Clinical Translation and Validation Core

临床转化和验证核心

• 批准号: 10491900
• 负责人: Rama Chellappa
• 金额: $ 11.1万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491900
• 关键词: Advanced Development; Advertising; Aging; Ambulatory Care; Area; Artificial Intelligence; Caring; Clinic; Clinical; Clinical Engineering; Clinical Research; Cognition; Cognitive; Collaborations; Communities; Consent; Consultations; Data; Data Analyses; Data Collection; Dementia; Development; Development Plans; Devices; Documentation; Elderly; Ensure; Future; Geriatrics; Goals; Health Technology; Home; Human Subject Research; Impaired cognition; Institutes; Institutional Review Boards; Intervention; Laboratories; Leadership; Long-Term Care; Maintenance; Measurement; Medical center; Mentorship; Methods; Minority Recruitment; Monitor; Nursing Homes; Outcome; Performance; Physical Function; Pilot Projects; Preparation; Primary Health Care; Procedures; Registries; Research; Research Design; Research Personnel; Resources; Safety; Scientist; Site; Technology; Testing; Training; Translational Research; Translations; Trust; Universities; Validation; Work; artificial intelligence algorithm; base; clinical translation; collaboratory; design; experience; feasibility testing; frailty; human subject; human subject protection; innovation; interest; programs; protocol development; prototype; recruit; resilience; synergism; technology development

The Johns Hopkins University (JHU) Artificial Intelligence (Al) and Technology Collaboratory (AITC) proposes a Clinical Translation and Validation Core that aims to cultivate and support cutting edge Al prototype testing and exploratory studies that are needed to develop crucial larger scale and confirmatory pilots in order to advance the development of effective Al technologies to facilitate independence in older adults. This core is designed to serve as a hub and a clinical laboratory for innovators to validate prototypes and undertake rigorous feasibility testing for the Al algorithms and technology devices in clinical and "real-world" settings. The specific aims of the Clinical Translation and Validation Core are 1) To provide state-of-the-art scientific (Clinical and Engineering) expertise and work with the administrative core to facilitate soliciting proposals and identifying and selecting Al approaches or technologies to be clinically validated in the Collaboratory or our partner sites; 2) To develop and maintain a research registry with emerging Al approaches or technologies to be validated in clinics and identify clinical researchers (and their clinical studies) and other stakeholders interested in validating Al algorithms or technologies in their clinics or other real-world settings; 3) To provide the AITC investigators identified in aim 1, with mentorship and training in all aspects of human subjects' research, including study conceptualization, study design and outcomes, definition of interventions, measurement, data analysis, protocol development and implementation, regulatory approval, quality assessment, and standard operating procedures related to aging, dementia and the maintenance of independence; 4) to provide intellectual leadership necessary to identify and match Al researchers with clinical research investigators that are best suited to successfully validate prototypes and undertake rigorous feasibility testing for the artificial intelligence algorithms and technology devices in both clinical and "real-world" settings; and 5) to facilitate the transition of successful prototypes into clinical studies in collaboration with the leadership of the Pilot Cores (Aging and AD) as well as all other cores. To achieve these goals, the core is led by an Al and technology development experienced investigator partnered with a Geriatrics Clinician Scientist with expertise in translational research focused on physical and cognitive decline in older adults. This balanced leadership will facilitate the development, implementation, and conduct of prototype development and testing in this core. A highly skilled and experienced research program manager with expertise in minority recruitment and the measurement of frailty and mobility will facilitate the completion of these aims. These aims will be carried out in collaboration with the leaders of all other cores. Additional resources are provided by the JHU Institute of Clinical and Translational Research, which will help to ensure optimal study design, implementation, measurement, and interpretation of results, and Fast Forward, a translationally-focused unit at JHU, will facilitate health technology development that focuses on using Al to maximize independence in older adults.

约翰·霍普金斯大学（JHU）人工智能（AL）和技术合作公司（AITC）提议 旨在培养和支持尖端原型测试的临床翻译和验证核心 以及开发至关重要的更大规模和确认飞行员所需的探索性研究 推进开发有效的AL技术，以促进老年人独立。这个核心是 旨在用作创新者的枢纽和临床实验室，以验证原型和进行原型 对临床和“现实世界”设置中AL算法和技术设备的严格可行性测试。这 临床翻译和验证核心的具体目的是1）提供最先进的科学（临床 和工程学）专业知识并与行政核心合作，以促进提案和 识别和选择在协作或我们的临床验证的AL方法或技术 合作伙伴网站； 2）使用新兴的方法或技术来开发和维护研究注册中心 在诊所中得到验证，并确定临床研究人员（及其临床研究）和其他利益相关者 有兴趣在其诊所或其他现实世界中验证AL算法或技术； 3）提供 AITC的调查人员在AIM 1中确定了人类受试者各个方面的指导和培训 研究，包括研究概念化，研究设计和结果，干预的定义， 测量，数据分析，协议开发和实施，法规批准，质量 评估以及与衰老，痴呆和维持有关的标准操作程序 独立; 4）提供必要的智力领导才能确定和与AL研究人员与临床相匹配 最适合成功验证原型并实现严格可行性的研究调查员 测试临床和“现实世界”设置中的人工智能算法和技术设备； 5）促进成功原型与与 飞行员核心（老化和广告）以及所有其他核心的领导。为了实现这些目标，核心被领导 由AL和技术开发经验丰富的研究人员与老年临床医生合作 在翻译研究方面的专业知识集中在老年人的身体和认知能力下降。这个平衡 领导力将促进原型开发和测试的开发，实施和行为 这个核心。一位高技能和经验丰富的研究计划经理，在少数族裔招聘方面具有专业知识 脆弱和流动性的测量将有助于完成这些目标。这些目标将是 与所有其他核心的领导人合作进行。 JHU提供了其他资源 临床和转化研究所，这将有助于确保最佳研究设计，实施， 结果的测量和解释，以及在JHU上以翻译为中心的单元的快进，将 促进卫生技术开发，重点是利用AL来最大化老年人的独立性。