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 primarymedical care in community-based primary care practices and specialty care at UVM Children's Hospital. Wehave a strong referral base and established collaborations with primary care practices throughout the regionand across subspecialty practices. This will enable access to pediatric clinical trials through the ISPCTN for allchildren in our area, including underserved and minority populations. The objective of this proposal is toexpand the infrastructure and expertise in the conduct of pediatric clinical trials at UVM, in order to addressdisparities and improve access to clinical trials in rural, underserved areas. UVM is committed to becoming anintegral component of the IDeA States Pediatric Clinical Trials Network (ISPCTN), and will advance the goalsof the network through the following specific aims: 1. UVM will establish a comprehensive pediatric clinicaltrials site within the ISPCTN. In collaboration with the ISPCTN, UVM will build a strong foundation bytraining 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 CareProfessionals/faculty, coordinators, and data management personnel will be strategically trained to conductpediatric 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 clinicaltrials throughout our network. Our clinical investigators, nurses, support staff, and data managers will developnext-generation expertise through experience and specific mentoring and training. 3. UVM will enhanceaccess for rural, underserved, and minority children in VT and northern NY to pediatric clinical trialsthrough ISPCTN participation, with the goal of improving the health of all children. By building acomprehensive 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 andnorthern NY that will have a meaningful impact on the health of all children. Metrics for enrollment ofunderserved populations will be established. Our outreach program will leverage our existing relationships andcollaborations with rural networks of health providers and patients to offer participation in pediatric clinicaltrials. Our IMproving Pediatric Access to Clinical Trials VT (IMPACT VT) program will consolidate our existingexpertise into an enduring, accessible pediatric clinical trial infrastructure with the ISPCTN. Prioritization of theECHO Program focus areas aligns with the needs of our population, expertise, and interests.

Public Health Relevance

Despite being a large segment of the population; rural; minority; and underserved children are traditionallyunderrepresented in clinical trials; often due to decreased access. Failure to represent these children inpediatric studies overlooks the needs of an important segment of the population; limits the scientific evidencebase 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 clinicaltrials for these children and in the long-term will decrease these disparities with the goal of improving health forall children.

National Institute of Health (NIH)
Office of The Director, National Institutes of Health (OD)
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
Application #
Study Section
Special Emphasis Panel (ZHD1-DRG-S (55))
Program Officer
Douthard, Regine
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Vermont & St Agric College
Schools of Medicine
United States
Zip Code