Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

对现有 NIH 拨款和合作协议进行紧急竞争性修订（紧急补充 - 临床试验可选）

• 批准号: 10697144
• 负责人: VIVEK Ramchandra NERURKAR
• 金额: $ 405.01万
• 依托单位: MOREHOUSE SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-08 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697144
• 关键词: Agreement; Award; Biological; Biometry; Budgets; Clinical; Clinical Research; Clinical Trials; Collaborations; Common Data Element; Communication; Communities; Consultations; Data; Data Analyses; Data Collection; Data Management Resources; Data Science; Development; Electronic Health Record; Ensure; Environment; Fostering; Funding; Future; Grant; Health; Homelessness; Individual; Infrastructure; Institution; Intervention; Knowledge; Leadership; Measurement; Mental Health; Mentors; Methodology; Migrant; Outcome; Patient Recruitments; Persons; Pilot Projects; Postdoctoral Fellow; Procedures; Process; Productivity; Professional Organizations; Quality Control; Reduce health disparities; Research; Research Activity; Research Design; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Rural; Science; Secure; Sexual and Gender Minorities; Site; Standardization; Time; Training; Translational Research; U-Series Cooperative Agreements; Underrepresented Minority; United States National Institutes of Health; Work; base; behavioral health; data access; data harmonization; data management; data repository; demographics; education resources; electronic data; environmental disparity; ethnic disparity; expectation; geographic disparity; health disparity; health equity; health inequalities; implementation facilitation; improve minority health; industry partner; innovation; institutional capacity; inter-institutional; marginalized population; minority health disparity; operation; programs; quality assurance; racial and ethnic; research study; social health determinants; social structure; socioeconomic disparity; substance use; success; symposium; tool; underserved community; user-friendly

PROJECT SUMMARY Currently, as the national resource to advance the science of minority health and health disparities, the RCMI Coordinating Center (RCMI-CC) has been hamstrung by budgetary constraints. Thus, funding from this competitive revision will bolster clinical and translational research innovation activities that are vital to the operations of a vibrant research network devoted to gaining new knowledge about the causes of health disparities, developing scalable measurement tools for studying health inequities, and implementing effective and culturally responsive interventions to mitigate ethnic and geographic disparities in health and advance health equity. Specific Aim 1. Develop a Robust Data Management System for the RCMI Clinical Research Network. Approach: Implement a secure infrastructure for storing and providing access to study-related documents and materials; establish a data management system for study data collection emphasizing Common Data Elements (CDEs) and harmonized data from electronic health records; provide methodological consultation to RCMI investigators on study design, regulatory compliance, biostatistics, data science, data management and analysis, and facilitate network coordination of research activities including support for a Network Steering Committee. Specific Aim 2. Implement a Clinical Research Pilot Projects Program. Approach: Solicit, review and fund collaborative proposals submitted by post-doctoral fellows and early-stage investigators from two or more RCMI grantee institutions and their RCMI and non-RCMI mentors on research projects, aimed at improving minority health and reducing health disparities. Specific Aim 3. Facilitate Multi-RCMI Research Studies. Approach: Engage the RCMI Consortium,community-based organizations, professional societies, federal agencies or programs, academic and industry partners, to share training and educational resources focused on reducing health disparities; establish master trial agreements with network study sites and implement plans to reduce start-up for multi-site studies; develop standard operating procedures (SOPs) for multi-RCMI research and expand the size and scope of the annual RCMI Consortium National Conference. By achieving these specific aims, the RCMI-CC will have the necessary infrastructure to foster the development and facilitate the implementation of rigorous inter-institutional clinical research studies on the biological and social determinants of health disparities. Moreover, the expectation is that this expanded infrastructure will result in increased research productivity and heightened grant success.

项目概要 目前，作为推进少数民族健康和健康差异科学的国家资源，RCMI 协调中心（RCMI-CC）因预算限制而陷入困境。因此，这笔资金 竞争性修订将支持对临床和转化研究创新活动至关重要 一个充满活力的研究网络的运作，致力于获取有关健康原因的新知识 差距，开发可扩展的测量工具来研究健康不平等，并实施有效的 和文化响应干预措施，以减少健康和进步方面的种族和地理差异 健康公平。 具体目标 1. 为 RCMI 临床研究网络开发强大的数据管理系统。 方法：实施安全的基础设施来存储和提供对研究相关文档和内容的访问 材料;建立研究数据收集的数据管理系统，强调通用数据元素 （CDE）和电子健康记录的统一数据；向 RCMI 提供方法咨询 研究设计、法规遵从性、生物统计学、数据科学、数据管理和 分析，并促进研究活动的网络协调，包括支持网络指导 委员会。 具体目标 2. 实施临床研究试点项目计划。 方法：征求、审查和资助博士后研究员和早期阶段提交的合作提案 来自两个或多个 RCMI 受资助机构的研究人员及其 RCMI 和非 RCMI 导师的研究 旨在改善少数民族健康和减少健康差距的项目。 具体目标 3. 促进多 RCMI 研究。 方法：让 RCMI 联盟、社区组织、专业协会、联邦 机构或项目、学术和行业合作伙伴，共享培训和教育资源，重点关注 减少健康差距；与网络研究中心建立主试验协议并实施计划 减少多地点研究的启动；为多 RCMI 研究制定标准操作程序 (SOP) 扩大年度 RCMI 联盟全国会议的规模和范围。 通过实现这些具体目标，RCMI-CC 将拥有必要的基础设施来促进 开发并促进严格的机构间临床研究的实施 健康差异的生物和社会决定因素。此外，预计这种扩展 基础设施将提高研究生产力并提高资助成功率。