Clinical Sites for the IDeA States Pediatric Clinical Trials Network

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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