatically find study participants, and 3) use of Quality Improvement tools.
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