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

摘要-杜克大学母胎医学单位（MFMU）网络临床中心 杜克临床中心将是一个新的中心，参与该网络的全部范围，招募多样化的 在杜克以及维克森林大学（WFU）卫星站点的患者群体中。杜克的历史悠久 参与MFMU网络，首先作为临床中心，最近作为卫星中心。此外 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： 参与NIAID和CDC网络的随机试验和队列研究。杜克临床中心将 在制定新的研究方案方面，特别是在传染病领域， 早产中的怀孕和健康差异。该中心现有的多样化研究人群 集水区包括来自多个杜克地区的黑人和拉丁裔的丰富代表，以及 WFU。此外，该团队在临床试验合作、招募、保留和 后续行动，这将有助于网络的目标，提高严谨性和可重复性，数据共享， 包括不同的患者群体和劳动力。该中心拥有大型门诊设施， 建立基础设施，以便在高风险诊所招募患者，并与 低风险诊所的产科通才合作伙伴。杜克临床中心，由临床和翻译支持 杜克和WFU的科学奖（CTSA）将促进公平和包容的环境， 为所有研究者、患者和参与者营造尊重的氛围。该团队拥有强大的合作历史 与儿科、药理学和哺乳方面的专家合作，并将利用这些合作， 创新，高质量的科学MFMU网络。杜克临床中心的拟定具体目标 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（和任何未来MFMU网络指定的站点）;行政、科学、财政和数据 管理;站点内部和站点之间的通信、协作和协调流程。目标2. 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者和工作人员 人口-使用创新战略，如基于社区的伙伴关系，双语研究人员， 进行社区参与的研究和定性方法，在网络研究中招募对象。目的 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-特别在传染病领域促进创新研究， 围产期药理学、早产差异和围产期流行病学;确保严格收集 可复制的高质量数据;并利用机构资源， 研究者和临床研究团队

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