Clinical Core

临床核心

• 批准号: 10714509
• 负责人: Saurabh Mehta
• 金额: $ 43.06万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-13 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10714509
• 关键词: Adoption; Area; Biometry; Budgets; Businesses; Clinical; Clinical Investigator; Clinical Research; Collaborations; Communicable Diseases; Communities; Consensus; Coupled; Data Analyses; Data Management Resources; Databases; Development; Devices; Ecuador; Funding; Goals; Health; Human; Incubators; India; Infection; International; Leadership; Learning; Malignant Neoplasms; Needs Assessment; New York; New York City; Nongovernmental Organizations; Nutritional status; Outcome; Outpatients; Participant; Patients; Phase; Point of Care Technology; Population; Research Design; Research Infrastructure; Research Personnel; Research Support; Resources; Role; Rotation; Sample Size; Sampling; Site; Structure; Technology; Testing; Training; Translations; Uganda; United States National Institutes of Health; Universities; Validation; Work; biobank; clinical practice; clinical research site; clinical translation; commercialization; design; experience; global health; improved; low and middle-income countries; nutrition; patient population; point of care; point of care testing; point-of-care diagnostics; prototype; success; technology development; tool; training opportunity; validation studies

Point of Care Technologies for Nutrition, Infection and Cancer for Global Health (PORTENT) 4.0 Clinical Translation and Validation Core Abstract The Clinical Translation and Validation Core is a unique differentiator for PORTENT – one that has been established through many years of capacity building by the leadership. Consisting of a one-of-a-kind worldwide network of partner clinical sites in New York, Uganda, Ecuador and India, this network will provide access to a much more diverse range of clinical populations, clinical and community expertise, and biobanks than are currently accessible to PoC developers. The core has been structured to be responsive to the needs of the center, allowing us to allocate funds and resources to sites where clinical support is best matched to the validation and training needs of the projects. Each site will have a baseline budget to enable local capacity building with the goal of further establishing them as recognized worldwide centers of excellence in PoC diagnostic validation before the end of the proposed effort. The core will focus on four main goals: (1) to enable human and clinical validation of PORTENT center and POCTRN network developed Point-of-Care (PoC) technologies by providing access to a wide array of sample biobanks and unique patient populations, (2) to support the design (including statistical support) of validation studies conducted by the project teams, (3) to work with the Tech Core to identify new and existing PoC projects which can be transitioned to human validation and the Dissemination Core to develop the annual needs assessment consensus, and (4) to provide access sites for developer clinical rotations. The establishment of this clinical network will be transformative to the development and translation of PoC devices for global health because it will significantly lower the barriers for developers to target their technologies to this broader set of populations. As noted in our needs assessment, patients in LMICs are some of the most vulnerable in the world and are located where access to PoC technology could have the highest impact. Success with PORTENT could significantly improve local health outcomes in these areas.

全球健康营养、感染和癌症护理点技术（PORTENT） 4.0临床翻译和验证核心 摘要 临床翻译和验证核心是PORTENT的一个独特优势- 通过多年的领导能力建设。由独一无二的组成 在纽约、乌干达、厄瓜多尔和印度的全球合作临床研究中心网络，该网络将 提供更多样化的临床人群、临床和社区专业知识， 和生物银行比目前可访问的生物数据库开发人员。核心的结构是 响应中心的需求，使我们能够将资金和资源分配给临床支持的地点， 与项目的验证和培训需求最匹配。每个研究中心都将有一个基准预算， 促进当地能力建设，以进一步将其建立为公认的全球中心 在建议的工作结束之前，在诊断验证方面取得卓越的成绩。核心将聚焦四个 主要目标：（1）使人类和临床验证的PORTENT中心和POCTRN网络的发展 床旁（Point-of-Care）技术，通过提供对各种样本生物库和独特患者的访问， 人群，（2）支持项目进行的验证研究的设计（包括统计支持） 团队，（3）与技术核心合作，以确定新的和现有的可过渡到 人类验证和传播核心，以制定年度需求评估共识，以及（4） 为开发人员临床轮换提供访问站点。该临床网络的建立将 这对全球健康的医疗器械的开发和转化具有变革性意义，因为它将 大大降低了开发人员将其技术针对这一更广泛的 人口。正如我们的需求评估所指出的，中低收入国家的病人是世界上最脆弱的群体之一 并且位于能够获得可再生能源技术的最大影响的地方。成功使用PORTENT可以 显著改善这些地区的当地卫生成果。