Clinical Research Resources and Facilities Core

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Rural Americans are more likely to die from cancer, heart disease, stroke, chronic lung diseases, and even SARS-CoV-2 infection than persons living in urban areas, yet rural populations are consistently underrepresented in clinical trials. Clinical research focused on the health issues confronting diverse rural populations is critical to addressing and remediating West Virginia’s (WV) significant health disparities. The overall goal of the Clinical Research Resources and Facilities (CRRF) Core is to overcome obstacles to clinical study participation faced by rural residents while supporting the development of the next generation of clinical trialists and ensuring the highest quality of study conduct. Building on the considerable CRRF Core achievements in Years 6-10 that included implementation of the Clinical Trials Center of Excellence (COE), we will accomplish the overall goal by achieving three specific aims. Specific Aim 1 is to develop comprehensive infrastructure and collaborations across WV that facilitate clinical study participation among diverse rural populations. We will accomplish this aim using several strategies. Two new clinical trials partners, Berkeley Medical Center/WVU Eastern Campus, located in WV’s eastern panhandle, and the Veterans Affairs (VA) facility in Huntington, expand the geographic footprint of WVCTSI clinical trials. Existing clinical trials centers at established WVCTSI partners, Marshall University and Charleston Area Medical Center, will be more closely aligned under the COE umbrella through the establishment of the WVCTSI Clinical Trials Council. Importantly, our new National Institutes of Health-funded mobile clinical trials unit, a 39-foot Winnebago customized to include two exam rooms and laboratory space, will provide WVCTSI investigators the ability to enroll study participants in the farthest corners of rural WV. Finally, we will implement and promote telehealth as a clinical research platform to reach potential participants across the state. Specific Aim 2 will build strong clinical research teams by providing the next generation of clinical trialists with the skills and qualifications to effectively lead research teams. The Principal Investigators’ (PI) Academy, established in the current funding cycle, will provide a forum for discussion of clinical trial issues and mentoring of early-stage investigators. To address a critical shortage of study coordinators in WV, we will develop and implement an online certificate program in clinical trial coordination, in collaboration with the WVU School of Nursing. In Specific Aim 3 we will develop and implement a standardized set of performance metrics across all WVCTSI clinical trial sites to drive clinical trial efficiency and quality. As site performance excellence is critical to the safety of participants and the success of any clinical trial, we will implement a menu of metrics to facilitate timely identification and resolution of potential problems that may affect participant safety, study efficiency, and/or study impact. The metrics will be reviewed and agreed upon by the WVCTSI Clinical Trials Council.