Clinical trials are the gold standard for assessing the effectiveness and safety of treatments in the medical field. However, experts agree that children routinely receive medical therapies that have not been studied in clinical trials involving pediatric subjects. Additionally, nearly 20% of US children are affected by at least one chronic disease, but clinical trials focused on the etiology, prevention, and/or treatment of these illnesses are often limited to extrapolating from adult-derived data. Residents of rural areas in particular are more likely to report limited access to and/or awareness of available clinical trials. When interviewed, children enrolled in clinical trials state that their participation provided them with access to a larger variety of treatment options, improved their understanding of their disease, and provided them with the opportunity to help other people. Thus, there exists a critical need to increase the opportunity for children, including remote rural children, to participate in clinical trials. The long-term goals of the Sunflower Pediatric Clinical Trials Research Extension (SPeCTRE) are to: 1) provide enhanced opportunities for children in rural and underserved areas of Kansas and neighboring IDeA states to participate in clinical trials; and 2) to increase the capability of pediatric clinicians and researchers within Kansas to develop and conduct clinical trials. The specific objective in this application is to extend the reach of the IDeA Network to children in rural and underserved areas within Kansas by extending existing infrastructure. This objective will be accomplished by: 1) using the statewide healthcare outreach infrastructure of the University of Kansas Medical Center (KUMC) sponsored Area Health Education Centers (AHECs) to identify clinical trials performance sites across rural Kansas; 2) employing telehealth resources provided by the University of Kansas Center for Telemedicine and Telehealth to bridge distance barriers to clinical trials follow-up and subject retention; 3) increase community and healthcare provider awareness of and participation in pediatric clinical trials through coordinated outreach efforts including social media, academic detailing, and the use of participant registries within the KUMC system and available to the public; and 4) increasing the workforce capacity to conduct pediatric clinical trials in Kansas by recruiting rural health care providers and health sciences students into clinical research and training these professionals in the principles of research and responsible clinical trials conduct. Longitudinal evaluation and improvement of all clinical trials-related operations conducted by SPeCTRE will be accomplished by measuring outcomes measures that will be organized according to the RE-AIM framework, a well-established method of ensuring the long-term sustainability and growth of public health and outreach programs. Funding SPeCTRE will increase clinical trials enrollment of Kansas children from rural and underserved areas, enhance access to innovative medical therapies for Kansas children, and improve workforce capacity in Kansas to conduct pediatric clinical trials, all in order to eventually support the development of better care options for children.

Public Health Relevance

Children often receive medical treatments that have only been thoroughly tested in adults, but enrolling children in clinical trials?the highest quality research method available to study medical treatments?is difficult for a variety of reasons. The goal of the Sunflower Pediatric Clinical Trials Research Extension (SPeCTRE) is to improve the opportunity for children in rural and underserved areas of Kansas and neighboring states to participate in clinical trials. SPeCTRE will conduct outreach, education, and engagement activities that will extend clinical trials participation opportunities to children in rural and underserved areas of Kansas and eventually neighboring states, which will help to support the development of better care options for children.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Clinical Research Cooperative Agreements - Single Project (UG1)
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Special Emphasis Panel (ZHD1-DRG-S (55))
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Tamburro, Robert F
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University of Kansas
Schools of Medicine
Kansas City
United States
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