Dartmouth Regional Pediatric Clinical Trials Unit

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Abstract Dartmouth is home to a robust pediatric academic program centered in the Children's Hospital at Dartmouth (CHaD). While it can demonstrate pockets of excellence in clinical trials targeting children and pregnant women, it lacks a coordinated home to resource such trial activities and to foster professional development. The IDeA States Pediatric Clinical Trials Network (ISPCTN) offers a timely opportunity to craft a center for pediatric clinical trials, to leverage existing resources and develop new ones, to recruit investigators and groups to this core, and to engage local as well as multi-center clinical trials. Organization of our regional presence in the form of the Dartmouth Regional Pediatric Clinical Trials Unit (DRP-CTU) will allow recruitment of a diverse pediatric population, including those who are rural and underserved. To accomplish this, we propose a partnership of three Enrollment Centers, one located at Dartmouth- Hitchcock-Lebanon (Coordinating Center), one at DH-Manchester (urban with large rural catchment area), and one at the Dartmouth CO-OP (extensive rural access) – to provide flexible and robust access to regional populations. A Senior Advisory Committee composed of campus leaders will provide guidance and support navigation of institutional challenges. We will also engage local and ISPCTN resources to establish a program of faculty and staff professional development and create a Mentoring Committee for pro-active implementation. Finally, we plan to stimulate and support our pediatric research community in the multicenter study of pediatric conditions and processes. We also plan to collaborate with our neighboring ISPCTN applicant - the University of Vermont Children's Hospital - and conduct a joint Pediatric Clinical Trials Forum annually. This initiative will provide a much-needed central coordinating platform for the conduct of pediatric clinical trials in the Dartmouth community. It will support existing and new investigators, expanding our clinical trials universe, stimulating expansion of our portfolio, and offering new opportunities for professional development with the resultant recruitment/training of new faculty and research staff. !