Resource Core

资源核心

• 批准号: 10254242
• 负责人: JAMES C OATES
• 金额: $ 30.97万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-25 至 2022-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10254242
• 关键词: ARHGEF5 gene; Achievement; African American; Autoimmunity; Automation; Biological; Biological Markers; Biological Specimen Banks; Biopsy; Budgets; Clinic Visits; Clinical; Clinical Research; Collaborations; Collection; Communities; Consultations; Data; Data Analyses; Disease; Electronic Health Record; Enrollment; Epigenetic Process; Faculty; Fibrosis; Foundations; Funding; Future; Genetic; Genetic Markers; Goals; Health Promotion; Human Resources; Immunology; Individual; Industry Collaboration; Infrastructure; International; Interstitial Lung Diseases; Knowledge; Link; Longitudinal cohort; Lupus Nephritis; Medical Records; Methodology; Methods; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Pathway interactions; Patient Recruitments; Patients; Peripheral Blood Mononuclear Cell; Phenotype; Process; Productivity; Quality Control; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Resources; Rheumatism; Rheumatology; Sampling; Schedule; Scleroderma; Services; Skin; Specimen; Surveys; Systemic Lupus Erythematosus; Systemic Scleroderma; Targeted Research; Time; Translational Research; Translations; Visit; anticancer research; base; cancer immunotherapy; clinical care; cohort; community engagement; community organizations; data repository; demographics; design; experience; flexibility; follow-up; health disparity; improved; lipidomics; member; minority health; multidisciplinary; novel; patient advocacy group; patient oriented; patient population; phenotypic data; recruit; response; translational scientist; volunteer

PROJECT SUMMARY The Clinical and Community Resource Core will build on the strong foundation established by the MCRC Patient Resource Core at MUSC during the past 4 years. Since 2012 this core has served a local, national, international, and corporate base by providing a well phenotyped longitudinal cohort of predominantly African-American systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) patients and matched control data and banked biological samples. A recent formal survey of the research base indicated that needs are now exceeding the MCRC infrastructure. First, investigators need more intensive longitudinal follow-up of patients with specific disease sub-phenotypes such as scleroderma interstitial lung disease and lupus nephritis. Second, fresh biological specimens such as peripheral blood mononuclear cells and skin biopsies are needed in addition to banked specimens. Third, additional coordinator support is needed to facilitate efficient collection of fresh specimens and assist with regulatory requirements. Finally, translational scientists and junior investigators require consultation about engagement with the community, disease-specific study design and data interpretation, proposal feasibility analysis, and methods for flexibly adapting the services of the core to their needs. The Clinical and Community Resource Core (CCR Core) will flexibly expand on the services by providing the ability to more finely phenotype patients in the medical record in order to efficiently recruit patients for studies and more rigorously follow the longitudinal cohort during scheduled clinical visits. Automated reporting of specific SLE and SSc phenotypes will facilitate more efficient remote ordering of biological specimens. This automation will enable us to refocus coordinator resources to increase the percentage of clinic visits covered by the MCRC and fulfill requests by the research base. The core’s specific aims are to: 1) Maintain and flexibly expand the CCR Core with novel electronic health record (EHR) infrastructure to provide a well phenotyped, longitudinal cohort of SLE and SSc subjects and matched control volunteers to support the current and future needs of the research base; 2) Maintain and flexibly expand the CCR Core with novel EHR infrastructure to efficiently provide well phenotyped, banked and fresh biological specimens, both from within and beyond the existing longitudinal cohort, based on the ongoing and projected future needs of the research base; 3) Provide resources to link communities impacted by SSc and SLE and investigators in the research process, from project planning to dissemination and health promotion, by engaging with community members, community organizations and patient advocacy groups; and 4) Provide consultative and regulatory support to current and future projects of the research base. No other resource can provide fine phenotype data and samples from this unique population of patients. The community engagement facilitated by the core can increase the relevance of research performed by the base as well as its translation to a community of SLE and SSc patients with known health disparities.

项目摘要 临床和社区资源核心将基于MCRC患者建立的强大基础 在过去的4年中，MUSC的资源核心。自2012年以来，该核心为当地，国际， 和公司群 全身性红斑狼疮（SLE）和系统性硬化症（SSC）患者，并匹配的对照数据和 银行的生物样品。最近对研究基础的正式调查表明，需求现在超出 MCRC基础架构。首先，研究人员需要对特定患者进行更密集的纵向随访 疾病亚表征，例如硬皮病性肺肺疾病和狼疮性肾炎。第二，新鲜 生物学标本，例如外周血单核细胞和皮肤活检，除了 存放标本。第三，需要额外的协调支持以促进有效收集新鲜 标本并协助监管要求。最后，翻译的科学家和初级调查员 需要就与社区的互动，特定于疾病的研究设计和数据进行咨询 解释，提案可行性分析以及灵活地适应核心服务的方法 需要。临床和社区资源核心（CCR核心）将通过提供服务灵活地扩展服务 在病历中更精细的表型患者以有效招募患者进行研究的能力 在预定的临床就诊期间，更严格地跟随纵向队列。特定的自动报告 SLE和SSC表型将对生物规格的更有效的远程订购。这个自动化 将使我们能够重新调整协调员资源来增加MCRC涵盖的诊所就诊百分比 并满足研究基础的要求。核心的具体目的是：1）维护并灵活地扩展 具有新型电子健康记录（EHR）基础设施的CCR核心提供了良好的表型，纵向 SLE和SSC受试者的队列以及匹配的控制志愿者，以支持当前和未来的需求 研究基础； 2）通过新颖的EHR基础架构维护并灵活地扩展CCR核心以有效提供 良好的表型，储存和新鲜的生物学标本，无论是从现有纵向内外的 同类，根据研究基础的持续和预计的未来需求； 3）提供链接的资源 在研究过程中受到SSC和SLE和调查人员影响的社区，从项目计划到 通过与社区成员，社区组织和 患者倡导组； 4）为当前和未来的项目提供咨询和监管支持 研究基础。没有其他资源可以从这个独特的人群中提供精美的表型数据和样本 患者。核心准备的社区参与可以增加进行的研究的相关性 根据基础，将其转化为已知健康差异的SLE和SSC患者社区。