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

德克萨斯儿童医院和贝勒医学院 TrialNet 临床中心

• 批准号: 9434987
• 负责人: Maria Jose Redondo
• 金额: $ 19.4万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9434987
• 关键词: Acute; Award; Beta Cell; Caring; Cell physiology; Cessation of life; Child; Childhood; Chronic; Cities; Clinical; Clinical Research; Collaborations; Communities; Community Health Centers; Diabetes Mellitus; Environment; Etiology; Family; Fostering; Funding; Funding Agency; Geography; Health; Healthcare; Insulin; Insulin-Dependent Diabetes Mellitus; International; Lead; Life; Medical; Medicine; Mentors; National Institute of Diabetes and Digestive and Kidney Diseases; Newborn Infant; Participant; Pathogenesis; Pathway interactions; Patients; Pediatric Hospitals; Pediatrics; Pregnant Women; Prevention; Prevention Research; Prevention trial; Provider; Records; Recruitment Activity; Research; Research Personnel; Role; Site; Structure; Texas; Travel; United States; United States National Institutes of Health; Woman; collaborative environment; college; cost; cost effective; cost effectiveness; ethnic minority population; experience; follow-up; improved; innovation; insulin dependent diabetes mellitus onset; interest; novel; prevent; programs; public health relevance; racial and ethnic; response; study population; success

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.

描述（由申请人提供）：TrialNet是一个国际临床研究中心联盟，旨在加速发现预防或延迟1型糖尿病（T1 D）发作的方法。TrialNet目前面临的挑战是提高受试者招募和随访的有效性和成本效益，以及随后参与预防试验。此外，有效的T1 D研究需要研究人员之间和资助机构之间的合作环境，同时促进初级研究人员对T1 D研究的兴趣，并使更大的T1 D研究社区富有成效。 我们建议建立德克萨斯儿童医院/贝勒医学院（TCH/BELLE）TrialNet临床中心，其中包括休斯顿的TCH/BELLE和圣安东尼奥的BELLE儿童医院作为附属机构。我们的计划将通过将德克萨斯州最大的两个城市纳入一个临床中心，为TrialNet提供一个非常大的候选人库。将通过利用TCH/CDC广泛的医疗保健地理结构（6个TCH/CDC研究中心、1个社区卫生中心、48个综合儿科诊所网络和德克萨斯州圣安东尼奥市的儿童医院）来提高疗效和成本效益，以最大限度地减少受试者旅行。我们的计划将促进TrialNet访问高T1 D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和NIDDK及其合作伙伴积极合作，通过利用强大的PI，合作研究者和机构在T1 D研究中的富有成效的合作记录，开发和开展旨在预防或延迟T1 D或改善T1 D患者β细胞功能的研究。此外，我们还组建了一支由来自不同背景的合作研究者组成的优秀团队，他们对T1 D研究合作有着共同的兴趣。我们的计划将通过建立一个创新的TrialNet初级研究者与研究基金，通过TrialNet初级研究者奖，获得TCH/T1 D TrialNet共同研究者的T1 D研究指导，以及在其他TrialNet网站活动中发挥积极作用，包括参与者招募和随访，来促进初级研究者对T1 D研究的兴趣。最后，我们计划通过创建一个新的TrialNet研究小组，让TrialNet研究人员、研究参与者、T1 D患者及其家属和T1 D护理提供者积极参与T1 D研究，在参与T1 D预防研究的所有各方之间建立强有力的伙伴关系。更大的T1 D社区将通过糖尿病营地，T1 D当地组织和一个新的TrialNet Newspage进一步接触。 上述强有力的计划，PI在T1 D病因学和发病机制方面的专业知识，她与多中心T1 D研究的富有成效的合作记录，她作为活跃的TrialNet中心的PI的经验，TCH/CDC对TrialNet的机构承诺，以及良好的研究环境，预期TCH/CDC Houston-San Antonio TrialNet临床中心的成功。