NICHD Maternal-Fetal Medicine Units Networks

项目摘要/摘要 阿拉巴马大学伯明翰分校(UAB)母胎医学(MFM)分部提交了以下材料 申请有限竞争续期以继续作为尤尼斯·肯尼迪的临床中心参与 施莱弗NICHD母婴医学部(MFMU)网络，以完成目前的试验。我们呈现的是 我们中心的属性和在MFMU网络内的卓越表现记录，以及一个子网站 路易斯安那州的奥克斯纳浸信会医疗中心。我们仍然致力于网络调查重大案件的目标 临床产科方面的问题，特别是与低出生体重、早产、产科和内科有关的问题 妊娠并发症。我们妇女生殖中心内著名的研究基础设施 Health(CWRH)是该应用程序的核心，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 在过去的六个五年周期中，UAB一直发挥着领导作用，为 指导委员会和小组委员会一级的网络，与最高级别的 任何中心的效率，并在很大程度上参与了所产生的数据的陈述和发布。 在MFMU历史上的32个临床中心中，一名UAB研究员首次撰写了&gt；17%的网络 出版物和&gt；17%的国家会议发言。我们调查小组的现任成员已经 积累了300多人年积极参与支持MFMU项目的经验；我们的研究 同样，工作人员的累积超过300人/年。医学博士艾伦·蒂塔和医学博士布莱恩·凯西将继续 分别充当PI和替代PI。调查小组包括2名前MFMU PI和6名MFMU PI 曾经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、方案遵从性、保留、随访、数据质量和研究开始- 时间到了，MFMU网络数据协调中心历来将我们的中心排名第一或第二 2003至2015年间，参与中心的比例为71%(10/14)(总体排名第一，比例为53%)。我们继续 成为最有效率的网站：根据可用人口进行调整，我们在 大多数网络研究。我们丰富了高危人群，强大的研究文化和全天候覆盖 成功纳入网络研究的符合筛查条件的患者比例将使我们继续保持这一高水平 性能水平。如果此次有限续订成功，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 调查团队和经验丰富的人员，以全面实施和完成正在进行的MFMU 网络协议和项目。这一成功延伸到对大型非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，以确定优先事项并全面参与 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.