Genomic/Proteomic PTB Network: UAB Clinical Core Center

说明(申请人提供)：早产仍然是围产期发病率和死亡率的主要原因，早产率继续上升，预防早产的有效干预措施仍然是虚幻的。25年来，我们机构妇女健康研究中心的研究人员在这一领域提供了强大的临床研究领导。我们已经成功地获得了数百万美元的联邦资金，用于进行临床研究，旨在提高我们对早产病理生理学的理解，并在前瞻性随机试验中测试许多潜在的干预措施。我们小组的生产力已导致在早产及其预防领域发表了数百份出版物。我们在进行高质量、精心设计的临床试验方面的卓越表现广为人知。与这一应用密切相关的是我们在进行多中心试验并在研究网络中发挥领导作用方面的独特优势和成功，包括NICHD母胎医学单位网络，我们已经参与该网络近15年。事实上，在最近的成员机构客观排名中，UAB在该网络的14个中心中的总体表现排名第一。因此，我们认为我们处于特别有利的地位，不仅可以有效地参与，而且可以作为拟议的基因组和蛋白质网络中的临床核心中心提供领导。在本申请中，我们将详细介绍我们极其成功的临床研究设施和基础设施。我们还将强调我们有据可查的优势，包括患者的应计和保留、高质量的数据获取和录入、启动新试验的快速升级、协议遵守、分析和发布效率，以及NICHD MFMU网络在协议开发和实施方面的协作成功，这似乎是拟议的新网络所基于的模式。我们相信，我们对这个项目的热情和承诺将是显而易见的，我们相信我们的资格将非常有竞争力被考虑。

DESCRIPTION (provided by applicant): Preterm birth remains the leading cause of perinatal morbidity and mortality, the rate of preterm birth continues to increase, and effective interventions to prevent preterm birth remain illusive. Investigators in the Center for Research in Women's Health at our institution have provided strong clinical research leadership in this area for 25 years. We have successfully acquired millions of dollars in federal funding to conduct clinical studies designed to improve our understanding of the pathophysiology of preterm birth as well as to test many potential interventions in prospective randomized trials. The productivity of our group has resulted in hundreds of publications in the area of preterm birth and its prevention. Our excellence in performing high quality well-designed clinical trials is widely known. Germane to this application is our particular strength and success in performing multi-center trials and providing a leadership role in research networks including the NICHD Maternal-Fetal Medicine Units Network in which we have been a participating institution for nearly 15 years. Indeed, UAB was ranked first in overall performance among the 14 centers in this Network in the most recent objective ranking of member institutions. Thus, we believe that we are particularly well-positioned, not only to effectively participate, but also to provide leadership as a Clinical Core Center in the proposed Genomic and Proteomic Network. In this application, we will describe in detail our extremely successful clinical research facilities and infrastructure. We will also emphasize our well-documented strengths including patient accrual and retention, high-quality data acquisition and entry, rapid ramp-up to initiate new trials, protocol adherence, analysis and publication productivity, and collaborative success in protocol development and implementation in the NICHD MFMU Network which appears to be a model upon which the proposed new network is based. We believe that our enthusiasm and commitment to this project will be evident and we believe that our qualifications will be very competitive for consideration.