Texas Children's Hospital and Baylor College of Medicine TrialNet Clinical Center

简介（由申请人提供）：TrialNet是一个由临床研究中心组成的国际联盟，旨在加速发现预防或延迟1型糖尿病（T1D）发病的方法。TrialNet目前面临的挑战是提高受试者招募和随访以及随后参与预防试验的疗效和成本效益。此外，有效的T1D研究需要研究人员和资助机构之间的合作环境，同时促进初级研究人员对T1D研究的兴趣，并有效地参与更大的T1D研究社区。我们建议建立一个德克萨斯儿童医院/贝勒医学院（TCH/BCM）试验网临床中心，包括休斯顿的TCH/BCM和圣安东尼奥的BCM儿童医院作为附属医院。我们的项目将通过将德克萨斯州两个最大的城市纳入一个临床中心，为TrialNet提供一个非常大的候选人库。通过利用TCH/BCM广泛的医疗保健地理结构（6个TCH/BCM站点，一个社区卫生中心，一个由48个综合儿科办公室组成的网络，以及德克萨斯州圣安东尼奥的BCM儿童医院）来减少受试者的旅行，将提高疗效和成本效益。我们的项目将促进TrialNet进入高T1D研究兴趣的研究人群，如种族/少数民族、新生儿和孕妇。我们致力于与TrialNet、NIDDK及其合作伙伴积极合作，开发和开展旨在预防或延缓T1D，或改善T1D患者β细胞功能的研究，利用强大的PI、共同研究者和机构在T1D研究中富有成效的合作记录。此外，我们还组建了一支优秀的合作研究团队，他们来自不同的背景，对T1D研究合作有着共同的兴趣。我们的项目将促进初级研究者对T1D研究的兴趣，通过设立一个创新的TrialNet初级研究者，通过TrialNet初级研究者奖获得研究资金，获得TCH/BCM TrialNet联合研究者的T1D研究指导，并在其他TrialNet网站活动中发挥积极作用，包括参与者招募和跟进。最后，我们计划在所有参与T1D预防研究的各方之间建立强有力的伙伴关系，通过创建一个新的TrialNet研究小组，将TrialNet研究人员、研究参与者、T1D患者、他们的家人和T1D护理提供者作为T1D研究的积极参与者。更大的T1D社区将进一步通过糖尿病营，T1D当地组织和一个新颖的TrialNet新闻。上述强有力的计划，PI在T1D病因和发病机制方面的专业知识，她与多中心T1D研究的富有成效的合作记录，她作为活跃的TrialNet中心PI的经验，TCH/BCM对TrialNet的机构承诺，以及良好的研究环境，都预示着TCH/BCM休斯顿-圣安东尼奥试验网络临床中心的成功。

DESCRIPTION (provided by applicant): TrialNet is an international consortium of clinical research centers that aim to accelerate the path of discovery to approaches to prevent or delay the onset of type 1 diabetes (T1D). TrialNet's current challenge is increasing efficacy and cost-effectiveness of subject recruitment and follow-up, and subsequent participation in prevention trials. In addition, effective T1D research requires a collaborative environment among investigators and with funding agencies, while promoting interest in T1D research among junior investigators, and engaging the larger T1D research community productively. We propose to establish a Texas Children's Hospital/Baylor College of Medicine (TCH/BCM) TrialNet Clinical Center that includes TCH/BCM in Houston with BCM Children's Hospital in San Antonio as Affiliate. Our program will provide TrialNet access to an extraordinary large pool of candidates by encompassing the two largest cities in Texas into a single Clinical Center. Efficacy and cost -effectiveness will be enhanced by utilizing TCH/BCM widespread health care geographical structure ( six TCH/BCM sites, a community health center, a network of 48 integrated pediatric offices, and BCM Children's Hospital in San Antonio, Texas) to minimize subject travel. Our program will facilitate TrialNet access to study populations of high T1D research interest, such as racial/ethnic minorities, newborns and pregnant women. We are committed to active collaboration with TrialNet, and NIDDK and its partners to develop and conduct studies aiming to prevent or delay T1D, or improve beta-cell function in T1D patients, by capitalizing on strong PI, co- investigator and institutional track records of productive collaboration in T1D research. Further, we have assembled an outstanding team of co-investigators from different backgrounds with a shared interest in T1D research collaboration. Our program will promote interest in T1D research among junior investigators by establishing an innovative TrialNet Junior Investigator with research funds through a TrialNet Junior Investigator Award, access to T1D research mentoring by TCH/BCM TrialNet co-investigators, and an active role in other TrialNet site activities, including participant recruitment and follow -up. Finally, we plan to develop a strong partnership among all parties involved in T1D prevention research, by creating a novel TrialNet Research Group that will engage TrialNet investigators, study participants, T1D patients, their families and T1D care providers as active participants in T1D research. The larger T1D community will be further reached out through diabetes camp, T1D local organizations, and a novel TrialNet Newspage. The robust program outlined above, the PI's demonstrated expertise on the etiology and pathogenesis of T1D, her track record of productive collaboration with multicenter T1D studies, her experience as PI of an active TrialNet center, TCH/BCM institutional commitment to TrialNet, and excellent research environment anticipate the success of a TCH/BCM Houston-San Antonio TrialNet Clinical Center.