Type 1 Diabetes TrialNet: Toronto Clinical Center

 描述(申请人提供)：尽管目前对1型糖尿病(T1D)的治疗有效，但糖尿病长期并发症的重大风险仍然存在。多项研究表明，与1型糖尿病相关的自身免疫在临床表现前几年就已被发现，而且T1D是可以预测的。1型糖尿病试验网络研究小组的目标是通过研究T1D的发病机制和试验干预这一过程的治疗方法来防止β细胞的损失。为了实现TrialNet的目标，成功的临床中心必须保持和开发高效的招募方法，鼓励受试者参与后续和预防研究，并以高效和准确的方式进行研究。此外，他们必须通过参与TrialNet活动和委员会以及增加临床和/或科学专业知识来为整个任务做出贡献。此应用程序的目标反映了我们中心实现TrialNet使命的方法：·描述多伦多临床中心作为一个创新和有效的TrialNet网站的进展和功能，该网站已经建立了广泛的地区和国家网络，在糖尿病社区中建立了广泛的联系。因此，我们的网站在18个临床中心中登记参加预防之路研究的筛查和监测阶段的受试者数量排名第五，保留率非常高，超过90%。通过使用TrialNet协调中心的报告和我们网站收集的数据，仔细分析招募方法的有效性，使我们能够优化努力，在过去3年中增加了为预防之路研究筛选的受试者数量。·说明TrialNet工作中的领导和协作角色，例如Wherrett博士领导的重组人谷氨酸脱羧酶对新发病受试者1型糖尿病进展的影响研究，管理我们网站和加拿大附属网络的所有加拿大法规要求，以及我们的协调员在制定材料支持招聘方面的作用。·突出用来帮助附属网站提供培训和专门支持的方法，如筛选、活动识别和开发。详细介绍了通过新的环节提高招聘和成本效率的方法，通过开发共享的审查和同意文件工具来优化IRB审查的效率，监测招聘工作的成功和进行研究的方法。描述了一项关于设立奖学金以支持1型糖尿病新的临床研究人员的建议。

 DESCRIPTION (provided by applicant): Despite effective current therapies for Type 1 diabetes (T1D), significant risks of long term complications of diabetes exist. Multiple studies have demonstrated that autoimmunity associated with type 1 diabetes is found years before its clinical presentation and that T1D can be predicted. The goals of the Type 1 Diabetes TrialNet Study Group are to prevent loss of beta cells through study of the pathogenesis of T1D and trials of therapies to intervene in the process. To reach TrialNet's goal, successful Clinical Centers must maintain and develop highly effective recruitment approaches, encourage participation of subjects in follow up and prevention studies and carry out studies in a highly efficient and accurate manner. In addition, they must contribute to the overall mission by engagement in TrialNet activities and committees and adding clinical and/or scientific expertise. The aims of this application reflect our center's approach to meeting TrialNet's mission: • To describe the progress and function of the Toronto Clinical Center as an innovative and effective TrialNet site that has developed an extensive regional and national network with broad links in the diabetes community. As a result, our site ranks 5th of 18 Clinical Centers in the number of subjects enrolled in screening and monitoring phases of the Pathway to Prevention study with a very high retention rate of over 90%. Careful analysis of the effectiveness of recruitment approaches through the use of reports from TrialNet's Coordinating Center and data collected by our site has allowed us to optimize efforts yielding an increase in the number of subjects screened for the Pathway to Prevention Study over the past 3 years. • To illustrate leadership and collaborative roles in TrialNet efforts such as Dr. Wherrett's leadership of the Study of Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects Study, management of all Canadian regulatory requirements for our site and the Canadian Affiliate Network, and our coordinators' roles in developing materials to support recruitment. • To highlight approaches used to assist Affiliate Sites with training and specialized support such as screening event identification and development. Methods to enhance recruitment and cost efficiency through new links, optimize efficiency of IRB review through the development of shared tools for review and consent documents, monitor the success of recruitment efforts and study conduct are detailed. A proposal for a fellowship to support new clinical researchers in type 1 diabetes is described.