Clinical Studies Core

临床研究核心

• 批准号: 10204697
• 负责人: BRYAN O BUCHHOLZ
• 金额: $ 8124.2万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-17 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10204697
• 关键词: 2019-nCoV; Address; Adherence; Affect; Android; Ants; Assisted Living Facilities; Bedside Testings; Boston; Businesses; COVID-19 pandemic; Care Technology Points; Caregivers; Cessation of life; Characteristics; Child; Chronic Obstructive Airway Disease; Clinical; Clinical Research; Clinical Sciences; Communities; Consent; Data; Day center care; Detection; Development; Device or Instrument Development; Devices; Diagnosis; Discipline of Nursing; Disease; Elderly; Engineering; Enrollment; Environment; Event; Funding; General Hospitals; Geography; Goals; Gold; HIV; Health; Healthcare; Heart Diseases; Hematological Disease; Home environment; Homelessness; Immunocompromised Host; Income; Incubators; Individual; Infection; Infrastructure; Institution; Institutional Review Boards; Laboratories; Lead; Logistics; Lung diseases; Massachusetts; Medical; Medical Device; Mentors; Migrant Workers; Military Personnel; Morbidity - disease rate; National Heart, Lung, and Blood Institute; National Institute of Biomedical Imaging and Bioengineering; Nursing Homes; Online Systems; Participant; Patients; Performance; Plants; Population; Predictive Value; Pregnant Women; Protocols documentation; Religion and Spirituality; Reproducibility; Research; Research Design; Research Support; Resources; Restaurants; Rural; Rural Community; Safety; Schools; Sensitivity and Specificity; Site; Sleep Disorders; Socioeconomic Status; Sports; Subway; Target Populations; Technology; Testing; Training; Translational Research; Transportation; United States National Institutes of Health; Universities; Validation; Veterans; Vision; Work; Workplace; Youth; after-school program; base; clinical center; cohort; commercialization; community building; cost; data management; diagnosis standard; flexibility; health care availability; health care settings; human subject protection; improved; industry partner; innovation; medical schools; mortality; new technology; novel; performance tests; practice-based research network; programs; success; technology development; usability; viral detection; working group

RESEARCH SUMMARY/ABSTRACT The goal of this initiative is to fast-track the implementation of carefully selected CAPCaT-supported projects that can help address the urgent healthcare issues created by the COVID-19 pandemic. The extent and urgency of the situation requires an aggressive approach to accelerate the delivery of solutions to address the immediate needs. The proposed approach augments the strong technical, clinical and commercialization expertise of CAPCaT to get needed solutions into practice within weeks to months. The Center for Advancing Point of Care Technologies (CAPCaT) in Heart, Lung, Blood, and Sleep Diseases is an offshoot of a highly successful medical product incubator, the Massachusetts Medical Device Development Center (M2D2) at the University of Massachusetts Lowell and Medical School campuses. The founding goal of M2D2 was to accelerate the development of medical devices, combining the engineering and business expertise of UMass Lowell (UML) with the clinical expertise of UMass Medical School (UMMS) in Worcester. Expanding upon the vision and success of M2D2, the goal of CAPCaT is to support projects to develop and optimize novel point of care technologies (POCT) to improve the diagnosis and management of heart, lung, blood, and sleep diseases. We have focused on these diseases because of the significant morbidity, mortality, and cost associated with these diseases. Combined, these diseases account for 41% of deaths in the US and lead to over $400B in direct health care expenses plus lost income to affected patients and caregivers. UMass has an established track record of clinical expertise and technology development in the HLBS diseases. CAPCaT funds projects that are in the later stages of POCT development, with a focus on the clinical validation of those devices. CAPCaT, along with M2D2, has a network of industry partners and funders to support the development and commercialization of promising technologies. Among our industry partners are Johnson & Johnson, Boston Scientific, Amgen, and Hologic. CAPCaT is one of four Point of Care Technology Research Network (POCTRN) Centers (Emory/GA Tech, Northwestern, and Johns Hopkins University house the others). CAPCaT has worked with the other POCTRN Centers and its Coordinating Center (CIMIT-Mass General Hospital) and our scientific and program officers at NHLBI and NIBIB to review the situation and to understand unmet needs and resources accessible by the network that can make a difference.

研究概要/摘要 该举措的目标是快速实施精心挑选的 CAPCaT 支持的项目 可以帮助解决 COVID-19 大流行造成的紧急医疗保健问题的项目。这 局势的严重性和紧迫性要求采取积极的做法，加速提供解决方案 解决眼前的需要。所提出的方法增强了强大的技术、临床和 CAPCaT 的商业化专业知识可在几周到几个月内将所需的解决方案付诸实践。 心脏、肺、血液和睡眠护理点技术推进中心 (CAPCaT) 疾病是非常成功的医疗产品孵化器马萨诸塞州医疗器械公司的一个分支 开发中心 (M2D2) 位于马萨诸塞大学洛厄尔分校和医学院校园。这 M2D2 的创立目标是加速医疗设备的开发，将工程与技术相结合 麻省大学洛厄尔分校 (UML) 的业务专业知识与麻省大学医学院 (UMMS) 的临床专业知识 伍斯特。 CAPCaT 扩展了 M2D2 的愿景和成功，其目标是支持项目 开发和优化新型护理点技术 (POCT)，以改善疾病的诊断和管理 心脏、肺、血液和睡眠疾病。我们之所以关注这些疾病是因为 与这些疾病相关的发病率、死亡率和费用。这些疾病加起来占 41% 美国的死亡人数超过 $400B 直接医疗费用加上受影响患者的收入损失 和护理人员。麻省大学在临床专业知识和技术开发方面拥有良好的记录 HLBS 疾病。 CAPCaT 资助处于 POCT 开发后期的项目，重点关注 这些设备的临床验证。 CAPCaT 与 M2D2 一起拥有行业合作伙伴和资助者网络 支持有前途的技术的开发和商业化。我们的行业合作伙伴包括 强生公司、波士顿科学公司、安进公司和 Hologic。 CAPCaT 是四个护理点技术研究网络 (POCTRN) 中心之一（埃默里大学/GA Tech、 西北大学和约翰·霍普金斯大学是其他大学的所在地）。 CAPCaT 已与其他 POCTRN 合作 中心及其协调中心（CIMIT-麻省总医院）以及我们的科学和项目官员 NHLBI 和 NIBIB 审查情况并了解未满足的需求和可利用的资源 可以发挥作用的网络。