Arkansas Center for Advancing Pediatric Therapeutics (ArCAPT)

项目摘要 目前，美国绝大多数针对儿童的研究都不包括儿童。 居住在NIH确定的24个符合IDEA条件的州/地区，如阿肯色州。因此， 可能无法推广到相当大比例的疾病负担最高的儿童， 肥胖、糖尿病、早产、肺和神经发育障碍。未来的治疗和非治疗 如果要改善这些儿童的健康状况，就必须向他们提供治疗试验。阿肯色州 儿童研究所（阿克里）准备立即解决的总体方案目标， IDEA国家儿科临床试验网络（ISPCTN），从而努力缩小“临床试验差距”， 生活在美国的孩子。为此，我们成立了阿肯色州儿科进步中心， 治疗学（ArCAPT）。我们的努力将以中心假设为指导，即ArCAPT将使 参与不同群体的婴儿，儿童和青少年在专业设计，创新 最高质量和科学价值的临床试验。我们将利用我们独特的病人基础， 知识资本和既定的机构间资源，以加强由 NIH和其他支持的研究。我们建立的临床试验企业和资深儿科临床骨干 研究人员将使我们能够探索个体发育，环境暴露和 四个高度优先领域的疾病：上呼吸道和下呼吸道疾病;肥胖;神经发育和前，后， 和产后发育。我们的假设将通过执行三个具体目标进行测试：1）链接 建立机构间和机构内资源，支持儿科临床试验。我们将合作 与阿肯色州儿童医院和阿肯色州大学医学科学合作， 儿科试验，解决种族和少数民族健康问题的影响， 环境因素和疾病，因为它们与治疗终点有关。2）。提供监督 研究和临床试验实施的专业发展。我们将继续保持和扩大我们的 现有的临床研究团队，并通过高等教育培养下一代儿科临床研究人员。 在儿科临床试验中的质量教育。3）。打造最先进的临床试验平台 婴儿、儿童和青少年。使用跨学科团队，包括多个儿科 我们将扩大临床研究，测试和验证新技术，工具和方法， 用于评价人种/种族、个体发育、环境、疾病和治疗反应之间的界面。 该提案的结果将通过系统地改善阿肯色州及其他地区儿童的健康状况， 解决IDEA州人口的独特健康挑战。

PROJECT SUMMARY The vast majority of research conducted in children in the United States (US) today does not include children living in the 24 IDeA eligible states/territories identified by the NIH such as Arkansas. Consequently, findings may not be generalizable to a substantial proportion of children who carry the highest disease burdens such as obesity, diabetes, pre-maturity, lung and neurodevelopmental disorders. Future therapeutic and non- therapeutic trials must be available to these children if their health status is to be improved. Arkansas Children's Research Institute (ACRI) is prepared to immediately address the overarching program goals of the IDeA States Pediatric Clinical Trial Network (ISPCTN) and thereby, work to close the “clinical trial gap” for children living in IDeA states. To this end, we have formed the Arkansas Center for Advancing Pediatric Therapeutics (ArCAPT). Our efforts will be directed by the central hypothesis that ArCAPT will enable the participation of diverse groups of infants, children and adolescents in expertly designed, innovative clinical trials of the highest quality and scientific value. We will leverage our unique patient base, intellectual capital and established inter-institutional resources to enhance pediatric clinical trials funded by the NIH and other supported research. Our established clinical trial enterprise and cadre of senior pediatric clinical investigators will enable us to explore the impact and intersection of ontogeny, environmental exposure and disease in four high priority areas: upper and lower airway disease; obesity; neurodevelopment and pre-, peri- and postnatal development. Our hypothesis will be tested by executing three specific aims: 1) Link established inter- and intra-institutional resources supporting pediatric clinical trials. We will partner with Arkansas Children's Hospital and the University of Arkansas for Medical Sciences to increase the scope of pediatric trials, address the impact of racial and ethnic minority health issues and the intersection of environmental factors and disease as they relate to therapeutic endpoints. 2). Provide supervised professional development in research and clinical trial implementation. We will maintain and expand our existing clinical research teams and train the next generation of pediatric clinical researchers through high quality education in the conduct of pediatric clinical trials. 3). Create a state-of-the-art clinical trial platform for infants, children and adolescents. Using a cross-disciplinary team involving multiple pediatric subspecialists, we will expand clinical research and test and validate new technologies, tools and approaches for evaluating the interface between race/ethnicity, ontogeny, environment, disease and treatment response. The outcome of this proposal will improve the health of children of Arkansas and beyond by systematically addressing the unique health challenges of IDeA state populations.