Duke University Maternal-Fetal Medicine Units (MFMU) Network Clinical Center

杜克大学母胎医学中心 (MFMU) 网络临床中心

基本信息

批准号：
10681052
负责人：
BRENNA L. HUGHES
金额：
$ 35.02万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-01 至 2030-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10681052
关键词：
Address Area Black race Catchment Area Chad Child Climate Clinic Clinical Clinical Research Clinical Trials Clinical and Translational Science Awards Cohort Studies Collaborations Collection Communicable Diseases Communication Communities Country Data Data Coordinating Center Discipline of obstetrics Disparity Enrollment Ensure Environment Equity Fostering Future General Practitioners Goals Healthcare Home Individual Infant Infrastructure Institution International Lactation Latinx Lead Location Maternal Health Maternal Mortality Maternal-Fetal Medicine Units Network Maternal-fetal medicine Mothers National Institute of Allergy and Infectious Disease National Institute of Child Health and Human Development North Carolina Outcome Participant Patients Pediatrics Perinatal Perinatal Epidemiology Persons Pharmacology Physicians Population Population Heterogeneity Pregnancy Premature Birth Prevention Process Productivity Protocols documentation Public Health Qualitative Methods Recording of previous events Reproducibility Research Research Design Research Infrastructure Research Methodology Research Personnel Resources Risk Satellite Centers Science Site Southeastern United States Specialist Training Translational Research United States Universities adverse outcome bilingualism black patient clinical care clinical center community engaged research data management data sharing design disadvantaged background diversity and inclusion evidence base experience follow-up forest health disparity health equity high risk improved infant morbidity/mortality innovation marginalized population maternal morbidity mortality neonatal care neonatal health neonatal morbidity obstetric care offspring operation outcome disparities outpatient facility participant enrollment patient population pregnancy health pregnant randomized trial recruit

项目摘要

ABSTRACT – Duke University Maternal-Fetal Medicine Units (MFMU) Network Clinical Center The Duke Clinical Center will be a new center that participates in the full scope of the Network, enrolling a diverse population of patients at Duke as well as a Wake Forest University (WFU) satellite site. Duke has a long history of participation in the MFMU Network, first as a clinical center, and most recently as a satellite center. In addition to conducting trials in the MFMU Network, the Duke Perinatal Research Center (DPRC) has vast experience in enrolling for randomized trials and cohort studies with NIAID and CDC Networks. The Duke Clinical Center will bring special strength in developing new research protocols, particularly in the areas of infectious diseases in pregnancy and health disparities in preterm birth. The diverse research population available in the center’s catchment area includes an enriched representation of Black and Latinx from multiple Duke locations, as well as WFU. Moreover, the team has a strong track record in clinical trials collaborations, recruitment, retention, and follow up that will contribute to the Network’s goals of enhancing rigor and reproducibility, data sharing, and inclusion of diverse patient groups and workforce. The Center has large scale outpatient facilities as well with an established infrastructure for enrolling patients at both high risk clinics as well as in collaboration with generalist obstetrics partners in low risk clinics. The Duke Clinical Center, supported by Clinical and Translational Science Awards (CTSAs) at both Duke and WFU, will promote an environment of equity and inclusion, fostering a respectful climate for all investigators, patients, and participants. The team has a strong history of collaboration with specialists in pediatrics, pharmacology and lactation and will leverage those collaborations to bring forward innovative, high quality science to the MFMU Network. The proposed specific aims for the Duke Clinical Center are Aim 1. Oversee and manage operations of the Duke Clinical Center – provide the infrastructure, oversight, expertise, and resources to conduct Duke Clinical Center studies, including contributions from the WFU satellite site (and any future MFMU Network-designated sites); administrative, scientific, fiscal, and data management; communication, collaboration, and coordination processes within and between sites. Aim 2. Maximize recruitment and retention of study participants, as well as investigators and staff, from diverse populations – use innovative strategies, such as community-based partnerships, bilingual research staff, and conduct of community-engaged research and qualitative methods for enrolling subjects in Network studies. Aim 3. Design and implement high-impact research protocols in collaboration with the Data Coordinating Center and other Network sites – contribute innovative research specifically in the areas of infectious diseases, perinatal pharmacology, disparities in preterm birth, and perinatal epidemiology; ensure rigorous collection of reproducible, high-quality data; and leverage institutional resources to maintain robust collaboration between the investigators and clinical research teams

摘要 – 杜克大学母胎医学中心 (MFMU) 网络临床中心杜克临床中心将成为一个全面参与该网络的新中心，招募多元化的杜克大学的患者群体以及维克森林大学 (WFU) 卫星站点拥有悠久的历史。参与 MFMU 网络，首先作为临床中心，最近作为卫星中心。为了在 MFMU 网络中进行试验，杜克围产期研究中心 (DPRC) 在以下方面拥有丰富的经验：参加 NIAID 和 CDC 网络的随机试验和队列研究。为制定新的研究方案提供特殊的力量，特别是在传染病领域该中心的研究人群多种多样。集水区包括来自多个杜克大学地点的黑人和拉丁裔的丰富代表，以及此外，该团队在临床试验合作、招募、保留和培训方面拥有良好的记录。后续行动将有助于网络提高严谨性和可重复性、数据共享和该中心拥有大型门诊设施以及医疗中心，涵盖不同的患者群体和劳动力。已建立的基础设施，用于在高风险诊所招募患者以及与杜克临床中心的低风险诊所的全科产科合作伙伴，由临床和转化支持。杜克大学和 WFU 的科学奖 (CTSA) 将促进公平和包容的环境，促进尊重所有研究人员、患者和参与者的氛围该团队有着悠久的合作历史。与儿科、药理学和哺乳学专家合作，并将利用这些合作来推动 MFMU 网络的创新、高质量科学杜克临床中心拟议的具体目标。目标 1. 监督和管理杜克临床中心的运营——提供基础设施、进行杜克临床中心研究的监督、专业知识和资源，包括来自 WFU 卫星站点（以及任何未来 MFMU 网络指定的站点）；目标 2. 管理；站点内部和站点之间的沟通、协作和协调流程。最大限度地招募和保留来自不同领域的研究参与者以及研究人员和工作人员人群——使用创新策略，例如基于社区的伙伴关系、双语研究人员和进行社区参与的研究和将受试者纳入网络研究的定性方法。 3. 与数据协调部门合作设计和实施高影响力的研究协议中心和其他网络站点做出贡献——特别是在传染病领域的创新研究，围产期药理学、早产差异和围产期流行病学确保严格收集数据；可重复的、高质量的数据；并利用机构资源来维持机构之间的强有力的合作研究人员和临床研究团队