Type 1 Diabetes TrialNet Clinical Centers - Kansas City

 描述（由申请人提供）：TrialNet预防途径（PTP）和1型糖尿病（T1 D）预防试验的结果表明，在注定发展T1 D的个体中，成功减少β细胞自身免疫破坏的潜力。最终目标是保存足够的β细胞群以预防明显的T1 D。为了实现这一长期目标，迫切需要确定足够多的T1 D风险个体， 消除参与T1 D预防试验的时间和旅行相关障碍。本申请的具体目标是创建一个临床中心和附属网络，将TrialNet的覆盖范围扩展到距离密苏里州堪萨斯城4-5小时车程的代表性不足的地区。通过与其他临床中心和附属机构合作，我们将帮助改善T1 D风险受试者的识别，其识别率足以满足当前和未来试验的入组要求，这些试验旨在保护T1 D风险受试者的β细胞质量，并为我们地区的所有风险受试者提供方便的预防试验。我们对新的和现有的附属公司有承诺，这些附属公司将针对堪萨斯城3小时半径范围内约3370个现有T1 D儿科患者家庭和近470个新发T1 D儿科患者家庭/年。在同一地区，我们承诺新的附属机构将针对约4300个患有T1 D的成年人家庭和每年440个家庭 新发T1 D的成年人。为提高筛选及保留的有效性，我们将部署一个先前已验证的全面业务模式，以最大限度地提高其他疾病状态下治疗的临床试验的性能，并将应用一个新型的实时信息驱动系统（“StudyHawk”）来识别参与PTP的合格候选人。为了提高筛选效率，我们将利用实时事件处理（“StudyHawk”）来最大限度地提高每小时招聘的招聘量，并将应用质量改进方法来识别和应对表现不佳的网站。堪萨斯城临床中心的最终结果将是扩大对TrialNet的访问，并在服务不足的地区进行预防试验，建立中西部临床中心网络，并通过开发新方法来提高生产力，增加对风险受试者的识别，增加对临床试验的参与，并与所有TrialNet共享。

 DESCRIPTION (provided by applicant): 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.