The West Virginia Pediatric Clinical Trials Network

摘要

Abstract The West Virginia Pediatric Clinical Trials Network (WVPCTN) will work as a Clinical Center of the IDeA States PCTN to provide clinical trial access to individuals in the rural, central Appalachian state of West Virginia and surrounding counties included in the immediate service area. The WVPCTN will be critically poised to serve as a Clinical Center based on the historical, physical, psychosocial, and fiscal burdens brought about by a multitude of chronic disease conditions and a wide variety of environmental risk factors that contribute to those conditions in West Virginia. The WVPCTN is well positioned to be successful as a Clinical Center due to a combination of a variety of structural and human resources already in place that address: Subject Identification, Subject Recruitment and Study Performance. Specifically, the WVPCTN will utilize the following: for Subject Identification - the Integrated Data Repository of the WVU CTSI (containing over 2 million patient records), large neonatal and school age cohorts from our Birth Score and CARDIAC projects (described in detail in the Research Plan), and targeted cohorts from the West Virginia Perinatal Partnership Network, the Center of Excellence in Disabilities and the WVU Department of Occupational and Environmental Studies; for Subject Recruitment – WVU General and Specialty Clinics, our CTSI sponsored Practice Based Research Network, the infrastructure of our Dental COHRA grant, the infrastructure from Birth Score and CARDIAC, and a variety of specialized existing settings; for Study Performance – an experienced investigator pool, a group of mentee investigators, and the resources and oversight of the WVU CTSI sponsored Clinical Trials Research Unit core. These features and resources, together with strong and sustained partnerships throughout the state, and the multiple environmentally related conditions of our citizens, uniquely position us to both be successful at PCTN trials and propose new trials for the PCTN. The WVPCTN will add to a long standing commitment to pediatric focused initiatives across the state and benefit from statewide networks that have been established, in part through active IDeA State mechanisms. As such, we are uniquely positioned to fully leverage additional funds to efficiently establish the infrastructure to provide access to cutting edge trials which will impact the health of the children of West Virginia.