Rural children, like those in Vermont and northern New York, are underrepresented in pediatric clinical trials. The University of Vermont (UVM) serves a large catchment area in this region, where children receive primary medical care in community-based primary care practices and specialty care at UVM Children's Hospital. We have a strong referral base and established collaborations with primary care practices throughout the region and across subspecialty practices. This will enable access to pediatric clinical trials through the ISPCTN for all children in our area, including underserved and minority populations. The objective of this proposal is to expand the infrastructure and expertise in the conduct of pediatric clinical trials at UVM, in order to address disparities and improve access to clinical trials in rural, underserved areas. UVM is committed to becoming an integral component of the IDeA States Pediatric Clinical Trials Network (ISPCTN), and will advance the goals of the network through the following specific aims: 1. UVM will establish a comprehensive pediatric clinical trials site within the ISPCTN. In collaboration with the ISPCTN, UVM will build a strong foundation by training a core team and establish the infrastructure to initiate and maintain a pediatric clinical trials center. This award will support a team that will subsequently build and enhance collaborative opportunities in multi- center ISPCTN pediatric clinical trials. 2. Through training, mentoring, and participation in ISPCTN trials, we will expand local expertise in the conduct of pediatric clinical trials in the UVM Network. Health Care Professionals/faculty, coordinators, and data management personnel will be strategically trained to conduct pediatric clinical trials. An ongoing program of courses, staff training, and mentoring by the core team (developed in aim 1) will be established to carefully expand a well-trained team who will serve pediatric clinical trials throughout our network. Our clinical investigators, nurses, support staff, and data managers will develop next-generation expertise through experience and specific mentoring and training. 3. UVM will enhance access for rural, underserved, and minority children in VT and northern NY to pediatric clinical trials through ISPCTN participation, with the goal of improving the health of all children. By building a comprehensive outreach program and a confidential registry of available participants for ISPCTN clinical trials, we will assure access to state-of-the art clinical trials for rural, underserved, and minority children of VT and northern NY that will have a meaningful impact on the health of all children. Metrics for enrollment of underserved populations will be established. Our outreach program will leverage our existing relationships and collaborations with rural networks of health providers and patients to offer participation in pediatric clinical trials. Our IMproving Pediatric Access to Clinical Trials VT (IMPACT VT) program will consolidate our existing expertise into an enduring, accessible pediatric clinical trial infrastructure with the ISPCTN. Prioritization of the ECHO Program focus areas aligns with the needs of our population, expertise, and interests.
Despite being a large segment of the population, rural, minority, and underserved children are traditionally underrepresented in clinical trials, often due to decreased access. Failure to represent these children in pediatric studies overlooks the needs of an important segment of the population, limits the scientific evidence base and leads to unequal distribution of the opportunity to benefit from medicine and research. Our program, IMproving Pediatric Access to Clinical Trials in Vermont (IMpact VT) will increase access to pediatric clinical trials for these children and in the long-term will decrease these disparities with the goal of improving health for all children.
