NICHD Maternal-Fetal Medicine Units (MFMU) Network

 描述(由申请人提供)：阿拉巴马大学伯明翰分校(UAB)母胎医学部提交此申请，以续签我们作为尤尼斯·肯尼迪·施莱弗NICHD母胎医学部(MFMU)网络临床中心的参与。我们展示了我们中心整体上持续的卓越表现记录，并明确了新的特点和我们的计划，以增加我们对网络调查临床产科主要问题的贡献，特别是与低出生体重早产、产科和妊娠并发症相关的问题。我们拥有完善的研究基础设施，在MFMU网络内外进行相关的临床试验和观察性研究方面拥有丰富的经验。作为网络参与中心，在过去五年的周期中，UAB一直在指导委员会和小组委员会层面为网络提供研究指导方面发挥领导作用(一项由UAB牵头的试验启动，两项其他方案获得批准)，以任何中心中最高的效率进行网络试验，并显著参与产生的数据的展示和发布。在该网络历史上的31个临床中心中，一名UAB研究员首次撰写了277本MFMU网络出版物中的约54本(19.5%)。在国家会议上总共453次网络介绍中，一名UAB调查员介绍了19.6%。UAB SITE MFM团队的现任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；我们目前的研究人员也同样积累了超过250人年的MFMU研究项目。医学博士Alan Tita和医学博士Joseph Biggio将分别继续担任PI和候补PI。调查团队包括两名之前的SITE PI和7名成员，他们曾经或现在担任网络方案主席(Biggio博士目前正在进行一项三臂试验，以评估子宫和阴道孕酮对预防双胞胎肺结核的作用-PROCESS)或小组委员会成员(Tita博士目前在出版委员会和阿尔卑斯山和到达方案小组委员会；Biggio博士也是APPS试验小组委员会的成员-单胎短子宫颈研究方案的Pessary和阴道孕酮研究方案)。最后，根据患者招募、遵守方案、保留和随访、数据质量和研究启动时间，自2003年以来，MFMU网络数据协调中心以71%(10/14)的时间将我们排在参与中心中的第一或第二(总体第一，53%的时间)。如果成功，在这次竞争性续签申请中，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、增援的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，作为NICHD MFMU网络中心，我们将在未来五年保持良好的竞争地位。我们概述了在下一个周期内可能将我们的目标人口扩大到至少一个辅助地点的计划，经过 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.