Clinical Sites for the IDeA States Pediatric Clinical Trials Network

项目主任/首席调查员(最后、第一、中间)：Rosalyn的Singleton 摘要 阿拉斯加土生土长的儿童患侵袭性细菌疾病的比率在美国是最高的， 肺炎/毛细支气管炎，慢性化脓性肺部疾病，包括支气管扩张，维生素D缺乏和 软骨病、儿童早期龋齿以及肥胖症和神经发育障碍的高患病率。许多. 这些情况与环境影响有关，包括家庭拥挤、缺乏管道 水、过渡饮食、减少体力活动和烟草暴露。阿拉斯加原住民部落健康 联盟(ANTHC)，一个为阿拉斯加原住民提供全州服务的非营利性健康组织 由阿拉斯加土著人民拥有和运营的人，正在合作多个项目，重点是 这些儿童健康问题。然而，NIH支持的儿科临床试验的发展受到了挑战 人口相对较少，其中约一半广泛分布在各地的偏远地区 国家和有限的儿科研究基础设施。ANTHC建议成为儿科临床试验 IDEA国家儿科临床试验网络中心发展能力和能力 进行儿科临床试验，特别是在阿拉斯加的农村和服务不足的地区。ANTHC及其地方 区域部落合作伙伴，南方基金会(SCF)将实施和启动临床试验，以解决 阿拉斯加原住民儿童健康不平等及其对上/下呼吸道环境影响的优先事项 疾病；肥胖；产前、围产期和产后结局；以及神经发育。ANTHC和SCF的临床和 研究人员将通过IDEA计划内的活动获得指导和专业发展 发展和保持研究能力，从而提高这些组织成功的能力 在未来竞争NIH的研究资金。ANTHC和SCF的研究人员将与其他 资助研究人员在儿科临床研究参与方面提供更大的多样性，加快研究 完成，并允许与经验丰富的调查人员合作。ANTHC参与这一网络 解决在竞争研究资金以解决阿拉斯加土著儿童健康问题方面取得进展的关键障碍 通过临床试验的不平等。IDEA儿科临床试验网络为 ANTHC在更短的时间内与更大的群体一起参与关键干预措施的评估，并建立 具备启动临床试验的研究能力。 OMB编号0925-0001/0002(08/12版批准至2015年8月31日)页面续格式页面

Program Director/Principal Investigator (Last, First, Middle): Singleton, Rosalyn Abstract Alaska Native children experience the some of the highest reported U.S. rates for invasive bacterial disease, pneumonia/bronchiolitis, chronic suppurative lung disease including bronchiectasis, vitamin D deficiency and rickets, and early childhood caries, and high prevalence of obesity and neurodevelopmental disorders. Many of these conditions are associated with environmental influences, including household crowding, lack of piped water, transitioning diet, decreased physical activity, and tobacco exposure. The Alaska Native Tribal Health Consortium (ANTHC), a not-for-profit health organization providing statewide services for Alaska Native people and owned and operated by the Alaska Native people, is collaborating on multiple projects focused on these child health issues. However, development of NIH supported pediatric clinical trials has been challenged by a relatively small population, of which approximately half is widely dispersed in remote areas throughout the state and limited pediatric research infrastructure. ANTHC proposes to become a pediatric clinical trials center within the IDeA States Pediatric Clinical Trials Network to develop the capacity and capability to conduct pediatric clinical trials, particularly in rural and underserved areas of Alaska. ANTHC and its local regional Tribal partner, Southcentral Foundation (SCF), will implement and initiate clinical trials that address Alaska Native child health inequities with priorities on environmental influences on upper/lower airway disease; obesity; pre-, peri-, and postnatal outcomes; and neurodevelopment. ANTHC and SCF clinical and research staff will receive mentoring and professional development through activities within the IDeA program to develop and maintain research capacity thereby improving the ability for these organizations to successfully compete for NIH research funding in the future. ANTHC and SCF researchers will collaborate with other funded investigators to provide greater diversity in pediatric clinical study participation, accelerate study completion, and allow partnering with experienced investigators. ANTHC's participation in this network addresses critical barriers to progress in competing for research funding to address Alaska Native child health inequities through clinical trials. The IDeA pediatric clinical trials network provides an opportunity for ANTHC to participate in evaluations of key interventions with a larger group in a shorter time period and build research capacity to be able to initiate clinical trials. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) Page Continuation Format Page