NICHD Maternal-Fetal Medicine Units Networks

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PROJECT SUMMARY/ABSTRACT The Maternal-Fetal Medicine (MFM) Division of the University of Alabama at Birmingham (UAB) submits this application for limited competition renewal to continue to participate as a clinical center of the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) Network in order to complete ongoing trials. We present our center’s attributes and record of exceptional performance within the MFMU Network, as well as a subsite at Ochsner Baptist Medical Center in Louisiana. We remain committed to the Network’s goals of investigating major problems in clinical obstetrics, particularly those related to low birth weight, prematurity, obstetric and medical complications of pregnancy. The renowned research infrastructure within our Center for Women’s Reproductive Health (CWRH) is a centerpiece of this application and has extensive experience in successfully leading large clinical trials and observational studies both within and outside the MFMU Network. As a Network center over the last six 5-year cycles, UAB has consistently played a leadership role in providing research direction for the Network at the Steering Committee and sub-committee levels, conducted Network trials with the highest efficiency of any center, and participated significantly in the presentation and publication of data generated. Among 32 clinical centers in the history of the MFMU, a UAB investigator has first-authored >17% of Network publications and >17% of presentations at national meetings. Current members of our investigative team have accumulated over 300 person-years’ experience of active participation in support of MFMU projects; our research staff similarly cumulate over 300 MFMU person-years. Alan Tita, MD, PhD and Brian Casey, MD will continue to serve as PI and Alternate PI, respectively. The investigative team includes 2 previous MFMU PI’s and 6 members who have served or currently serve as Network protocol chairpersons or Subcommittee members. Finally, on the basis of patient recruitment, protocol adherence, retention, follow-up, data quality, and study start- up time, the MFMU Network Data Coordinating Center historically ranked our center #1 or #2 among the participating centers 71% (10/14) of the time between 2003 and 2015 (#1 overall, 53% of the time). We continue to be the most efficient site: adjusted for the available population, we enroll the highest number of participants in most network studies. Our enriched high-risk population, strong research culture and 24/7 coverage and the high proportion of screen-eligible patients successfully enrolled into network studies will allow us to continue this high level of performance. If successful in this limited renewal, we will continue to deploy our facilities, data management systems (including our electronic perinatal record system), recruitment resources, reinforced investigative team and highly experienced personnel toward fully implementing and completing ongoing MFMU Network protocols and projects. This success extends to leadership of large non-MFMU consortia conducting clinical trials and long term follow-up studies. Herein, we outline our plans to prioritize and fully participate in ongoing MFMU Network studies.