Core-005

核心005

• 批准号: 10409669
• 负责人: JAMES E. HEUBI
• 金额: $ 60.76万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-14 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10409669
• 关键词: Center for Translational Science Activities; Clinical; Clinical Research; Clinical Sciences; Communities; Data; Development; Disease; Environment; Future; Goals; Health Personnel; Infrastructure; Knowledge; Monitor; Organoids; Participant; Process; Protocols documentation; Recording of previous events; Research; Research Design; Research Personnel; Resources; Special Population; Surveys; Training; Translational Research; Underrepresented Populations; Underserved Population; clinical center; empowered; experience; first-in-human; gene therapy; health disparity; innovation; multidisciplinary; process optimization; programs; recruit; research study; skills training; tool; translational research program

The goal of the Hub Research Capacity Core of the Center for Clinical and Translational Science and Training (CCTST) is to support the clinical and translational research enterprise of the future. As outlined in the FOA, the Hub includes two cores: Participant and Clinical Interactions (PCI) and Integrating Special Populations (ISP). The PCI Core will focus on improvement of infrastructure and processes to conduct clinical and translational research, with an overall goal to enhance the experience of participants and investigators. This will be accomplished through the following Specific Aims: 1) engage stakeholders in conducting clinical and translational research; 2) promote development of a diverse, multidisciplinary workforce of the future; and 3) optimize the processes to conduct high-quality research studies in a safe environment. Examples of the approaches to accomplish these aims include: engaging stakeholders through conducting biannual surveys; extending clinical and translational research capabilities to underserved populations and those with health disparities through a mobile unit; developing skills training in clinical research to provide knowledge on clinical research implementation and the resources available to study investigators and study teams; streamlining protocol assessment, review, approval, and monitoring; and utilizing state-of-art Clinical and Translational Research Center (CTRC) infrastructure and highly qualified research personnel to conduct first-in-man treatments such as gene therapy or use of organoids for treatment of diseases. The CCTST has a strong history of effectively integrating special populations into clinical and translational research. Our Integrating Special Populations Initiative (ISPI) will build on well-developed programs by increasing the participation of special populations in research design and equipping research teams with the tools needed to overcome barriers to research participation for special populations. To achieve this goal, we will 1) support innovative strategies for engaging underrepresented populations in research studies; 2) expand infrastructure support for integrating special populations into research; and 3) optimize recruitment of special populations using biomedical data. These efforts will result in the development of a network of health care providers, community partners, and researchers empowered to launch new research that will impact the most vulnerable and hardest to reach special populations experiencing the greatest burden of health disparities.

临床和转化科学中心的中心研究能力核心的目标， 培训（CCTST）是为了支持未来的临床和转化研究企业。中概述的 FOA，该中心包括两个核心：参与者和临床互动（PCI）和集成特殊 人口（ISP）。PCI核心将专注于改善基础设施和流程，以进行临床 和转化研究，总体目标是提高参与者和研究人员的经验。 这将通过以下具体目标来实现：1）让利益相关者参与临床研究， 和转化研究; 2）促进未来多元化，多学科劳动力的发展; 3)优化流程，在安全的环境中进行高质量的研究。的实例 实现这些目标的办法包括：通过开展半年一次的调查，让利益攸关方参与; 将临床和转化研究能力扩展到服务不足的人群和健康状况不佳的人群 通过一个移动的单位的差异;在临床研究中发展技能培训，以提供临床知识 研究实施以及研究者和研究团队可用的资源;精简 方案评估、审查、批准和监测;并利用最先进的临床和转化技术 研究中心（CTRC）的基础设施和高素质的研究人员进行首次在人 治疗，例如基因治疗或使用类器官治疗疾病。CTST拥有强大的 将特殊人群有效纳入临床和转化研究的历史。我们的整合 特殊人口倡议（ISPI）将通过增加特殊人口的参与， 研究设计中的特殊人群，并为研究团队提供克服 特殊人群参与研究的障碍。为了实现这一目标，我们将：1）支持创新 使代表性不足的人口参与研究的战略; 2）扩大基础设施支持， 将特殊人群纳入研究; 3）优化特殊人群的招募， 生物医学数据。这些努力将导致发展一个由保健提供者、社区和社区组成的网络。 合作伙伴和研究人员有权启动新的研究，这将影响最脆弱和最困难的 帮助那些承受最大健康差距负担的特殊人群。