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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.

营养、感染和癌症护理点技术促进全球健康（PORTENT）