Vanderbilt University: Clinical Center Application, Type 1 Diabetes TrialNet

范德比尔特大学：临床中心申请，1 型糖尿病 TrialNet

• 批准号: 8913146
• 负责人: WILLIAM E RUSSELL
• 金额: $ 49.99万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8913146
• 关键词: Adult; Affect; Age; American; Area; Autoimmune Process; Back; Boston; Caring; Cells; Chicago; Child; Childhood; Clinic; Clinical; Clinical Trials; Collaborations; Communities; Development; Diabetes Mellitus; Diabetes prevention; Disease; Enrollment; Environment; Epidemiology; Family; Funding; Future; Future Generations; Genetic; Goals; Health; Health Care Costs; Immune system; Immunologics; Incidence; Individual; Institutional Review Boards; Insulin; Insulin-Dependent Diabetes Mellitus; International; Investments; Leadership; Life; Life Expectancy; Marketing; Metabolic; Mission; Monitor; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Pancreas; Participant; Patients; Performance; Population; Positioning Attribute; Prevention; Prevention Research; Prevention strategy; Prevention trial; Process; Protocols documentation; Public Health; Public Relations; Radial; Recruitment Activity; Research; Research Personnel; Resources; Risk; Role; Site; Staging; Tennessee; Toddler; Training; Translational Research; United States National Institutes of Health; Universities; Work; base; career; clinical care; cost; diabetic patient; experience; improved; medical specialties; metropolitan; network models; novel; outreach; pediatric department; prevent; programs; screening; success; urban area

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.

描述（由申请人提供）：数十年来，1 型糖尿病 (T1D) 的发病率每年以 3-5% 的速度增加，其中在幼儿中增长最快。预防策略对于减轻糖尿病给个人和公共健康带来的巨大负担至关重要，并且还可能影响治愈或逆转已经患病者的疾病的策略。作为 2009 年唯一加入 TrialNet 联盟的新临床中心，范德比尔特大学在参与者招募和参与方面拥有极其出色的记录，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。我们中心为拟议的工作带来了丰富的资源。我们有一个非常庞大且受到仔细跟踪的 T1D 患者和家庭基础，可以从中继续吸引参与者。我们获得了社区的广泛参与和对我们努力的认可，并且在临床试验中的参与者参与和保留方面拥有非常出色的记录，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，我们建立了一个由 14 个附属机构组成的分布广泛、充满热情的团体，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附属公司，并扩大和加强表现不佳的附属公司的活动。我们提出新的方向来扩大我们的影响力：将我们中心的服务范围扩展到地方和国家层面的多个自身免疫患者社区，这是一个迄今为止未得到充分利用的符合筛查条件的 T1D 家庭库。我们与田纳西州卫生部建立了合作伙伴关系，将 TrialNet 引入田纳西州的所有公共卫生中心，如果成功，可能会成为其他州推广的网络模型。我们中心的媒体宣传范围非常广泛，我们建议扩大国内和国际媒体的影响力，这将继续使整个网络受益。我们记录了我们的 PI 和协调员在网络层面在新预防研究的开发和执行、公共关系、附属管理和参与以及研究协调方面所发挥的领导作用。我们记录了范德比尔特糖尿病中心和儿科部门对我们的申请的强有力的机构支持，以扩大 NIDDK 的财政投资。范德比尔特大学将支持该网络认可的任何选项，以加快 IRB 对研究的批准。最后，我们展示了范德比尔特大学拥有一批强大的早期研究人员，他们的职业生涯已经受到 TrialNet 的影响。我们制定了一项计划，让他们更加积极地以智力和科学的方式参与网络工作，同时进一步发展他们的职业生涯。范德比尔特 TrialNet 临床中心利用这套广泛且多样化的 TrialNet 资源，有望成为 T1D 预防和改善全世界 T1D 患者生活的领导者。