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，西弗吉尼亚州临床和转化研究所（WVCTSI）建立了临床试验中心 西弗吉尼亚大学健康科学中心的卓越（COE）。从那时起，就有一个 临床试验活动的大幅增加，有效试验的数量双重和临床试验参与 与前5年相比，增加了10倍。预计临床试验入学率将 继续增加，需要进一步的COE增长。此外，在下一个融资周期（11年 - 15），我们将在全州范围内扩展COE服务。 WVCTSI最近被选为国家的领先地点 心脏，肺和血液研究所恢复了队列，这是一项观察性研究，急性后遗症。 19。WVCTSI，特别是COE将负责其他10个站点的管理（9个CTR和2个CTSA） 具有不同程度的临床试验基础设施。 COE活动中的爆炸需要改变，并且 对现有空间进行翻新，以优化服务交付和管理。更改的完成 该项目提出的改革将确保实现以下特定目标。具体目标 （1）增加临床研究参与并改善服务提供。我们将创建一项额外的研究 检查室并改进现有检查室，以便多次临床试验参与者访问 可以同时安排并紧邻研究团队，与临床增加一致 期望的研究活动。具体目标（2）提高生产力并确保临床研究的信心 团队。拟议的空间翻新将允许参与者当前公开缺乏的机密性 COE办公空间。通过架设新墙，将划定工作区域，以充满信心 更好的集中工作人员。此外，定义的合作工作空间，对全州至关重要 将创建COE扩展。具体目的（3）利用电信来改善访问和连接 临床研究团队并增加远程团队之间的协作。专用的电信空间和 用于临床研究的视听设备将使远程医疗使用和全州沟通能够增加 对于临床试验委员会，可以监督遥远站点的临床试验效率和质量（请参阅CRRF） 详细信息核心部分）。此外，项目中提议的空间和设备将启用新的远程医疗 在CRRF核心部分提出的远程患者学习访问的平台 （AIM 1）此续订应用程序。最后，专门的电信空间将改善 NHLBI恢复队列研究的遥远临床研究团队。