Alterations and Renovations for Clinical Research Resources and Facilities

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In 2017, the West Virginia Clinical and Translational Institute (WVCTSI) established the Clinical Trials Center of Excellence (COE) at West Virginia University’s Health Sciences Center. Since that time, there has been a substantial increase in clinical trial activity with the numbers of active trials doubling and clinical trial participation increasing 10-fold compared with the previous 5-year period. It is anticipated that clinical trial enrollment will continue to increase, requiring further growth of the COE. In addition, during the next funding cycle (Years 11- 15), we will extend COE services statewide. WVCTSI has recently been chosen as a lead site for the National Heart, Lung, and Blood Institute RECOVER Cohort, an observational study of post-acute sequelae of COVID- 19. WVCTSI, specifically the COE will be responsible for management of 10 other sites (9 CTRs and 2 CTSAs) with varying degrees of clinical trials infrastructure. The explosion in COE activity requires alterations and renovations to the existing space to optimize service delivery and management. The completion of the alterations and renovations proposed in this project will ensure accomplishment of the following specific aims. Specific Aim (1) Increase clinical research participation and improve service delivery. We will create an additional research exam room and make improvements to the existing exam room such that multiple clinical trial participant visits can be scheduled concurrently and in close proximity to the research team, aligning with the increased clinical research activity expected. Specific Aim (2) Enhance productivity and ensure confidentiality for clinical research teams. The proposed space renovations will allow for participant confidentiality that is lacking in the current open COE office space. By erecting new walls, work areas will be delineated, allowing for confidentiality as well as better concentration of COE staff. In addition, defined space for collaborative work, so essential to the statewide COE expansion, will be created. Specific Aim (3) Utilize teleconferencing to improve access and connectivity for clinical research teams and increase collaboration among remote teams. Dedicated teleconferencing space and audio-visual equipment for clinical research will enable increased telehealth use and statewide communication for the Clinical Trials Council, enabling oversight of clinical trials efficiency and quality at distant sites (See CRRF Core Section for details). In addition, the space and equipment proposed in the project will enable new telehealth platforms for the conduct of remote patient study visits (when appropriate) proposed in the CRRF Core section (Aim 1) of this renewal application. Finally, dedicated teleconferencing space will improve the management of distant clinical research teams in the NHLBI RECOVER Cohort study.