Highly skilled physician investigators are urgently needed for pediatric trial teams that can take advantage ofnew technologies and respond to the increasing demands of high quality pediatric clinical trials. At the sametime, rural and underserved communities need access to and to benefit from these clinical trials. Locally,regionally, and nationally, UNM Pediatric Clinical Trial Site (PCTS) will support and advance clinical trials. Ourimpact is significant because 1) UNM PCTS will be a portal of entry to our diverse patient populations includingunderrepresented racial and ethnic groups as well as geographically isolated and under-resourced ruralcommunities. Our community-engaged approach strengthens recruitment of these diverse populations intoresearch studies and will improve health among pediatric populations. 2) UNM PCTS is a needed asset locallyand regionally. UNM PCTS will devote a structured and skilled research team including trained investigators toconduct pediatric clinical trials. 3) UNM PCTS will bring unique capabilities to the Institutional DevelopmentAwards (IDeA) States Pediatric Clinical Trials Network (ISPCTN), including collaboration with the Clinical andTranslational Research Infrastructure Network (CTR-IN) through our Clinical and Translational Science Award(CTSA) Mountain West Research Consortium (MWRC). Our clinical site will be a hub for other IDeA and non-IDeA sites; it will increase opportunity for partner sites to participate in pediatric clinical trials as they wouldcontribute to accelerated patient enrollment and increase diversity of the patient population. 4) We haveunique and established strengths in clinical study infrastructure and Translational Workforce Development(TWD) as part of UNM Clinical and Translational Science Center (CTSC) that will provide valuable assets tothe entire ISPCTN. 5) Finally, UNM PCTS will have experienced principal investigators (PIs) participating inmultisite pediatric clinical trials and recruitment and retention from communities and rural areas statewide.They will be a great asset to the ISPCTN Network and Steering Committee. UNM PCTS will offer anexperienced team of researchers to work with the IDeA states Data Coordinating and Operations Center(DCOC) of the ISPCTN. The team will improve access to relevant populations and accelerate overall studyaccrual and retention of participants while generating high-quality data that meet regulatory standards. UNMPCTS and collaborators will offer expertise needed to identify research topics of high priority, including ruraland underserved communities. We will exert a positive impact on access and on the quality of multisitepediatric studies in a measureable way. We will accomplish this by increasing the speed and efficiency ofmultisite pediatric trials and by using innovative methods to improve engagement, enrollment, and retention ofdiverse populations from New Mexico and other IDeA and non-IDeA states. We will sustain Networkproductivity by training independent pediatric clinical-trial investigators as we sustain the influence on the field.

Public Health Relevance

UNM PCTSN will provide the research infrastructure as well as the supervised professional development inresearch and clinical trial implementation. We will build a dedicated pediatric clinical trial teams at ourinstitutions and will partner with IDeA and non-IDeA state institutions to improve access to relevant populationsand accelerate overall study accrual and retention of participants; our effort will have a sustained influence onchild health and advancing knowledge in the field.

National Institute of Health (NIH)
Office of The Director, National Institutes of Health (OD)
Clinical Research Cooperative Agreements - Single Project (UG1)
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Special Emphasis Panel (ZHD1-DRG-S (55))
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Douthard, Regine
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University of New Mexico Health Sciences Center
Schools of Medicine
United States
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