Clinical Core

临床核心

• 批准号: 10735583
• 负责人: David D. McManus
• 金额: $ 25.56万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10735583
• 关键词: Acceleration; Address; Adherence; Adoption; Advisory Committees; Antigens; Blood; COVID-19; COVID-19 pandemic; COVID-19 test; Caregivers; Chronic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Network; Communication; Community Health Networks; Competence; Data; Data Collection; Device or Instrument Development; Devices; Diagnosis; Disease Management; Elements; Enrollment; Ensure; Evaluation; Geography; Goals; Health; Health Personnel; Health Promotion; Health system; Heart; Heart Diseases; Hematological Disease; Home; Informatics; Infrastructure; Investments; Lung; Lung diseases; Methods; Monitor; Participant; Patient Care; Patient Recruitments; Patients; Point of Care Technology; Practice Guidelines; Process; Provider; RADx Tech; Race; Reporting; Research; Resource-limited setting; Resources; SARS-CoV-2 infection; Services; Sleep; Sleep Disorders; Technology; Testing; Time; Translations; United States National Institutes of Health; Validation; Work; acute care; advanced disease; clinically relevant; commercialization; community organizations; design; digital; digital health; empowerment; ethnic diversity; experience; health equity; health equity promotion; health inequalities; home test; improved; industry partner; innovation; member; new technology; novel; operation; patient advocacy group; patient engagement; patient oriented; point of care; pragmatic study; prevent; racial diversity; success; technology research and development; tool; trial design; underserved community; usability; validation studies

Project Summary/Abstract – Clinical Core Point-of-care (POC) and home-based technologies are increasingly important tools for patients, caregivers, and healthcare providers to diagnose and treat critical health issues. In acute care settings, clinicians and caregivers need real-time data to guide management of potentially rapidly changing health conditions; in home settings, providers seek new ways to better communicate and engage patients in promoting health and managing chronic conditions. The commercialization and adoption of technologies sold over the counter and intended for home use has been accelerated by the COVID-19 pandemic and increasingly allows for the realization of more empowered and proactive patient care. As a Technology Research and Development Center (TRDC), the goal of the Center for Advancing Point of Care Technologies (CAPCaT) is to develop and optimize novel POC and home-based technologies to improve the diagnosis and treatment of Heart, Lung, Blood and Sleep (HLBS) disorders. The CAPCaT Clinical Core will contribute to this goal by leveraging core competencies to facilitate clinical validation and usability studies, especially those that address health inequity and can be used in underserved communities. As the primary POC Technology Research Network (POCTRN) member responsible for leading clinicals studies for RADx Tech, CAPCaT partnered with community organizations, practice-based and academic clinical trial networks, members of the FDA and other regulators, and industry partners to design and execute inclusive clinical studies involving over 15,000 participants from racially and geographically diverse backgrounds.(1) The CAPCaT Clinical Core will capitalize on its unique infrastructure and expert team to continue to provide support for the design and execution of clinical studies to demonstrate the usability and efficacy of devices that advance disease management. To date, the CAPCaT Clinical Core has worked successfully with its External Advisory Committee and Data Safety Monitoring Board to monitor, engage, and support 23 HLBS innovators by providing technical, logistical, and operational support to CAPCaT teams conducting later-stage clinical validation and usability studies, including demonstration studies that adapt technologies for use in lower resource environments. Our team, experience and competencies make us uniquely suited to provide the broad array of services that facilitate clinical research and support the development of devices to improve the diagnosis and treatment of HLBS disorders and promote health equity. Our objectives in achieving this goal are to continue: 1) Select clinically relevant POC and home-based technologies and design innovative and inclusive clinical validation and usability studies; 2) Support CAPCaT clinical validation and usability studies that engage key stakeholders to contextualize study findings and promote implementation.

项目摘要/摘要-临床核心 护理点(POC)和基于家庭的技术对于患者、护理人员和 医疗保健提供者诊断和治疗严重的健康问题。在急性护理环境中，临床医生和护理人员 需要实时数据来指导对潜在快速变化的健康状况的管理；在家庭环境中， 医疗服务提供者寻求新的方式来更好地与患者沟通并让患者参与到促进健康和管理慢性病的工作中来 条件。商业化和采用在柜台上出售的供家庭使用的技术 新冠肺炎大流行加速了使用，并越来越多地允许实现更多 增强主动性和主动性的患者护理。作为技术研究和开发中心(TRDC)，目标是 先进护理点技术中心(CAPCaT)的主要任务是开发和优化新型PoC 和基于家庭的技术，改善心肺、血液和睡眠的诊断和治疗 (HLBS)障碍。CAPCaT临床核心将通过利用核心能力为这一目标做出贡献 促进临床验证和可用性研究，特别是那些解决健康不平等问题并可用于 在服务不足的社区。作为PoC技术研究网络(POCTRN)的主要成员 负责领导RADx Tech的临床研究，CAPCaT与社区组织合作， 基于实践和学术的临床试验网络，FDA和其他监管机构的成员，以及行业 合作伙伴设计和执行包容性临床研究，涉及15,000多名来自种族和 地理背景不同。(1)CAPCaT临床核心将利用其独特的基础设施和 专家团队将继续为临床研究的设计和执行提供支持，以证明 促进疾病管理的设备的可用性和有效性。到目前为止，CAPCaT临床核心已经 成功地与其外部咨询委员会和数据安全监测委员会合作， 并通过向CAPCaT团队提供技术、后勤和运营支持，支持23家HLBS创新者 进行后期临床验证和可用性研究，包括适应 在低资源环境中使用的技术。我们的团队、经验和能力使我们独一无二 适合于提供广泛的服务，以促进临床研究和支持 改进HLBS疾病的诊断和治疗，促进健康公平的设备。我们的目标是 实现这一目标将继续：1)选择临床相关的POC和基于家庭的技术和设计 创新和包容的临床验证和可用性研究；2)支持CAPCaT临床验证和 让关键利益相关者参与的可用性研究，以将研究结果与背景联系起来并促进实施。