Alterations and Renovations for Clinical Research Resources and Facilities

临床研究资源和设施的改造和翻新

• 批准号: 10505672
• 负责人: Sally Lynn Hodder
• 金额: $ 25.18万
• 依托单位: WEST VIRGINIA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10505672
• 关键词: Achievement; Area; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Cohort Studies; Collaborations; Communication; Communities; Conduct Clinical Trials; Core Facility; Distant; Ensure; Equipment; Explosion; Funding; Goals; Growth; Health; Health Sciences; Housing; Improve Access; Infrastructure; Institutes; Lead; National Heart, Lung, and Blood Institute; Observational Study; Participant; Patients; Post-Acute Sequelae of SARS-CoV-2 Infection; Productivity; Research; Research Activity; Resources; Schedule; Services; Site; Time; Translational Research; Universities; Visit; Visual; West Virginia; Work; clinical trial enrollment; clinical trial participant; cohort; improved; research facility; service delivery; symposium; telehealth

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.

2017年，西弗吉尼亚临床与转化研究所（WVCTSI）成立了临床试验中心 从那时起，西弗吉尼亚大学健康科学中心就设立了卓越中心（COE）。 临床试验活动大幅增加，活跃试验数量和临床试验参与数量翻倍 预计临床试验入组人数将比前5年增加10倍。 继续增加，需要进一步增加 COE 此外，在下一个资助周期（11-11 年）。 15)，我们将延长 COE 服务期限 WVCTSI 最近被选为国家的领先站点。 心肺血液研究所 RECOVER Cohort，一项针对新冠肺炎急性后遗症的观察性研究 19. WVCTSI，特别是 COE 将负责管理其他 10 个站点（9 个 CTR 和 2 个 CTSA） COE 活动的爆炸式增长需要改变和不同程度的临床试验基础设施。 对现有空间进行翻修，以优化服务提供和管理。 本项目提出的改造将确保实现以下具体目标。 (1) 增加临床研究参与并改善服务提供 我们将创建一个额外的研究。 检查室并对现有检查室进行改进，以便多个临床试验参与者参观 可以同时安排在研究团队附近，与增加的临床工作保持一致 预期的研究活动。 具体目标 (2) 提高生产力并确保临床研究的机密性。 拟议的空间改造将允许参与者保密，而这在当前的开放中是缺乏的。 COE 办公空间将通过竖立新墙来划分，从而保证保密性和安全性。 更好地集中 COE 人员此外，明确的协作工作空间对于司法区至关重要。 将创建 COE 扩展 具体目标 (3) 利用电话会议改善访问和连接。 临床研究团队并加强远程团队之间的协作。 用于临床研究的视听设备将增加远程医疗的使用和司法沟通 为临床试验委员会提供服务，能够监督远程站点的临床试验效率和质量（参见 CRRF 核心部分了解详细信息）此外，该项目中提议的空间和设备将实现新的远程医疗。 CRRF 核心部分提出的用于进行远程患者研究访问（适当时）的平台 此续订申请的目标 1 最后，专用电话会议空间将改善管理。 NHLBI RECOVER Cohort 研究中的远程临床研究团队。