Clinical Core

临床核心

基本信息

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
项目类别：
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

项目摘要

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 临床转化和验证核心抽象的临床翻译和验证核心是 PORTENT 的独特优势 — 由领导层经过多年的能力建设而建立。纽约、乌干达、厄瓜多尔和印度的全球合作临床中心网络，该网络将提供接触更加多样化的临床人群、临床和社区专业知识的机会，和生物库比目前 PoC 开发人员可以访问的核心的结构是：响应中心的需求，使我们能够向提供临床支持的地点分配资金和资源最适合项目的验证和培训需求。每个站点都会有一个基准预算。促进当地能力建设，目标是进一步将其打造成公认的全球中心在拟议的工作结束之前，PoC 诊断验证的卓越性将集中在四个方面。主要目标：(1) 实现 PORTENT 中心和 POCTRN 网络的人体和临床验证通过提供广泛的样本生物库和独特患者的访问点护理 (PoC) 技术人群，(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，确定可以过渡到的新的和现有的 PoC 项目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是对全球健康领域 PoC 设备的开发和转化具有变革意义，因为它将显着降低了开发人员将其技术应用于更广泛的领域的障碍正如我们的需求评估中所指出的，中低收入国家的患者是世界上最脆弱的人群之一。并且位于 PoC 技术的使用可能会产生最大影响的地方。显着改善这些地区的当地健康状况。