NICHD Maternal-Fetal Medicine Units (MFMU) Network

 描述（由申请人提供）：亚拉巴马大学伯明翰分校（UAB）母胎医学部提交本申请，以更新我们作为Eunice Kennedy Shriver NICHD母胎医学单位（MFMU）网络临床中心的参与。我们提出我们中心的持续记录的特殊性能的整体和指定的新属性和我们的计划，以增加我们的贡献网络的目标调查的主要问题，在临床产科，特别是那些有关低出生体重早产儿，产科和医疗并发症的怀孕。我们拥有完善的研究基础设施和在MFMU网络内外进行相关临床试验和观察性研究的丰富经验。作为过去五个五年周期的网络参与中心，UAB一直在指导委员会和小组委员会层面为网络提供研究方向方面发挥领导作用（一项UAB领导的试验开始，另外两项方案获得批准），以任何中心的最高效率进行网络试验，并积极参与所产生数据的展示和出版。在该网络历史上的31个临床中心中，UAB研究者首次撰写了277篇MFMU网络出版物中的约54篇（19.5%）。在全国会议上，网络总共作了453次发言，其中19.6%是由一名UAB调查员作的发言。UAB站点MFM团队的当前成员已经积累了超过200人-年的积极参与支持MFMU研究项目的经验;我们当前的研究人员同样积累了超过250人-年的MFMU经验。Alan Tita，MD，PhD和Joseph Biggio，MD将分别继续担任PI和替代PI。调查小组包括两名以前的研究中心PI和7名曾担任或目前担任网络协议主席的成员（Biggio博士目前正在进行3组试验，以评估子宫托和阴道孕酮对双胞胎PTB预防的作用-前景）或小组委员会成员（Tita博士目前是出版委员会以及ALPS和ARRIVE协议小组委员会的成员; Biggio博士也是APPS试验的小组委员会成员-子宫托与阴道孕酮用于单胎短宫颈研究方案）。最后，根据患者招募、方案依从性、保留和随访、数据质量和研究启动时间，MFMU网络数据协调中心自2003年以来71%（10/14）的时间将我们在参与中心中排名第一或第二（总体排名第一，53%）。如果成功的话，在这个竞争性的续约申请中，我们将部署我们的设施，设备，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，以开发和实施MFMU网络协议和项目。我们相信，在未来五年内，我们作为NICHD MFMU网络中心的竞争性更新仍然处于有利地位。我们概述了计划，在下一个周期内，在经过适当的评估后，可能将我们的目标人群扩大到至少一个辅助站点。 NICHD和数据协调中心。

 DESCRIPTION (provided by applicant): The Maternal-Fetal Medicine Division of the University of Alabama at Birmingham (UAB) submits this application to renew our participation as a clinical center of the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) Network. We present our center's ongoing record of exceptional performance overall and specify new attributes and our plans to increase our contributions 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. We have a well-established research infrastructure and extensive experience in performing relevant clinical trials and observational studies both within and outside the MFMU Network. As a Network participating center over the last five 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 (one UAB-led trial starting and 2 other protocols approved), conducted Network trials with the highest efficiency of any center, and participated significantly in the presentation and publication of data generated. Among 31 clinical centers in the history of the Network, a UAB investigator has first-authored approximately 54 (19.5%) of 277 current MFMU Network publications. Of 453 total Network presentations at national meetings, a UAB investigator presented 19.6%. Current members of the UAB site MFM team have accumulated well over 200 person-years' experience of active participation in support of MFMU research projects; our current research staff similarly cumulate over 250 MFMU person-years. Alan Tita, MD, PhD and Joseph Biggio, MD will continue as PI and Alternate PI, respectively. The investigative team includes two previous site PI's and 7 members who have served or currently serve as Network protocol chairpersons (Dr. Biggio currently for the 3- arm trial to evaluate pessary and vaginal progesterone for PTB prevention in twins - PROSPECT) or Subcommittee members (Dr. Tita is currently on Publications Committee and ALPS and ARRIVE protocol subcommittees; Dr. Biggio is also on the subcommittee of the APPS trial - pessary vs. vaginal progesterone for singleton short cervix study protocol). Finally, on the basis of patient recruitment, protocol adherence, retention and follow-up, data quality, and study start-up time, the MFMU Network Data Coordinating Center ranked us #1 or #2 among the participating centers 71% (10/14) of the time since 2003 (#1 overall, 53% of the time). If successful, in this competitive renewal application, we will deploy our facilities, equipment, data management systems (including our electronic perinatal record system), recruitment resources, reinforced investigative team and highly experienced personnel even more to develop and implement MFMU Network protocols and projects. We believe that we remain well positioned for competitive renewal as an NICHD MFMU Network center for the next five years. We outline plans to potentially expand our target population to at least one ancillary site during the next cycle after appropriate evaluation by the NICHD and Data Coordinating Center.