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

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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