NICHD Maternal-Fetal Medicine Units Networks

项目总结/摘要 位于伯明翰的亚拉巴马大学（UAB）的母胎医学（MFM）分部提交了这份报告。 申请有限竞争延续，以继续作为Eunice Kennedy临床中心参与 Shriver NICHD母胎医学单位（MFMU）网络，以完成正在进行的试验。我们提出 我们中心的属性和在MFMU网络中的卓越表现记录，以及位于 Ochsner Baptist Medical Center路易斯安那州我们仍然致力于该网络的目标，即调查主要的 产科临床问题，特别是与低出生体重、早产、产科和医疗 妊娠并发症。我们女性生殖中心内著名的研究基础设施 健康（CWRH）是这个应用程序的核心，并在成功领导大型 MFMU网络内外的临床试验和观察性研究。作为网络中心， 在过去的六个5年周期中，UAB一直在为研究提供方向方面发挥领导作用， 在指导委员会和小组委员会一级进行网络试验， 该中心的工作效率高于任何中心，并积极参与了所产生数据的介绍和出版。 在MFMU历史上的32个临床中心中，UAB研究者首次撰写了>17%的网络 出版物和在国家会议上的发言超过17%。我们调查组的现任成员 积累了超过300人年的积极参与支持MFMU项目的经验;我们的研究 工作人员同样累积超过300个MFMU人-年。Alan Tita，MD，PhD和Brian凯西，MD将继续 分别担任PI和候补PI。调查小组包括2名前MFMU PI和6名 曾担任或目前担任网络协议主席或小组委员会成员的成员。 最后，根据患者招募、方案依从性、保留、随访、数据质量和研究开始- 截至目前，MFMU网络数据协调中心历史上将我们的中心排在第一或第二位， 在2003年至2015年期间，参与中心占71%（10/14）（总体排名第一，占53%）。我们继续 成为最有效的网站：根据可用人口进行调整，我们在 大多数网络研究。我们丰富的高风险人群，强大的研究文化和24/7的覆盖面和高风险的研究。 筛选合格患者成功入组网络研究的比例将使我们能够继续保持这一高水平 性能水平。如果在这次有限的续约中取得成功，我们将继续部署我们的设施、数据 管理系统（包括我们的电子围产期记录系统），招聘资源，加强 调查小组和经验丰富的人员充分执行和完成正在进行的MFMU 网络协议和项目。这一成功延伸到大型非MFMU财团的领导， 临床试验和长期随访研究。在此，我们概述了我们的计划，优先考虑并充分参与 正在进行的MFMU网络研究。

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.