Vanderbilt University: Clinical Center Application, Type 1 Diabetes TrialNet

描述（由申请人提供）：几十年来，1型糖尿病（T1 D）的发病率每年增加3-5%，在非常年轻的人群中增长最快。预防策略对于减轻糖尿病的巨大个人和公共卫生负担至关重要，并且可能也会影响治愈或逆转那些已经患病的人的疾病的策略。作为2009年被TrialNet联盟接纳的唯一一家新的临床中心，范德比尔特大学在参与者招募和参与方面有着非常出色的记录，并且在临床中心中处于有利地位，可以继续为TrialNet的成功做出贡献。我们的中心为所提出的工作带来了丰富的资源。我们有一个非常大的和仔细遵循的T1 D患者和家庭基础，从继续吸引参与者。我们已经获得了大量的社区参与和对我们努力的认可，并且在临床试验中有着非常强的参与者参与和保留记录，目前是自我们进入以来启动的两项正在进行的预防试验的主要招募网站。我们有 在我们中心的大力支持下，开发了一个由14个附属机构组成的广泛分布和热情的小组，将TrialNet带到美国各地的小社区和大都市地区。我们的经验将使我们能够利用机会增加新的子公司，扩大和加强表现不佳的子公司的活动。我们提出了新的方向，以进一步我们的影响力：我们中心的存在，以多个自身免疫性患者社区在地方和国家层面的扩展，迄今未充分利用的水库T1 D家庭有资格进行筛选。我们已经与田纳西州卫生部建立了合作伙伴关系，将TrialNet带入田纳西州的所有公共卫生中心，如果成功的话，这将成为其他州推广的网络模式。我们中心的媒体推广一直很广泛，我们建议扩大国家和国际媒体的存在，这将继续有利于整个网络。我们记录了我们的PI和协调员在网络层面的领导作用，包括新预防研究的开发和执行、公共关系、附属机构管理和参与以及研究协调。我们记录了范德比尔特糖尿病中心和儿科对我们申请的强有力的机构支持，这些支持扩大了NIDDK的财政投资。范德比尔特大学将支持网络支持的任何选项，以加快IRB对研究的批准。最后，我们展示了一个强大的早期阶段的调查人员，他们的职业生涯已经受到影响的TrialNet在范德比尔特。我们概述了一项计划，以更积极地让他们在智力和科学上参与网络的工作，同时促进他们的职业生涯。利用这一广泛而多样化的TrialNet启发资源，范德比尔特的TrialNet临床中心处于有利地位，成为T1 D预防和改善全球T1 D患者生活的领导者。

DESCRIPTION (provided by applicant): The incidence of Type 1 diabetes (T1D) has been increasing 3-5% per year for decades, most rapidly in the very young. A prevention strategy is essential to alleviate the tremendous personal and public health burden of diabetes and will likely also influence strategies to cure or reverse the disease in those already afflicted. As the only new Clinical Center admitted to the TrialNet consortium in 2009, Vanderbilt University has an extremely strong record of participant recruitment and engagement and is well-positioned among Clinical Centers to continue to make a difference in the success of TrialNet. Our center brings abundant resources for the work proposed. We have a very large and carefully followed T1D patient and family base from which to continue to draw participants. We have gained substantial community involvement and endorsement of our efforts and have a very strong record of participant engagement and retention in clinical trials, currently being the leading recruitment site for the two ongoing prevention trials that were initiated since our entry. We have developed a widely distributed and enthusiastic group of 14 Affiliates, well supported by our Center, to bring TrialNet to a broad spectrum of small communities and metropolitan areas throughout the US. Our experience will allow us to take advantage of opportunities to add new affiliates and expand and enhance the activities of underperforming affiliates. We propose novel directions to further our reach: an extension of our Center's presence to multiple autoimmune patient communities at the local and national levels, a hitherto underutilized reservoir of T1D families eligible for screening. We have developed a partnership with the Tennessee Department of Health to bring TrialNet into all public health centers of the state of Tennessee, which if successful, could be a network model for outreach in other states. The media outreach of our center has been extensive and we propose an expanded national and international media presence that will continue to benefit the entire network. We document the leadership roles that our PI and coordinators have had at the network level in the development and execution of new prevention studies, in public relations, in affiliate management and engagement, and in study coordination. We document strong institutional support of our application by both the Vanderbilt Diabetes Center and the Department of Pediatrics in ways that amplify the financial investment by the NIDDK. Vanderbilt University will support any options the network endorses to expedite IRB approval of studies. Finally, we demonstrate a strong pool of early stage investigators whose careers have already been influenced by TrialNet at Vanderbilt. We outline a plan to more vigorously engage them intellectually and scientifically in the work of the network while furthering their careers. Using this broad and diverse set of TrialNet-inspired resources, the TrialNet Clinical Center at Vanderbilt is well positioned to be a leader in T1D prevention and in improving the lives of people with T1D throughout the world.