Nutrition for Precision Health, powered by the All of Us Research Program: Research Coordinating Center

项目摘要/摘要 拟议的RTI国际-康奈尔研究协调中心(RCC)的总体目标是 提供无缝的运营支持和多学科经验，以建立营养领域的共识 为精密健康联盟(NPHC)。在一年规划阶段，我们将优先考虑效率和 促进饮食单元设计的客观性(1：常规膳食评估；2：控制喂养膳食 干预；以及3：家庭饮食干预)嵌套在我们所有人和他们的研究方案中。在4场比赛中- 年内实施阶段，我们将推动模块1-3的实施，使流量达到质量 数据和样本，并将经过管理的、支持人工智能(AI)的数据集成到 我们所有的研究人员工作台，使用我们建立的数据协调流程和系统。 我们方法的创新包括在难以接触到的人群中进行饮食研究的工具， 具体的(或受试者自己对照)临床试验，以及可穿戴设备研究工具和分析。 具体地说，拟议的农村发展协调委员会将在管理和协调NPHC及其研究方面表现出色 倡议、临床干预措施以及数据和生物制品共享，如下所示： 目标1：优化模块1-3的科学严谨性 目标2：确保NPHC研究数据是公平的(可查找、可访问、可互操作和可重复使用) 目标3：支持无缝数据收集、管理和传输，包括传输到研究员工作台 目标4：最大限度地缩短模块1-3的启动时间 目标5：最大限度地提高联合体沟通和协作的效率 启动NPHC是为了解决营养方面的主要研究差距；这些差距的性质和 NPHC活动的复杂性怎么强调都不为过。RCC将由多名负责人领导 在协调中心和多地点领导力和生物统计学方面具有互补专业知识的调查人员 (RTI的甘茨博士)以及营养干预和临床专业知识(康奈尔大学的梅塔博士) 支持围绕设计和分析、数据管理和管理核心组织的强大和多样化团队 制度，研究落实。其他关键组成部分包括单一IRB和医疗安全 监控。RCC还将受益于我们的集体机构优势，拥有广泛的- 与NPHC相关的范围研究和临床背景(例如，组学、生物信息学、人工智能、临床试验 干预、营养评估)。建议成立的农村资源中心已作好充分准备，以支持 NPHC的使命是开发具有临床意义的算法，预测个体对食物和 饮食模式和改善美国不同人群的健康。

PROJECT SUMMARY/ABSTRACT The overarching goal of the proposed RTI International–Cornell Research Coordinating Center (RCC) is to provide seamless operational support and multidisciplinary experience for building consensus in the Nutrition for Precision Health Consortium (NPHC). In the 1-year planning phase, we will prioritize efficiency and objectivity in facilitating the design of diet modules (1: usual dietary assessment; 2: controlled feeding dietary intervention; and 3: domiciled dietary intervention) nested in All of Us and their research protocols. In the 4- year implementation phase, we will facilitate the implementation of Modules 1–3, enable the flow of quality data and specimens across the NPHC, and integrate curated, Artificial intelligence (AI)–ready data into the All of Us Researcher Workbench, using our established data coordination processes and systems. Innovations in our approach include tools for conducting dietary studies in hard-to-reach populations, idiographic (or subject-as-own-control) clinical trials, and wearables research tools and analytics. Specifically, the proposed RCC will excel in administrating and coordinating NPHC and its research initiatives, clinical interventions, and data and biospecimen sharing, as follows: Aim 1: Optimize the scientific rigor of Modules 1–3 Aim 2: Ensure NPHC study data are FAIR (Findable, Accessible, Interoperable, and Reusable) Aim 3: Enable seamless data collection, curation, and transfer including to the Researcher Workbench Aim 4: Minimize time to launch of Modules 1–3 Aim 5: Maximize the efficiency of consortium communications and collaborations NPHC is being launched to address major research gaps in nutrition; the nature of these gaps and the complexity of the NPHC activities cannot be underscored enough. RCC will be led by Multiple Principal Investigators with complementary expertise in coordinating center and multisite leadership and biostatistics (Dr. Gantz at RTI) and nutritional intervention and clinical expertise (Dr. Mehta at Cornell University) with the support of a strong and diverse team, organized around cores for Design and Analytics, Data Curation and Systems, and Study Implementation. Other key components include single IRB and medical safety monitoring. The RCC will also benefit from our collective institutional strengths, with an expert pool of wide- ranging research and clinical backgrounds pertinent to the NPHC (e.g., omics, bioinformatics, AI, clinical trial intervention, nutritional assessment). The proposed RCC is immediately and amply prepared to support to NPHC in its mission to develop clinically meaningful algorithms that predict individual responses to food and dietary patterns and to improve health across diverse U.S. populations.