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）和基于家庭的技术是越来越重要的工具，对于患者，护理人员和 医疗保健提供者诊断和治疗关键健康问题。在急性护理环境中，临床医生和看护人 需要实时数据来指导潜在迅速变化的健康状况的管理；在家庭环境中， 提供者寻求新的方法来更好地沟通并吸引患者促进健康和管理慢性 状况。柜台上出售的技术的商业化和采用 使用了Covid-19的大流行加速使用，并越来越多地实现更多 授权和积极主动的患者护理。作为技术研发中心（TRDC），目标 前进的护理技术中心（CAPCAT）是开发和优化新型POC 以及基于家庭的技术，以改善心脏，肺，血液和睡眠的诊断和治疗 （HLB）疾病。 CAPCAT临床核心将通过利用核心能力来促进这一目标 促进临床验证和可用性研究，尤其是那些应对健康不平等的研究，可以使用 在服务不足的社区中。作为主要POC技术研究网络（POCTRN）成员 负责RADX技术领先的临床研究，Capcat与社区组织合作， 基于实践和学术临床试验网络，FDA和其他监管机构的成员以及行业 设计和执行包容性临床研究的合作伙伴，涉及来自种族的15,000多名参与者 （1）Capcat临床核心将利用其独特的基础设施和 专家团队继续为临床研究的设计和执行提供支持，以证明 推进疾病管理的设备的可用性和效率。迄今为止，Capcat临床核心具有 与外部咨询委员会和数据安全监控委员会成功合作，以监视，参与， 并通过向CAPCAT团队提供技术，后勤和运营支持来支持23 HLB的创新者 进行后期临床验证和可用性研究，包括适应的示威研究 用于较低资源环境中的技术。我们的团队，经验和能力使我们独特 适合提供各种服务，以促进临床研究并支持发展 改善HLB疾病诊断和治疗并促进健康公平的设备。我们的目标 实现此目标是继续：1）选择临床上相关的POC和家庭技术和设计 创新和包容性的临床验证和可用性研究； 2）支持CAPCAT临床验证和 可用性研究使关键利益相关者将研究结果与背景相关化并促进实施。